Patent Docs

CVC Submits Motion No. 2 in Opposition to Broad’s Substantive Motion No. 2 to Substitute the Count

February 5, 2020

By Kevin E. Noonan —

Continuing explication of the motions submitted on January 9th to the U.S. Patent and Trademark Office Patent Trial and Appeal Board in Interference No. 106155 between Senior Party The Broad Institute, Harvard University, and the Massachusetts Institute of Technology (collectively, "Broad") and Junior Party the University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC") is CVC's Motion No. 2 in Opposition to the Broad's Substantive Motion No. 2 to Substitute the Count.

To recap, the Broad's Substantive Motion No. 2 seeks to have the Board substitute the Count in the interference. Count 1 of the interference as declared is:

An engineered, programmable, non-naturally occurring Type II CRISPR-Cas system comprising a Cas9 protein and at least one guide RNA that targets and hybridizes to a target sequence of a DNA molecule in a eukaryotic cell, wherein the DNA molecule encodes and the eukaryotic cell expresses at least one gene product and the Cas9 protein cleaves the DNA molecules, whereby expression of the at least one gene product is altered; and, wherein the Cas9 protein and the guide RNA do not naturally occur together, wherein the guide RNAs comprise a guide sequence fused to a tracr sequence.

or

A eukaryotic cell comprising a target DNA molecule and an engineered and/or non-naturally occurring Type II Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)-— CRISPR associated (Cas) (CRISPR-Cas) system comprising
    a) a Cas9 protein, or a nucleic acid comprising a nucleotide sequence encoding said Cas9 protein; and
    b) a single molecule DNA-targeting RNA, or a nucleic acid comprising a nucleotide sequence encoding said single molecule DNA-targeting RNA; wherein the single molecule DNA-targeting RNA comprises:
        i) a targeter-RNA that is capable of hybridizing with a target sequence in the target DNA molecule, and
        ii) an activator-RNA that is capable of hybridizing with the targeter-RNA to form a double-stranded RNA duplex of a protein- binding segment,
    wherein the activator-RNA and the targeter-RNA are covalently linked to one another with intervening nucleotides; and
    wherein the single molecule DNA-targeting RNA is capable of forming a complex with the Cas9 protein, thereby targeting the Cas9 protein to the target DNA molecule, whereby said system is capable of cleaving or editing the target DNA molecule or modulating transcription of at least one gene encoded by the target DNA molecule.

The Broad's proposed Count 2 is:

A method, in a eukaryotic cell, of cleaving or editing a target DNA molecule or modulating transcription of at least one gene encoded by the target DNA molecule, the method comprising:
    contacting, in a eukaryotic cell, a target DNA molecule having a target sequence with an engineered and/or non-naturally-occurring Type II Clustered Regularly lnterspaced Short Palindromic Repeats (CRISPR)-CRISPR associated Cas) (CRISPR-Cas) system comprising:
        a) a Cas9 protein, and
        b) RNA comprising
            i) a targeter-RNA that is capable of hybridizing with the target sequence of the DNA molecule or a first RNA comprising (A) a first sequence capable of hybridizing with the target sequence of the DNA molecule and (B) a second sequence; and
            ii) an activator-RNA that is capable of hybridizing to the targeter-RNA to form an RNA duplex in the eukaryotic cell or a second RNA comprising a tracr sequence that is capable of hybridizing to the second sequence to form an RNA duplex in the eukaryotic cell,
    wherein, in the eukaryotic cell, the targeter-RNA or the first sequence directs the Cas9 protein to the target sequence and the DNA molecule is cleaved or edited or at least one product of the DNA molecule is altered.

The distinction the Broad makes is between embodiments of CRISPR methods that are limited to "single-molecule guide RNA" (aka "fused" or "covalently linked" species), versus embodiments that encompass single-molecule and "dual molecule" species (wherein in the latter versions, the "targeter-RNA" and "activator-RNA" as recited in the proposed Count are not covalently linked). The Broad argues that this Count should be adopted by the Board because it "properly describes the full scope of the interfering subject matter between the parties because both parties have involved claims that are generic, non-limited RNA claims." The brief also argues that proposed Count 2 "sets the correct scope of admissible proofs [i.e., their own] for the breakthrough invention described by the generic claims at issue in these proceedings—the successful adaption of CRISPR-Cas9 systems for use in eukaryotic environments," which The Broad contends current Court 1 (in either alternative) does not.

The brief also requests that the Broad be accorded benefit to its provisional application U.S. Serial No. 61/736,527, and that CVC not be accorded benefit to any of its earlier applications (which just maintains the status quo requiring CVC to move to be accorded benefit), because CVC's applications-in-interference were not accorded benefit when this interference was declared.

The Broad's argument in support of its motion is that Count 1 is too narrow for encompassing just a subset of the parties' involved claims. In particular, the brief asserts that most of the Broad's involved clams encompass "non-limited" RNA systems and methods. Similarly, the brief argues that CVC itself has many claims directed to non-limited RNA systems and methods and has entire applications that do not recite claims to non-limited RNA systems and methods. The Broad asserts that Count 1 does not permit the Broad to rely on its earliest and best proofs of invention, which the brief states is "plainly unfair." This unfairness would preclude the Broad from establishing what the brief terms "the fundamental breakthrough – the invention of use of CRISPR in eukaryotic cells" (emphasis in brief). Failing to substitute the Count would instead improperly focus the priority question on who invented the single molecule modification. Colorfully, the brief declares that "[a]llowing the interference to proceed with Count 1 would permit the (single molecule RNA) tail to wag the (breakthrough use of CRISPR in eukaryotic cells) dog."

The claims include such generic species that encompass both single-molecule and dual molecule embodiments, according to the brief, but the breakthrough invention was adapting CRISPR-Cas9 to be used in eukaryotic cells, an argument the Broad has used consistently here and in the earlier '048 interference to distinguish its claims from CVC's. The brief notes that the first disclosure of this use was in a scientific journal article by some of the Broad's named inventors that "has become by far the most frequently cited CRISPR publication" as evidence of the groundbreaking nature of the invention. Also cited (as a reminder to the Board of its earlier decision, the basis thereof and the Federal Circuit's affirmance of it) is the Board's earlier decision that there was no reasonable expectation of adapting CRISPR for use in eukaryotic cells as further evidence of the breakthrough nature of (as asserted herein) the Broad's invention.

CVC's brief begins by characterizing the Broad's argument that Count 1 of the interference as declared "potentially' exclude Broad's best proofs relating to dual-guide (i.e., dual-molecule) experiments" is a "pretext," because, inter alia, Proposed Count 2 "goes far beyond converting Count 1 into a generic-guide count." Instead, according to CVC, "it transforms Count 1 into a method so broad that it no longer requires formation of the DNA-targeting complex that includes crRNA, tracrRNA, and Cas9." In addition, according to CVC, Proposed Count 2 does not require that the CRISPR-Cas9 complex even have an effect on the target DNA; rather, it recites that "'a product of the DNA' is altered in some unspecified way" (emphasis in brief), which could include (according to CVC) "alterations to RNA or protein caused by processes that are unrelated to the activity of CRISPR-Cas9" including contamination. And the changes the Broad has effected in Proposed Count 2 "have nothing to do with whether the RNA limitation is single-molecule or generic, Broad's only purported reason for needing a new count."

CVC further argues that the Broad's motion is contrary to the provisions of precedential Board decision, Louis v. Okada, 59 U.S.P.Q.2d 1073 (B.P.A.I. 2001). Under Louis, a party must satisfy a three-prong test: "'(1) should make a proffer of the party's best proofs, (2) show that such best proofs indeed lie outside of the scope of the current count, and (3) further show that the proposed new count is not excessively broad with respect to what the party needs for its best proofs.'" CVC's position (explicated in the brief) is that the Broad failed to provide what Louis required for the "significant alterations" made to Count 1 resulting in Count 2. In addition, CVC argues that the Broad has not shown that Count 1 excludes their best proofs, equivocating in using characterizations like its best proofs only potentially fall outside the scope of Count 1. And CVC alleges that the Broad's representations to the Board regarding its best proofs including dual-guide experiments are contradictory to ("flatly contradicts") positions the Broad has taken in ex parte prosecution. And CVC characterizes these prior statements as admissions that preclude the Broad from advancing these arguments in this interference.

In arguing the specifics of what CVC alleges are the Broad's deficiencies in satisfying the Louis standards, CVC quotes the case to the effect that there must be "'a genuine need to change the count, and not simply cause a change for change's sake'" that cannot be supplied outside the brief supporting the motion under 37 C.F.R. § 41.121(b) and 37 C.F.R. § 41.208(b). The changes in Proposed Count 2 "significantly alter the scope of Count 1 in ways that go far beyond encompassing dual-molecule CRISPR-Cas9." The brief provides a table:

The brief summarizes these unnecessary changes as"

• "first, Broad has inexplicably eliminated structural and functional limitations that specify the formation of the three-component DNA-targeting complex that includes crRNA, tracrRNA, and Cas9."

• "Second, Broad has inexplicably eliminated the requirement that this complex have activity with effects at the DNA level (e.g., cleaving or editing or modulating transcription of DNA). Rather, Proposed Count 2 encompasses merely altering a "product of the DNA molecule" in unspecified ways. Problematically, this breadth includes alterations to downstream products of DNA, such as RNA and protein, that have nothing to do with the activity of the CRISPR-Cas9 system."

• "Third, Broad has inexplicably converted Count 1 from a 'cell' or 'system' to a 'method.'"

• "Fourth, Broad has inexplicably eliminated the alternative language in CVC's part of Count 1 reciting 'or a nucleic acid comprising a nucleotide sequence comprising . . . .'"

CC's brief characterizes as "thread-bare" the Broad's justifications related to its best proofs including use of dual-molecule guide RNA for practicing CRISPR in eukaryotic cells, and argues that the Broad's experts "turned a blind eye" the these differences between Count 1 and Proposed Count 2, "testifying that the only difference they considered was with respect to the single-molecule or generic format of the RNA." According to CVC's brief, the Broad could have achieves its purported "best proofs" goal by proposing a McKelvey Count reciting Claim 15 of the '359 patent:

An engineered, programmable, non-naturally occurring Type II CRISPR-Cas system comprising a Cas9 protein and at least one guide RNA that targets and hybridizes to a target sequence of a DNA molecule in a eukaryotic cell, wherein the DNA molecule encodes and the eukaryotic cell expresses at least one gene product and the Cas9 protein cleaves the DNA molecules, whereby expression of the at least one gene product is altered; and, wherein the Cas9 protein and the guide RNA do not naturally occur together.

