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  • Webinar on CRISPR

    Technology Transfer Tactics will be offering a webinar entitled "CRISPR Confusion: A Legal and Practical Analysis for IP Professionals" on November 14, 2017 from 11:00 am to 12:00 pm (ET).  Patents Docs author Kevin E. Noonan of McDonnell Boehnen Hulbert & Berghoff LLP will cover the following topics:

    • A brief overview of the technology
    • A review of the patent positions of the parties
    • A discussion of the arguments raised in the Interference
    • An assessment of the PTAB's decision and its effect on the patents and applications
    • Analysis of strategies for further appeal
    • Impact on patent practice — claim strategy
    • Impact on licensing
    • Predictions regarding the patent and licensing landscape if the parties do not settle
    • Likelihoods and advantages of settlement

    The registration fee for the webinar is $197.  Those interested in registering for the webinar, can do so here.

    Technology Transfer Tactics

  • Bayer Pharma AG v. Watson Laboratories, Inc. (Fed. Cir. 2017)

    By Kevin E. Noonan –

    BayerThe Federal Circuit reversed a finding of non-obviousness on Friday based on clear error by the District Court on factual underpinnings of its obviousness determination, in Bayer Pharma AG v. Watson Laboratories, Inc.  Such decisions are rare, in view of the relevant standard of review.

    The standard of review after a bench trial on a district court's determination of whether a claim is obvious is clear error for factual questions and de novo review for questions of law (including obviousness itself).  Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1359 (Fed. Cir. 2007).  Clear error is a relatively deferential standard; as enunciated by the Supreme Court:

    "A finding is 'clearly erroneous' when[,] although there is evidence to support it, the reviewing court on the entire evidence is left with the definite and firm conviction that a mistake has been committed."  United States v. U.S. Gypsum Co., 333 U.S. 364, 395 (1948).

    The question arose in ANDA litigation over oral disintegration tablet (ODT) formulations of the erectile dysfunction drug vardenafil, wherein the formulation is an uncoated tablet that disintegrates rapidly when ingested orally; it is sold by Bayer as Staxyn® (an alternative formulation to Bayer's brand name Levitra® product).

    Litigation ensued over Orange Book-listed U.S. Patent No. 8,613,950, with Bayer asserting claims 9 and 11:

    8.  A drug formulation in the form of an uncoated tablet which disintegrates rapidly in the mouth and releases the drug in the mouth without swallowing the tablet comprising vardenafil hydrochloride trihydrate, and at least two sugar alcohols.

    9.  The drug formulation according to claim 8, wherein said sugar alcohols are a mixture of sorbitol and mannitol.

    11.  The drug formulation of claim 8, wherein at least one sugar alcohol is sorbitol.

    Watson PharmaceuticalsWatson adduced evidence of nine prior art references relevant to the ODT limitation recited in these claims, and another seven references asserted for the sorbitol and mannitol limitations.  Watson argued that the skilled worker would be motivated to make an ODT formulation for vardenafil, choose sorbitol and mannitol as component sugar alcohols, and make the formulation an immediate release formulation (required by the limitation "releases the drug in the mouth without swallowing the tablet").  The District Court rejected Watson's arguments and also opined that the cited art taught away from immediate release ODT formulations and that the objective indicia supported its nonobviousness determination.  As a consequence, the District Court held that Watson had not proven by clear and convincing evidence that asserted claims 9 and 11 would have been obvious.

    The Federal Circuit reversed in an opinion by Judge Moore, joined by Judges Lourie and O'Malley.  The opinion finds clear error in the factual findings of the District Court (although it leaves undisturbed the District Court's finding that the objective indicia support the nonobviousness decision).  With regard to ODT vardenafil formulations, the opinion attributes the District Court's finding to the testimony of Bayer's expert, Dr. Wicks being more persuasive than Watson's expert, Dr. Jacobs.  This testimony was directed to the absence of ODT formulations for erectile dysfunction drugs reflecting a general inapplicability of this formulation technology to be used with this class of drug.  This conclusion was based on the scarcity of ODT formulations for these drugs on the presumptive filing date, and failure of others (such as Pfizer with its Viagra® product) to market such drugs after announcing their intention to do so.  The Federal Circuit found clear error in this conclusion, in the face of the nine references adduced by Watson to support its argument with regard to ODT formulations.  In particular the opinion states:

    Dr. Jacobs testified that the Chang reference states "drugs for [ED] would be good candidates for ODT formulation."  He testified the Boolell and Fryburg references each disclose formulating vardenafil as an ODT.  He testified that numerous companies had already begun formulating ODT versions of ED drugs: Pfizer filed the Bell-Huff patent application directed to sildenafil ODT; Eisai filed the Furitsu patent application claiming an ODT formulation of phosphodiesterase inhibitors; and Lavipharm filed the Chen international patent application, identifying ODT versions of sildenafil [citations to the record omitted].

    And the nature of the District Court's contrary determination as clear error arose at least in substantial part because "[t]hese six references—Chang, Boolell, Fryburg, BellHuff, Furitsu, and Chen—are absent from the district court's decision."

