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  • PTAB Life Sciences Report — Part IV

    By John Cravero and Richard Martin —

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

    Smith & Nephew, Inc. v. ConforMIS, Inc.

    PTAB Petition:  IPR2017-00510; filed December 20, 2016.

    Patent at Issue: U.S. Patent No. 7,981,158 ("Patient selectable joint arthroplasty devices and surgical tools," issued July 19, 2011) claims methods of generating, making, designing, and using a patient-matched surgical tool.

    Petitioner Smith & Nephew, Inc. is challenging the '158 patent on four grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, the '158 patent is the subject of a litigation captioned ConforMIS, Inc. v. Smith & Nephew, Inc., No. 1:16-cv-10420- IT (D. Mass.).  Also, Petitioner is filing a petition concurrently for inter partes review of the '158 patent (IPR2017-00511).


    Smith & Nephew, Inc. v. ConforMIS, Inc.

    PTAB Petition:  IPR2017-00511; filed December 20, 2016.

    Patent at Issue:  U.S. Patent No. 7,981,158 ("Patient selectable joint arthroplasty devices and surgical tools," issued July 19, 2011) claims methods of generating, making, designing, and using a patient-matched surgical tool.

    Petitioner Smith & Nephew, Inc. is challenging the '158 patent on two grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, the '158 patent is the subject of a litigation captioned ConforMIS, Inc. v. Smith & Nephew, Inc., No. 1:16-cv-10420- IT (D. Mass.).  Also, Petitioner is filing a petition concurrently for inter partes review of the '158 patent (IPR2017-00510).


    Lexion Medical LLC. v. SurgiQuest, Inc.

    PTAB Petition:  IPR2017-00518; filed December 21, 2016.

    Patent at Issue:  U.S. Patent No. 9,095,372 ("System and method for improved gas recirculation in surgical trocars with pneumatic sealing," issued August 5, 2015) claims a system for insufflation and recirculation of insufflation fluid in a surgical procedure.

    Petitioner Lexion Medical LLC is challenging the '372 patent on one ground as obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, the '372 patent is the subject of litigation captioned ConMed Corporation et al. v. Lexion Medical LLC., No. 6:16-cv-944-DNH/ATB (E.D. NY.).


    Smith & Nephew, Inc. v. ConforMIS, Inc.

    PTAB Petition:  IPR2017-00544; filed December 27, 2016.

    Patent at Issue:  U.S. Patent No. 7,534,263 ("Surgical tools facilitating increased accuracy, speed and simplicity in performing joint arthroplasty," issued May 19, 2009) claims tools and methods of making tools for repairing articular surfaces repair materials and for repairing an articular surface.

    Petitioner Smith & Nephew, Inc. is challenging the '263 patent on five grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, the '263 patent is the subject of a litigation captioned ConforMIS, Inc. v. Smith & Nephew, Inc., No. 1:16-cv-10420- IT (D. Mass.).  Also, Petitioner is filing a petition concurrently for inter partes review of the '263 patent (IPR2017-00545).


    Smith & Nephew, Inc. v. ConforMIS, Inc.

    PTAB Petition:  IPR2017-00545; filed December 27, 2016.

    Patent at Issue:  U.S. Patent No. 7,534,263 ("Surgical tools facilitating increased accuracy, speed and simplicity in performing joint arthroplasty," issued May 19, 2009) claims tools and methods of making tools for repairing articular surfaces repair materials and for repairing an articular surface.

    Petitioner Smith & Nephew, Inc. is challenging the '263 patent on five grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, the '263 patent is the subject of a litigation captioned ConforMIS, Inc. v. Smith & Nephew, Inc., No. 1:16-cv-10420- IT (D. Mass.).  Also, Petitioner is filing a petition concurrently for Inter Partes Review of the '263 patent (IPR2017-00544).


    Kaz USA, Inc. v. Exergen

    PTAB Petition:  IPR2016-01186; filed July 14, 2016.

    PTAB Trial Instituted Document filed December 27, 2016.

    Patent at Issue:  U.S. Patent No. 7,346,386 ("Temporal artery temperature detector," issued March 18, 2007) claims a body temperature detector.

    Petitioner KAZ USA, Inc. is challenging the '386 patent on six grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or obvious under 35 U.S.C. § 103(a) (grounds 2 through 6).  View the petition here.  Administrative Patent Judges Phillip J. Kauffman (author), Meredith C. Petravick, and William V. Saindon issued a decision instituting inter partes review of claims 1 and 2 as being anticipated under 35 U.S.C. § 102(b) by Pompei '813; claims 3, 4, 22, and 24 as obvious under 35 U.S.C. § 103(a) over Pompei '813 and Pompei '091; claims 1 and 2 as obvious under 35 U.S.C. § 103(a) over Banke and Houdas; and claims 3, 4, 22, and 24 as obvious under 35 U.S.C. § 103(a) over Banke, Houdas, and Pompei '091.

    Related Matters:  According to the petition, the '386 patent is involved in the litigation captioned Exergen Corp. v. Microlife Corp. et al., No. 1:15-cv-13387 (D. Mass).

  • Bayer CropScience AG v. Dow Agrosciences LLC (Fed. Cir. 2017)

    By Donald Zuhn —

    Federal Circuit SealEarlier this month, in Bayer CropScience AG v. Dow Agrosciences LLC, the Federal Circuit concluded that the District Court for the Eastern District of Virginia correctly confirmed an international arbitration tribunal's award of $455 million, modified the judgment such that post-judgment interest accrues at the federal statutory rate, and affirmed the judgment as modified.