CVC also argues that Proposed Count 2 "does not specify that the DNA-targeting complex contains: (a) the first RNA and the second RNA; or (b) the targeter-RNA and the activator-RNA" (emphasis in brief), instead requiring only that "the targeter-RNA or the first sequence directs the Cas9 protein to the target sequence," an interpretation that CVC demonstrates Broad's experts did not dispute despite the reality that all three components are necessary for the DNA targeting complex. And CVC points out that Proposed Count 2 is consistent with the understanding in the art prior to publication of the Jinek 2012 reference that corresponds to disclosure of CVC's earliest priority document (A programmable dual-RNA-guided DNA endonuclease in adaptive bacterial immunity, Science 337: 816-21).

CVC reiterates its argument that Proposed Count 2 does not require CRISPR-Cas9 to exhibit DBA-altering effects due to its excessive breadth, again affirmed (or at least not effectively rebutted" by the Broad's experts. Moreover Proposed Count 2 changes the count from being directed to a eukaryotic cell or a CRISPR system to a method, which CVC characterizes as "change for change's sake" and that "without justification" Count 2 deletes limitations related to "a) Cas9 protein, or a nucleic acid comprising a nucleotide sequence encoding the Cas9 protein," [CVC-2], and "b) a single molecule DNA-targeting RNA, or a nucleic acid comprising a nucleotide sequence encoding said single molecule DNA targeting RNA," [CVC-3]. Citing Louis, CVC argues that the Broad has not shown a "compelling reason" for the proposed changes making Proposed Count 2 broader than Count, and that the proposed Count is "broader than the parties' common invention," citing Conservolite, Inc. v. Widmayer, 21 F.3d 1098, 1104 (Fed. Cir. 1994).

Finally, CVC argues that the Broad's claims in interference all recite "single-molecule RNA" embodiments of CRISPR, which defines the "common interfering subject matter" and thus rebut the Broad's arguments regarding its best proofs for dual-molecule RNA embodiments. The brief accuses the Broad of equivocating regarding its best proofs, also contrary to the requirements in Louis and that the Broad's "alleged best proofs" do not justify substitution of Count 1 with Proposed Count 2 and deficiencies in the Broad's expert testimony supporting its position. These deficiencies include characterization of the prior art that contradict statements and positions taken by the Broad (according to CVC) during ex parte prosecution which CVC asserts are admissions that prevent the Broad from making these assertions in support of its motion to substitute the Count.

CVC further asserts that the Broad has not shown that Proposed Count 2 is patentable over the prior art, as set forth in another table:

From this CVC concludes "[b]ecause these numerous unexplained broadening alterations raise "a serious question" with respect to the patentability of Proposed Count 2, Broad has not satisfied its burden to address patentability over the art," citing Louis.

As an alternative, CVC argues that, if the Board adopts what the brief calls "a generic-guide count," Count 1 should remain in the interference because it is patentably distinct from Proposed Count 2, supported by the differences in limitations as set forth in the remainder of the brief.
The Zombie Apocalypse of Patent Eligibility Reform and a Possible Escape Route

February 4, 2020

By Michael Borella —

The hopes of anyone in favor of patent reform targeting 35 U.S.C § 101 have been official dashed — or at least put on hold. In an interview with the Intellectual Property Owner's association (IPO) last week, Senator Thom Tillis (at right), Chair of the Senate's Subcommittee on Intellectual Property, indicated that the body would not be completing its work on legislatively addressing patent eligibility.

Tillis stated that "[g]iven the reasonable concerns that have been expressed about the draft as well as the practical realities of the difficulty of passing legislation, absent stakeholder consensus I don't see a path forward for producing a bill—much less steering it to passage—in this Congress." He suggested that the Subcommittee is not against reform, but that it needs to be provided with a clearer plan for next steps. He would "encourage all stakeholders to work with Senator Coons and [him] to develop a consensus driven approach." Indeed, it seems as if such an approach is a requirement for entry. "If we're going to get anything done on this issue, everyone will have to compromise," he said. "Anything less than that is dead on arrival."

This is in stark contrast to a joint statement released last year by Senators Tillis and Coons. Just a few months ago, they wrote that "the U.S. patent system with regard to patent eligibility is broken and desperately needs to be repaired," and "[w]e feel confident that, working together, we can ensure that the United States patent system reclaims its reputation as the gold standard for promoting innovation."

But soon after this statement made the rounds, rumblings began about § 101 reform not happening. Conspiratorial theories suggested that lobbyists from powerful and deep-pocketed parties had convinced the senators that it would not be in their best interests to continue their efforts. But Senator Tillis chalks up the difficulties to disagreement and stubborness amongst the stakeholders.

Thus, patent legislation seems to be off the table for 2020. The Subcommittee plans to look into other matters, such as copyright and counterfeiting. This leaves us with eligibility reform in an undead state — ostensibly alive but not currently breathing.

Despite members of all three branches of government acknowledging that § 101 is a significant problem as currently interpreted, two of those branches are not planning on addressing the issue further, and the third is trying but lacks the authority to make the substantial changes needed.

In January, the Supreme Court denied certiorari on eight § 101 petitions (five two weeks ago and three more last week), including several that were well-situated for appeal. It seems clear that the Court is happy to let patent eligibility percolate in the Federal Circuit and district courts a while longer.

The U.S. Patent and Trademark Office (USPTO) has finally acknowledged the § 101 dilemma under Director Andrei Iancu, and it rolled out new patent eligibility guidance a little over a year ago. But even after a recent update, problems remain, and the USPTO's efforts are the application of a band-aid on a patient needing surgery. Moreover, fixing the § 101 quagmire should be the job of the courts (realizing that they made a mistake and that the blast radius of Alice v. CLS Bank and its progeny is much wider than is reasonable and continues to grow) or Congress (legislative overruling that line of cases). But neither have stepped up.

At the core of the dispute is policy. Do we want a broad and extensive patent law that encompasses software and business method inventions that largely process information, should these types of innovations be excluded from patenting, or is there a happy middle ground?

Ultimately, patent eligibility is a binary decision — a claim is valid under § 101 or it is not. On one side are stakeholders that believe the current interpretation of § 101 is so unworkably vague that it fails its public notice function; that is, from reading the statutes and case law, even a reasonably well-educated individual cannot determine whether certain types of inventions fall within the eligible or the ineligible bucket. On the other side are those who consider the law to be just about right because it allows rapid dismissal of potentially specious infringement lawsuits.

Part of the problem with trying to find a compromise position between these two camps (arguably there are more than two camps, but the majority of patent professionals, patentees, and technologists will fall in one or the other) is that they each see § 101 as having a different purpose. The pro-reform contingent views the statute as only defining what inventions and discoveries are or are not eligible for patenting, thus providing direction for applicants seeking to make difficult technological and financial investment decisions. The anti-reform group views it as a tool to avoid costly litigation.

Both viewpoints have merit. The reason for the clash, however, speaks to the ambiguity of the standard. Applicants just don't know what might or might not be eligible with any degree of certainty, so they file and prosecute patent applications in the expected manner — flirting around the edges of eligibility. This results in the USPTO issuing some of these applications as patents, a few of which will be asserted. The accused infringer, of course, usually wants to get out of court as quickly as possible, and is therefore motivated to contend that these patents are ineligible. In this way, the interests have become tied together. But this does not have to be the case.

A possible solution that addresses both concerns can be based on the following observation: many if not most patent eligibility invalidations are based on the claims being broad, vague, or reciting elements well-known in the prior art. In other words, § 101 has become a less sophisticated way of applying a conclusory §§ 102, 103, or 112 analysis.

If you accept that this is the case (and it is — just look to ChargePoint v. SemaConnect, The Chamberlain Group v. Techtronic Industries, and American Axle v. Neapco Holdings) then here is a modest proposal: (i) let § 101 reform happen, abrogating Alice, Mayo v. Prometheus, and essentially all § 101 jurisprudence since the 1952 Patent Act, so that there are no more ill-defined judicial exceptions, and (ii) allow rapid, limited-scope, pre-discovery motions for claim invalidity in district courts.

The first part of the proposal addresses the "what is eligible?" question by taking us back to a more cogent and predictable regime elucidated in Diamond v. Chakrabarty — eligible inventions are "anything under the sun that is made by man." The confusion and debate over § 101 will largely be a thing of the past, and we only need consider whether the claims are to a process, machine, article of manufacture, or composition of matter.

The second part tackles the situation where a plaintiff aggressively asserts a questionably-issued patent. The reason for pushing this concern out of § 101 is based on the observation that most claims invalidated under § 101 are likely to be subject to prior art, enablement, or written description challenges (see the interpretation of Alice prong two in Berkheimer v. HP and Judge Moore's dissent in American Axle, for example). Those not as vulnerable to non-§ 101 issues almost invariable should have been found eligible (see Ultramercial v. Hulu and most diagnostic method and graphical interface patents, for example).

A district court judge would have discretion allow these rapid, limited-scope, pre-discovery motions for invalidity under §§ 102, 103, and/or 112. The defendant would be given one shot at any of these motions. For prior-art-based contentions, the defendant gets to use only one reference or one combination of references, so long as the motivation to combine is straightforward and clear. For written description or enablement contentions, the defendant gets one argument. The level of skill in the art would need to be apparent on the record or otherwise clearly understood.

Since those in favor of the current murky state of § 101 often claim that there are many so-called "bad patents" that are clearly invalid, they get to put their money where their mouth is. If a patent so clearly subject to invalidity, it should be almost trivial to find the prior art or make the § 112 arguments.

Of course, the contours of these motions would have to be fleshed out by the presiding judge on a case by case basis. But if these non-§ 101, limited-scope invalidity contentions cannot be made, then the case should not be dismissed on the pleadings.

In sum, this proposal is an attempt to reduce and hopefully eliminate the practice under Alice of taking patent rights away from inventors and patentees based on conclusory reasoning and an incomplete view of what has been invented.

Perhaps Senator Tillis believes that Congress cannot act on § 101 reform because a proposed solution like this one may go beyond the scope of what Congress can legislate. Courts have control over their dockets and it would likely be unconstitutional for the legislative branch to start telling district court judges how to manage their caseload.

In that case, maybe § 101 reform failed because it cannot succeed in its current form. There very well may be no legislative compromise solution that makes all stakeholders in the patent-eligibility debate ready to sign on. Instead, a more holistic approach requires a certain degree of effort and cooperation from all branches of government. The USPTO needs to reduce the number of low-quality patents that it issues, while simultaneously not holding up high-quality inventions for years in prosecution. Congress needs to return § 101 to its basics. The courts need to refrain from killing off patents based on overgeneralizations and unfounded presumptions, while also allowing low-quality patents that slip through the USPTO to be invalidated without putting an undue burden on defendants.

Hopefully, all of the above would not end up being the patent law equivalent of pushing Jello uphill.
Life Sciences Court Report

February 2, 2020

By Bryan Helwig —

About Life Sciences Court Report: We will periodically report on recently filed biotech and pharma litigation.

Amgen Inc. v. Zydus Pharmaceuticals (USA) Inc.
1-20-cv-00075; filed January 17, 2020 in the District Court of Delaware

• Plaintiffs: Amgen Inc. and Les Laboratoires Servier
• Defendants: Cadila Healthcare Ltd. d/b/a Zydus Cadila and Zydus Pharmaceuticals (USA) Inc.

