Patent Docs

Senior Party Sigma-Aldrich Files Opposition to Junior Party Substantive Preliminary Motion No. 1 in Interference No. 106,133

April 18, 2022

By Kevin E. Noonan —

On December 3rd, Junior Party the Broad Institute, Harvard University, and MIT (collectively, Broad) filed its Substantive Preliminary Motion No. 1 in Interference No. 106,133 (which names Sigma-Aldrich as Senior Party), asking the Patent Trial and Appeal Board to substitute the interference Count, pursuant to the provisions of 37 C.F.R. §§ 41.121(a)(1)(i) and 41.208(a)(2). On March 16th Senior Party Sigma-Aldrich filed its Opposition to Broad's Motion.

As a reminder, Broad's Proposed Substitute Count takes the "McKelvey" format (comprising in the alternative a claim from one of each Party's applications in interference); the proposed change is in the portion of the Count reciting Broad's claims:

Proposed Count No. 3 (numbered presumably for consistency with other pending CRISPR-related interferences):

Sigma-Aldrich Application No. 15/456,204 (as declared)

or

Claim 2 of Broad Application No. 16/177,403:

52. A method comprising: introducing into, or expressing in, a eukaryotic cell having a DNA molecule,
    (I) a Cas9 protein or one or more nucleotide sequences encoding the Cas9 protein;
    (II) an RNA or one or more nucleotide sequences encoding the RNA, the RNA comprising: (a) a first RNA comprising a first ribonucleotide sequence and a second ribonucleotide sequence, and (b) a second RNA;
and
    (III) a template polynucleotide;
    wherein, the second RNA forms an RNA duplex with the second ribonucleotide sequence, and
    wherein, in the eukaryotic cell, the first ribonucleotide sequence directs the Cas9 protein to a target sequence of the DNA molecule, whereby the Cas9 cleaves both strands of the DNA molecule and the cleavage is repaired by integration of the template polynucleotide into the DNA molecule in the eukaryotic cell.

In proposing this Substitute Count, Broad emphasizes Sigma-Aldrich's contentions during prosecution that its invention comprised "cleave + insertion" CRISPR methods in eukaryotic cells which were patentably distinct from embodiments comprising "cleavage only" followed by non-homologous end joining of the cleaved DNA target. In making this Motion, Broad clearly intends to cabin Broad's claims at risk in the interference to a small subset of its claims.

In support of its Motion, Broad relied heavily on Sigma-Aldrich's arguments taking substantially the same position in Interference No. 106,132 against Junior Party the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier (collectively, "CVC") (see "Sigma-Aldrich Files Substantive Preliminary Motion 1 to Change the Count in Interference No. 106,132"), including arguments Sigma-Aldrich has made regarding the propriety of its claims not being part of other interferences having interfering subject matter limited to "cleavage only" eukaryotic CRISPR methods:

Sigma is properly not a party to those pending 'cleavage only' interferences because all of Sigma's involved claims are directed solely to the patentably distinct 'cleavage plus integration' technological advance in the art.

Sigma-Aldrich's Opposition's first argument for the Board to deny Broad's Motion No. 1 is procedural, that Claim 52 of U.S. Application No. 16/177,403 (the '403 application) had not been determined to be allowable when Broad filed its motion. In addition, Sigma-Aldrich contends "Broad's Claim 52 is exceedingly broad for at least eight reasons," as well as being properly subject to the first inventor to file requirements under the Leahy-Smith America Invents Act (and thus ineligible for consideration in an interference). Sigma-Aldrich also contends that" Broad never even asserts, let alone demonstrates, that "cleavage plus altering gene expression" is patentably distinct from "cleavage plus integration by [Homology-Dependent Recombination] HDR" (in a footnote providing a tally that "[o]f Broad's 461 involved patent claims, 340 claims are directed to "cleavage plus altering gene expression" (or an analogous recital), 42 claims are directed to insertion of a "template", and 8 dependent claims are directed to "cleavage plus integration by HDR"). Finally, Sigma-Aldrich asserts that Broad has neglected to "explain how Claim 52 is patentable over Sigma P1." Citing Louis v. Okada, 2011 Pat. App. 21 LEXIS 24048, at *10 (BPAI May 25, 2011), Sigma-Aldrich contends that a party in an interference must show that there is a genuine need to change the Count and not make a "change for change's sake."

With regard to the procedural deficiencies of Claim 52, Sigma-Aldrich asserts that Claim 52 on the date Broad files its motion had not been determined to be allowable by the Examiner and, indeed, prosecution of the '403 application had been suspended by the Examiner due to the Declaration of the '133 Interference (and is still suspended). As Sigma-Aldrich notes, "[i]nexplicably, the Examiner indicated Claim 52 was allowable 9 days before Time Period 3 in the interference (the deadline for filing Oppositions to each party's Preliminary Motions, as well as arising after cross-examination of each party's expert witnesses). This "after-the-fact (and procedurally improper)" occurrence doesn't provide Broad with justification to file its Motion prior to the Examiner's allowance of Claim 52, Sigma-Aldrich asserts. And moreover, Sigma-Aldrich contends that Broad's filing of their motion is contrary to the Board's mandates when it granted leave on September 20, 2022 for the parties to file their preliminary motions, specifically:

Broad's proposed Count 3 also includes Sigma application 15/456,204 claim 31, as in Count 1, but replaces Broad patent 8,697,359, claim 15 with Broad application 16/177,403 claim 52, which has not yet been determined to be allowable. (See Broad List, Paper 21, 5:7–6:12.)