    At the center of the dispute between Bayer CropScience NV and Bayer CropScience AG ("Bayer") and Dow Agrosciences LLC, Mycogen Plant Science, Inc., Agrigenetics, Inc., and Phytogen Seed Co. ("Dow") was a 1992 cross-licensing agreement between Hoechst AG (Bayer's predecessor) and Lubrizol Genetics, Inc. (Dow's predecessor), in which Hoechst granted Lubrizol Genetics licenses to the Leemans patent family (which describes and claims various technologies related to the pat gene, which confers resistance to the herbicide glufosinate) and the Strauch patent family.  Bayer CropScience NV now owns or co-owns the Leemans patent family as a successor of Plant Genetic Systems NV.  Bayer CropScience AG owns the Strauch patent family as a successor of Hoechst AG.  Article 4 of the 1992 agreement restricted the parties' use of the licensed technology, and Article 12 of the 1992 agreement stated that the agreement was to be governed by and construed in accordance with French law and that disputes were to be decided by arbitration in accordance with the Rules of Conciliation and Arbitration of the International Chamber of Commerce.

    Dow AgroSciences LLC produces the Enlist E3, Enlist E3+IR, Enlist Soybean, Enlist Cotton, Widestrike, and Widestrike 3 products, each of which contains the pat gene, through its subsidiaries, Mycogen Plant Science, Inc., Agrigenetics, Inc., and Phytogen Seed Co.  Between 2007 and 2008, Dow entered into a series of agreements with MS Technologies, LLC regarding the pat gene, and this collaboration resulted in the creation of the Enlist E3 products.

    In 2012, Bayer terminated the 1992 agreement with Dow, accusing Dow of materially breaching Article 4 of the agreement.  Bayer then sued Dow for infringement of several patents involved in the 1992 agreement.  Dow moved to dismiss or stay the action based on Article 12 of the agreement, and the District Court stayed the action.  Dow also filed six requests for inter partes reexamination of several patents involved in the 1992 agreement and one reissue patent corresponding to a patent involved in the agreement, alleging inter alia that certain claims of the patents were invalid for obviousness-type double patenting over two of the Strauch patents and a third patent.  (The opinion notes that the inter partes reexaminations remain pending before the U.S. Patent and Trademark Office and did not alter the Court's resolution of the appeal.)

    In 2015, an arbitral tribunal entered an award, finding that (1) Dow breached the 1992 agreement by effectively sublicensing the pat gene to MS Tech; (2) Dow infringed various claims of the Leemans patents by its creation and other activities involving the Enlist and Widestrike products; (3) certain asserted claims were not invalid for inadequate written description or lack of enablement; and (4) certain asserted patents were not invalid for obviousness-type double patenting over the Strauch patent.  The tribunal awarded Bayer $455,459,187 in damages, including $374,731,000 in lost-opportunity damages under French law for breach of contract and $67,837,000 in reasonable-royalty damages under U.S. law for patent infringement, and also awarded Bayer pre-award interest using a rate of 8% and declared that the same rate would apply to "post-award interest."

    Bayer moved the District Court to confirm the arbitral award, and Dow cross-moved to vacate the award.  Dow also moved to amend the judgment such that post-judgment interest would accrue at the rate specified by 28 U.S.C. § 1961(a) and not at the tribunal's 8% rate for "post-award interest."  The District Court confirmed the arbitral award and denied Dow's motion to amend the judgment, and Dow appealed to the Federal Circuit.

    The Federal Circuit, after concluding that it had jurisdiction under 28 U.S.C. § 1295(a)(1), turned to the arbitral award, stating that:

    Judicial review of the arbitral award at issue here is very limited even if, as we assume for present purposes, the standards governing both international and domestic arbitration apply.  In numerous ways, the relevant federal statutes and precedents make clear that ordinary legal or factual error is not a ground for disturbing an arbitral award like the one at issue here.

    The Court also noted that "[a] challenger must meet related, and similarly high, standards to support a refusal to confirm an award as contrary to public policy."

    In view of the strict limits for disturbing an arbitral award, the Federal Circuit rejected Dow's arguments attacking the arbitral award as counter to U.S. law or policies governing double patenting and post-patent-expiration royalties.  With respect to Dow's double patenting argument, the Federal Circuit stated that "[t]he tribunal carefully scrutinized Dow's argument," and "concluded that the patents were not commonly owned because Bayer CropScience AG and Bayer CropScience NV were different entities and Dow had not provided sufficient evidence to pierce the corporate veil separating them."  The Court also rejected Dow's argument that the tribunal's contract-damages award is partially unenforceable because it violates U.S. patent law limits on the recovery of post-expiration royalties for practicing a patent, determining that:

    Under the standards for public-policy and manifest-disregard challenges, we conclude, Dow has not established that the contract award—more precisely, the portion of the award reaching past the 2023 expiration of the RE’962 reissue patent—must be vacated based on Brulotte.

    The Court noted that in Brulotte v. Thys Co., 379 U.S. 29 (1964), the Supreme Court held unenforceable a licensing agreement that required the licensee to pay royalties after the expiration of the patent.

    The Federal Circuit also rejected a number of other arguments presented by Dow for vacating the arbitral award, including the arbitral tribunal's (1) rejection of Dow's written description and enablement defenses, (2) ruling on Bayer's reissue patent, (3) misconstruction of relevant contract provisions, and (4) imposition of an 8% rate for pre-award interest.  With respect to Dow's written description and enablement defenses, the Court noted that "its arguments amount to no more than allegations of ordinary legal error," and determined that "[t]he tribunal's analysis shows no manifest disregard of law or other error meeting the standards for rejection of arbitral determinations."  The Court also determined that none of Dow's other arguments warranted vacating the arbitral award.

    Although the Federal Circuit affirmed the District Court's decision to confirm the arbitral award, the Federal Circuit concluded that the District Court abused its discretion in denying Dow's motion to amend the judgment to use the federal statutory rate for post-judgment interest for the period beginning with the entry of the District Court's judgment.  The Federal Circuit therefore exercised its discretion under 28 U.S.C. § 2106 to "affirm, modify, vacate, set aside or reverse any judgment, decree, or order of a court lawfully brought before it for review," and modified the District Court's judgment to include the relief requested by Dow's motion to amend (i.e., post-judgment interest accruing from the date on which the District Court entered judgment at the rate established in § 1961).  The Federal Circuit then affirmed the judgment as modified.