Claim: Infringement of U.S. Patent Nos.:

• 7,361,649: "β-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it"
• 7,361,650: "γ-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it"
• 7,867,996: "γ-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it"
• 7,879,842: "β-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it"

Synoposis: Amgen asserts infringement of the '649, '650, '996, and '842 patents. Amgen is the holder of approved NDA 20-6143 for Corlanor® (ivabradine) for the treatment of certain cases of chronic heart failure. Amgen asserts that the method of manufacture, and/or their use of Corlanor® are covered by one or more claims of the Patents-in Suit. Cadila submitted ANDA No. 213442 seeking approval to market generic Corlanor®.

View the complaint here.

Novartis Pharmaceuticals Corp. v. Alembic Pharmaceuticals, Ltd.
1-20-cv-00074; filed January 17, 2020 in the District Court of Delaware

• Plaintiff: Novartis Pharmaceuticals Corp.
• Defendants: Alembic Global Holdings SA, Alembic Pharmaceuticals, Inc., and Alembic Pharmaceuticals, Ltd.

Claim: Infringement of U.S. Patent Nos.:

• 8,101,659: "Methods of treatment and pharmaceutical composition"
• 8,796,331: "Methods of treatment and pharmaceutical composition"
• 8,877,938: "Compounds containing S-N-valeryl-N-{[2'-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl}-valine and (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and cations"
• 9,388,134: "Compounds containing S-N-valeryl-N-{[2'-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl)-valine and (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and cations"

Synopsis: Novartis asserts infringement of the '659, '331, '938, and '134 patents. Novartis is the holder of New Drug Application No. 207620 for the commercial manufacturing, marketing, sale, and use of ENTRESTO® (sacubitril and valsartan) tablets, to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction, and for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Actavis submitted ANDA No. 213682, seeking FDA approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of sacubitril/valsartan tablets, generic versions of Novartis’s ENTRESTO® tablets.

View the complaint here.

Merck Sharp and Dohme Corp. v. Actavis Laboratories FL, Inc. f/k/a Watson Laboratories, Inc.
1-20-cv-20217; filed January 17, 2020 in the Southern District Court of Florida

• Plaintiffs: Cubist Pharmaceuticals LLC f/k/a Cubist Pharmaceuticals, Inc.; MSD International GmbH; MSD Investment Holdings (Ireland); Merck Sharp & Dohme Corp.; Optimer Pharmaceuticals LLC f/k/a Optimer Pharmaceuticals, Inc.
• Defendants: Actavis Laboratories FL, Inc. f/k/a Watson Laboratories, Inc. – Florida; Actavis Pharma, Inc. f/k/a Watson Pharma, Inc.; Teva Pharmaceuticals USA, Inc.

Claim: Infringement of U.S. Patent Nos.:

• 7,378,508: "Polymorphic crystalline forms of tiacumicin B"
• 7,863,249: "Macrolide polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof"
• 7,906,489: "18-membered macrocycles and analogs thereof"
• 8,586,551: "18-membered macrocycles and analogs thereof"
• 8,859,510: "Macrocyclic polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof"

Synopsis: Cubist asserts infringement of the '508, '249, '489, '551, and '510 patents. Cubist is the holder of NDA No. 201699 for DIFICID® (fidaxomicin) tablets for oral use for the treatment of Clostridium difficile associated diarrhea in adults. Actavis submitted ANDA No. 208443 seeking approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of generic copies of DIFICID® (fidaxomicin) tablets.

View the complaint here.

Vanda Pharmaceuticals Inc. v. Apotex Inc.
1-20-cv-00083; filed January 21, 2020 in the District Court of Delaware

• Plaintiff: Vanda Pharmaceuticals Inc.
• Defendants: Apotex Corp. and Apotex Inc.

Claim: Infringement of U.S. Patent Nos.:

• 10,449,176: "Treatment of circadian rhythm disorder"

Synoposis: Vanda asserts infringement of the '176 patent. Vanda is the holder of NDA 205,677 for Hetlioz® (tasimelteon) for the treatment of Non-24, a circadian rhythm sleep disorder. Apotex submitted ANDA No. 211607 seeking approval to to commercially manufacture and sell generic tasimelteon capsules for the treatment of Non-24.

View the complaint here.

Amgen Inc. v. Zydus Pharmaceuticals (USA) Inc.
3-20-cv-00678; filed January 21, 2020 in the District Court of New Jersey

• Plaintiffs: Amgen Inc. and Les Laboratoires Servier
• Defendants: Cadila Healthcare Ltd. d/b/a Zydus Cadila and Zydus Pharmaceuticals (USA) Inc.

Claim: Infringement of U.S. Patent Nos.:

• 7,361,649: "β-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it"
• 7,361,650: "γ-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it"
• 7,867,996: "γ-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it"
• 7,879,842: "β-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it"

Synoposis: Amgen asserts infringement of the '649, '650, '996, and '842 patents. Amgen is the holder of approved NDA 20-6143 for Corlanor® (ivabradine) for the treatment of certain cases of chronic heart failure. Amgen asserts that the method of manufacture, and/or their use of Corlanor® are covered by one or more claims of the Patents-in Suit. Cadila submitted ANDA No. 213442 seeking approval to market generic Corlanor®.

View the complaint here.

Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.
1-20-cv-00093; filed January 22, 2020 in the District Court of Delaware

• Plaintiff(s): Vanda Pharmaceuticals Inc
• Defendant(s): Teva Pharmaceuticals USA, Inc.

Claim: Infringement of U.S. Patent No.:

• 10,449,176: "Treatment of circadian rhythm disorders"

Synopsis: Vanda asserts infringement of the '176 patent. Vanda is the holder of NDA 205,677 for Hetlioz® (tasimelteon) for the treatment of Non-24, a circadian rhythm sleep disorder. Teva submitted ANDA No. 211601 seeking approval to to commercially manufacture and sell generic tasimelteon capsules for the treatment of Non-24.

View the complaint here.

Washington State University v. Pro Orchard Management LLC
2-20-cv-00038; filed January 22, 2020 in the District Court of Washington

• Plaintiff: Washington State University
• Defendants: Apple King LLC and Pro Orchard Management LLC

Claim: Infringement of U.S. Patent No.:

• PP21710: "Apple tree named 'WA-2'"

Synopsis: Washington State University (WSU) claims infringement of the '710 patent for an apple cultivar developed by WSU known as WA-2. WSU alleges that Pro Orchard Management infringed Patent No. 21,710 by asexually reproducing and growing WA 2 apple trees and by harvesting WA 2 apples and consigning them to Apple King, LLC for sale. WSU further alleges that Apple King, LLC has infringed the '710 patent by selling WA 2 apples that unlicensed growers such as Pro Orchard Management, LLC have consigned to it for sale. In addition, the WSU alleges that Pro Orchard Management, LLC and,Apple King, LLC have induced infringement of Plant Patent No. 21,710 by providing WA 2 budwood to unlicensed persons who have used the budwood to asexually reproduce WA 2 apple trees.

View the complaint here.
Broad Files Opposition to CVC’s Motion No. 1 for Priority Benefit

January 30, 2020

By Kevin E. Noonan —

One of the briefs filed on January 9th in Interference No. 106,115 between Senior Party The Broad Institute, Harvard University, and the Massachusetts Institute of Technology (collectively, "Broad") and Junior Party the University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC") was the Broad's Opposition to CVC's Motion No. 1 to be accorded benefit to three priority applications for Count No. 1 in the interference as declared by the U.S. PTO.

To recap, Count 1 of the interference as declared is:

An engineered, programmable, non-naturally occurring Type II CRISPR-Cas system comprising a Cas9 protein and at least one guide RNA that targets and hybridizes to a target sequence of a DNA molecule in a eukaryotic cell, wherein the DNA molecule encodes and the eukaryotic cell expresses at least one gene product and the Cas9 protein cleaves the DNA molecules, whereby expression of the at least one gene product is altered; and, wherein the Cas9 protein and the guide RNA do not naturally occur together, wherein the guide RNAs comprise a guide sequence fused to a tracr sequence.

or

A eukaryotic cell comprising a target DNA molecule and an engineered and/or non-naturally occurring Type II Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)-— CRISPR associated (Cas) (CRISPR-Cas) system comprising
    a) a Cas9 protein, or a nucleic acid comprising a nucleotide sequence encoding said Cas9 protein; and
    b) a single molecule DNA-targeting RNA, or a nucleic acid comprising a nucleotide sequence encoding said single molecule DNA-targeting RNA; wherein the single molecule DNA-targeting RNA comprises:
        i) a targeter-RNA that is capable of hybridizing with a target sequence in the target DNA molecule, and
        ii) an activator-RNA that is capable of hybridizing with the targeter-RNA to form a double-stranded RNA duplex of a protein- binding segment,
    wherein the activator-RNA and the targeter-RNA are covalently linked to one another with intervening nucleotides; and
    wherein the single molecule DNA-targeting RNA is capable of forming a complex with the Cas9 protein, thereby targeting the Cas9 protein to the target DNA molecule, whereby said system is capable of cleaving or editing the target DNA molecule or modulating transcription of at least one gene encoded by the target DNA molecule.

CVC was not granted priority to its earliest priority documents (USSN 61/652,086, filed May 25, 2012 (P1); USSN 61/716,256, filed October 19, 2012 (P2): USSN 61/757,640, filed January 28, 2013 (P3)) when this interference was declared, and filed this authorized motion on October 14th to be accorded benefit.

CVC's Substantive Motion No. 1 argued that it was entitled to priority to its earliest provisional filings, because these applications set forth in detail the disclosure for at least one embodiment falling within the scope of Count 1. CVC further argued that these priority documents "disclosed, for the first time, that complexes of Cas9 and a double- or single-molecule DNA-targeting RNA . . . are useful for targeted DNA cleavage and described numerous applications of this gene-editing technology, including modifying target DNA in eukaryotic cells" and that "[t]he CVC inventors immediately understood that the CRISPR-Cas9 DNA-cleavage complex could be used in a variety of different cellular and noncellular settings." The brief recited (prophetic) Example 1 in the P1 specification, asserting that the failure of the P1 specification to show actual reduction to practice is not required to satisfy the requirement for entitlement benefit. CVC also cautioned the Board against any attempt by the Broad to "erroneously to link the issues in this motion to the PTAB's termination of Interference No. 106,048 due to no interference-in-fact," stating that "the legal and factual issues raised here are fundamentally different from those decided in the prior '048 proceeding" based on the PTAB's own prior statements of the grounds for its no interference-in-fact determination. Rather, according to CVC:

[A person of ordinary skill in the art] reading P1 in light of the state of the art at the time of filing would have understood that the application describes and enables at least one embodiment within the scope of Count 1. Moreover, post-filing-date publications report successfully practicing CVC's claimed invention in eukaryotes using the very methods and components that P1 describes. The Board should therefore accord CVC the benefit of P1's May 25, 2012 filing date with respect to Count 1.