Authorization for this motion is GRANTED to the extent that Broad may present arguments to substitute current Count 1 with proposed Count 3 wherein the Broad portion of the count reflects a patented or allowable claim. The motion shall be entitled "BROAD MOTION 1."

Sigma-Aldrich sets out a timeline for the Board's consideration, and in particular Broad's assertion in the motion that Claim 52 had been allowed (which seems at a minimum premature):

As set forth in its Opposition, Sigma-Aldrich identifies four substantive changes between the version of Claim 52 contained in Broad's proposed Count No. 3 and Claim 52 as allowed: the amendment "(1) introduces the new limitation of cleaving "both strands" of the DNA; (2) converts the active language limitation that "the template polynucleotide repairs" the cleavage, to the passive language limitation that the cleavage "is repaired by integration of the polynucleotide into the DNA molecule"; (3) introduces the term "integration" into the claim for the first time; and (4) removes the limitation that the cleavage repair is "by homology directed repair." Moreover, Sigma-Aldrich contends that the Examiner did not in fact indicate Claim 52 was allowable, either upon filing the amendment or in the "miscellaneous communication – no action count" communication issued thereafter, characterizing Broad's assertions to the contrary "misleading." Sigma-Aldrich reproduces portions of the U.S. Patent and Trademark Office's Patent Application Information Retrieval (PAIR) website to illustrate its argument in this regard, supported by copies of Office Actions containing express statements such as "The request for reconsideration has been considered but does NOT place the application in condition for allowance."

Sigma-Aldrich cites this evidence in support of its argument that Claim 52 was not in condition for allowance before the deadline date of Time Period 1, when Preliminary Motions were due. This evidence is also an indication that the Examiner's actions "indicating" Claim 52 was allowable are procedurally irregular, according to Sigma-Aldrich because, inter alia, they "change[d] the fundamental operative facts for a contested Motion pending before the Board," which "is inconsistent with at least the spirit of the USPTO's rules." "[C]ountenancing such ex parte maneuvering to alter key facts that are in an active inter partes dispute," Sigma-Aldrich contends, threatens to "undermine the Board's sole jurisdiction over the disputed subject matter, and would encourage future parties to similarly leverage ongoing ex parte prosecution to gain a possible strategic advantage in a co-pending interference." These allegations, of course, raise issues going far beyond this Motion and this Interference and implicate the Board's institutional legitimacy. In this interference Sigma-Aldrich contends that these activities are prejudicial.

The Opposition then asserts that on the merits Broad has failed to satisfy its burden that changing the Count is necessary in this interference, specifically with regard to lacking the assertion that such a change will accommodate a party's "best proofs." In addition, Sigma-Aldrich contends that the "best proofs" of its invention Broad asserts do not require a donor template, even though proposed Count 3 expressly requires a donor template, citing Broad's affirmative assertions in its Motion No. 1. Sigma-Aldrich also characterizes Broad's arguments to use the term "non-template claims" to "fabricate" a self-serving argument Sigma-Aldrich says it has not made. Sigma-Aldrich further argues that Broad has mischaracterized its arguments regarding what is patentably distinct, and also has failed to argue that Count 1 recites two patentably distinct inventions. Continuing its theme of Broad's mischaracterizations, Sigma-Aldrich states that "Broad alters the quotes of Sigma's arguments in that parallel interference [No. 106,132] in a misleading attempt to redraft CVC's claim limitation into two separate components: "such as 'cleaving or editing' or 'modulating transcription,'" whereas Sigma-Aldrich contends that it made clear in that interference that "CVC's claims permit proofs of invention directed to cleavage alone" (emphasis in brief). (Sigma-Aldrich makes a similar argument with regard to there being any patentable distinction between Sigma's claims to "cleavage + integration by HDR" and Broad's claims to "cleavage + altering gene expression.") Sigma-Aldrich reminds the Board that its position, made in its List of Proposed Motions, was that Count 1 encompassed CRISPR-mediated cleavage in a eukaryotic cell either to integrate a heterologous DNA sequence or alter expression of the targeted gene sequence (Sigma-Aldrich attesting to have taken the same position before the Board in the '132 Interference; indeed, Sigma-Aldrich expends several pages of its Opposition outlining specifically how its positions taken in this interference are "entirely consistent" with its positions taken in the '131 Interference). And, as Sigma-Aldrich notes, "[e]ven assuming arguendo that Sigma had raised a distinction between "cleavage plus integration" claims and so-called "Non-Template Claims" (which as discussed above is not true), Broad itself—as the movant—does not make any such contention in its motion." Broad has been content, according to Sigma-Aldrich, with "rel[ying] on Sigma's supposed arguments, while purposely taking no position itself on that (completely self-fabricated) issue" (emphasis in brief), citing almost two dozen instances of this alleged rhetorical conduct in Broad's Motion. It is but a short hop in Sigma-Aldrich's argument to its conclusion that Broad has accordingly not satisfied its burden that there is a good reason to change the Count in this interference. Sigma-Aldrich further argues that Broad has not shown that its "best proofs" include both sgRNA and dgRNA species.

Sigma-Aldrich also sets forth a claim chart, comparing Claim 15 and 18 of its U.S. Patent No. 8,697,359 (which form the basis for Broad's contribution to Count 1 as declared in this interference with Broad's Claim 52 of U.S. Application No. 16/177,403:

Sigma-Aldrich argues that this comparison shows that "Broad's unallowed Claim 52 is excessively broad and thus grossly inadequate to reasonably conform to either of the parties' inventions, not the least of which is that Claim 52 is not even limited to a CRISPR-Cas9 system."