    Bayer CropScience AG v. Dow Agrosciences LLC (Fed. Cir. 2016)
    Nonprecedential disposition
    Panel: Circuit Judges Moore, Taranto, and Chen
    Opinion by Circuit Judge Taranto

  • Conference & CLE Calendar

    CalendarMarch 21, 2017 – "USPTO Examiner Interview Strategies: Preparing for and Conducting Interviews to Advance Patent Prosecution" (Strafford) – 1:00 to 2:30 pm (EDT)

    March 21, 2017 – Post-argument discussion on Impression Products, Inc. v. Lexmark International, Inc. case (American University Washington College of Law Program on Information Justice & Intellectual Property) – 4:15 to 5:45 pm (Eastern), American University Washington College of Law in Washington, DC

    March 22, 2017 – "Patent Infringement: A Legal and Economic Outlook" (The Knowledge Group) – 3:00 to 5:00 pm (EST)

    March 30, 2017 – "Latest PTAB Decisions: Leveraging Trends in Institution and Final Written Decisions, Understanding Federal Circuit Scrutiny To Date" (Strafford) – 1:00 to 2:30 pm (EDT)

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

  • Washington College of Law Post-Argument Discussion of Impression Products v. Lexmark International

    Washington College of LawAs part of its ongoing Supreme Court series, the American University Washington College of Law Program on Information Justice & Intellectual Property will be hosting a post-argument discussion on the Impression Products, Inc. v. Lexmark International, Inc. case from 4:15 to 5:45 pm (Eastern) on March 21, 2017 at the American University Washington College of Law in Washington, DC.  The panel discussion will be moderated by Prof. Michael Carroll, American University Washington College of Law, with a panel consisting of Paul Hughes of Mayer Brown, Counsel for Petitioner; and Ariel Lavinbuk of Robins, Russell, Englert, Orseck, Untereiner & Sauber LLP, representing Costco Wholesale Corp. on amicus brief.

    Additional information about the post-argument discussion, including registration/CLE information, can be found here.

  • Webinar on Latest PTAB Decisions

    Strafford #1Strafford will be offering a webinar/teleconference entitled "Latest PTAB Decisions: Leveraging Trends in Institution and Final Written Decisions, Understanding Federal Circuit Scrutiny To Date" on March 30, 2017 from 1:00 to 2:30 pm (EDT).  Thomas L. Irving, Joshua L. Goldberg, and Cory C. Bell of Finnegan Henderson Farabow Garrett & Dunner will analyze the latest precedential and other notable Patent Trial and Appeal Board (PTAB) decisions in 2016 as well as PTAB outcomes at institution and final disposition, and offer IP counsel insight into what these decisions mean going forward and offer best practices for handling inter partes reviews (IPRs), covered business methods (CBMs), and other matters before the PTAB.  The webinar will review the following issues:

    • What are the latest developments regarding PTAB rulings on IPRs, CBMs and other matters?
    • What impact will these developments have on PTAB practice?
    • How have recent Federal Circuit opinions impacted practice at the PTAB?
    • What trends are anticipated for 2017—and how will this change PTAB practice?

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

  • Webcast on Patent Infringement Damages

    The Knowledge GroupThe Knowledge Group will offer a live webcast entitled "Patent Infringement: A Legal and Economic Outlook" on March 22, 2017 from 3:00 to 5:00 pm (EST).  Michael A. Einhorn, Ph.D., Economic Consultant and Expert Witness and author of "Media, Technology, and Copyright: Integrating Law and Economics"; Jeffery A. Stec, Vice President, Charles River Associates; and Clifford Chad Henson of Nelson Bumgardner PC will provide attendees with an in-depth analysis of patent infringement in legal and economic perspective, and also discuss recent court opinions and their impact on the current landscape of patent infringement litigation.  The panel will cover the following topics:

    • Basics of Patent Infringement Damages
    • Analytic Frameworks for Estimating Damages
    • Determining the Royalty Base
    • Understanding the Entire Market Value Rule
    • Calculating a Reasonable Royalty Rate
    • Standards for Proving Lost Profits Damages
    • Effect of FRAND Obligations and Competition Law on Patent Damages
    • Impact of Recent Court Decisions on Patent Damages Calculation

    The registration fee for the webcast is $299 (regular rate) or $199 (government/nonprofit rate).  Those interested in registering for the webinar can do so here.

  • PTAB Life Sciences Report — Part III

    By John Cravero and Richard Martin —

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

    Smith & Nephew, Inc. v. ConforMIS, Inc.

    PTAB Petition:  IPR2017-00487; filed December 14, 2016.

    Patent at Issue:  U.S. Patent No. 9,295,482 ("Patient selectable joint arthroplasty devices and surgical tools," issued March 29, 2016) claims joint arthroplasty system for repairing a diseased or damaged joint of a patient.

    Petitioner Smith & Nephew, Inc. is challenging the '482 patent on six grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, the '482 patent is the subject of a litigation captioned ConforMIS, Inc. v. Smith & Nephew, Inc., No. 1:16-cv-10420-IT (D. Mass.).  Also, Petitioner is filing a petition concurrently for Inter Partes Review of the '482 patent (IPR2017-00488).


    Smith & Nephew, Inc. v. ConforMIS, Inc.

    PTAB Petition:  IPR2017-00488; filed December 14, 2016.

    Patent at Issue:  U.S. Patent No. 9,295,482 ("Patient selectable joint arthroplasty devices and surgical tools," issued March 29, 2016) claims joint arthroplasty system for repairing a diseased or damaged joint of a patient.

    Petitioner Smith & Nephew, Inc. is challenging the '482 patent on six grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, the '482 patent is the subject of a litigation captioned ConforMIS, Inc. v. Smith & Nephew, Inc., No. 1:16-cv-10420-IT (D. Mass.).  Also, Petitioner is filing a petition concurrently for Inter Partes Review of the '482 patent (IPR2017-00487).


    Acclarent, Inc. v. Ford D Albritton IV

    PTAB Petition:  IPR2017-00498; filed December 15, 2016.