Just as CVC's brief in support of Substantive Motion No. 1 to be accorded priority benefit to these provisional applications tracked (in large part) its arguments regarding priority to these provisional application if the Board granted the Broad's motion to substitute its Proposed Count No. 2, the Broad's Opposition brief tracks the same arguments made in its Opposition to CVC's Motion to be accorded benefit to these priority documents for Proposed Count 2 here with regard to Count 1 in the interference as declared. (Indeed, discerning readers will appreciate that much of our description of the Broad's arguments in this brief are the same set forth in our description of the Broad's Opposition to CVC Responsive Motion No. 2.) Broadly stated, these arguments are: "(1) the PTAB's fact findings in the [earlier] 048 interference" (which the Broad argues are binding in this interference) and "(2) an independent assessment of the evidence of record."

With regard to its first argument, the Broad asserts that the PTAB's fact-findings in the '048 interference preclude CVC from establishing benefit to P1 and P2, based on a 2012 reference to Jinek et al. (2012, A programmable dual-RNA-guided DNA endonuclease in adaptive bacterial immunity, Science 337: 816-21) and the finding that a person of ordinary skill in the art would not have had a reasonable expectation of success in performing CRISPR in eukaryotic cells. This argument is one of lack of an adequate written description and illustrates another aspect of a familiar conundrum: a specification cannot provide an adequate written description if one of ordinary skill in the art would not have had a reasonable expectation of success in achieving the invention (which was the basis for the PTAB's decision in the '048 interference that there was no interference-in-fact). The Broad's brief further argues that the skilled artisan would have expected bacterial CRISPR would need "its own set of unique conditions" to be adapted to practice in eukaryotic cells, which P1 and P2 did not disclose. Finally regarding this argument, the Broad asserts that neither of CVC's P1 or P2 do priority documents disclosed anything not found in the Jinek reference, except for well-known techniques in the art, and PTAB found that the combination of Jinek plus these known prior art techniques did not render eukaryotic CRISPR obvious.

The Broad's second argument is that the Board should arrive at this same conclusion if the evidence is assessed de novo. The Broad asserts that neither the P1 nor P2 priority documents provide a constructive reduction to practice of eukaryotic embodiments of CRISPR because none of the "fictitious" embodiments relied upon by CVC's expert were disclosed in P1 or P2, calling them "post-hoc creations of CVC's expert, manufactured by stitching together disparate disclosures from P1 and P2, using Proposed Count 2 as a roadmap." The brief alleges that P1 and P2 provide no "blazemarks" for practicing eukaryotic CRISPR, and even if the Board finds there were blazemarks there were no eukaryotic experiments or specific instructions needed to satisfy the written description or enablement requirements of 35 U.S.C. § 112. Finally, in this portion of the argument the brief asserts that the third priority document contained in CVC's request for priority benefit is irrelevant because it was filed after publication of scientific references disclosing eukaryotic CRISPR by Broad and Harvard scientists and named inventors.

The brief provides a synopsis of the "State of the CRISPR Art by 2012" in the Broad's view, relying on PTAB findings from the '048 Interference. The brief cites the generic disclosure in P1 regarding methods for introducing nucleic acids into cells, a characterization acknowledged by CVC's expert in this interference. According to the Broad, the P1 and P2 references were limited to in vitro examples and routine methods known in the art. The brief further argues that there was "continuing uncertainty" regarding the ability to practice eukaryotic embodiments of CRISPR until the Broad's Zhang and colleagues demonstrated that CRISPR could be adapted to eukaryotic cells. This uncertainty is supported (as it was in the '048 interference) by quotations from CVC's published scientific journal articles and interviews. Also, as before, the Broad notes that CVC's expert in the '048 interference had published a paper contemporaneously that cast doubt on whether CRISPR could be used in eukaryotic cells. And of course the brief notes that the Broad inventors were able to achieve eukaryotic CRISPR as set forth in the Broad's earliest priority date, December 12, 2012. (In this regard the brief makes the argument that the P3 priority document shows achievement of eukaryotic CRISPR only after getting assistance from Broad inventors, specifically George Church.)

The brief then sets forth a further synopsis of the '048 interference and its outcome, which does not bear repeating here (see "PTAB Decides CRISPR Interference in Favor of Broad Institute — Their Reasoning" and "Regents of the University of California v. Broad Institute, Inc. (Fed. Cir. 2018): Federal Circuit Affirms PTAB in Appeal of CRISPR Interference").

Finally, the Broad sets forth its legal arguments based on the fact finding by the PTAB in the '048 interference, to the effect that neither P1 nor P2 satisfy the requirements of § 112 sufficient to establish constructive reduction to practice of eukaryotic embodiments of CRISPR. These arguments are based, as the Broad's arguments have been based throughout this interference, on the issue preclusive effects of 37 C.F.R. § 41.127(a)(1) and corresponding Standing Order Rule 127(a)(1). Further, the Broad argues that the PTAB's decision in the '048 interference is law of the case and controlling here, under MPEP 706.07(h)(XI)(A). The Broad also argues that CVC has used this "law of the case" doctrine during ex parte prosecution to overcome prior art-based rejections over the Broad's extensive eukaryotic CRISPR portfolio of granted patents.

The brief next asserts that CVC's arguments for being accorded priority benefit to P1 and P2 are contrary to the PTAB's findings in the '048 interference. Specifically, the brief cites CVC's current expert's assertions that P1 or P2 plus the ordinary skill in the art showed possession of eukaryotic CRISPR, which the Broad argues is contrary to the PTAB's decision that the skilled person would have had no reasonable expectation of success. The brief sets forth express portions of the PTAB's earlier decision in support of this argument with regard to reasonable expectation of success, the need for a unique set of conditions for practicing CRISPR in eukaryotic cells, and that the practice of CRISPR in vitro combined with well-known techniques for expressing heterologous genes in eukaryotic cells did not render eukaryotic CRISPR obvious. These circumstances preclude CVC from being accorded priority benefit to P1 and P2 as a matter of law, the Broad argues, based on lack of enablement, including the utility requirement embodied in that statute.

The brief concludes by providing the Broad's point-by-point rebuttal of CVC's arguments concerning why the prior PTAB decision are not preclusive, and further argues that de novo review of the record does not support CVC's position. These arguments are based on: 1) failure of P1 or P2 to disclose embodiment E4, E5, or E6 cited in CVC's motion; 2) there being no "blazemarks" in P1 or P2 regarding how to create these undisclosed ("fictitious") embodiments (with extensive rebuttal of CVC's expert's testimony); 3) that the P1 and P2 disclosures fail to anticipate or render obvious Proposed Count 2 as required under 37 C.F.R. § 41.201; 4) that the fictitious embodiments are incomplete for failure to disclose "a specific target sequence or delivery method to the [eukaryotic] cell"; and 5) there is no support in the P1 or P2 disclosures for anything but in vitro embodiments of CRISPR, and thus no possession in view of recognized uncertainty in the art (and set forth in detail in the brief). As a final argument, the brief sets forth in detail how, in the Broad's view, the P1 and P2 priority documents no not provide an enabling disclosure under the factors set forth in In re Wands.
Meanwhile, Back at the Broad-CVC Interference . . .

January 29, 2020

By Kevin E. Noonan —

January 9th was a busy day at the Patent Trial and Appeal Board (PTAB). On that day no fewer than five substantive briefs were filed in Interference No. 106,115, two by Senior Party The Broad Institute, Harvard University, and the Massachusetts Institute of Technology (collectively, "Broad"), and three by Junior Party the University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC"). All five were oppositions to counterpart substantive motions by the opposing party; the Broad oppositions will be discussed first.

Broad Opposition No. 1 was filed in opposition to CVC's Responsive Motion No. 2, wherein CVC asked to be accorded benefit of the filing dates of three provisional applications with regard to Broad's proposed Count 2 (USSN 61/652,086, filed May 25, 2012 (P1); USSN 61/716,256, filed October 19, 2012 (P2): USSN 61/757,640, filed January 28, 2013 (P3)). To recap, Count 1 of the interference as declared is:

An engineered, programmable, non-naturally occurring Type II CRISPR-Cas system comprising a Cas9 protein and at least one guide RNA that targets and hybridizes to a target sequence of a DNA molecule in a eukaryotic cell, wherein the DNA molecule encodes and the eukaryotic cell expresses at least one gene product and the Cas9 protein cleaves the DNA molecules, whereby expression of the at least one gene product is altered; and, wherein the Cas9 protein and the guide RNA do not naturally occur together, wherein the guide RNAs comprise a guide sequence fused to a tracr sequence.

or

A eukaryotic cell comprising a target DNA molecule and an engineered and/or non-naturally occurring Type II Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)-— CRISPR associated (Cas) (CRISPR-Cas) system comprising
    a) a Cas9 protein, or a nucleic acid comprising a nucleotide sequence encoding said Cas9 protein; and
    b) a single molecule DNA-targeting RNA, or a nucleic acid comprising a nucleotide sequence encoding said single molecule DNA-targeting RNA; wherein the single molecule DNA-targeting RNA comprises:
        i) a targeter-RNA that is capable of hybridizing with a target sequence in the target DNA molecule, and
        ii) an activator-RNA that is capable of hybridizing with the targeter-RNA to form a double-stranded RNA duplex of a protein- binding segment,
    wherein the activator-RNA and the targeter-RNA are covalently linked to one another with intervening nucleotides; and
    wherein the single molecule DNA-targeting RNA is capable of forming a complex with the Cas9 protein, thereby targeting the Cas9 protein to the target DNA molecule, whereby said system is capable of cleaving or editing the target DNA molecule or modulating transcription of at least one gene encoded by the target DNA molecule.

The Broad's proposed Count 2 is:

A method, in a eukaryotic cell, of cleaving or editing a target DNA molecule or modulating transcription of at least one gene encoded by the target DNA molecule, the method comprising:
    contacting, in a eukaryotic cell, a target DNA molecule having a target sequence with an engineered and/or non-naturally-occurring Type II Clustered Regularly lnterspaced Short Palindromic Repeats (CRISPR)-CRISPR associated Cas) (CRISPR-Cas) system comprising:
        a) a Cas9 protein, and
        b) RNA comprising
            i) a targeter-RNA that is capable of hybridizing with the target sequence of the DNA molecule or a first RNA comprising (A) a first sequence capable of hybridizing with the target sequence of the DNA molecule and (B) a second sequence; and
            ii) an activator-RNA that is capable of hybridizing to the targeter-RNA to form an RNA duplex in the eukaryotic cell or a second RNA comprising a tracr sequence that is capable of hybridizing to the second sequence to form an RNA duplex in the eukaryotic cell,
    wherein, in the eukaryotic cell, the targeter-RNA or the first sequence directs the Cas9 protein to the target sequence and the DNA molecule is cleaved or edited or at least one product of the DNA molecule is altered.