These arguments include that:

• "Broad Claim 52 is not limited to a "standard" CRISPR-Cas9 system, illustrated by this claim comparison:

• "Broad's Claim 52 encompasses NHEJ end ligation, which is fundamentally different from homology-directed repair," illustrated by this claim comparison:

• "Broad Claim 52 encompasses a system with no tracr-RNA/Activator RNA that interacts with the Cas9 protein," end ligation, which is fundamentally different from homology-directed repair," illustrated by this claim comparison:

• "Broad Claim 52 encompasses a crRNA/Targeter RNA that performs all of the guiding functions of the guide RNA (emphasis in brief)," illustrated by this graphic:

• "Broad Claim 52 does not require that the guide RZNA hybridize to/bind with the target sequence," illustrated by this claim comparison:

• "Broad Claim 52 encompasses a split-Cas9 System, which Is beyond the scope of this interference and Broad's disclosed proofs of invention," illustrated by this graphic from Broad's Application 61/915,267:

• "Broad Claim 52 encompasses a guide RNA genus, but Broad's Disclosed proofs of invention are limited to a sgRNA species," and

• "Broad Claim 52 encompasses a wild-type Cas9 protein that would not be capable of entering a eukaryotic cell."

Sigma-Aldrich illustrates its AIA-related argument, that Broad's '403 application is not entitled to pre-AIA treatment with this graphic, showing the disjuncture between pre- and putatively post-AIA priority dates:

The basis for Sigma-Aldrich's assertions is that these applications claim embodiments comprising luciferase, which Sigma-Aldrich contends is not disclosed in any pre-AIA priority documents and thus breaks the benefit chain to pre-AIA treatment, a position Sigma-Aldrich argues it has taken since filing an Appendix to its List of Proposed Motions, and supported by this table:

Sigma-Aldrich's final two arguments in its Opposition are that, to the extent that claim correspondence is at issue between the parties it has addressed those arguments more fully in its Opposition to Broad's Preliminary Motion No. 3, and that the final deficiency in Broad's arguments in support of its motion to change the Count is that its motion fails to assert, much less establish, that its proposed Count 3 is patentable to Broad over Sigma's Provisional Application No. 61/734,256.
Faux-Populist Patent Fantasies from The New York Times

April 17, 2022

By Kevin E. Noonan —

On a spring Saturday in a year when three major holidays — Easter, Passover, and Ramadan — coincided or overlapped, The New York Times Editorial Board decided it was time to announce that the "United States Patent and Trademark Office is in dire need of reform" ("Save America's Patent System," The New York Times, April 16, 2022). Were that the case, the Times' rhetoric would deserve serious consideration; as it is, the Times continues a history of wrongheaded, faux populist rhetoric that comes to the entirely wrong conclusion.

This is evinced immediately by the principle basis for the sentiment regarding the patent system — "Drugs cost too much!" — and the basis for this conclusion: the Initiative for Medicines, Access and Knowledge (I-MAK), a policy advocacy group dedicated to lowering drug prices by attacking the patent system. The Times' reliance on I-MAK is particularly inopportune in light of recent events. First, Professor Adam Mossoff of George Mason University's Antonin Scalia School of Law published a report for the Hudson Institute, entitled "Unreliable Data Have Infected the Policy Debates Over Drug Patents," that raised serious issues over the data I-MAK relies upon in making its policy arguments regarding the relationship between drug pricing and patents. Professor Mossoff's critique was sufficiently provocative that Senator Thom Tillis wrote to I-MAK asking them to explain themselves (see E. McDermott, Tillis Wants More Info on I-MAK and Other Data Driving Anti-Patent Narratives Around Drug Pricing). I-MAK responded, not with the information the Senator requested but with a reiteration of their rhetoric (see E. McDermott, I-MAK Defends Integrity of Its Patent Data in Response to Tillis Letter), prompting the Senator to ask for further clarification. Professor Mossoff's analysis suggests the Senator will have a long wait for a satisfactory answer.

The Times also wrongfoots its example of so-called "patent evergreening" — insulin manufacturers providing devices for administering doses of the drug. The Times might have had a point if drug companies had taken off the market traditional insulin in vials and administered by patient injection with syringes — but a simple search shows that this is not the case. What these devices supply are ways for a patient to readily inject the correct dose, therefore improving compliance and avoiding dosage mishaps, which improves clinical outcomes and so is desirable to physicians because it avoids complications, thus reducing costs to payors such as insurance companies. And it is the very "simplicity" of the technology that prevents any one company from dominating the injection device market — after all, many different drugs besides insulin are delivered using such devices — and that both warrant and require patent protection, lest knockoffs flood the marketplace. This protects both American industry — from whence exactly does the Times Editorial Board suppose such cheap knockoffs would arise? — as well as providing the return on investment that regulatory approval costs require to incentivize development of products having such benefits for patients, their doctors, the insurance industry, and (because the bulk of drug costs are borne by the U.S. government one way or the other) taxpayers. And should the Times Editorial Board wish to understand rather than grandstand about this issue, there is academic scholarship, such as Professor Erika Lietzen's work in "The 'Evergreening' Metaphor in Intellectual Property Scholarship" and "Distorted Drug Patents" that would provide much better information for their readers.