    Moreover, specific statements in the District Court's opinion relating to its determination that the recited claims were non-obvious were "contradicted by the references cited by Dr. Jacobs that the court failed to consider," according to the Court's opinion.  The panel also identified positive statements from each of these references supporting the use of ODT formulations with vardenafil.  In addition, the opinion noted that "more than one company" applied for patents on ODT vardenafil formulations (a almost "reverse" objective index) and that the cited references were particularly directed to ODT and rapid dissolving ED formulations.  "All of these references indicate a person of ordinary skill in the art would have considered ODT formulations applicable to ED drugs," according to the opinion, and that some of them indicated that the skilled worker would have understood the references to apply particularly to vardenafil.  And Bayer's expert, Dr. Wicks, did not "cast doubt" on the weight of Watson's evidence in this regard in the Federal Circuit's view.  Rather, the opinion states that "[t]his case does not present a situation in which the district court's credibility determination can be understood to discount the prior art references it failed to address based on one expert's characterization of the prior art," citing Senju Pharm. Co. v. Lupin Ltd, 780 F.3d 1337, 1351 (Fed. Cir. 2015).

    The panel recognized that "[i]t is understood [that the District Court] discount[ed] the prior art references it failed to address based on [Bayer's] expert's characterization of the prior art," citing FilmTec Corp. v. Hydranautics, 982 F.2d 1546, 1553 (Fed. Cir.1992).  But the panel notes "a district court cannot, through a credibility determination, ignore the wealth of evidence, especially as in this case where the expert did not even address it."  A specific failure by the District Court was its reliance in the absence of ODT formulations of ED on the market at the relevant time as evidence of nonobviousness, because "[t]he motivation to combine inquiry is not limited to what products are forthcoming or currently available on the market" (if only in this case because of the vagaries of navigating the regulatory pathway at the FDA).  The motivation to prepare an ODT formulation of vardenafil was evident to the panel from the cited references, which were enough for the Federal Circuit to find clear error in the District Court's contrary determination.

    With regard to the choice of sugar alcohol components of the claimed formulation, the opinion notes that it was known in the art to include a sugar alcohol in ODT formulations (regardless of the active ingredient).  The dispute, according to the opinion, was whether the choice of sorbitol and mannitol as component sugar alcohols would have been obvious.  As with the ODT limitation, the Federal Circuit characterized the District Court's factual findings on this issue to be based on the competing testimony of Drs. Wick (Bayer) and Jacobs (Watson).  While not "question[ing] the district court's credibility determinations," here too the Federal Circuit found clear error in its conclusions.  The error was once again the District Court's reliance and focus on commercial availability rather than what was taught in the art, in the panel's opinion.  Part of that prior art was an off-the-shelf ODT excipient ("Pharmaburst") present in embodiments comprising mannitol alone or a combination of mannitol and sorbitol; the opinion notes that use of this excipient was taught in the '950 patent specification.  The District Court's conclusion that "there was nothing in the prior art that would have given the [person of ordinary skill in the art] a reason to use sorbitol in addition to mannitol in an ODT" was clearly erroneous in light of this evidence, according to the opinion.  The remainder of Watson's cited prior art was consistent with this understanding that mannitol or the combination of mannitol and sorbitol in ODT formulations was known in the prior art, and thus the District Court's determination to the contrary was clear error according to the Federal Circuit.  Particularly in regard to the relevance of FDA approval on the question of obviousness for a pharmaceutical formulation, the opinion states that "[w]hile FDA approval may be relevant to the obviousness inquiry,[] a lack of FDA approval cannot negate an otherwise apparent motivation to formulate a product."

    Finally, with regard to the question of whether it would have been obvious to develop an immediate-release ODT formulation of vardenafil, the District Court had held that the prior art taught away from making an oral immediate-release formulation based on expert testimony that vardenafil was bitter-tasting and that the expected increased bioavailability resulting from such a formulation would be deleterious for older men (an obvious target population for the drug).  While leaving undisturbed these factual findings, the panel found clear error in "elevat[ing] these findings to teaching away" as the District Court had done.  This error arose because the District Court's decision (in the panel's view) was based on whether the skilled worker would favor one formulation over another (e.g., delayed release), whereas the proper inquiry is whether the art taught that the alternative was "unlikely to be productive," citing Santarus, Inc. v. Par Pharm., Inc., 694 F.3d 1344, 1354 (Fed. Cir. 2012) (quoting Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006).  "When there are only two possible formulations and both are known in the art at the time, the fact that there may be reasons a skilled artisan would prefer one over the other does not amount to a teaching away from the lesser preferred but still workable option," and "obviousness 'does not require that the motivation be the best option, only that it be a suitable option from which the prior art did not teach away,'" according to the opinion, citing Par Pharm., Inc. v. TWI Pharm., Inc., 773 F.3d 1186, 1197–98 (Fed. Cir. 2014).

    In addition to overturning the District Court's obviousness determination the Federal Circuit awarded costs to Watson.

    Bayer Pharma AG v. Watson Laboratories, Inc. (Fed. Cir. 2017)
    Panel: Circuit Judges Lourie, Moore, and O'Malley
    Opinion by Circuit Judge Moore

  • USPTO Issues Final Rule Establishing Patent Agent Privilege

    By Josh Rich —

    USPTO SealEarlier today, the U.S. Patent and Trademark Office's Patent Trial and Appeal Board ("PTAB") published its Final Rule establishing the attorney-client privilege for application in PTAB proceedings.[1]  Before the PTAB, any communications between a client and a patent practitioner reasonably necessary and incident to the practitioner's authority will be protected by the attorney-client privilege applicable under Federal law.  But "patent practitioner" is defined far more broadly than just as attorneys, it includes both U.S. patent agents and foreign patent practitioners.  Thus, in 30 days when the rule takes effect, patent agent-client communications will be protected in inter partes review, post-grant review, the transitional program for covered business method patents, and derivation proceedings.