    Patent at Issue:  U.S. Patent No. 9,011,412 ("Apparatus, system and method for manipulating a surgical catheter and working device with a single hand," issued April 21, 2015) claims a system, methods of use, and an apparatus of a guide catheter insertable through an external body passage of a subject.

    Petitioners Acclarent, Inc. and Johnson & Johnson are challenging the '412 patent on five grounds as being anticipated under 35 U.S.C. § 102(b) (grounds 1, 3, and 4) or obvious under 35 U.S.C. § 103(a) (grounds 2 and 5).  View the petition here.

    Related Matters:  According to the petition, the '498 patent is the subject of litigation captioned Dr. Ford Albritton IV v. Acclarent, Inc., No. 3:16-cv-03340-D (N.D. Texas).  Also, the '498 patent was the subject of a breach of contract and declaratory judgement case filed by Petitioner captioned Acclarent Inc. v. Ford Albritton IV, No. 5:16-cv-06919 (N.D. Cal.), which was dismissed without prejudice.


    Fisher & Paykel Healthcare Ltd    . v. ResMed Ltd.

    PTAB Petition:  IPR2017-00501; filed December 16, 2016.

    Patent at Issue:  U.S. Patent No. 9,027,556 ("Mask system," issued May 12, 2015) claims a mask system for delivery of a supply of gas at positive pressure to a patient for medical treatment.

    Petitioner Fisher & Paykel Healthcare Ltd. is challenging the '556 patent on twelve grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, the '556 patent is the subject of litigation captioned Fisher & Paykel Healthcare Ltd. v. ResMed Corp., No. 3:16-cv-02068-DMS-WVG (S.D. Cal.).  Also, Petitioner is filing a petition concurrently for Inter Partes Review of the '556 patent (IPR2017-00504).


    Insys Development Co., Inc. v. GW Pharma Ltd.

    PTAB Petition:  IPR2017-00503; filed December 16, 2016.

    Patent at Issue:  U.S. Patent No. 9,066,920 ("Use of one or a combination of phyto-cannabinoids in the treatment of epilepsy," issued June 30, 2015) claims a method of treating partial seizure comprising administering cannabidiol (CBD), to a patient wherein the CBD is present in a specified amount or with tetrahydrocannabinol.

    Petitioner Insys Development Company, Inc. is challenging the '920 patent on three grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, there are no related maters.


    Fisher & Paykel Healthcare Ltd. v. ResMed Ltd.

    PTAB Petition:  IPR2017-00504; filed December 16, 2016.

    Patent at Issue:  U.S. Patent No. 9,027,556 ("Mask system," issued May 12, 2015) claims a mask system for delivery of a supply of gas at positive pressure to a patient for medical treatment.

    Petitioner Fisher & Paykel Healthcare LTD. is challenging the '556 patent on ten grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, the '556 patent is the subject of litigation captioned Fisher & Paykel Healthcare Ltd. v. ResMed Corp., No. 3:16-cv-02068-DMS-WVG (S.D. Cal.).  Also, Petitioner is filing a petition concurrently for Inter Partes Review of the '556 patent (IPR2017-00501).


    Merck Sharp & Dohme Corp. v. Mayne Pharma International Pty Ltd.

    PTAB Petition:  IPR2016-01186; filed June 11, 2016.

    PTAB Trial Instituted Document filed December 19, 2016.

    Patent at Issue:  U.S. Patent No. 6,881,745 ("Pharmaceutical compositions for poorly soluble drugs," issued April 19, 2005) claims a pharmaceutical composition consisting of an antifungal drug.

    Petitioner Merck Sharp & Dohme Corp. challenged the '745 patent on eleven grounds as being anticipated under 35 U.S.C. § 102(b) (grounds 1-9) or obvious under 35 U.S.C. § 103(a) (grounds 10 and 11).  View the petition here.  Administrative Patent Judges Toni R. Scheiner (author), Erica A. Franklin, and Jacqueline T. Harlow issued a decision instituting inter partes review of whether claims 1–3, 5–7, 9, 11, 12, and 14 are anticipated under 35 U.S.C. § 102 by Kai; claims 1, 3, 5, and 7 are anticipated under 35 U.S.C. § 102 by Thorpe; and claims 1–3, 5–7, and 9-14 are obvious under 35 U.S.C. § 103 over Kai, Sangekar, and Babcock.

    Related Matters:  According to the petition, the '745 patent is involved in a litigation captioned Mayne Pharma International Pty Ltd. v. Merck & Co., Inc., Case No. 15-cv-00438 (D. Del.).

  • Judge Bryson Rules That Jury Need Not Be Apprised of Presumption of Validity Standard for Granted Claims

    By Kevin E. Noonan —

    District Court for the Eastern District of TexasThis is a time when the eternal verities are routinely called into question, particularly in patent law.  For example, Judge Linn can state in a concurrence that, while there is no reason "in policy or statute" why the claims in Sequenom v. Ariosa are not patent eligible, he must rule that they are not based on binding Supreme Court precedent.  And earlier this week, Judge Bryson, sitting by designation in the District Court for the Eastern District of Texas (Marshall Division) ruled in a motion in limine in Erfindergemeinschaft Uroprep GbR v. Eli Lilly & Co. that a jury need not receive an instruction regarding the presumption of validity enshrined in the patent statute at 35 U.S.C. § 282 (Memorandum Opinion and Order).

    The basis for Eli Lilly's motion was that a jury might be confused by an instruction on the presumption, and Judge Bryson noted in his decision that district court cases have come down on "each side of the question."  In this case he decided to exclude evidence regarding the presumption, stating:

    In the Court's judgment, the use of the phrase "presumption of validity" would add little to the jury's understanding of the burden of proof on the validity issues.  Moreover, the phrase might be confusing to the jury, to the extent that the jury is required to consider both that phrase and the Court's instructions on the burden of proof.  At minimum, the use of the term "presumption" would require a further definitional instruction by the Court, without leading to any greater insight on the jury's part as to the nature of the burden of proof on the validity issues.  Accordingly, the Court will exclude the use of the phrase "presumption of validity" and instead will address the burden of proof in its instructions to the jury.