The editorial resurrects for a new age an idea current at the turn of the century — that applicants could "wear down" examiners who would then grant patents "out of kindness, I suppose" — which created the ill-considered Claims and Continuation rules changes promulgated by the Patent Office encouraged by scholarship untethered to the realities of the Office or patent prosecution (see "The 'Word' on the New Continuation Rules (from the USPTO Webcast)" — Part I and Part II); they were enjoined by the District Court of East Virginia (see "Tafas v. Dudas; SmithKline Beecham Corp. v. Dudas (E.D. Va. 2007)") and invalidated six months later. These limitations on prosecuting patents were particularly deleterious for the type of complicated technology common in the biotechnology and pharmaceutical arts, where patent examiners, who are typically not lawyers and, while having degrees and perhaps experience in the relevant technologies are not "cutting edge," understandably require time to absorb and apply patent law to claims for such complex inventions. Ironically, it is the very diligent gatekeeping function that the Times Editorial Board alleges the examiners are not doing that causes the delays that require applicants to pursue lengthy prosecution efforts (all while the twenty years from filing term clock is ticking and applicants are losing time during which commercial products embodying their inventions have exclusivity).

Paradoxically, the very means by which Congress has provided a mechanism for eliminating "bad patents" (which frequently just means someone else's patent that prevents you from selling something you'd like to; see "The IPO's Marc Adler on Patent 'Quality'"), the Patent Trial and Appeal Board and the various flavors of post-grant review afforded challengers under the Leahy-Smith America Invents Act, come in for criticism, based on rules permitting the Board to refuse to institute a proceeding based on avoiding duplicate adjudications before the Office and in the courts (see M. Buttman, "Turning Away a Patent Challenge: The NHK-Fintiv Rule Explained," Bloomberg Law, March 3, 2021). In doing so, the Editorial Board comes perilously close to accusing the former Director of instituting the rules improperly, and in the process (again ironically) illustrating why Justice Thomas and others advocate overturning the protections from libel suits by public officials in N.Y. Times v. Sullivan.

Because no one can always be wrong — including the Times Editorial Board — there are a few, albeit precious few, reasonable ideas in the editorial. One is giving examiners more time for examination, which could "solve" the excess prosecution "problem" the editors perceive exists. Another is having increased public participation, although the means for achieving this goal smacks of the same motivation that has made virologists out of financial advisors during the pandemic — the idea that people who actually understand the process and issues are somehow suspect. And the idea asserted by the Times Editorial Board that the PTO does not coordinate with other agencies like the FDA and FTC is just wrong and illustrated by an example not representative of the realities of patent prosecution, such as the duty of candor and the penalty for violating it called inequitable conduct.

Perhaps the editors will be motivated to look into some of the deficiencies of their reasoning and understanding of the real issues facing innovation that the patent system grapples with, like "efficient infringement" by large companies with the financial wherewithal to expropriate smaller companies' inventions (see "The Proper Role of the Federal Circuit" and "The ACLU, Working for the Man"). But this is unlikely because reality does not fit the editors preconceived notion of what "everybody knows" (see "The Road to Hell Is Paved with What Everybody Knows"). The editorial pages of the Times have a long history with this type of prejudice (see "Science Fiction in The New York Times"; "The Anti-Patent Beat Goes on at The New York Times"; "Anti-Patent ("Sullivan?") Malice by The New York Times"; "The Continuing Assault on Innovation at The New York Times"; "War is Peace, Freedom is Slavery, Ignorance is Strength"; "New York Times to Innovation: Drop Dead"; and "More Patent Nonsense from The New York Times") and frankly there is no reason to think it will change. There is nothing in this latest editorial to the contrary.
Before You Complain About So-Called Bad Patents, Read This

April 17, 2022

By Michael Borella —

This weekend The New York Times published an editorial opinion entitled "Save America's Patent System." It bemoans the purported prevalence of "bad patents" — including "uninspiring tweaks" to existing products — that supposedly undermine innovation. This led the Times to call for radical patent reform.

The Times continues a trend that has been at play for well over a decade now. The "bad patents" narrative raises its misguided head from time to time and lodges complaints about the supposed inequities of the patent system. According to the Times, these include higher drug prices and extortion by patent assertion entities.

Perhaps ironically, the Times does not identify any of these "bad" patents. Every U.S. Patent has at least two unique numbers by which it can be differentiated from all others, but none of these are provided. Therefore, it is unclear which patents the Times believes to be "bad."

Further, the Times does not go into any detail regarding how it determined the "badness" of these unidentified patents. What part of the patents did the editorial board consider? Did they ask a patent attorney for help? Did they properly consider how the scope of the claimed invention might be construed?

If you think that you can just look at an issued patent and determine that it is "bad," think again. All patents are required to be novel and non-obvious (among other requirements). But the legal principles of novelty and non-obviousness are notoriously tricky, even for seasoned U.S. Patent and Trademark Office (USPTO) patent examiners, patent attorneys, and federal judges.

First of all, the claims of the patent define the invention. These numbered paragraphs at the end of each patent are where you start. All too often the popular press does little more than read the abstract of the patent and conclude that the patent is "bad." But the abstract is required by the USPTO to be no more than 150 words and thus is almost always a high-level summarization of what is claimed. Put another way, concluding that a patent is "bad" through a cursory reading of it is not unlike determining the guilt of a person accused of a crime by only considering their shoe size.

Instead, the claims must be construed. Claim terms are given their ordinary and customary meaning (e.g., based on dictionary definitions or how the term is used in the relevant field). Further, one must look to the specification of the patent to determine whether the inventors used any particular term in an unconventional fashion that would override its ordinary and customary meaning. Also, one must look to the file history of the patent (a written record of back-and-forth arguments made between the patentee and the USPTO that led to the granting of the patent) to determine whether the patentee made representations that would further color the definition of the terms. In some cases, testimony of the inventors or experts in the patent's field of technology may also be used to determine how the claims are to be interpreted.

As a consequence, rather than just glancing at the abstract, a drawing or two, or the claims themselves, the process for determining whether the claims are valid may require reviewing many hundreds of pages of documents. Further, much of the patent statute has been heavily interpreted by the courts. Thus, even after all of this material is reviewed, applying the law to the claims may involve additional review of a few dozen Supreme Court and Federal Circuit decisions. This is a process that can take weeks. And even after that, reasonable minds can differ. The legal notion of non-obviousness is still somewhat subjective.