    The Final Rule reflects only small changes from a Proposed Rule published on October 18, 2016.  That Proposed Rule, in turn, came about because the issue of whether patent agent-client communications were discoverable was clearly in play.  In the USPTO, there was no clear rule on the issue and PTAB administrative law judges made discovery decisions on a case-by-case basis.  A recent Federal Circuit case had recognized such a privilege in Federal court litigation, but a subsequent Texas state law case found otherwise.  Based on the uncertainty over the rule, and a roundtable the USPTO had held in February 2015 to discuss privilege issues generally, the PTAB recognized the need for a clear rule.

    Numerous government agencies, intellectual property organizations, companies, and individuals had participated in the roundtable.  Nineteen parties also submitted comments afterward.  The strong consensus was that a privilege on communications between a client and a patent agent or foreign practitioner should be adopted, but there were various proposals for how to do so.  Suggested approaches included Federal legislation, a multilateral treaty, and the adoption of a rule by the USPTO.  Notably, the last of the options was criticized for potentially not being able to bind courts.

    However, in March 2016, the Federal Circuit held that communications between a client and a non-attorney patent agent that relate to Patent Office proceedings are privileged in Federal court cases.  In re Queen's University at Kingston, 820 F.3d 1287 (Fed. Cir. 2016).  In earlier cases, district courts had taken a variety of approaches ranging from fully recognizing such a privilege to finding that privilege applies only when the patent agent is supervised by a licensed attorney to rejecting the privilege entirely.  Following the line of cases rejecting such a privilege, the District Court compelled a patentee to produce communications between its employees and its non-attorney patent agents; the Federal Circuit reversed that determination based on a petition for mandamus.

    The Federal Circuit first considered which circuit's law to apply.  The issue of choice of law has special importance in the area of privilege, because Federal Rule of Evidence 501 provides that "in a civil case, state law governs privilege regarding a claim or defense for which state law supplies the rule of decision."  Fed. R. Evid. 501.  But the Federal Circuit applies its own law if a question arises out of an issue of substantive patent law.  Here, the Court found that a patentee's communications with its patent agent regarding prosecution of the patent are potentially relevant to substantive issues including claim construction, validity, and inequitable conduct.  Thus, the Court applied its own law, rather than any specific state's law.

    Then, to determine whether a patent agent privilege exists under Rule 501, the Court started with the Rule's indication that the common law — "in light of [a court's] reason and experience" — governs a claim of privilege.  In doing so, the Rule did not intend to freeze the law of privilege as of any given time, but rather intended to allow courts "to continue the evolutionary development of testimonial privileges."  The Federal Circuit found that the circumstances — including the unique roles of patent agents, congressional recognition of their authority to act, the Supreme Court's characterization of their activities as the practice of law, and current realities of patent litigation — counseled that the law had evolved to the point where it should recognize a patent-agent privilege independent of any involvement by a lawyer.

    Over fifty years ago, the Supreme Court had established that patent agents have a unique role in American law.  Sperry v. Florida ex rel. Florida Bar, 373 U.S. 379 (1963).  They are not members of any state bar (and therefore are not attorneys), but are authorized to practice before the Patent Office.  As the Sperry Court found, that practice is not law-like activity, it is actually the congressionally-authorized practice of law itself.  In Queen's University, the Federal Circuit applied that holding and found that it would counsel the adoption of a privilege to allow communications between any patent practitioner (agent or attorney) to the same degree.  As the Federal Circuit stated:

    Whether those communications are directed to an attorney or his or her legally equivalent patent agent should be of no moment.  Indeed, if we hold otherwise, we frustrate the very purpose of Congress's design: namely, to afford clients the freedom to choose between an attorney and a patent agent for representation before the Patent Office.

    Queen's University, 820 F.3d at 1298.[2]  Of course, because a patent agent is licensed to practice only before the Patent Office, the scope of the patent agent privilege is limited to communications in furtherance of, or reasonably necessary and incident to, patent prosecution tasks.  Other communications, such as opinions on infringement or the validity of another party's patents, are not subject to a patent-agent privilege.

    However, in August 2016, a Texas appellate court decided the Federal Circuit's Queen's University decision on patent-agent privilege would not apply in Texas state court proceedings.  In re Silver, 05-16-00774-CV, 2016 WL 4386004 (Tex. Ct. App. Aug. 17, 2016).  Unlike Rule 501 of the Federal Rules of Evidence, the Texas Rules of Evidence do not allow courts to recognize new discovery privileges.  The Texas court then found that the Queen's University holding was not binding upon it because the Federal Circuit was applying its own law in a patent case, where Federal patent law provided the rules for decision.  In contrast, the Silver case was a breach of contract case governed by Texas state law.  The Court therefore did not recognize any privilege and required the documents to be produced.  Interestingly, one of the judges dissented based on reasoning somewhat different from the Queen's University decision.  Specifically, he relied on the Sperry finding that patent agents were practicing law to determine that patent agents would qualify as "lawyers" under Texas privilege law because they were "person[s] authorized . . . to practice law in any state or nation" under Rule 503 of the Texas Rules of Evidence.  He therefore suggested that patent agent-client communications should be protected under the existing attorney-client privilege, rather than under a new privilege.