    The Court based its decision on Federal Circuit precedent, specifically Chiron Corp. v. Genentech, Inc., 363 F.3d 1247, 1258-59 (Fed. Cir. 2004).  In that case the issue was framed differently:  in particular, the question was whether instructions on the burden of proof were error for not including an instruction on the presumption of validity.  The Chiron court found no error because "the presumption of validity and heightened burden of proving invalidity 'are static and in reality different expressions of the same thing — a single hurdle to be cleared,'" citing Am. Hoist Derrick Co. v. Sowa Sons, Inc., 725 F.2d 1350, 1360 (Fed. Cir. 1984).  Perhaps more germane to Judge Bryson's decision, the Chiron court went on to say that "the presumption is one of law, not fact, and does not constitute `evidence' to be weighed against the challenger's evidence," citing Avia Group Int'l Inc. v. L.A. Gear Cal., Inc., 853 F.2d 1557, 1562 (Fed. Cir. 1988).  The Chiron court's reasoning, however, was that the instruction that the jury should apply the "clear and convincing" standard to the evidence made exclusion of an instruction on the presumption of validity not to be error.

    Judge Bryson's reasoning suggests that should Uroprep pursue an instruction on the proper evidentiary standard, his ruling should not affect the outcome.  It seems curious, however, that such a fundamental principle regarding the implication of the patent grant — that a patent is statutorily entitled to the presumption — should be kept from the fact-finder.  These are strange days indeed.

  • PTAB Life Sciences Report — Part II

    By John Cravero and Richard Martin —

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

    MonoSol Rx, LLC v. ICOS Corp.

    PTAB Petition:  IPR2017-00412; filed December 6, 2016.

    Patent at Issue:  U.S. Patent No. 6,943,166 ("Compositions comprising phosphodiesterase inhabitors for the treatment of sexual disfunction [sic]," issued September 13, 2005) claims a method of treating sexual dysfunction in a patient in need thereof comprising orally administering inhibitors of cyclic guanosine 3',5'-monophosphate specific phosphodiesterase type 5.

    Petitioner MonoSol Rx, LLC is challenging the '166 patent on three grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, the '166 patent is currently the subject of the following litigations (all in the Eastern District of Virgina):  Eli Lilly v. Cipla USA, Inc., et al., 16-cv-1208, Eli Lilly v. Aurobindo Pharma Ltd., et al., 16-cv-1121, Eli Lilly v. Alembic Pharma., Ltd., et al., 16-cv-1120, Eli Lilly v. Mylan Pharma., Inc., 16-cv-1122, Eli Lilly v. Actavis Laboratories UT, Inc., 16-cv-1119, Eli Lilly v. Sun Pharmaceuticals Industries, Ltd., et al., 16-cv-518, Eli Lilly v. Teva Pharmaceuticals, USA, Inc., 16-cv-519, Eli Lilly v. Zydus Pharma. (USA), Inc., 16-cv-520; Eli Lilly v. Sun Pharma. Industries, 16-cv-1168, Eli Lilly v. Teva Pharma. USA, Inc., 16-cv-1169, and Eli Lilly v. Zydus Pharma. (USA) Inc., 16-cv-1170.  Also, the '166 patent was/is the subject of Inter Partes Review IPR2016-00678 (IntelGenX Corp.; filed 02/26/2016; denied 09/01/2016), and IPR2017-00323 (Mylan Pharmaceuticals; filed 11/22/2016; pending).


    Edwards Lifesciences Corp. v. Boston Scientific Corp. and Boston Scientific Scimed, Inc.

    PTAB Petition:  IPR2017-00444; filed December 7, 2016.

    Patent at Issue:  U.S. Patent No. 6,915,560 ("Apparatus for contracting, loading or crimping self-expanding and balloon expandable stent devices," issued July 12, 2005) claims a stent crimper apparatus for manipulating a medical device comprising at least three coupled movable blades.

    Petitioner Edwards Lifesciences Corp is challenging the '560 patent on two grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, the '560 patent is subject of a litigation captioned Boston Scientific Corp. and Boston Scientific Scimed, Inc. v. Edwards Lifesciences Corp., Civil Action No. 8:16-cv-0730 (C.D. Cal.).


    Alembic Pharmaceuticals Ltd. v. UCB Pharma GmbH
    Amerigen Pharmaceuticals Ltd. v. UCB Pharma GmbH
    Torrent Pharmaceuticals, Ltd. v. UCB Pharma GmbH

    PTAB Petition:  IPR2016-01596; filed August 22, 2016.

    PTAB Petition:  IPR2016-01665; filed August 22, 2016.

    PTAB Petition:  IPR2016-01636; filed August 18, 2016.

    PTAB Trial Instituted Document filed December 7, 2016.

    Patent at Issue:  U.S. Patent No. 6,858,650 ("Stable salts of novel derivatives of 3,3-diphenylpropylamines," issued February 22, 2005) claims derivatives of 3,3-diphenylpropylamines and salt forms.

    Petitioners Alembic Pharmaceuticals (IPR2016-01596), Amerigen Pharmaceuticals (IPR2016-01665), and Torrent Pharmaceuticals, Ltd. (IPR2016-01636) are challenging the '650 patent on three grounds as obviousness under 35 U.S.C. § 103(a).  All Petitioners seek joinder with IPR2016-00510 (Mylan Pharmaceuticals Inc. and Mylan Laboratories Ltd.; filed 2/2/2016; instituted 7/20/2016) through Motions for Joinder under 35 U.S.C. § 315(c), 37 C.F.R. §§ 42.22 and 42.122(b).  View the petitions here (IPR2016-01596); here (IPR2016-01665); and here (IPR2016-01636).  Administrative Patent Judges Kristina M. Kalan, Robert A. Pollock, and Michelle N. Ankenbrand (author) issued a decision instituting inter partes review of whether claims 1–5 and 21–24 of the '650 patent as obvious under 35 U.S.C. § 103 over the combination of Postlind, Bundgaard publications, Detrol Label, and Berge; and claims 1–5 and 21–24 of the '650 patent as obvious under 35 U.S.C. § 103 over the combination of Brynne, Bundgaard publications, and Johansson.  The Judges also ordered that Case IPR2016-01596, Case IPR2016-01665, and Case IPR2016-01636 are joined with IPR2016-00510 and administratively terminated under 37 C.F.R. § 42.72, and all further filings in the joined proceedings shall be made in Case IPR2016-00510.  View the decisions here (IPR2016-01596); here (IPR2016-01665); and here (IPR2016-01636).