Furthermore, some of the most innovative ideas and products are obvious only when 20-20 hindsight is applied. If you look at a patented invention and think "I could have done that!" slow down and think again about whether you could have come up with that idea only having the information available to the inventors at the time the application for this patent was filed.

Did the Times go through this process before complaining about "bad" patents? It seems unlikely.

Nonetheless, the Times did get some things right. It wrote that the USPTO has "devolved into a backwater office that large corporations game, politicians ignore and average citizens are wholly excluded from." This is mostly correct. The high cost of doing business with the USPTO (not to mention attorneys' fees) is prohibitive for most Americans. And the economics do favor the companies with deep pockets who can persist through multiple rounds of examination. And some patent assertion entities do act in bad faith, spamming lawsuits with the hope of recovering nuisance damages.

But this is not the whole story. To be fair, the USPTO regularly issues patents that it probably should not. But the USPTO also throws up arbitrary barriers to patenting solid inventions on the basis of dicey reasoning.

The quality of examination at the USPTO varies dramatically between art units and examiners. Not all examiners are equally well-trained on the technology or the law. Some seasoned examiners have 95% allowance rates and others allow less than 5% of their examined applications. If an individual inventor or small business patentee finds themselves with a difficult examiner, they may lack the resources to conduct an extended prosecution or to appeal. In some cases, the patentee will give up simply because it cannot afford to continue.

Also, once a patent is issued, the story is not over. Since the passing of the America Invents Act in 2011, patents can be pulled back into the USPTO for further review. Typically this occurs prior to or during litigation. Also, the 2014 Alice Corp. v. CLS Bank decision from the Supreme Court has made it significantly easier to invalidate software patents on completely sketchy grounds. As a result, litigation of even a patent reasonably believed to be valid is a very risky and expensive process.

The Times also fails to explain how small businesses can struggle to obtain a few (often just one or two) patents, and then have to spend millions over the course of years to shut down copyists and free-riders. In the last decade, the term "efficient infringer" has been used to describe how a large corporation can infringe its competitors' patents with little risk of consequence. Seeing a patent all the way from application to issuance to successfully winning an injunction, settlement, or damages award is not unlike trying to hop across a minefield on one leg.

Moreover, the strain on innovation goes both ways — an overly permissive patent system would limit innovation, but so does an overly strict system. Not granting patents that should be granted disincentivizes innovators from publicly disclosing their inventions and motivates the use of trade secrets instead. And an economy based on trade secret limits our ability to share our advances in science and technology — to stand on the shoulders of giants.

So determining whether a patent is "good" or "bad" is not at all analogous to sorting ripe fruit from rotten. It is a process that requires more than a glance and a roll of the eyes. You need to put in the work.

If the Times wants to improve the patent system, it needs to call for a higher quality of examination at the USPTO rather than a higher bar for non-obviousness. It needs to call for lower fees and a less onerous examination process for individual inventors and small companies. And it needs to stop its vigorous hand-waving away of the complexities of patent law in order to provide a more accurate and well-reasoned viewpoint.
Conference & CLE Calendar

April 17, 2022

April 19, 2022 – "Strategies for Stopping Patent Infringement on Amazon" (IPWatchdog and Vorys) – 12:00 pm (ET)

April 19, 2022 – Examination practices and procedural guidance for 35 U.S.C. § 103 obviousness rejections (Part 1) – virtual Instructor-Led Training (vILT) series (U.S. Patent and Trademark Office) – 9:00 am to 11:00 am (ET)

April 20, 2022 – Examination practices and procedural guidance for 35 U.S.C. § 103 obviousness rejections (Part 1) – virtual Instructor-Led Training (vILT) series (U.S. Patent and Trademark Office) – 1:00 pm to 3:00 pm (ET)

April 21, 2022 – "IP Developments in Russia: What You Need to Know" (The Intellectual Property Owners Association) – 11:00 am to 12:00 pm (ET)

April 21, 2021 – "UPC Masterclass: Participation Decision Making with Example Case Studies" (Mathys & Squire) – 6:00 pm (London time)

April 21, 2022 – Examination practices and procedural guidance for 35 U.S.C. § 103 obviousness rejections (Part 1) – virtual Instructor-Led Training (vILT) series (U.S. Patent and Trademark Office) – 5:00 pm to 7:00 pm (ET)

April 26-27, 2022 – Paragraph IV Disputes Conference (American Conference Institute) – New York City

May 24, 2022 – Examination practices and procedural guidance for 35 U.S.C. § 103 obviousness rejections (Part 2) – virtual Instructor-Led Training (vILT) series (U.S. Patent and Trademark Office) – 9:00 am to 11:00 am (ET)

May 25, 2022 – Examination practices and procedural guidance for 35 U.S.C. § 103 obviousness rejections (Part 2) – virtual Instructor-Led Training (vILT) series (U.S. Patent and Trademark Office) – 1:00 pm to 3:00 pm (ET)

May 26, 2022 – Examination practices and procedural guidance for 35 U.S.C. § 103 obviousness rejections (Part 2) – virtual Instructor-Led Training (vILT) series (U.S. Patent and Trademark Office) – 5:00 pm to 7:00 pm (ET)
Webinar on Stopping Patent Infringement on Amazon

April 16, 2022

IPWatchdog and Vorys will be offering a webinar entitled "Strategies for Stopping Patent Infringement on Amazon" on April 19, 2022 at 12:00 pm (ET). Jessica Cunning, Jeremy Harrison, Tim Ardizzone, and Jake Morgan of Vorys and Gene Quinn of IPWatchdog, Inc. will discuss avenues through which patent owners can leverage their patents to remove infringing products from the Amazon.com marketplace.