    Against this background, the PTAB proposed a new rule.  The proposed rule received wide, almost unanimous support among commentators.  Indeed, as the promulgation of the Final Rule shows, the comments expressing concern related more to issues that the rule did not address than the rule itself.  Most notably, several commentators expressed concern that the rule would expand the scope of permitted practice for patent agents to include PTAB proceedings.  However, patent agents are already permitted to participate in PTAB proceedings, and privilege applies to communications during all aspects of USPTO practice, including traditional practice.  That is, the only question addressed by the rule is whether such communications would later be discoverable in PTAB proceedings, not who can participate in such proceedings (which is addressed in 37 CFR § 11.5(b)).  One key point changed from the proposed rule to the final rule, however, was how it addressed privilege for foreign patent agents and others permitted to practice before the USPTO in a limited capacity.  The definitions in the rule were adjusted to reflected the PTAB's intent to protect communications between any such practitioners and clients from discovery.  Thus, the final rule (soon to be 37 CFR § 42.57) reads as follows:

    (a) Privileged communications. A communication between a client and a USPTO patent practitioner or a foreign patent practitioner that is reasonably necessary and incident to the scope of the patent practitioner's authority shall receive the same protections of privilege under Federal law as if that communication were between a client and an attorney authorized to practice in the United States, including all limitations and exceptions.

    (b) Definitions. The term ''USPTO patent practitioner'' means a person who has fulfilled the requirements to practice patent matters before the United States Patent and Trademark Office under § 11.7 of this chapter.  ''Foreign jurisdiction patent practitioner'' means a person who is authorized to provide legal advice on patent matters in a foreign jurisdiction, provided that the jurisdiction establishes professional qualifications and the practitioner satisfies them.  For foreign jurisdiction patent practitioners, this rule applies regardless of whether that jurisdiction provides privilege or an equivalent under its laws.

    (c) Scope of coverage. USPTO patent practitioners and foreign jurisdiction patent practitioners shall receive the same treatment as attorneys on all issues affecting privilege or waiver, such as communications with employees or assistants of the practitioner and communications between multiple practitioners.

    [1] 82 Fed. Reg. 51570-75 (Nov. 7, 2017).

    [2] The Queen’s University decision was a 2-1 decision with Judge Reyna dissenting both on the basis of any need for such a privilege and the evidentiary basis upon which the Court relied.

  • PTAB Life Sciences Report

    By John Cravero —

    USPTO SealAbout the PTAB Life Sciences Report:  Each month we will report on developments at the PTAB involving life sciences patents.

    Pfizer Inc. v. Biogen, Inc and Genentech, Inc.

    PTAB Petition:  IPR2017-02126; filed October 6, 2017.

    Patent at Issue:  U.S. Patent No. 7,682,612 ("Treatment of hematologic malignancies associated with circulating tumor cells using chimeric anti-CD20 antibody," issued March 23, 2010) claims a method of treating chronic lymphocytic leukemia (CLL) in a human patient, comprising administering rituximab to the patient in an amount effective to treat the CLL, wherein the rituximab is administered to the patient at a dosage of 500 mg/m2.

    Petitioner Pfizer Inc. is challenging the '612 patent on three grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petiton, the '612 patent is involved in inter partes review IPR2017-01227 (Celltrion, Inc.; filed 03/31/2017; institution denied 10/12/2017) and IPR2017-01230 (Celltrion, Inc.; filed 03/31/2017; institution denied 10/12/2017).


    Pfizer Inc. v. Biogen, Inc and Genentech, Inc.

    PTAB Petition:  IPR2017-02127; filed October 6, 2017.

    Patent at Issue:  U.S. Patent No. 8,206,711 ("Treatment of chronic lymphocytic leukemia using anti-CD20 antibodies," issued June 26, 2012) claims a method of treating chronic lymphocytic leukemia (CLL) in a human patient, comprising administering rituximab to the patient in an amount effective to treat the CLL, wherein the rituximab is administered to the patient at a dosage of 500 mg/m2.

    Petitioner Pfizer Inc. is challenging the '711 patent on three grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petiton, the '711 patent is involved in inter partes review IPR2017-01229 (Celltrion, Inc.; filed 03/31/2017; institution denied 10/23/2017).


    Actavis LLC v. Abraxis Bioscience, LLC

    PTAB Petition:  IPR2017-01101; filed April 4, 2017.

    Institution of Inter Partes Review; entered October 10, 2017.

    Patent at Issue:  U.S. Patent No. 7,820,788 ("Compositions and methods of delivery of pharmacological agents," issued October 26, 2010) claims a pharmaceutical composition for injection comprising paclitaxel and a pharmaceutically acceptable carrier, wherein the pharmaceutically acceptable carrier comprises albumin, wherein the albumin and the paclitaxel in the composition are formulated as particles, wherein the particles have a particle size of less than about 200 nm, and wherein the weight ratio of albumin to paclitaxel in the composition is about 1:1 to about 9:1.

    Petitioner Actavis LLC is challenging the '788 patent on two grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or obvious under 35 U.S.C. § 103(a) (ground 2).  View the petition here.  Administrative Patent Judges Jeffrey N. Fredman, Rama G. Elluru, and Susan L. Mitchell (author) issued a decision instituting inter partes review of whether claims 1-9, 11, and 12 of the '788 patent are anticipated by Desai; claims 1-12 of the '788 patent are obvious over Desai; and claims 1-12 of the '788 patent are obvious over the combination of Desai, Kadima, and Liversidge.

