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  • FDA Relents, Grants Premarket Authorization to 23andMe Genetic Diagnostics Test

    By Kevin E. Noonan —

    FDAOn April 6th, the U.S. Food and Drug Administration (FDA) continued to loosen the reins on the genetic diagnostic and DNA analysis company 23andMe with regarding to direct-to-consumer (DTC) genetic testing related to predicting disease risk.  While falling short of permitting the company to provide risk analysis for disease likelihood in individuals per se, the agency granted permission to market its genetic diagnostic kits for a limited number of diseases according to an official announcement.  The agency's actions suggest that it believes there is sufficient evidence that the risks to the public it perceived that motivated its earlier restrictions are not as likely as once thought.

    23andMeThe FDA's actions come on the heels of the agency's approval of DNA diagnostics for Bloom's Syndrome earlier this year (see "23andMe Receives FDA Approval for Genetic Diagnostic Test").  Readers may recall that the FDA effectively stopped 23andMe from selling its genetic analysis kit, which the company marketed as Personal Genomic Services (PGS) in November 2013 by issuing a Warning Letter to the Company (see "FDA Threatens Agency Action Against 23andMe Over Personal Genetic Testing").  According to the FDA, genetic diagnostics assays fall under the agency's purview and authority because they are medical devices (21 U.S.C. § 321(h)).  According to its earlier letter, the testing service offered "is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body."  At that time, the agency professed a desire to work with the company to assist in developing the type and quantity of evidence required for approval, but warned that it had spent "significant time" evaluating the PGS test and providing feedback to 23andMe.  By complying with the agency by submitting the evidence for approval of a much more limited test, 23andMe was able to get the Bloom's Syndrome test approved.

    KitThis most recent approval is for ten genetic diseases as detected by 23andMe's at-home health-and-ancestry DNA testing kit (retailing at $199).  The kit detects single nucleotide polymorphisms (SNPs) related to development of these ten diseases having a genetic component:

    • Late-onset Alzheimer's – detecting the ε4 variant in the APO-E gene
    • Parkinson's  – the G2019S variant in the LRRK2 gene and the N370S variant in the GBA gene
    • Celiac disease – a variant in the HLA-DQ2.5 haplotype
    • Hereditary thrombophilia – Factor V Leiden variant in the F5 gene, and the Prothrombin G20210A variant in the F2 gene
    • Alpha-1 Antitrypsin Deficiency – PI*Z and PI*S variants in the SERPINA1 gene
    • Gaucher's disease type 1 – N370S, 84GG, and V394L variants in the GBA gene
    • Early-onset primary dystonia – deltaE302/303 variant in the DYT1 gene,
    • Factor XI deficiency – F283L, E117X, and IVS14+1G>A variants in the F11 gene,
    • Glucose-6-phosphate dehydrogenase deficiency – Val68Met variant in the G6PD gene,
    • Hereditary hemochromatosis – C282Y and H63D variants in the HFE gene

    The agency did not grant approval for tests related to developing a disease in an individual, in particular for detecting disease-related variants of the BRCA1 or BRCA2 genes related to breast and ovarian cancer.  Rather, the test results are predictive for the risk of inheritance of these genes by offspring, to be used inter alia to identify prospective parental pairs who both carry a disease-related allele and thus are at heightened risk for having a child with the disease.

    FDA approval for genetic health risk reports were evaluated through the de novo classification pathway, a regulatory process for low-to-moderate-risk medical devices, the company said.  In its approval, the FDA indicated it will create a class II exemption for 23andMe's substantially equivalent reports for other diseases and risk-predictive genes, provided that the company complies with agency requirements for establishing efficacy and safety.  These actions open a pathway for the company to release additional genetic health risk reports, 23andMe also said in its announcement.  "These special controls, when met along with general controls, provide reasonable assurance of safety and effectiveness for these and similar [genetic health risk] tests," the FDA added.  And the agency announced that it will outline a pathway for similar exemption for other DTC companies in the Federal Register.

    These tests are much more limited in scope than 23andMe's original test, which included more than 250 "diseases and conditions" such as BRCA gene mutations, diabetes, coronary artery disease, an sensitivities to drugs such as warfarin, clopidigrel, and 5-fluorouracil.  But the agency's approval, and avowed intention to permit 23andMe, and other companies, to market DTC genetic diagnostic tests suggest that the dawn of the age of personalized medicine has crept ever closer to breaking.

  • PTAB Life Sciences Report — Part I

    By John Cravero —

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

    Reckitt Benckiser LLC v. Ansell Healthcare Products LLC

    PTAB Petition:  IPR2017-00063; filed October 12, 2016.

    PTAB Trial Instituted; entered February 1, 2017.