There is no registration fee for this webinar. However, those interested in registering for the webinar, should do so here.
USPTO Course on Examination Practices for Obviousness Rejections

April 16, 2022

As part of its virtual Instructor-Led Training (vILT) series, the U.S. Patent and Trademark Office will be offering a course where attendees can learn more about examination practices and procedural guidance for 35 U.S.C. § 103 obviousness rejections. Part 1 of the course will be held on April 19, 2022 from 9:00 am to 11:00 am (ET), April 20, 2022 from 1:00 pm to 3:00 pm (ET), and April 21, 2022 from 5:00 pm to 7:00 pm (ET); and Part 2 will be held on May 24, 2022 from 9:00 am to 11:00 am (ET), May 25, 2022 from 1:00 pm to 3:00 pm (ET), and May 26, 2022 from 5:00 pm to 7:00 pm (ET). The dates and times for Part 3 have not yet been announced. The course is based on recent training delivered to patent examiners, and will provide hypothetical examples of how to construct clear and complete 35 U.S.C. § 103 obviousness rejections. Attendees will learn basic information regarding:

• Obviousness statute
• Graham v. John Deere obviousness inquiries
• Guidelines for obviousness rejections
• Definition of a "prima facie" case

Those interested in registering for the webinar can do so here.
IPO Webinar on IP Developments in Russia

April 16, 2022

The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "IP Developments in Russia: What You Need to Know" on April 21, 2022 from 11:00 am to 12:00 pm (ET). Janet Cord of Ladas & Parry LLP, Victoria Friedman of Dennemeyer & Associates S.A., and Mark P. Mathison of Kilpatrick Townsend & Stockton LLP will provide updates related to protection and enforcement of IP in Russia, including the impact of sanctions on the maintenance of Russian IP and developments in Russian laws and in Russian courts impacting IP owners, and update attendees on other late-breaking IP developments related to the situation in Russia and discuss how IP owners should proceed in these uncertain and unprecedented times.

The registration fee for the webinar is $150 for non-members or free for IPO members (government and academic rates are available upon request). Those interested in attending the webinar should register here.
Mathys & Squire UPC Masterclass

April 16, 2022

Mathys & Squire will be offering a "UPC Masterclass: Participation Decision Making with Example Case Studies" on April 21, 2021 at 6:00 pm (London time). Chris Hamer and Andreas Wietzke of Mathys & Squire LLP will discuss all relevant aspects including the pros and cons of the UPC from the perspective of patent applicants, in-house counsel, and decision makers, and look at example case studies covering a range of industries, portfolio sizes and markets, as well as potential approaches.

While there is no cost to participate in the program, those interested in attending the webinar can register here.
Amgen Inc. v. Vidal (Fed. Cir. 2022)

April 14, 2022

By Donald Zuhn –-

Earlier today, the Federal Circuit reversed the Final Written Decision, and reconsideration of that decision, by the U.S. Patent and Trademark Office Patent Trial and Appeal Board, which determined that claims 1-24 of U.S. Patent No. 8,952,138 were unpatentable under 35 U.S.C. § 103(a).

The '138 patent is directed to methods for refolding proteins at high concentrations using a controlled reduction-oxidation (redox) reaction. Claim 1, the lone independent claim, is set forth below:

1. A method of refolding a protein expressed in a non-mammalian expression system and present in a volume at a concentration of 2.0 g/L or greater comprising:
    (a) contacting the protein with a refold buffer comprising a redox component comprising a final thiol-pair ratio having a range of 0.001 to 100 and a redox buffer strength of 2 mM or greater and one or more of:
        (i) a denaturant;
        (ii) an aggregation suppressor; and
        (iii) a protein stabilizer; to form a refold mixture;
    (b) incubating the refold mixture; and
    (c) isolating the protein from the refold mixture.

This appeal arose from a challenge of the '138 patent in an inter partes review by Petitioners Apotex Inc. and Apotex Corp. In its Final Written Decision, the Board construed the term "final thiol-pair ratio" as meaning "the relationship of the reduced and oxidized redox species used in the redox component of the refold buffer as defined by the [following] equation":
                    [reductant]²                    [oxidant]

Based on this construction, the Board determined that the Petitioners had demonstrated that claims 1-24 were unpatentable over U.S. Patent Publication No. 2007/0238860 in view of Hevehan and Clark, 54 Biotechnology & Bioengineering 221 (1997). Amgen appealed the Board's construction and determination of unpatentability, Apotex declined to participate in the appeal, and the USPTO intervened to defend the Board's decision.

On appeal, Amgen argued that the Board misconstrued the term "final thiol-pair ratio" because the claim "language makes clear that the redox component is a distinct volume from the refold buffer, and it is that redox component [rather than the refold buffer] that comprises the claimed 'final thiol-pair ratio'" (emphasis in Appellant's brief). According to the opinion, the Office "assume[d] that the only way to give meaning to the word 'final' in 'final thiol-pair ratio' and make sense of the '138 patent's claims and specification is to understand 'final thiol-pair ratio' in the context of the ultimate solution—i.e., the refold mixture—rather than specific ingredients therein—e.g., the redox component."