    Related Matters:  According to the petition, the '788 patent was asserted in Abraxis BioScience, LLC v. Actavis LLC, Case No. 2:16-cv-09074-JMV-MF (D.N.J. April 6, 2016), and in Abraxis BioScience, LLC v. Cipla Ltd., Case No. 2:16-cv-09074 (D.N.J. Dec. 7, 2016).  Also, Petitioners filed petitions for inter partes review of related U.S. Patent Nos. 8,853,260 (IPR2017-01100; filed 04/04/2017; institution denied 10/11/2017); 7,923,536 (IPR2017-00804; filed 01/30/2017; instituted 07/27/2017; pending); and 8,138,229 (IPR2017-01104; filed 04/04/2017; instituted 10/10/2017; pending).


    Actavis LLC v. Abraxis Bioscience, LLC

    PTAB Petition:  IPR2017-01104; filed April 4, 2017.

    Institution of Inter Partes Review; entered October 10, 2017.

    Patent at Issue:  U.S. Patent No. 8,138,229 ("Compositions and methods of delivery of pharmacological agents," issued October 26, 2010) claims a liquid pharmaceutical composition for injection comprising paclitaxel and a pharmaceutically acceptable carrier, wherein the pharmaceutically acceptable carrier comprises albumin, wherein the albumin and the paclitaxel in the composition are formulated as particles, wherein the particles have a particle size of less than about 200 nm, wherein the weight ratio of albumin to paclitaxel in the composition is about 1:1 to about 9:1, wherein the liquid pharmaceutical composition comprises about 0.5% to about 5% by weight of albumin, and wherein the liquid pharmaceutical composition further comprises saline.

    Petitioner Actavis LLC is challenging the '229 patent on two grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or obvious under 35 U.S.C. § 103(a) (ground 2).  View the petition here.  Administrative Patent Judges Jeffrey N. Fredman (author), Rama G. Elluru, and Susan L. Mitchell issued a decision instituting inter partes review of whether claims 1-19 and 21-48 of the '229 patent are anticipated by Desai; claims 1-19 and 21-48 of the '229 patent are obvious over Desai; claims 1-19 and 21-48 of the '229 patent are obvious over the combination of Desai, Kadima, and Liversidge; claim 20 of the '229 patent are obvious over the combination of Desai and Taxol label; and claim 20 of the '229 patent is obvious over the combination of Desai, Taxol label, Kadima, and Liversidge.

    Related Matters:  According to the petition, the '229 patent was asserted in Abraxis BioScience, LLC v. Actavis LLC, Case No. 2:16-cv-09074-JMV-MF (D.N.J. April 6, 2016), and in Abraxis BioScience, LLC v. Cipla Ltd., Case No. 2:16-cv-09074 (D.N.J. Dec. 7, 2016).  Also, Petitioners filed petitions for inter partes review of related U.S. Patent Nos. 8,853,260 (IPR2017-01100; filed 04/04/2017; institution denied 10/11/2017); 7,923,536 (IPR2017-00804; filed 01/30/2017; instituted 07/27/2017; pending); and 7,820,788 (IPR2017-01101; filed 04/04/2017; instituted 10/10/2017; pending).


    Samsung Bioepis Co., Ltd. v Genentech, Inc.

    PTAB Petition:  IPR2017-01960; filed August 25, 2017

    Institution of Inter Partes Review; entered October 13, 2017.

    Patent at Issue:  U.S. Patent No. 7,892,549 ("Treatment with anti-ErbB2 antibodies," issued February 22, 2011) claims a method for the treatment of a human patient with breast cancer that overexpresses ErbB2 receptor, comprising administering a combination of an antibody that binds ErbB2, a taxoid, and a further growth inhibitory agent to the human patient in an amount effective to extend the time to disease progression in the human patient, wherein the antibody binds to epitope 4D5 within the ErbB2 extracellular domain sequence.

    Petitioner Samsung Bioepis Co., Ltd is challenging the '549 patent on six grounds as obvious under 35 U.S.C. § 103(a).  Petitioners also seek joinder with IPR2017-00737 through Motions for Joinder under 35 U.S.C. § 315(c), and 37 C.F.R. §§ 42.22 and 42.122(b).  View the petition here.  Administrative Patent Judges Zhenyu Yang, Christopher G. Paulraj, and Robert A. Pollock (author) issued a decision instituting inter partes review of whether 1–11 and 14–17 are obvious over the combination of Baselga '97 and Gelmon; claim 12 is obvious over the combination of Baselga '97, Gelmon, and Drebin; claim 13 is obvious over the combination of Baselga '97, Gelmon, and Presta; claims 1–11 and 14–17 are obvious over the combination of Baselga '96, Baselga '94, and Gelmon; claim 12 is obvious over the combination of Baselga '96, Baselga '94, Gelmon, and Drebin; and claim 13 is obvious over the combination of Baselga '96, Baselga '94, Gelmon, and Presta.  The Judges also ordered that IPR2017-01960 and IPR2017-00737 be joined and administratively terminated IPR2017-01960 under 37 C.F.R. § 42.72, and all further filings in the joined proceedings shall be made in IPR2017-00737 (Petitioners, Hospira, Inc.; filed 01/20/2017; instituted 07/27/2017; pending).