    Patent at Issue:  U.S. Patent No. 9,074,027 ("Dip-formed synthetic polyisoprene latex articles with improved intraparticle and interparticle crosslinks," issued July 7, 2015) claims a synthetic polyisoprene elastomeric glove or condom made of a layer of elastomer comprising: synthetic polyisoprene particles; inter-polyisoprene particle crosslinks; and intra-polyisoprene particle crosslinks, wherein the intra-polyisoprene particle crosslinks and inter-polyisoprene particle crosslinks are substantially uniformly distributed among and between the synthetic polyisoprene particles.

    Petitioners Reckitt Benkiser LLC, Reckitt Benckiser Corporate Services Ltd., Reckitt Benckiser (ENA) B.V., Reckitt Benckiser Group plc, Reckitt Benckiser plc, and SSL Manufacturing (Thailand) Ltd. are challenging the '027 patent on written description issues in the chain of priority under 35 U.S.C. § 112; and also one ground as being anticipated under 35 U.S.C. § 102(b).  View the petition here.  Administrative Patent Judges Michael J. Fitzpatrick (author), Susan L. C. Mitchell, and Amanda F. Wieker issued a decision instituting inter partes review of claims 1–20 as being anticipated under 35 U.S.C. § 102 by U.S. Patent Application Publication No. US2009/0272384 A1.

    Related Matters:  According to the petition, the '027 patent is involved in the litigation:  Ansell Healthcare Products LLC v. Reckitt Benckiser LLC, C.A. No. 1:15-cv-00915 (D. Del.).  The petitioners concurrently filed a petition for inter partes review of U.S. Patent No. 9,074,029 (IPR2017-00066; Petitioner Reckitt Benkiser; filed 10/12/2016; Instituted 02/01/2017; pending).


    Reckitt Benckiser LLC v. Ansell Healthcare Products LLC

    PTAB Petition:  IPR2017-00066; filed October 12, 2016.

    PTAB Trial Instituted; entered February 1, 2017.

    Patent at Issue:  U.S. Patent No. 9,074,029 ("Dip-formed synthetic polyisoprene latex articles with improved intraparticle and interparticle crosslinks," issued July 7, 2015) claims a synthetic, dip-formed polyisoprene elastomeric condom comprising: synthetic polyisoprene particles, said synthetic polyisoprene particles bonded to each other through intra-polyisoprene particle crosslinks and inter-polyisoprene particle crosslinks; wherein the intra-polyisoprene particle crosslinks and the inter-polyisoprene particle crosslinks are such that the molecular weight is less than about 8000 g/mol between the crosslinks.

    Petitioners Reckitt Benkiser LLC, Reckitt Benckiser Corporate Services Ltd., Reckitt Benckiser (ENA) B.V., Reckitt Benckiser Group plc, Reckitt Benckiser plc, and SSL Manufacturing (Thailand) Ltd are challenging the '029 patent on written description issues in the chain of priority under 35 U.S.C. § 112; and also one ground as being anticipated under 35 U.S.C. § 102(b).  View the petition here.  Administrative Patent Judges Michael J. Fitzpatrick (author), Susan L. C. Mitchell, and Amanda F. Wieker issued a decision instituting inter partes review of claims 1–20 as being anticipated under 35 U.S.C. § 102 by U.S. Patent Application Publication No. US2009/027238 A1.

    Related Matters:  According to the petition, the '029 patent is involved in the litigation:  Ansell Healthcare Products LLC v. Reckitt Benckiser LLC, C.A. No. 1:15-cv-00915 (D. Del.).  The petitioners concurrently filed a petition for inter partes review of U.S. Patent No. 9,074,027 (IPR2017-00063; Petitioner Reckitt Benkiser; filed 10/12/2016; Instituted 02/01/2017; pending).


    Argentum Pharmaceuticals LLC. v. CIPLA Ltd.

    PTAB Petition:  IPR2017-00807; filed February 2, 2017.

    Patent at Issue:  U.S. Patent No. 8,168,620 ("Combination of azelastine and steroids," issued May 1, 2012) claims a pharmaceutical formulation comprising:  azelastine, or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable ester of fluticasone, wherein said pharmaceutical formulation is in a dosage form suitable for nasal administration.

    Petitioners Argentum Pharmaceuticals LLC; Intelligent Pharma Research LLC; APS GP LLC; APS GP Investors LLC; and KVK-Tech, Inc. are challenging the '620 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.

    Related Matters:  According to the petition, the '620 patent is involved in the litigations:  Meda Pharms. Inc. v. Apotex Inc., 14-cv-01453 (D. Del.); Meda Pharms. Inc. v. Teva Pharms., 15-cv-00785 (D. Del.); and Meda Pharms. Inc. v. Perrigo UK Finco Ltd., 16-cv-00794 (D. Del.).