The panel agreed with Amgen, noting that "[a] straightforward reading of the claim language indicates that the 'final thiol-pair ratio' is an attribute of the redox component." The opinion also notes that the '138 patent specification distinguishes between the terms:

• "final thiol-pair ratio" — "In various embodiments the redox component has a final thiol-pair ratio" (emphasis in opinion);
• "buffer thiol-pair ratio" – "As used herein, the term 'buffer thiol-pair ratio' is defined by the relationship of the reduced and oxidized redox species used in the refold buffer . . ." (emphasis in opinion); and
• "system thiol-pair ratio" — "The buffer thiol-pair ratio is, however, only one component in determining the total system thiol-pair ratio in the total reaction" (emphasis in opinion).

In view of the claim language and disclosure in the specification, the panel determined that:

[T]he specification clearly and exclusively describes "final thiol-part ratio" as an attribute of the redox component. If claim 1 covered a [thiol-pair ratio] calculated in the refold buffer—as the Board construed and analyzed claim 1—claim 1 would have recited a "buffer thiol-pair ratio" rather than "final thiol-pair ratio."

The opinion states that "[t]he Board's construction, which treats the claimed 'final thiol-pair ratio' as an attribute of the redox component in the refold buffer rather than of the redox component independent of the refold buffer, is inconsistent with the plain language of claim 1 and the specification and is therefore unreasonably broad" (emphasis in opinion). The panel, therefore, held that the Board misconstrued the term "final thiol-pair ratio," and reversed the Board's decision, holding that Apotex had failed to demonstrate that claims 1-24 of the '138 patent were unpatentable under § 103(a).

Amgen Inc. v. Vidal (Fed. Cir. 2022)
Nonprecedential disposition
Panel: Circuit Judges Chen, Schall, and Stoll
Opinion by Circuit Judge Chen
Roche Diagnostics Corp. v. Meso Scale Diagnostics, LLC (Fed. Cir. 2022)

April 13, 2022

By Kevin E. Noonan —

U.S. patent law grants patent owners the right to grant licenses to their patents in analogy to landlords granting rents to real property as a license to use without obtaining ownership. 35 U.S.C. §§ 261-262. But the complexities that can ensue, both in what is licensed and when it is licensed (and when those licenses expire) can be daunting to the extent that the parties don't always agree. Such a case was decided by the Federal Circuit in Roche Diagnostics Corp. v. Meso Scale Diagnostics, LLC.

The technology relates to immunoassays that use in electrochemiluminescence (ECL) and certain patents to that technology. As stated at the beginning of the Federal Circuit's majority opinion, "Meso doesn't own these patents." Nevertheless, Roche filed a declaratory judgment action to have the court confirm its right to practice the claimed invention in the face of Meso's assertions that it held an exclusive license to them from a prior owner, IGEN International, Inc. These rights stem from Meso's origins in a joint venture between IGEN and Mesoscale Technologies. Meso was to perform a Research Program in ECL technology and was granted a license for the intellectual property arising therefrom (although as the opinion explains the scope of that license is at issue in this case). Roche is also an IGEN licensee, having obtained licenses originally obtained by Boehringer Mannheim GmbH upon its acquisition of that company by Roche (those licenses being limited to certain clinical fields of use relevant to the issues here). IGEN and Roche terminated those licenses and entered into new ones in 2003, granting Roche a non-exclusive license to ECL technology that contained field-of-use restrictions to "human patient diagnostics" but also permitted "incidental" out-of-field use subject to a 65% royalty rate. Roche paid IGEN $1.4 billion for the new license. Coincident with this new license IGEN transferred its ECL technology to a new venture, BioVeris. Then, in 2007, a Roche subsidiary acquired BioVeris for about $600 million and, Roche contended, with this acquisition all field-of-use restrictions ceased.

Not so fast, said Meso, who filed suit alleging that Roche breached the terms of the 2003 license by abrogating the field-of use restrictions. This lawsuit, in Delaware Chancery Court, was unsuccessful, because that court held Meso was not a party to that license and that only BioVeris (now owned by a Roche subsidiary) could enforce the field-of-use restrictions. Nevertheless, Meso was sufficiently persistent that Roche filed this DJ action to have determined once and for all the status of the license and any attendant field-of-use restrictions on its ability to sells ECL-reliant equipment without incurring patent infringement liability.

At trial, a jury found Meso had an exclusive license to the asserted patent claims, and that Roche directly infringed claim 33 of U.S. Patent No. 6,808,939 and induced infringement of claim 1 of U.S. Patent No. 5,935,779 and claims 38 and 44 of U.S. Patent No. 6,165,729. Adding insult to injury (short term, as it turned out), the jury also found that Roche's infringement was willful; the jury awarded $137,500,000 in infringement damages. The trial court granted Roche's JMOL on the jury's willfulness determination and denied Meso's motion for enhanced damages, as well as rendering judgment of non-infringement on three other patents for which Meso did not assert compulsory counterclaims. This appeal followed.

The Federal Circuit affirmed-in-part, reversed-in-part, vacated-in-part, and remanded, in an opinion by Judge Prost joined by Judge Taranto; Judge Newman dissented but only with regard to the jury's verdict of direct infringement of claim 33 of the '939 patent. The opinion sets forth relevant provisions of the licenses; with regard to the license between IGEN and Meso the panel recognized two "prongs" of licensed technology arising from this provision:

2.1. IGEN Technology. IGEN hereby grants to [Meso] an exclusive, worldwide, royalty-free license to practice the IGEN Technology to make, use and sell products or processes (A) developed in the course of the Research Program, or (B) utilizing or related to the Research Technologies; provided that IGEN shall not be required to grant [Meso] a license to any technology that is subject to exclusive licenses to third parties granted prior to the date hereof. In the event any such exclusive license terminates, or IGEN is otherwise no longer restricted by such license from licensing such technology to [Meso], such technology shall be, and hereby is, licensed to [Meso] pursuant thereto [emphasis in license term].