The distinction the Broad made in its Motion is between embodiments of CRISPR methods that are limited to "single-molecule guide RNA" (aka "fused" or "covalently linked" species), versus embodiments that encompass single-molecule and "dual molecule" species (wherein the in the latter versions the "targeter-RNA" and "activator-RNA" as recited in the proposed Count are not covalently linked). The Broad argued that the Board should adopt its Proposed Count 2 because it "properly describes the full scope of the interfering subject matter between the parties because both parties have involved claims that are generic, non-limited RNA claims." The brief also argued that Proposed Count 2 "sets the correct scope of admissible proofs [i.e., their own] for the breakthrough invention described by the generic claims at issue in these proceedings—the successful adaption of CRISPR-Cas9 systems for use in eukaryotic environments," which the Broad contended current Court 1 (in either alternative) does not.

CVC's Responsive Motion No. 2 argued that it was equally entitled to priority to its earliest provisional filings as the Broad was entitled to its provisional applications, by setting forth in detail the disclosure in its earlier priority applications for at least one embodiment falling within the scope of Proposed Count 2. In addition, and addressing the Broad's argument that CVC's disclosure (and this interference) were directed to single-molecule embodiments of CRISPR, CVC argued that on the contrary this priority document "disclosed, for the first time, that complexes of Cas9 and a double- or single-molecule DNA-targeting RNA . . . are useful for targeted DNA cleavage and described numerous applications of this gene-editing technology, including modifying target DNA in eukaryotic cells" and that "[t]he CVC inventors immediately understood that the CRISPR-Cas9 DNA-cleavage complex could be used in a variety of different cellular and noncellular settings." The brief recited (prophetic) Example 1 in the P1 specification, asserting that the failure of the P1 specification to show actual reduction to practice is not required to satisfy the requirement for entitlement benefit. CVC also cautioned the Board against any attempt by the Broad to "erroneously to link the issues in this motion to the PTAB's termination of Interference No. 106,048 due to no interference-in-fact," stating that "the legal and factual issues raised here are fundamentally different from those decided in the prior '048 proceeding" based on the PTAB's own prior statements of the grounds for its no interference-in-fact determination. Rather, according to CVC:

[A person of ordinary skill in the art] reading P1 in light of the state of the art at the time of filing would have understood that the application describes and enables at least one embodiment within the scope of Proposed Count 2. Moreover, post-filing-date publications report successfully practicing CVC's claimed invention in eukaryotes using the very methods and components that P1 describes. The Board should therefore accord CVC the benefit of P1's May 25, 2012 filing date with respect to Proposed Count 2.

In its opposition the Broad makes at least some of the arguments CVC anticipated, specifically that "[a] person of ordinary skill in the art . . . in 2012 could not have reasonably concluded from reading P1 or P2 – which disclose no more than in vitro experiments and laundry lists of routine techniques known in the at generally – that the [CVC] applicants possessed an embodiment that falls within the scope of Proposed Count 2." The Broad's brief sets forth two "separate and independent grounds" for this result: "(1) the PTAB's fact findings in the [earlier ']048 interference" (which the Broad argues are binding in this interference) and "(2)separate and independent de novo assessment of the evidence of record."

With regard to its first argument, the Broad asserts that the PTAB's fact-findings in the '048 interference preclude CVC from establishing benefit to P1 and P2, based on a 2012 reference to Jinek et al. (2012, A programmable dual-RNA-guided DNA endonuclease in adaptive bacterial immunity, Science 337: 816-21) and the finding that a person of ordinary skill in the art would not have had a reasonable expectation of success in performing CRISPR in eukaryotic cells. This argument is one of lack of an adequate written description and illustrates another aspect of a familiar conundrum: a specification cannot provide an adequate written description if one of ordinary skill in the art would not have had a reasonable expectation of success in achieving the invention (which was the basis for the PTAB's decision in the '048 interference that there was no interference-in-fact). The Broad's brief further argues that the skilled artisan would have expected bacterial CRISPR would need "its own set of unique conditions" to be adapted to practice in eukaryotic cells, which P1 and P2 did not disclose. Finally regarding this argument, the Broad asserts that neither of CVC's P1 or P2 do priority documents disclosed anything not found in the Jinek reference, except for well-known techniques in the art, and PTAB found that the combination of Jinek plus these known prior art techniques did not render eukaryotic CRISPR obvious.

The Broad's second argument is that the Board should arrive at this same conclusion if the evidence is assessed de novo. The Broad asserts that neither the P1 nor P2 priority documents provide a constructive reduction to practice of eukaryotic embodiments of CRISPR because none of the "fictitious" embodiments relied upon by CVC's expert were disclosed in P1 or P2, calling them "post-hoc creations of CVC's expert, manufactured by stitching together disparate disclosures from P1 and P2, using Proposed Count 2 as a roadmap." The brief alleges that P1 and P2 provide no "blazemarks" for practicing eukaryotic CRISPR, and even if the Board finds there were blazemarks there were no eukaryotic experiments or specific instructions needed to satisfy the written description or enablement requirements of 35 U.S.C. § 112. Finally, in this portion of the argument the brief asserts that the third priority document contained in CVC's request for priority benefit is irrelevant because it was filed after publication of scientific references disclosing eukaryotic CRISPR by Broad and Harvard scientists and named inventors.

The brief provides a synopsis of the "State of the CRISPR Art by 2012" in the Broad's view, relying on PTAB findings from the '048 Interference. The brief cites the generic disclosure in P1 regarding methods for introducing nucleic acids into cells (e.g., "infection, lipofection, electroporation, calcium phosphate precipitation," and others), a characterization acknowledged by CVC's expert in this interference. According to the Broad, the P1 and P2 references were limited to in vitro examples and routine methods known in the art. The brief further argues that there was "continuing uncertainty" regarding the ability to practice eukaryotic embodiments of CRISPR until the Broad's Zhang and colleagues demonstrated that CRISPR could be adapted to eukaryotic cells. This uncertainty is supported (as it was in the '048 interference) by quotations from CVC's published scientific journal articles and interviews. Also, as before, the Broad notes that CVC's expert in the '048 interference had published a paper contemporaneously that cast doubt on whether CRISPR could be used in eukaryotic cells. And of course the brief notes that the Broad inventors were able to achieve eukaryotic CRISPR as set forth in the Broad's earliest priority date, December 12, 2012. (In this regard the brief makes the argument that the P3 priority document shows achievement of eukaryotic CRISPR only after getting assistance from Broad inventors, specifically George Church.)

The brief then sets forth a further synopsis of the '048 interference and its outcome, which does not bear repeating here (see "PTAB Decides CRISPR Interference in Favor of Broad Institute — Their Reasoning" and "Regents of the University of California v. Broad Institute, Inc. (Fed. Cir. 2018): Federal Circuit Affirms PTAB in Appeal of CRISPR Interference").

Finally, the Broad sets forth its legal arguments based on the fact finding by the PTAB in the '048 interference, to the effect that neither P1 nor P2 satisfy the requirements of §112 sufficient to establish constructive reduction to practice of eukaryotic embodiments of CRISPR. These arguments are based, as the Broad's arguments have been based throughout this interference, on the issue preclusive effects of 37 C.F.R. § 41.127(a)(1) and corresponding Standing Order Rule 127(a)(1). Further, the Broad argues that the PTAB's decision in the '048 interference is law of the case and controlling here, under MPEP 706.07(h)(XI)(A). The Broad also argues that CVC has used this "law of the case" doctrine during ex parte prosecution to overcome prior art-based rejections over the Broad's extensive eukaryotic CRISPR portfolio of granted patents.

The brief next asserts that CVC's arguments for being accorded priority benefit to P1 and P2 are contrary to the PTAB's findings in the '048 interference. Specifically, the brief cites CVC's current expert's assertions that P1 or P2 plus the ordinary skill in the art showed possession of eukaryotic CRISPR, which the Broad argues is contrary to the PTAB's decision that the skilled person would have had no reasonable expectation of success. The brief sets forth express portions of the PTAB's earlier decision in support of this argument with regard to reasonable expectation of success, the need for a unique set of conditions for practicing CRISPR in eukaryotic cells, and that the practice of CRISPR in vitro combined with well-known techniques for expressing heterologous genes in eukaryotic cells did not render eukaryotic CRISPR obvious. These circumstances preclude CVC from being accorded priority benefit to P1 and P2 as a matter of law, the Broad argues, based on lack of enablement, including the utility requirement embodied in that statute.

The brief concludes by providing the Broad's point-by-point rebuttal of CVC's arguments concerning why the prior PTAB decision are not preclusive, and further argues that de novo review of the record does not support CVC's position. These arguments are based on: 1) failure of P1 or P2 to disclose embodiment E4, E5, or E6 cited in CVC's motion; 2) there being no "blazemarks" in P1 or P2 regarding how to create these undisclosed ("fictitious") embodiments (with extensive rebuttal of CVC's expert's testimony); 3) that the P1 and P2 disclosures fail to anticipate or render obvious Proposed Count 2 as required under 37 C.F.R. § 41.201; 4) that the fictitious embodiments are incomplete for failure to disclose "a specific target sequence or delivery method to the [eukaryotic] cell"; and 5) there is no support in the P1 or P2 disclosures for anything but in vitro embodiments of CRISPR, and thus no possession in view of recognized uncertainty in the art (and set forth in detail in the brief). As a final argument, the brief sets forth in detail how, in the Broad's view, the P1 and P2 priority documents no not provide an enabling disclosure under the factors set forth in In re Wands.

The Broad's other brief filed January 9th will be the subject of another post.
Broad Institute Patents Remain Revoked in Europe

January 28, 2020

By Kevin E. Noonan —

Last January 17th, the Opposition Division (OD) of the European Patent Office revoked in its entirety European Patent No. EP 2771468, which named as Proprietors The Broad Institute, MIT, and Harvard College and had been opposed by Novozymes A/S, CRISPR Therapeutics GG, and several strawmen). Almost one year later to the day, the Technical Board of Appeal affirmed the revocation (after suggesting it would refer some of the Broad's questions and challenges to the OD's decision to the Enlarged Board of Appeal).

To recap, representative claims revoked by the OD are as follows:

1. A non-naturally occurring or engineered composition comprising:
a Clustered Regularly Interspersed Short Palindromic Repeats (CRISPR)-CRISPR associated (Cas) (CRISPR-Cas) system chimeric RNA (chiRNA) polynucleotide sequence, wherein the polynucleotide sequence comprises
    (a) a guide sequence of between 10 – 30 nucleotides in length, capable of hybridizing to a target sequence in a eukaryotic cell,
    (b) a tracr mate sequence, an
    (c) a tracrRNA sequence
    wherein (a), (b) and (c) are arranged in a 5' to 3' orientation,
    wherein when transcribed, the tracr mate sequence hybridizes to the tracrRNA sequence and the guide sequence directs sequence-specific binding of a CRISPR complex to the target sequence,
    wherein the CRISPR complex comprises a Type II Cas9 protein complexed with (1) the guide sequence that is hybridized to the target sequence, and (2) the tracr mate sequence that is hybridized to the tracrRNA sequence,
    wherein the tracrRNA sequence is 50 or more nucleotides in length.