    Related Matters:  According to the petition, the '650 patent is involved in litigation in the District of Delaware, captioned Pfizer, Inc. and UCB Pharma GmbH v. Mylan Pharmaceuticals, Inc., No. 1:15-cv-00079-GMS; the Northern District of West Virginia, captioned Pfizer Inc. and UCB Pharma GmbH v. Mylan Pharmaceuticals Inc., No. 1:15-cv-00013-IMK; and in the District of Delaware, captioned Pfizer, Inc. and UCB Pharma GmbH v. Sandoz, Inc., et al., No. 1:13-cv-01110-GMS.


    Medtronic PLC v. Neurovision Medical Products, Inc.

    PTAB Petition:  IPR2017-00456; filed December 8, 2016.

    Patent at Issue:  U.S. Patent No. 8,634,894 ("Electrode for prolonged monitoring of laryngeal electromyography," issued January 21, 2014) claims a device for use in monitoring electrical signals during laryngeal electromyography.

    Petitioners Medtronic PLC, Medtronic Xomed, Inc., and Medtronic, Inc. are challenging the '894 patent on six grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, the '894 Patent is the subject of a litigation captioned Neurovision Medical Products, Inc. v. Medtronic Public Limited Company et al., No. 2:16-CV-00127 (E.D. Tx.).  Also, the '894 patent was and is involved in IPR2015-00502 (Petitioner, NuVasive, Inc.; filed 12/24/2014; terminated through settlement 07/29/2015); IPR2016-01405 (Petitioners, Medtronic PLC, Medtronic Xomed, Inc., and Medtronic, Inc; filed 07/11/2016; instituted 12/29/2016); IPR2016-01406 (Petitioners, Medtronic PLC, Medtronic Xomed, Inc., and Medtronic, Inc; filed 07/11/2016; instituted 12/29/2016).  Petitioner has filed a Motion for Joinder under 35 U.S.C. § 315(c) and 37 C.F.R. §§ 42.22–42.122(b), to join the instant proceeding with IPR2016-01405 and IPR2016-1406.


    Mylan Pharmaceuticals Inc. v Allergan, Inc.

    PTAB Petition:  IPR2016-01127; filed June 3, 2016.

    PTAB Trial Instituted Document filed December 8, 2016.

    Patent at Issue:  U.S. Patent No. 8,685,930 ("Methods of providing therapeutic effects using cyclosporin components," issued April 1, 2014) claims a topical ophthalmic emulsion comprising cyclosporin A for treating an eye with keratoconjuctivitis sicca.

    Petitioner Mylan Pharmaceuticals Inc. is challenging the '930 patent on three grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or as obvious under 35 U.S.C. § 103(a) (grounds 2 and 3).  View the petition here.  Administrative Patent Judges Sheridan K. Snedden (author), Tina E. Hulse, and Christopher G. Paulraj issued a decision instituting inter partes review of whether claims 1−36 of the '930 patent are anticipated under 35 U.S.C. § 102 by Ding '979; claims 1−36 of the '930 patent are obvious under 35 U.S.C. § 103(a) over the combination of Ding '979 and Sall; and claims 11, 23, and 35 of the '930 patent are obvious under 35 U.S.C. § 103(a) over the combination of Ding '979, Sall, and Acheampong.

    Related Matters:  According to the petition, the '930 patent is involved in litigations captioned Allergan, Inc. v. Teva Pharmaceuticals USA, Inc., et al., No. 2:15-cv-01455 (E.D. Tex.); Allergan, Inc., v. Innopharma, Inc. and Pfizer, Inc., No. 2:15-cv-1504 (E.D. Tex.); and Allergan, Inc. v. Famy Care, Ltd., No. 2:16-cv-0401 (E.D. Tex.).  Also, the '048 patent (see below) was the subject of IPR2015-01283 (Petitioners Apotex Corp. and Apotex Inc.; filed 06/04/2015; terminated through settlement 12/16/2015).  Petitioner concurrently filed inter partes review petitions to related patents in Case IPR2016-01128 (U.S. Patent No. 8,629,111 B2); Case IPR2016-01129 (U.S. Patent No. 8,642,556 B2); Case IPR2016-01130 (U.S. Patent No. 8,633,162 B2); Case IPR2016-01131 (U.S. Patent No. 8,648,048 B2); and Case IPR2016-01132 (U.S. Patent No. 9,248,191 B2).


    Mylan Pharmaceuticals Inc. v Allergan, Inc.

    PTAB Petition:  IPR2016-01128; filed June 3, 2016.

    PTAB Trial Instituted Document filed December 8, 2016.

    Patent at Issue:  U.S. Patent No. 8,629,111 ("Methods of providing therapeutic effects using cyclosporin components," issued February 11, 2014) claims a topical ophthalmic emulsion comprising cyclosporin A.

    Petitioner Mylan Pharmaceuticals Inc. is challenging the '111 patent on three grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or as obvious under 35 U.S.C. § 103(a) (grounds 2 and 3).  View the petition here.  Administrative Patent Judges Sheridan K. Snedden, Tina E. Hulse, and Christopher G. Paulraj (author) issued a decision instituting inter partes review of whether claims 1−27 are anticipated under 35 U.S.C. § 102(b) by Ding '979; claims 1−27 are obvious under 35 U.S.C. § 103(a) over the combination of Ding '979 and Sall; and claims 11 and 16 as obvious under 35 U.S.C. § 103(a) over the combination of Ding '979, Sall, and Acheampong.