Meso asserted that its rights to the asserted patents stem from "prong (A)" of this license term, wherein the claimed technology "was developed in the course of the Research Program." The parties disagreed over the meaning of the word "developed" in this phrase, Roche contending it limited the licensed patents to those claiming newly invented technology while Meso's interpretation was without that limitation. The jury ultimately agreed with Meso and the District Court held that choice was one "between two reasonable views" in denying Roche's JMOL on this issue. (The jury also found Roche liable for inducement of infringement for technology falling under "prong B" but the Federal Circuit did not address this verdict because it reversed on other grounds discussed below.)

Roche reiterated its arguments before the Federal Circuit with insufficient avail to persuade a majority of the panel members. In addition to arguing the plain meaning of the word, Roche also asserted a "course of conduct" interpretation, to the extent that all the other parties to these agreements (Roche, IGEN, and BioVeris) had sold products that would have fallen within Meso's license throughout the period between 2003 and 2007 without Meso objecting. While agreeing that Roche's arguments "have considerable heft," the technology involved was claimed in the '779 and '729 patents (which predated the Research Program), for which the jury had found Roche liable for inducing infringement under 35 U.S.C. § 271(b) and which the panel unanimously agreed was erroneous. With regard to the jury's direct infringement verdict on the asserted '939 patent claim, this technology did not predate the Research Program. Moreover, the panel majority held that Roche had not preserved its argument that the evidence adduced in support of infringement was inadequate because it was relegated to a footnote. Accordingly, the majority affirmed the jury verdict that Roche directly infringed the '939 patent under 35 U.S.C. § 271(a).

Turning to Roche's liability for induced infringement, the Federal Circuit reversed because it found an absence of intent as well as an absence of an "inducing act" that would support liability. Citing the standards the Supreme Court enunciated in Global-Tech Appliances, Inc. v. SEB S.A., 563 U.S. 754, 765–66 (2011), the panel agreed with Roche that the District Court erred in applying a negligence standard ("known or should have known") rather than requiring a showing of specific intent (or "willful blindness") for finding inducement. And under this proper standard, the Federal Circuit held the jury's finding of infringement liability for inducement was "unsupportable."

A part of the panel's rationale was that the inducement finding (and the specific intent required to support it) was inconsistent with the District Court's grant of JMOL on willfulness, which is also assessed by a specific intent standard. In that JMOL grant the District Court stated that "at no time did Roche have a subjective intent to infringe (or induce infringement of) Meso's patent rights." (In a footnote, the Court noted that Meso had not cross-appealed the District Court's JMOL on willfulness. But somewhat curiously there was no mention in the opinion of the difference in the standard of proof between inducement, a preponderance, and willful infringement, clear and convincing evidence, and whether this difference should make a difference in the Court's conclusion.) The basis for the District Court's finding on willfulness was "Roche's reasonable interpretation of the contract provisions, [under which] Roche had no liability to Meso for patent infringement." A similar rationale underpinned the District Court's denial of Meso's motion for enhanced damages, wherein "[t]he evidence demonstrates that Roche had a good faith belief in its reasonable interpretation of the relevant contract provisions [and it also relied on Roche's] good faith, reasonable belief that the [BioVeris] acquisition meant the elimination of field-of-use restrictions—and, hence, no possibility of patent liability."

In a related issue, the Federal Circuit agreed with Roche that it had not committed any "inducing acts" within the "patent damages limitation period" under 35 U.S.C. § 286. The Court rejected Meso's argument that Roche's acts of inducement that arose during that period were continuing during the period where inducing acts would be subject to liability. But as the panel notes "[t]he district court did not cite any points of authority for this 'continuing-impact' standard, and neither does Meso," and contrary authority, specifically Standard Oil Co. v. Nippon Shokubai Kagaku Kogyo Co., 754 F.2d 345 (Fed. Cir. 1985), was both persuasive and controlling.

Finally, with regard to damages the Federal Circuit vacated and remanded on the principle that damages at trial had been imposed for direct infringement of the '939 patent and inducement of infringement on the '779 and '729 patents. In view of the Federal Circuit's decision that Roche was not liable for inducing infringement, Roche was entitled to a new damages trial under Omega Pats., LLC v. CalAmp Corp., 920 F.3d 1337, 1350 (Fed. Cir. 2019). In addition, the panel explicated the errors by the District Court in its apportionment calculus (or lack of it) regarding the extent to which the jury erred in arriving at the $137,500,000 damages award under Georgia-Pacific Corp. v. U.S. Plywood-Champion Papers, Inc., 446 F.2d 295 (2d Cir. 1971).

On Meso's cross-appeal regarding the three patents recited in Roche's DJ motion that the District Court held were not infringed because Meso did not state a compulsory counterclaim, the Federal Circuit agreed with Meso that while such an outcome might be appropriate for a future action involving these same patents the compulsory counterclaim doctrine does not bar assertion of these patents in the same proceeding. Thus, the Federal Circuit vacated and remanded for trial on these patents.

Judge Newman's dissent was based on her determination that Roche owned the '939 patent by virtue of their acquisition in the 2007 purchase from IGEN through BioVeris and thus Roche could not infringe its own patents. In her view, Meso has no rights to control the use of these patents outside the Research Program and she would reverse the District Court's denial of JMOL on the jury's verdict of direct infringement against Roche.

Roche Diagnostics Corp. v. Meso Scale Diagnostics, LLC (Fed. Cir. 2022)
Panel: Circuit Judges Newman, Prost, and Taranto
Opinion by Circuit Judge Prost; dissenting opinion by Circuit Judge Newman

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