    Related Matters:  According to the petition, the '549 patent is involved in inter partes reviews IPR2017-00737 (Hospira, Inc.; filed 01/20/2017; instituted 07/27/2017; pending); IPR2017-00739 (Hospira, Inc.; filed 01/20/2017; institution denied 07/27/2017); and IPR2017-01122 (Celltrion, Inc.; filed 03/21/2017; instituted 10/04/2017; pending).

  • Two-Way Media Ltd. v. Comcast Cable Communications, LLC (Fed. Cir. 2017)

    By Michael Borella —

    Federal Circuit SealTwo-Way Media brought an action against Comcast in the District of Delaware, claiming infringement of U.S. Patent Nos. 5,778,187, 5,983,005, 6,434,622, and 7,266,686.  The District Court dismissed the case on the pleadings, finding that all of the claims were ineligible under 35 U.S.C. § 101.  Two-Way Media appealed, and the Federal Circuit affirmed.

    The Supreme Court's Alice Corp. v. CLS Bank Int'l case 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 is directed to 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 generic computer implementation of an otherwise abstract process does not qualify as "significantly more."  On the other hand, a claimed improvement to a computer or technological process is typically patent-eligible.

    The Claimed Inventions

    The four patents-in-suit share a substantially common specification, and are directed to transmission of multimedia information over a network such as the Internet.  Claim 1 of the '187 patent was deemed representative of all claims of the '187 and '005 patents.  It recites:

    A method for transmitting message packets over a communications network comprising the steps of:
        converting a plurality of streams of audio and/or visual information into a plurality of streams of addressed digital packets complying with the specifications of a network communication protocol,
        for each stream, routing such stream to one or more users,
        controlling the routing of the stream of packets in response to selection signals received from the users, and
        monitoring the reception of packets by the users and accumulating records that indicate which streams of packets were received by which users, wherein at least one stream of packets comprises an audio and/or visual selection and the records that are accumulated indicate the time that a user starts receiving the audio and/or visual selection and the time that the user stops receiving the audio and/or visual selection.

    Claim 29, representative of the '622 patent, recites:

    A method for forwarding real-time information to one or more users having access to a communications network comprising:
        processing one or more streams of audio or visual information into one or more streams of packets for forwarding over the communications network, wherein at least one stream of packets comprises audio or video information,
        forwarding the digital packets to the users in response to information selection signals received from the users,
        verifying the operational status of the users' access to the communications network during delivery of the real-time information, and
        updating a database with indications of: (i) which streams of packets were received by which users, (ii) the time when delivery of each stream to each user commenced, and (iii) the time when delivery of each stream to each user terminated.

    Claim 30, representative of the '686 patent, recites:

    A method for metering real-time streaming media for commercial purposes, said method comprising:
        selecting an intermediate server from multiple intermediate servers;
        forwarding at least one copy of a real-time media stream from said intermediate server toward a user device;
        detecting a termination of said forwarding;
        after said termination, determining an extent of said real-time media stream forwarded toward said user device; and
        logging said extent for commercial purposes.

    The patents describe a problem related to transmission of packet data on the Internet.  Most of these transmissions are point-to-point, otherwise known as unicast.  In other words, there is one transmitting device and one receiving device.  Such mechanisms work well for certain types of communication, such as email or web transactions, but are inefficient for the distribution of multimedia, such as live video or audio streams, to many recipients.  There is no way for one device on the Internet to transmit a message addressed to all others.  And this limitation is by design — such broadcasts would rapidly overwhelm the capacity of the Internet as a whole.

    Internet multicasting, however, allows so-called multicast groups to be defined, and recipient devices may join these groups.  The transmitting device then sends a single copy of the packets through a series of one or more multicasting routers, each of which replicates the incoming stream of packets into two or more streams as needed to reach the recipient devices in the group.  When multicasting is functioning properly, a single transmission can reach multiple recipient devices without using significantly more network capacity that is absolutely needed.

    According to the Court:

    The patents describe the invention as an improved scalable architecture for delivering real-time information.  Embedded in the architecture is a control mechanism that provides for the management and administration of users who are to receive real-time information.

    In this system, the Primary Servers and Media Servers are interconnected by the internet.  The Control Servers connect users with Media Servers using a series of message exchanges.  The patents also describe monitoring network conditions and generating records about the real-time streams.

    Notably, the claims do not specifically mention multicasting.

    District Court Proceedings

    The District Court applied the Alice test first to claim 1 of the '187 patent.  It concluded that, under part one:

    The '187 and '005 patents are directed to the abstract idea of (1) sending information, (2) directing the sent information, (3) monitoring receipt of the sent information, and (4) accumulating records about receipt of the sent information.  The claims are thus directed to methods of sending and monitoring the delivery of audio/visual information.

    Under part two, the District Court found no evidence that the claims actually recite the architecture described in the patents' specification.  Accordingly, the District Court found that the claims did not include significantly more than this abstract idea, and therefore the'187 and '005 patents were ineligible under § 101.

    Regarding the remaining patents, the District Court found that "the '622 patent was directed to the abstract idea of monitoring the delivery of real-time information to a user or users, and the '686 patent was directed to the abstract idea of measuring the delivery of real-time information for commercial purposes."  Further, the additional elements in the representative claims were only generic computer components being used for their ordinary functionality.  As a result, these two patents were also found ineligible under § 101.