    Related Matters:  According to the petition, the '048 patent (see below) is involved in litigations captioned Allergan, Inc. v. Teva Pharmaceuticals USA, Inc., et al., No. 2:15-cv-01455 (E.D. Tex.); Allergan, Inc., v. Innopharma, Inc. and Pfizer, Inc., No. 2:15-cv-1504 (E.D. Tex.); and Allergan, Inc. v. Famy Care, Ltd., No. 2:16-cv-0401 (E.D. Tex.).  Also, the '048 patent was the subject of IPR2015-01282 (Petitioners Apotex Corp. and Apotex Inc.; filed 06/04/2015; terminated through settlement 12/16/2015).  Petitioner concurrently filed inter partes review petitions to related patents IPR2016-01127 (U.S. Patent No. 8,685,930 B2); Case IPR2016-01129 (U.S. Patent No. 8,642,556 B2); Case IPR2016-01130 (U.S. Patent No. 8,633,162 B2); Case IPR2016-01131 (U.S. Patent No. 8,648,048 B2); and Case IPR2016-01132 (U.S. Patent No. 9,248,191 B2).


    Mylan Pharmaceuticals Inc. v Allergan, Inc.

    PTAB Petition:  IPR2016-01129; filed June 3, 2016.

    PTAB Trial Instituted Document filed December 8, 2016.

    Patent at Issue:  U.S. Patent No. 8,642,556 ("Methods of providing therapeutic effects using cyclosporin components," issued February 4, 2014) claims a topical ophthalmic emulsion for treating a human eye comprising comprising cyclosporin A.

    Petitioner Mylan Pharmaceuticals Inc. is challenging the '556 patent on five grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or obviousness under 35 U.S.C. § 103(a) (grounds 2 through 5).  View the petition here.  Administrative Patent Judges Sheridan K. Snedden, Tina E. Hulse, and Christopher G. Paulraj (author) issued a decision instituting inter partes review of whether claims 1–20 are anticipated under 35 U.S.C. § 102(b) by Ding '979; claims 1–20 are obvious under 35 U.S.C. § 103(a) over Ding '979 and Sall; claims 14 and 19 are obvious under 35 U.S.C. § 103(a) over Ding '979, Sall, and Glonek; claims 11, 18, and 20 are obvious under 35 U.S.C. § 103(a) over Ding '979, Sall, and Acheampong; and claim 19 is obvious under 35 U.S.C. § 103(a) over Ding '979, Sall, Glonek, and Acheampong.

    Related Matters:  According to the petition, the '556 patent is involved in litigations captioned Allergan, Inc. v. Teva Pharmaceuticals USA, Inc., et al., No. 2:15-cv-01455 (E.D. Tex.); Allergan, Inc., v. Innopharma, Inc. and Pfizer, Inc., No. 2:15-cv-1504 (E.D. Tex.); and Allergan, Inc. v. Famy Care, Ltd., No. 2:16-cv-0401 (E.D. Tex.).  Also, the '048 patent (see below) was the subject of IPR2015-01286 (Petitioners Apotex Corp. and Apotex Inc.; filed 06/04/2015; terminated through settlement 12/16/2015).  Petitioner concurrently filed inter partes review petitions to related patents IPR2016-01127 (U.S. Patent No. 8,685,930 B2); Case IPR2016-01128 (U.S. Patent No. 8,629,111 B2); Case IPR2016-01130 (U.S. Patent No. 8,633,162 B2); IPR2016-01131 (U.S. Patent No. 8,648,048 B2); and Case IPR2016-01132 (U.S. Patent No. 9,248,191 B2).


    Mylan Pharmaceuticals Inc. v Allergan, Inc.

    PTAB Petition:  IPR2016-01130; filed June 3, 2016.

    PTAB Trial Instituted Document filed December 8, 2016.

    Patent at Issue:  U.S. Patent No. 8,633,162 ("Methods of providing therapeutic effects using cyclosporin components," issued February 4, 2014) claims a method of treating dry eye disease comprising topically administering an emulsion comprising cyclosporin A.

    Petitioner Mylan Pharmaceuticals Inc. is challenging the '162 patent on three grounds of being obvious under 35 U.S.C. § 103(a).  View the petition here.  Administrative Patent Judges Sheridan K. Snedden, Tina E. Hulse (author), and Christopher G. Paulraj issued a decision instituting inter partes review of whether claims 1–10, 12–14, 16–20, and 22–24 are obvious over Ding '979 and Sall; claims 11 and 21 are obvious over Ding '979, Sall, and Acheampong; and claim 15 is obvious over Ding '979, Sall, and Glonek.

    Related Matters:  According to the petition, the '162 patent is involved in litigations captioned Allergan, Inc. v. Teva Pharmaceuticals USA, Inc., et al., No. 2:15-cv-01455 (E.D. Tex.); Allergan, Inc., v. Innopharma, Inc. and Pfizer, Inc., No. 2:15-cv-1504 (E.D. Tex.); and Allergan, Inc. v. Famy Care, Ltd., No. 2:16-cv-0401 (E.D. Tex.).  Also, the '048 patent (see below) was the subject of IPR2015-01278 (Petitioners Apotex Corp. and Apotex Inc.; filed 06/04/2015; terminated through settlement 12/16/2015).  Petitioner concurrently filed inter partes review petitions to related patents IPR2016-01127 (U.S. Patent No. 8,685,930 B2); Case IPR2016-01128 (U.S. Patent No. 8,629,111 B2); Case IPR2016-01129 (U.S. Patent No. 8,642,556 B2); IPR2016-01131 (U.S. Patent No. 8,648,048 B2); and Case IPR2016-01132 (U.S. Patent No. 9,248,191 B2).


    Mylan Pharmaceuticals Inc. v Allergan, Inc.

    PTAB Petition:  IPR2016-01131; filed June 3, 2016.