2. A Clustered Regularly Interspersed Short Palindromic Repeats (CRISPR)-CRISPR associated (Cas) (CRISPR-Cas) vector system comprising one or more vectors comprising
    I. a first regulatory element operably linked to a nucleotide sequence encoding a CRISPR-Cas system chimeric RNA (chiRNA) polynucleotide sequence as defined in claim 1, and
    II. a second regulatory element operably linked to a nucleotide sequence encoding a Type II Cas9 protein comprising one or more nuclear localization sequences, of sufficient strength to drive accumulation of said Cas9 protein in a detectable amount in the nucleus of a eukaryotic cell;
    wherein components I and II are located on the same or different vectors of the system.

12. Use of the composition of claim 1, or the vector system of claim 2 or any claim dependent thereon for genome engineering, provided that said use is not a method for treatment of the human or animal body by surgery or therapy, and provided that said use is not a process for modifying the germline genetic identity of human beings.

17. Use of the composition of claim 1, or the vector system of claim 2 or any claim dependent thereon, in the production of a non-human transgenic animal or transgenic plant.

The OD issued its formal opinion on March 26th, which was consistent with a preliminary opinion prior to summoning Proprietor Broad Institute and the opponents to oral hearing. While this opinion found defects in certain substantive matters (such as claims 1, 2, 14, and 15 not satisfying Article 123(2) EPC), the majority of the claims were found to lack novelty (claims 1-6 and 9-17) or inventive step (claims 7 and 8) as a consequence of the OD's decision that EP 2771468 was not entitled to its priority claim.

The priority issue was raised based on the earliest two provisional applications (U.S. Provisional Application Nos. 61/736,527 and 61/748,427), as well as U.S. Provisional Application Nos. 61/791,409 and U.S. 61/835,931, which named Luciano Marraffini as an inventor, and which were owned by Rockefeller University. The priority documents and their named inventors are as follows:

• U.S. 61/736,527 named Zhang, Cong, Hsu, Ran, Habib, Cox, Lin and Maraffini as inventors
• U.S. 61/748,427 named Zhang, Cong, Hsu, Ran, Habib, Cox, Lin and Maraffini as inventors
• U.S. 61/758,468 named Zhang, Cong, Hsu, and Ran as inventors
• U.S. 61/769,046 named Zhang, Cong, Hsu, and Ran as inventors
• U.S. 61/791,409 named Zhang, Cong, Hsu, Ran, Habib, Cox, Lin and Maraffini, Bikard and Jian as inventors
• U.S. 61/802,174 named Zhang, Cong, Hsu, Ran, and Platt as inventors
• U.S. 61/806,375 named Zhang, Cong, Hsu, Ran, and Platt as inventors
• U.S. 61/814,263 named Zhang, Cong, Hsu, Ran, and Platt as inventors
• U.S. 61/819,803 named Zhang, Cong, Hsu, Ran, and Platt as inventors
• U.S. 61/828,130 named Zhang, Cong, Hsu, Ran, and Platt as inventors
• U.S. 61/835,931 named Zhang, Cong, Hsu, Ran, Cox, Lin, Maraffini, Platt, Santjana, Bikard and Jian as inventors
• U.S. 61/836,127 named Zhang, Cong, Hsu, and Ran as inventors

In Europe, under Article 87 EPC and Paragraph IV of the Paris Convention, priority to an earlier-filed application can be validly claimed by the prior applicant or by her successor in interest. In either case, the applicant must be someone having the right to claim priority. In the U.S., these provisional applications were filed in the name of the inventor and the EPO requires that there be an assignment of the invention on or before a European or PCT application is filed. (Of course, a PCT application can always be filed naming the inventors as applicants.) In this case, proper application of the applicable rules required both the named applicants (The Broad Institute, MIT and Harvard College) and Rockefeller to have been named as applicants when the application was filed. Rockefeller was not named as an applicant. Accordingly, the OD determined that the named Proprietors could only validly claim priority to the third provisional application, and by the filing date of that application there had published prior art that invalidated the granted claims. In this regard, the formal opinion followed the earlier preliminary opinion in stating that "[i]n both the EPC and the Paris convention systems the decisive fact for a valid claim of priority is the status of applicant, rather than the substantial requirement . . . to the subject matter of the first application" (emphasis in opinion). The OD determined that "neither the requirement of the applicant's identity nor the proof of a valid success in title [had] been fulfilled" for the claimed invention, and stressed that these were requirements to promote legal certainty that would protect third parties' interests, and that these requirements were not subject to the national law of the priority document. Nor, according to the preliminary opinion could the granted European patent properly claim priority to U.S. 61/758,468 because that document failed to disclose the length of the guide sequence as claimed.

The Broad made three arguments, all of which the OD rejected:

I. The EPO should have no power to assess legal entitlement to the right of priority.

II. In case of joint/multiple applicants in a first application, the meaning of the term "any person" under Article 87 EPC should be interpreted to mean "one or some indiscriminately" of the co-applicants.

III. The meaning of "any person who has duly filed" should be interpreted according to national law, in this case U.S. law.

The formal opinion noted that "[t]hese perspectives were not fully addressed by the OD's preliminary opinion, as they were submitted at a later stage," and the Technical Board of Appeal (TBoA) considered (and rejected) these arguments.

With regard to the first argument, the Broad contended that the OD (and the TBoA) should reconsider established practice and case law regarding the requirements for priority. The formal opinion set forth in this regard the status of the European Patent Convention as a "special agreement" as contemplated by Article 19 of the Paris Convention (PC), and thus the EPC cannot contravene the provisions of the PC. The purpose of the PC, according to the opinion, was to "provide a mechanism as simple as possible and appropriate for applicants to obtain international protection for their invention, as well as for patent offices to assess the validity of priority claims." The Broad challenged the EPO's competence to make priority determinations, which it contended were within the purview of the jurisdictions of the national courts of each member state. In their view, the EPO should presume that priority is properly claimed, and should be reviewed only on the basis that the priority document discloses the same invention claimed in any application filed under the EPC. The jurisdictional argument was based on the assertion that the EPO was never intended to have jurisdiction over whether a party was entitled to ownership of the property right to a priority document. If the EPO were to have such jurisdiction, it would need to be empowered to apply the national laws regarding ownership in each contracting state, according to the Broad. Also, under most legal systems, only a person alleging to be the rightful owner has a right to challenge ownership of a priority right. Finally, the proper portion of the EPC to be applied is Article 60(1) regarding determination of ownership of an EPC application, which is left to the national courts.

The OD rejected this approach, based in part on its refusal to follow a non-binding opinion of the Board in T239/16, in which the Board did not address the issue as a basis for revoking the patent in that proceeding. According to the OD, "the aforementioned established practice . . . has never been questioned to the extent of the EPO's power to assess legal entitlement to priority." The OD stressed that "[t]he assessment of the formal requirements does not determine the rightful owner of the priority right; rather it establishes whether the priority was validly claimed by those named as applicants in the later application (applicant's status), irrespective of their actual entitlement." The issue is not assessment of the substantive right of priority (i.e., inventorship) but the procedural point that the Applicant must have title to the priority right to properly have an application filed in its name (whether by assignment from the inventors or as successors in that title). This requirement is the basis for the EPO to be able to properly identify the prior art, which depends (as it did here) on the priority date to which an Applicant is entitled. If not, the EPO would be put in the position of granting patents without a reliable state of the art and, thus, invalid. The policy implications considered to be determinative by the OD were that "[l]egal certainty and the protection of the interests of the public (against the granting of invalid patents) require that priority is validly claimed, since this is relevant for defining the effective date of a claimed invention and for determining the relevant state of the art." The OD also rejected the Broad's argument that Article 60 was the proper basis for making the procedural priority determination, inter alia, because the Broad had not demonstrated that there was a deficiency in Articles 87-89 that needed supplementation or correction. Also, the OD views the two provisions to serve different purposes: Article 87 "serves to set the relevant date for the state of the art and ultimately affects the patentability of the invention" whereas Article 60 does not.

Accordingly, the OD rejected the Broad's first line of argument, stating that "the EPO has the task to assess the identity of the applicant, as well as the validity of its succession in title."

Regarding the Broad's second argument, that the meaning of the term "any person" under Article 87 EPC should be interpreted to mean "one or some indiscriminately" of the co-applicants, the OD considered the Broad's semantic argument (in French, no less) regarding the meaning of the language of the PC. In the Broad's view these semantics were consistent with an intent under the PC for "a more permissive notion of who is allowed to claim priority" in contrast with who would be permitted to file a divisional application from a prior EPC application, for example. The Broad further contended that as to third parties their interests would be protected by the "same invention" requirement for a valid priority claim. Finally, the Broad's interpretation of the requirement is consistent with how the PC has been implemented in the U.S., all arguments supported by expert legal opinions proffered to the OD.

Once again, the OD refused to "deviate from established practice" regarding the procedural priority requirements. The OD did not find "an exclusive indication as to whether the later application must be filed by 'all applicants' of the first or by 'any one' of them" in the language of 87 EPC. Commentaries on the EPC have been consistent with the current interpretation, according to the OD, as has EPO practice and case law including national case law, citing specific examples from several EPC member states. The OD further considered how the "all applicants" approach has been consistently applied in Boards of Appeal decisions and has been used as the "starting point [for] decisions[] concerning . . . valid assignment of the priority right" ("Stressing the fact that the right to claim priority originates from the applicant of the first application, so that, in principle, the applicant has to be the same for the first and the subsequent applications, the Boards concluded that where the first application has been filed jointly by two or more applicants, the right of priority belongs to them jointly.")

However, while the OD recognizes justifications in theory for permitting each of joint applicants to file EPC applications without the other, as a practical matter "allowing each joint applicant, separately or in different combinations with other co-applicants, to file a patent application claiming priority from the first application would lead to a multiplication of proceedings with identical content." The "logical consequences" of permitting this state of affairs would "run counter to the interests of patent offices and the public both in terms of procedural inefficiencies and of avoiding multiplication of protections for the same subject-matter, having different patent owners." Nor did the OD see any basis for giving U.S. provisional applications any special status and treatment.

Accordingly, the OD rejected the Broad's suggestion "to consider priority as validly claimed even when any one of the joint applicants of the first application is applicant of the later application would protect the legitimate interest of a joint applicant wishing to keep a priority right valid even when the co-operation of the other joint applicants is missing" because this approach "would have far reaching consequences, in particular the risk of multiple patenting."