    Federal Circuit Review

    The Court began its analysis of the District Court decision by noting that, under part one of Alice, the claims should be considered as a whole.  Nonetheless, the Court wrote that "[w]e look to whether the claims in the patent focus on a specific means or method, or are instead directed to a result or effect that itself is the abstract idea and merely invokes generic processes and machinery."

    Addressing claim 1 of the '187 patent, the Court criticized its "result-based functional language."  Particularly, "[t]he claim requires the functional results of converting, routing, controlling, monitoring, and accumulating records, but does not sufficiently describe how to achieve these results in a non-abstract way."  Making an analogy to the claims found ineligible in the Court's Electric Power Group decision from last year, "claim 1 manipulates data but fails to do so in a non-abstract way."

    Even when presented with claim constructions proposed by Two-Way Media, the Court found that they did not "indicate how the claims are directed to a scalable network architecture that itself leads to an improvement in the functioning of the system."  Thus, the claim was deemed abstract.

    Regarding the part two analysis, the Court took issue with the apparent disparity between what the claim actually recited and the improvements that Two-Way Media alleged that it provided.  The Court asserted that "[t]he main problem that Two-Way Media cannot overcome is that the claim—as opposed to something purportedly described in the specification—is missing an inventive concept."  Thus, even if the specification described an inventive concept in the disclosed architecture, this architecture was not claimed.  For instance:

    Two-Way Media asserts that the claim solves various technical problems, including excessive loads on a source server, network congestion, unwelcome variations in delivery times, scalability of networks, and lack of precise recordkeeping.  But claim 1 here only uses generic functional language to achieve these purported solutions . . . .  Nothing in the claims or their constructions, including the use of intermediate computers requires anything other than conventional computer and network components operating according to their ordinary functions.

    The Court also found no inventive concept in the ordered combination of claim 1's limitations.  Instead, "[t]he claim uses a conventional ordering of steps—first processing the data, then routing it, controlling it, and monitoring its reception—with conventional technology to achieve its desired result."

    Consequently, the Federal Circuit agreed with the District Court that the '187 and '005 patents were ineligible.

    Turning to the '622 and '686 patents, Two-Way Media complained that the District Court had "erred by oversimplifying the claims down to merely their preamble and failing to recognize the claims solve technical problems."  But the Court found no problem with citing to a preamble as the distillation of a claim.  Under prong one of Alice, according to the Court, it is appropriate to determine the "focus" of the claim.  Regardless, the Court rapidly dismissed Two-Way Media's arguments, concluding that "the claims here—directed to monitoring the delivery of real-time information to user(s) or measuring such delivery for commercial purposes—are similar to other concepts found to be abstract."

    With respect to part two of Alice, the Court found the claims lacking for the same reasons as claim 1 — "nothing in these claims requires anything other than conventional computer and network components operating according to their ordinary functions."  Therefore, the '622 and '686 patents were also found ineligible.

    Analysis

    At first blush, it may seem as if this case is in tension with Enfish v. Microsoft.  In Enfish, the claims at issue recited a self-referential database, and the Court looked to the specification to determine whether this invention engendered a technical improvement.  Notably, the Court wrote in Enfish:

    The specification also teaches that the self-referential table functions differently than conventional database structures.  According to the specification, traditional databases, such as those that follow the relational model and those that follow the object oriented model, are inferior to the claimed invention.  While the structural requirements of current databases require a programmer to predefine a structure and subsequent data entry must conform to that structure, the database of the present invention does not require a programmer to preconfigure a structure to which a user must adapt data entry.  Moreover, our conclusion that the claims are directed to an improvement of an existing technology is bolstered by the specification's teachings that the claimed invention achieves other benefits over conventional databases, such as increased flexibility, faster search times, and smaller memory requirements.

    Thus, one may refer to the specification in order to determine the improvements provided by the claims.  In contrast, Two-Way Media asked the Court to look to the specification to further flesh out the details of the invention that were not actually claimed.  This distinction should be appreciated before sounding the alarm regarding the Federal Circuit's § 101 consistency (or lack thereof).

    Having said that, the Federal Circuit certainly can be schizophrenic when applying § 101.  Different panels have reviewed claims at different levels of detail under part one of Alice.  These panels have also varied with respect to part two, with some looking to the specification for guidance while others mostly ignoring it.  As a result, it is still very difficult to predict whether any given set of claims will be found patent-eligible.

    So the Federal Circuit can be criticized for failing to provide a consistent interpretation of the Alice test.  But this case exhibits less inconsistency with prior cases than meets the eye.

    Two-Way Media Ltd. v. Comcast Cable Communications, LLC (Fed. Cir. 2017)
    Panel: Circuit Judges Lourie, Reyna, and Hughes
    Opinion by Circuit Judge Reyna

  • Conference & CLE Calendar

    CalendarNovember 6, 2017 – Biotechnology/Chemical/Pharmaceutical (BCP) Customer Partnership Meeting (U.S. Patent and Trademark Office) – Alexandria, VA

    November 7, 2017 – "Personal Jurisdiction After Bristol-Myers Squibb: Unresolved Issues, Shifting Plaintiff Strategies" (Strafford) – 1:00 to 2:30 pm (EST)

    November 9, 2017 – "Leveraging USPTO Examiner Count System: Efficiently Prosecuting Patents, Lowering Prosecution Costs" (Strafford) – 1:00 to 2:30 pm (EST)

    November 9, 2017 – "Patent Drafting: Trends, Reality and Avoiding Rejections" (LexisNexis) – 2:00 pm (ET)