    PTAB Trial Instituted Document filed December 8, 2016.

    Patent at Issue:  U.S. Patent No. 8,648,048 ("Methods of providing therapeutic effects using cyclosporin components," issued February 11, 2014) claims method of increasing tear production in the eye of a human by topically administering an emulsion comprising cyclosporin A.

    Petitioner Mylan Pharmaceuticals Inc. is challenging the '048 patent on three grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here.  Administrative Patent Judges Sheridan K. Snedden (author), Tina E. Hulse, and Christopher G. Paulraj issued a decision instituting inter partes review of whether claims 1–10, 12–14, 16–20, 22, and 23 are obvious over Ding '979 and Sall; claims 11 and 21 are obvious over Ding '979, Sall, and Acheampong; and claim 15 is obvious over Ding '979, Sall, Acheampong, and Glonek.

    Related Matters:  According to the petition, the '048 patent is involved in litigations captioned Allergan, Inc. v. Teva Pharmaceuticals USA, Inc., et al., No. 2:15-cv-01455 (E.D. Tex.); Allergan, Inc., v. Innopharma, Inc. and Pfizer, Inc., No. 2:15-cv-1504 (E.D. Tex.); and Allergan, Inc. v. Famy Care, Ltd., No. 2:16-cv-0401 (E.D. Tex.).  Also, the '048 patent was the subject of IPR2015-01284 (Petitioners Apotex Corp. and Apotex Inc.; filed 06/04/2015; terminated through settlement 12/16/2015).  Petitioner concurrently filed inter partes review petitions to related patents IPR2016-01127 (U.S. Patent No. 8,685,930 B2); Case IPR2016-01128 (U.S. Patent No. 8,629,111 B2); Case IPR2016-01129 (U.S. Patent No. 8,642,556 B2); Case IPR2016-01130 (U.S. Patent No. 8,633,162 B2); and Case IPR2016-01132 (U.S. Patent No. 9,248,191 B2).

  • USPTO News Briefs

    By Donald Zuhn —

    USPTO Enhances Transaction Security for Deposit Account Authorizations

    USPTO SealThe U.S. Patent and Trademark Office announced today via a USPTO Alert e-mail that effective Wednesday, March 15, 2017, any charge to a deposit account appearing on any paper filed by mail, facsimile transmission, or via the EFS-Web, Trademark Electronic Application System (TEAS), or other USPTO storefronts, must be signed by a person listed in the USPTO's Financial Manager system as having fee payer permissions.  The Office announcement notes that any paper containing an authorization to charge a deposit account that is signed by anyone other than a deposit account fee payer in Financial Manager will not be accepted and the fee will not be considered paid.  In an Official Gazette notice published on February 14, 2017, the Office indicated that the above change was being implemented in an effort to further secure deposit account transactions.  Additional information regarding the above change can be found in the Office's OG notice.  Customers requiring assistance with the addition of users to their deposit accounts or with updating their Financial Manager permissions, can contact the Office by e-mail at FeesHelp@uspto.gov or by calling 800-786-9199 or 571-272-1000.


    USPTO Announces 2017 National Inventors Hall of Fame Inductees

    National Inventors Hall of FameIn a post on the Director's Forum Blog, Commissioner for Patents Drew Hirshfeld noted that the National Inventors Hall of Fame, in partnership with the U.S. Patent and Trademark Office, had announced the 2017 National Inventors Hall of Fame inductees.  According to the post, the criteria for induction into the National Inventors Hall of Fame requires candidates to hold a U.S. patent that has contributed significantly to the nation's welfare and the advancement of science and the useful arts.  The fifteen new inductees to the Hall, and their contributions, are as follows:

    • Iver Anderson — Lead-Free Solder
    • Don Arney — Bambi Bucket® for Aerial Firefighting
    • Carolyn Bertozzi — Bioorthogonal Chemistry
    • Earle Dickson — Band-Aid® Adhesive Bandage
    • Harold Froehlich — Alvin Deep-Sea Submersible
    • Haren Gandhi — Automotive Exhaust Catalysts
    • Eli Harari — Floating Gate EEPROM
    • Howard Head — Laminate Ski; Oversized Tennis Racket
    • Beatrice Hicks — Device for Sensing Gas Density
    • Allene Jeanes — Dextran Production; Xanthan Gum
    • Marshall Jones — Industrial Lasers
    • Tom Leighton — Content Delivery Network
    • Daniel Lewin — Content Delivery Network
    • Frances Ligler — Portable Optical Biosensors
    • Augustine Sackett — Drywall

    Additional information about the new Hall inductees can be found at the National Inventors Hall of Fame website.  The new inductees will be honored in a two-day event, which kicks off with an illumination ceremony at the USPTO campus in Alexandria, Virginia on May 3, 2017, and then is followed by the 45th Annual National Inventors Hall of Fame Induction Ceremony on May 4 at the National Building Museum in Washington, DC.  The National Inventors Hall of Fame is located in the Madison Building on the USPTO campus in Alexandria, Virginia.


    USPTO Announces Availability of New DCM Tool

    EFS-WebThe U.S. Patent and Trademark Office announced today via a Patent Alert e-mail that a new interim solution is now available for the Digital Certificate Manager (DCM).  The new interim solution, which has been available for EFS-Web and Private PAIR authentication since last fall, provides a plug-in-free option for users to authenticate and manage their Public Key Infrastructure (PKI) certificates, and will expand browser options until a new, permanent solution is in place.  The existing Java Applet authentication method will continue to be available.  The interim solution, which uses Java Web Start technology, allows users to authenticate into EFS-Web, Private PAIR, and DCM utilizing their current digital certificate while providing users with more flexibility in browser choice by reducing the dependency on the Java Applet plug-in.  Users wishing to use the Java Web Start authentication method must have version 8 of the Java Runtime Environment (JRE) software installed.  Customers requiring assistance with the new interim solution should contact the Patent EBC by e-mail at ebc@uspto.gov or by calling 1-866-217-9197.