Finally, with regard to the Broad's third argument that the meaning of "any person who has duly filed" should be interpreted according to national law, the OD rejected the conclusion that this was a "special case" involving U.S. priority documents disclosed several inventions and that the invention by excluded inventors and Applicant were not within the scope of the granted claims. The OD held that the meaning of the term "any person who has duly filed" is limited to according a filing date. Adopting a different approach according to the OD "would be contrary to the scope of simplification of proceedings, as intended by the EPC legislator when choosing to focus solely on the status of an applicant in the EPC system both in Article 87(1) and in Article 60(3)." (The OD also notes in this regard that adopting the Broad's approach would have the effect of having U.S. law take precedence over the EPC, an outcome the OD could not accept.) In addition, this approach would increase complexity by requiring analysis under U.S. law. "Since this approach would disregard the wording and the scope of Article 4PC and Article 87 EPC, the OD sees no reason to depart from the established interpretation given by the BOAs that substantive entitlement is not a basis for the right of priority," the OD held and thus rejected the Broad's third argument.

Consequently, the OD further held that, in the absence of their priority claim all claims of EP 2771468 were invalid for lack of novelty and inventive step.

The TBoA does not immediately publish the basis for their decision, which will be the subject of a later post when it becomes available. For the Broad, the decision by the TBoA is final and thus the Broad has lost exclusive rights in Europe under this patent (and, presumably the nine related patents in Europe). Which may be one reason that the Broad issued a press release, suggesting that patent holders on CRISPR technology "move beyond litigation" and work together to ensure open and widespread access to CRISPR.
iLife Technologies, Inc. v. Nintendo of America, Inc. (N.D. Tex. 2020)

January 27, 2020

By Michael Borella —

With the eligibility rubric of Alice v. CLS Bank, an applicant/patentee must navigate a minefield of pre-issuance and post-issuance validity challenges under 35 U.S.C. § 101 in order to obtain and enforce a patent.

First, through clever drafting, the applicant must convince a U.S. Patent and Trademark Office (USPTO) examiner to not raise a § 101 rejection during prosecution. If one is raised, the applicant has to persuade the examiner, through amendment or argument, to withdraw it. If the examiner remains unpersuaded, an appeal to the USPTO's Patent Trial and Appeal Board (PTAB) must serve that function. Failing that, appeals to the Federal Circuit (which applies a highly-unpredictable eligibility analysis) and even the Supreme Court (which has not found a patent eligible since 1981) are possible. To be fair, it is unlikely that the high Court will grant certiorari on a § 101 issue these days, as we have recently seen.

Once issued, the patent might be able to be pulled back into the PTAB for a Post-Grant Review (PGR) or a Covered Business Method (CBM) Review. In addition to that, enforcement proceedings in a district court can subject the patent to further invalidity challenges under § 101 on the pleadings and at summary judgment. If the district court's § 101 decision is appealed, the patent then has to survive said eligibility analysis of the Federal Circuit, the decision of which could potentially be further appealed to the Supreme Court with said unlikely chance of being heard.

Only once these avenues have been exhausted can the patentee relax and use the surviving patent to enjoin a party from practicing the claimed invention or to seek damages therefrom without the specter of § 101 hanging over the proceedings (this specter is one of stock horror-movie fare — pale complexion, chunks of missing flesh, sharp claws — quite non-abstract, if you will). And yes, the patent also has to be found novel, non-obvious, properly specified, and infringed.

Clearly, an entity seeking an enforceable patent to protect its innovations from copyists and free-riders has a few hurdles to overcome. Perhaps this would not be a terrible conundrum if the law surrounding patent eligibility was clear. But it is not. Don't take my word for it — read what others more knowledgeable and eloquent have written.

In any event, iLife sued Nintendo in the Northern District of Texas for allegedly infringing U.S. Patent No. 6,864,796. At issue were the latter's Wii and Wii U motion control wands known as "Wiimotes".

As described by the Court:

The '796 patent generally discloses a system for evaluating body movement relative to an environment. The system includes a sensor that detects dynamic and static accelerative phenomena of the body. The sensor senses one or more absolute values, changes in value, or some combination of the same and generates an output signal to [a] processor. The processor then evaluates the signal to determine whether the body is in an acceptable or unacceptable state. The patent describes acceptable or unacceptable as within or beyond tolerance.

Regarding the patent, claim 1 was front and center in the accusation of infringment. It recites:

A system within a communications device capable of evaluating movement of a body relative to an environment, said system comprising:
    a sensor, associable with said body, that senses dynamic and static accelerative phenomena of said body, and
    a processor, associated with said sensor, that processes said sensed dynamic and static accelerative phenomena as a function of at least one accelerative event characteristic to thereby determine whether said evaluated body movement is within environmental tolerance
    wherein said processor generates tolerance indicia in response to said determination; and
    wherein said communication device transmits said tolerance indicia.

The case went to trial and the jury found that Nintendo infringed claim 1, awarding iLife slightly over $10 million in damages. The jury also found the patent to be not invalid on grounds of purportedly lacking adequate written description and enablement.

Nintendo moved for a judgment as a matter of law, arguing that claim 1 is invalid under § 101, indefinite, and lacks adequate written description and enablement. We will focus on the eligibility dispute.

In Alice, the Supreme Court set forth a two-part test to determine whether claims are directed to patent-eligible subject matter under § 101. One must first decide whether the claim at hand involves a judicially-excluded law of nature, a natural phenomenon, or an abstract idea. If so, then one must further decide whether any element or combination of elements in the claim is sufficient to ensure that the claim amounts to significantly more than the judicial exclusion. But elements or combinations of elements that are well-understood, routine, and conventional will not lift the claim over the § 101 hurdle. While this inquiry is generally carried out as a matter of law, factual issues can come into play when determining whether something is well-understood, routine, and conventional.

Applying part one of Alice, the Court found that, not unlike the Federal Circuit decision of Electric Power Group v. Alstom S.A., claim 1 was "directed to the abstract idea of gathering, processing, and transmitting . . . information." Further, the type of information at play — dynamic and static accelerative phenomena — did not render the claim any less abstract. The Court also noted that "[n]othing in claim 1, understood in light of the specification, requires anything other than conventional sensors and processors performing conventional activities previously known to the industry." Indeed, the Court cited to such an admission in the specification.

The Court also considered whether the claim involved an improvement to its recited hardware. Ultimately, the Court concluded that it did not, finding that "the claim does not disclose any improvement in the sensor's ability to collect information, such as collecting previously unknown information or collecting information more accurately [and] it does not disclose some improvement in the processor itself, such as faster or more powerful processing." Further, the claim "is not limited to any particular configuration of the components that results in a technological improvement . . . [i]nstead, the sensor and processor are merely tools to execute an abstract idea."

Finding claim 1 abstract, the Court moved on to part two of Alice. Unsurprisingly, the claim fared poorly, with the Court rapidly concluding that "[t]here is no inventive concept in the claim elements, whether considered individually or as an ordered combination . . . [and it] does not add any meaningful limitations to the routine steps of data collection, analysis, and transmission using conventional computer components."

Particularly, "[c]laim 1 requires neither a new source or type of information nor a new method of measuring information [and] provides for an unspecified set of rules for analyzing sensor data, but discloses no further details on those rules, like how data might be evaluated for a child versus an adult." The Court even used iLife's own claim construction argument that claim 1 "does not contain words requiring any special type of processing" against it.

iLife argued that, in its specification, "the claimed processor distinguishes between normal and abnormal accelerative events, and, when an abnormal event is identified, to indicate whether the abnormal event is tolerable, or within tolerance" as well as distinguishing "other physical characteristics, including temperature, pressure, force, sound, light, relative position, and the like." But the Court observed that the claim itself does not contain these details or limitations, and therefore does not satisfy part two of the test.

Consequently, the Court ruled the '796 patent invalid under § 101 as a matter of law, effectively rendering the jury verdict moot.

For anyone following § 101 jurisprudence, a quick glance at claim 1 was probably enough to provide an educated guess for which way the Court was going to rule. Recent § 101 opinions from the Federal Circuit have repeated found that claims lacking in technical detail — ones that recite what an invention does rather than how the invention accomplishes its goals — are generally abstract. This is not the dictionary definition of the word "abstract," but instead a legal fiction that a concrete and tangible invention can be invalid if it is defined in terms of its outcome rather than the process used to achieve that outcome.

Despite there being no inkling of this notion in § 101 of the patent statute and questionable support in the Supreme Court's cases, the post-Alice Federal Circuit has morphed patent-eligibility into a game in which one must guess the level of detail required for an invention to cross over from "abstract" to "non-abstract." If anything, such considerations are best addressed under §§ 102, 103, and 112 — the parts of the statute where over-broad claim language can be considered in a more cogent fashion. But with the Alice hammer all claims look like nails, so here we are. And the § 101 minefield becomes even more hazardous.

iLife Technologies, Inc. v. Nintendo of America, Inc. (N.D. Tex. 2020)
Order by Chief Judge Lynn
U.S. and China Approve Trade Agreement: Part 1

January 26, 2020

By Kevin E. Noonan —

On January 15th, the U.S. and China announced bilateral approval of an agreement resolving some of the trade disputes between the two countries that have developed (or become more evident) over the past three years. One of the most consistent (if sometimes incoherently expressed) policy positions taken by the Trump Administration (and Mr. Trump himself) is that the trade balance between the U.S. and China has been unbalanced and in need of correction. This idea is not unique to Mr. Trump (although its idée fixe nature may be) and has been a feature of the U.S. Trade Representative's Special 301 Report for the past decade (most recently last April). It has been the source of numerous tariffs imposed on China by this Administration (even in the face of criticism from economists and others that U.S. consumers and farmers, not the Chinese, bore the brunt of the consequences and the costs) and the periodic imposition of these tariffs has rattled the financial markets since the time when Mr. Trump first came into office.

Representatives from the U.S. and China announced, with much fanfare, the completion of the first round of what is envisioned (or purported) to be several agreements between the two countries, and released the text of the agreement that on its face looks favorable to U.S. interests but on further study may in fact not be.

The Agreement has eight chapters and several articles for each chapter. After reciting a Preamble containing the importance of a "bilateral economic and trade relationship" between the U.S. and China, and "adherence to international norms" to promote it, and acknowledging the "trade and investment concerns" identified by both countries and that it is desirable for the countries to resolve them, the Agreement in Chapter 1 immediately addresses Intellectual Property concerns.