    December 4, 2017 – "Aqua Products, Inc. v. Matal, Answers or More Questions?" – Part II (Federal Circuit Bar Association) – 1:00 to 2:00 pm

    ***Patent Docs is a media partner of this conference or CLE

  • BCP Customer Partnership Meeting

    USPTO Building FacadeThe U.S. Patent and Trademark Office will be holding its next biotechnology/chemical/pharmaceutical (BCP) customer partnership meeting on November 6, 2017 at the USPTO Headquarters (Alexandria, VA).  The agenda for the meeting is as follows:

    • Welcoming and Opening Remarks (10:00 – 10:10 am EDT) — Daniel Sullivan, Wanda Walker, and Andrew Wang, Directors, TC1600, USPTO

    • Application Readiness (10:10 – 14:40 am) — Martin Rater, Senior Statistician USPTO

    • 112(b)- Practitioners' Perspective (10:40 – 11:40 am) — Melissa Brand, IP Policy Director, BIO; Rachel Elsby of Akin Gump

    • Lunch (11:40 am – 12:10 pm)

    • 112(b) Discussion Panel (12:10 – 1:30 pm) — Bennett Celsa, QAS, TC1600 (moderator); Melissa Brand, IP Policy Director, BIO; Jessica Marks of Finnegan; Jeffrey Fredman, APJ, PTAB; Jean Witz, SPE, CRU; Mary Till, Senior Legal Advisor, OPLA; Janet Andres, SPE, TC1600; and Zachariah Lucas, QAS, TC1600

    • Break (1:30 – 1:40 pm)

    • Personalized Medicine (1:40 – 2:40 pm) — Bruce Kisliuk of Wilson Sonsini Goodrich & Rosati, P.C.

    • Prosecution Tips and Traps for Patent Applications Examined Under the AIA (2:40 – 3:30 pm) — Kathleen Fonda, Senior Legal Advisor, Office of Patent Legal Administration (OPLA), USPTO

    • Break (3:30 – 3:40 pm)

    • Tips on Filing Reissue Applications (3:40 – 4:30 pm) — Jean Witz, SPE, CRU

    • Closing Remarks (4:40 – 5:00 pm) – Directors, TC1600, USPTO

    Additional information regarding the BCP customer partnership meeting, including registration information for those wishing to attend the meeting or register for online participation, can be found here.

  • Webcast on USPTO Examiner Count System

    Strafford #1Strafford will be offering a webcast entitled "Leveraging USPTO Examiner Count System: Efficiently Prosecuting Patents, Lowering Prosecution Costs" on November 9, 2017 from 1:00 to 2:30 pm (EST).  Adriana L. Burgy, Christopher C. Johns, and Kai Rajan of Finnegan Henderson Farabow Garrett & Dunner will provide guidance on leveraging the United States Patent & Trademark Office (USPTO) Examiner Count System to prosecute patents more effectively, provide insight into the count system, and offer strategies for interacting with patent examiners.  The webinar will review the following issues:

    • What impact does the number of claims in the application have on the quality of examination in the first office action?
    • How can patent counsel use the incentives of the count system to the client’s advantage?
    • How and when should patent counsel interact with examiners for effective and efficient prosecution?

    The registration fee for the webcast is $297.  Those interested in registering for the webinar, can do so here.

  • Webcast on Personal Jurisdiction

    Strafford #1Strafford will be offering a webcast entitled "Personal Jurisdiction After Bristol-Myers Squibb: Unresolved Issues, Shifting Plaintiff Strategies" on November 7, 2017 from 1:00 to 2:30 pm (EST).  Wystan M. Ackerman of Robinson & Cole and Leah Kelman of Herrick Feinstein will discuss the issue of personal jurisdiction over corporate defendants in light of the Supreme Court's recent Bristol-Myers Squibb v. Superior Ct. and BNSF Railway Co. v. Tyrrell rulings, review the progression of the Court's prior decisions on corporate jurisdiction, as well as lower court decisions issued since the BMS/BNSF rulings, and discuss key unresolved legal issues and expected litigation tactics by plaintiffs.  The webinar will review the following issues:

    • What are the implications of Bristol-Myers Squibb v. Superior Court for litigation proceeding in states where the defendant is not subject to general jurisdiction?
    • Does the Fifth Amendment similarly restrict personal jurisdiction by a federal court that the Fourteenth Amendment imposes on state courts?
    • How have plaintiffs adjusted their litigation strategies in response to prior Supreme Court cases restricting corporate personal jurisdiction and what might we expect to see post-Bristol-Myers Squibb?

    The registration fee for the webcast is $197.  Those interested in registering for the webinar, can do so here.

  • Webinar on Patent Drafting

    LexisNexisLexisNexis will be offering a webinar on "Patent Drafting: Trends, Reality and Avoiding Rejections" on November 9, 2017 at 2:00 pm (ET).  Gene Quinn, founder of IPWatchdog.com; Todd Van Thomme of Nyemaster Goode; Cynthia Gilbert of Blueshift IP, LLC; and Dave Stitzel, IP Solutions Consultant at LexisNexis® IP will discuss the following:

    • Nautilus versus In re Packard.
    • Identifying the invention/improvement versus KSR 103 concerns.
    • Best practices for ensuring a complete and thorough specification.
    • Means-plus-function and other 112 matters.

    Those interested in registering for the webinar, can do so here.