These begin with generic representations such as "[t]he Parties shall ensure fair, adequate, and effective protection and enforcement of intellectual property rights. Each Party shall ensure fair and equitable market access to persons of the other Party that rely upon intellectual property protection" (Article 1.2) and then gets into specifics regarding Trade Secrets and Confidential Business Information (Article 1, Section B); Pharmaceutical-related Intellectual Property (Section C); Patents (Section D); Piracy and Counterfeiting on E-Commerce Platforms (Section E); Geographical Indications (Section F); Manufacture and Export of Pirated and Counterfeit Goods (Section G); Bad-Faith Trademarks (Section H); Judicial Enforcement and Procedure in Intellectual Property Cases (Section I); Bilateral Cooperation on Intellectual Property Protection (Section J); and Implementation (Section K). There are many specifics enunciated in these Sections, but they have in common that almost all of them recite a provision saying: "The United States affirms that its existing measures are consistent with its obligations in this Chapter" while setting forth specific representations and obligations for China to adhere to under these specific Sections. In context, these provisions appear to be an agreement that China will adopt U.S. law and practices (for example, in Article 1.5(2) regarding such specifics as when to shift the burden of proof to those accused of trade secret misappropriation in the face of a quantum of evidence that trade secret misappropriation has occurred) and "prohibit the unauthorized disclosure of undisclosed information, trade secrets, or confidential business information by government personnel or third party experts or advisors in any criminal, civil, administrative, or regulatory proceedings conducted at either the central or sub-central levels of government in which such information is submitted."

Regarding patents on pharmaceuticals, the agreement will loosen the strict application of Chinese law that has prevented applicants to provide supplemental information (i.e., not in the specification as filed) to support sufficiency of disclosure or a showing of inventive step in patent applications filed in China (which is a significant concession by China what will on its face provide patent protection for subject matter that was prior to signing the agreement unable to be patented). China also agrees to establish patent term extensions to make up for patent prosecution and regulatory approval delays. And the concessions in Section G regarding export of counterfeit goods may be the most significant, in view of accusations by the USTR of China's role in worldwide counterfeiting; particularly regarding counterfeit medicines, these requirements are very specific (Article 1:18(2)).

Chapter 2 involves technology transfer issues and the importance of having this objective achieved "on voluntary, market-based terms" in contrast to "forced" technology transfer, which is "a significant concern." This section addresses situations where the U.S. has alleged China has required disclosure of technology as a quid pro quo for coming to agreement with U.S. companies.

Chapter 3 sets forth the parties' agreement regarding trade in food and agricultural products, pledging "agricultural cooperation," although the terms of such agreements are "to be mutually agreed upon," i.e., not yet resolved. The agreement also contains provisions wherein the China-United States Scientific Cooperation and Exchange Program continues and there are to be "exchanges and dialogues on agricultural topics." But this chapter contains much more language regarding what the parties intend to address in future rather than firm (relatively) agreements on specific terms (and Annex 1:11 provides that "[f]or greater certainty, nothing in this Annex shall obligate either Party to expend, obligate, or transfer any funds, or to dedicate personnel or other resources to any cooperative activity"). Annex 2 of this Chapter concerns dairy products, infant formula, and inspections thereof (directed towards "meeting Chinese consumers' ever-growing needs"). Annex 3 concerns poultry (of particular concern in view of the propensity for variant strains of influenza to arise in domesticated poultry) and specifically committing the parties to sign and implement the Protocol on Cooperation on Notification and Control Procedures for Certain Significant Poultry Diseases within 30 days of when the agreement enters into force. Annex 4 concerns beef and commits the parties to continue to implement the 2017 Protocol for importing U.S. beef into China (with the terms of this agreement prevailing if there are inconsistencies), Annex 5 live breeding cattle, Annex 6 pork, and Annex 7 meat, poultry and processed meats, significantly wherein China acknowledges USDA's Food Safety and Inspection Service (FSIS) oversight over U.S.-sourced "meat, poultry meat, and processed meat and poultry meat facilities" but permitting China to have the right to audit U.S. food safety regulatory systems in coordination with FSIS. Annex 8 concerns electronic meat and poultry information systems to "access FSIS export certificates accompanying U.S. exports to China of meat, poultry, and meat and poultry products." Annex 9 concerns aquatic products (albeit committing to "resume bilateral meetings of the U.S.-China Technical Working Group on Seafood" and identifying steps to for China to provide evidence regarding controls for seafood products to be imported into the U.S.). Annex 10 concerns rice, and Annex 11 plant health (agreeing to consultations regarding a "phytosanitary protocol" for Chinese Bonsai, but excluding orchids). Also within the scope of this annex are phytosanitary protocols for imports to the U.S. of Chinese fragrant pear, Chinese citrus, and Chinese Jujube, and importation into China of U.S. potatoes, nectarines, blueberries, Hass avocadoes, barley, and alfalfa, but agreeing phytosanitary protocols are not required for frozen fruits and vegetables. Annex 12 concerns feed additives, premixes, compound feed, distillers' dried grains, and distillers' dried grains with solubles (mostly involving provisions that on-site audits or inspections are not required). Annex 13 concerns pet food and non-ruminant derived animal feed, wherein China will lift its ban on U.S. pet food containing ruminant ingredients and eliminate the use of polymerase chain reaction testing on such products. The parties also agree to have "technical discussions" in support of importing U.S. pet food into China while maintaining compliance with the 2004 Protocol on the Veterinary Health Requirements for Non-Ruminant Derived Animal Feed and Tallow to be Imported from the United States of America to the People's Republic of China. Annex 14 involves tariff rate quotas regarding food products; Annex 15 concerns "domestic support" in China regarding China's WTO obligations; and Annex 16 relates to agricultural biotechnology, with China agreeing to "implement a transparent, predictable, efficient, science- and risk-based regulatory process for safety evaluation and authorization of products of agricultural biotechnology." Finally, Annex 17, related to food safety, regards agreement that "[t]he Parties shall not implement food safety regulations, or require actions of the other Party's regulatory authorities, that are not science- or risk-based and shall only apply such regulations and require such actions to the extent necessary to protect human life or health" (without regard to the irony of the Trump administration including these provisions into this agreement). This chapter also contains appendices regarding food products not eligible for import from the U.S. to China.

Chapter 4 is directed to financial services, wherein the parties evince a belief that "they have a significant opportunity for cooperation and mutual benefit in bilateral services trade." Article 4.2 relates to banking services; Article 4.3 to credit rating services (including provisions that the U.S. "affirms it accords non-discriminatory treatment to Chinese credit rating service suppliers"); Article 4.4 for electronic payment services (including provisions that the U.S. "affirms it accords non-discriminatory treatment to Chinese electronic payment service suppliers, including UnionPay"); Article 4.5 to financial asset management services; Article 4.6 to insurance services; and Article 4.7 for securities, fund management, futures services.

Chapter 5 is directed towards macroeconomic policies and exchange rate matters and transparency, wherein the parties pledge to "respect the other Party's autonomy in monetary policy, in accordance with its domestic law," involving "pursuing policies that strengthen underlying economic fundamentals, foster growth and transparency, and avoid unsustainable external imbalances."

Chapter 6 is more directly aspirational regarding expanding trade, having to do with "trade and economic structural changes resulting from this Agreement and from other actions being taken by China to open up its economy and improve its trade regime should lead to improved trade flows, including significant increases in exports of goods and services to China by the United States and other countries." China agrees to import no less than $200 billion of U.S. goods between January 1, 2020 and December 31, 2021, with more specific quotas (because that is what they appear to be) of particular goods set out in Article 6.2 (including manufactured goods, agricultural goods, energy products and services); the agreement contains an extensive table of the types of goods and services encompassed by these provisions of the agreement.

Chapter 7 sets forth dispute resolution provisions in an "arrangement" wherein is provided a Trade Framework Group for setting forth the mechanisms for implementing the agreement (under Article 7.2.1, entitled "High Level Engagement"), to be led by the U.S. Trade Representative and "a designated Vice Premier" of the PRC. Also provided are "macroeconomic meetings" led by the U.S Secretary of the Treasury and the designated Vice Premier of the PRC. For "daily work, the agreement provides a Bilateral Evaluation and Dispute Resolution Office for each country. The agreement permits each country to request information from the other (Article 7.3) and Article 7.4 sets forth mechanisms for dispute resolution (specifics for the "working procedures" of the Group are set forth in Annex 7-A).

The final Chapter 8 involves amendments, entry into force and termination provisions, and for further negotiations.

As mentioned above, one interesting feature of the agreement is that many of the provisions setting forth standards for protection of party rights contain the affirmative statement (requirement to requirement) that "[t]he United States affirms that existing U.S. measures afford treatment equivalent to that provided for in this Article," indicating that the negotiators conceded to adopt U.S. standards for intellectual property protection and other matters falling within the scope of the agreement. Indeed, it is difficult to ascertain any concessions made by the U.S. for obtaining China's approval of these terms. There is an aphorism that if a deal seems to good to be true then perhaps it isn't (true, that is). It is contrary to this administration's puffery that the U.S. might not get the better part of any agreement it enters, and when making arrangements with economically weaker partners that may tend to be true because the odds tend to be stacked in our country's favor. But in view of China's strengths it might be foolish to think that the Chinese will be as accommodating as the Trump Administration would prefer them to be, and agreements inconsistent with these realities are likely to be ephemeral.
Conference & CLE Calendar

January 26, 2020

January 28, 2020 – Biotechnology/chemical/pharmaceutical (BCP) customer partnership meeting (U.S. Patent and Trademark Office) – Alexandria, VA

January 28, 2020 – "Obtaining Patent Protection for Polymorphs of Drug Compounds" (J A Kemp) – 3:30 to 4:30 pm (GMT)

January 30, 2020 – "American Axle: Does Patent Subject Matter Eligibility Depend on Enablement?" (Fitch Even) – 12:00 to 1:00 pm (ET)

February 4, 2020 – "Leveraging Active Voice in Patent Claims" (Practising Law Institute) – 1:00 to 2:00 pm (EST)

February 13, 2020 – "Litigating Civil and Criminal Trade Secret Cases: Trends, Best Practices, and Lessons Learned" (Practising Law Institute) – 1:00 to 2:00 pm (EST)

February 18, 2020 – "Patent Eligibility and Section 101 Update" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)
Webinar on Patent Eligibility and Section 101 Update

January 25, 2020

McDonnell Boehnen Hulbert & Berghoff LLP will be offering a live webinar entitled "Patent Eligibility and Section 101 Update" on February 18, 2020 from 10:00 am to 11:15 am (CT). In this presentation, MBHB attorney and Patent Docs author Michael Borella will provide an update on all fronts, and synthesize disparate threads into a cohesive set of best practices for handling 101 issues in patent prosecution in particular. The webinar will focus on software, business methods, and other technologies that relate to the "abstract idea" exception, though the issues and recommendations do cross over into the life sciences fields as well. Topics to be cobered will include:

• Introduction and background
• Current 101 framework
• Case law update (the good, the bad, and the even worse)
• The Patent Office's updated guidance — analysis and applications
• Congressional (in)actionBest practices in light of the above
• Best practices in light of the above

While there is no fee to participate, attendees must register in advance. Those wishing to register can do so here. CLE credit is pending for the states of California, Illinois, New Jersey, New York, North Carolina, and Virginia.

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