    Apotex Corp. v. Novartis AG

    PTAB Petition:  IPR2017-00854; filed February 3, 2017.

    Patent at Issue:  U.S. Patent No. 9,187,405 ("S1P receptor modulators for treating relasping-remitting multiple sclerosis," issued November 17, 2015) claims a method for reducing or preventing or alleviating relapses in Relapsing-Remitting multiple sclerosis in a subject in need thereof, comprising orally administering to said subject 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol, in free form or in a pharmaceutically acceptable salt form, at a daily dosage of 0.5 mg, absent an immediately preceding loading dose regimen.

    Petitioners Apotex Inc., Apotex Corp., Apotex Pharmaceuticals Holdings Inc., and Apotex Holdings, Inc. are challenging the '405 patent on three grounds as being anticipated under 35 U.S.C. § 102(b) (ground 3) or as obvious under 35 U.S.C. § 103(a) (grounds 1 and 2).  View the petition here.

    Related Matters:  According to the petition, the '405 patent is not involved in any related matters.


    Rimfrost AS v. Aker Biomarine Antarctic AS

    PTAB Petition:  IPR2017-00746; filed February 3, 2017.

    Patent at Issue:  U.S. Patent No. 9,028,877 ("Bioeffective krill oil compositions," issued May 12, 2015) claims a method of production of krill oil comprising using supercritical fluid extraction in a two stage process.  Stage 1 removes the neutral lipid by extracting with neat supercritical CO2 or CO2 plus approximately 5% of a co-solvent.  Stage 2 extracts the actual krill oils by using supercritical CO2 in combination with approximately 20% ethanol.

    Petitioner Rimfrost AS challenging the '877 patent on four grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, the '877 patent is involved in the litigation:  Aker Biomarine Antarctic AS v. Olympic Holding AS; Rimfrost AS; Emerald Fisheries AS, Rimfrost USA, LLC; Avoca Inc.; and Bioriginal Food & Science Corp. Case No. 1:16-CV-00035-LPS-CJB (D. Del.).  The '877 patent is also involved in U.S. International Trade Commission Investigation No. 337-TA-1019, instituted 09/16/2016.


    Rimfrost AS v. Aker Biomarine Antarctic AS

    PTAB Petition:  IPR2017-00748; filed February 3, 2017.

    Patent at Issue:  U.S. Patent No. 9,028,877 ("Bioeffective krill oil compositions," issued May 12, 2015) claims a method of production of krill oil comprising using supercritical fluid extraction in a two stage process.  Stage 1 removes the neutral lipid by extracting with neat supercritical CO2 or CO2 plus approximately 5% of a co-solvent.  Stage 2 extracts the actual krill oils by using supercritical CO2 in combination with approximately 20% ethanol.

    Petitioner Rimfrost AS challenging the '877 patent on five grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, the '877 patent is involved in the litigation:  Aker Biomarine Antarctic AS v. Olympic Holding AS; Rimfrost AS; Emerald Fisheries AS, Rimfrost USA, LLC; Avoca Inc.; and Bioriginal Food & Science Corp. Case No. 1:16-CV-00035-LPS-CJB (D. Del.).  The '877 patent is also involved in U.S. International Trade Commission Investigation No. 337-TA-1019, instituted 09/16/2016.


    Mylan Pharmaceuticals, Inc. v. Boehringer Ingelheim International GmbH

    PTAB Petition:  IPR2016-01563; filed August 10, 2016.

    PTAB Trial Instituted; entered February 3, 2017.

    Patent at Issue:  U.S. Patent No. 8,673,927 ("Uses of DPP-IV inhibitors," issued March 18, 2014) claims a method of treating type II diabetes mellitus comprising administering to a patient in need thereof a pharmaceutically effective oral amount of 1-[(4-methyl-quinazolin-2-yl)-methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)– amino-piperidin-1-yl)-xanthine, and a pharmaceutically effective amount of metformin, which is from 300 mg to 1000 mg once or twice a day, or delayed-release metformin in a dose of 500 mg to 1000 mg once or twice a day or 500 mg to 2000 mg once a day.

    Petitioners Mylan Pharmaceuticals, Inc., Mylan Laboratories Ltd., Mylan Inc., and Mylan N.V. are challenging the '927 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 Toni R. Scheiner, Brian P. Murphy (author), and Zhenyu Yang issued a decision instituting inter partes review of whether claims 1 and 10 are obvious under 35 U.S.C. § 103(a) over the '510 Publication, Ahrén, Hughes, and Brazg.

    Related Matters:  According to the petition, the '927 patent is the subject the following litigation:  Boehringer Ingelheim Pharmaceuticals Inc., et al. v. HEC Pharm Group, et al., No. 3:15-cv-05982-PGS-TJB (D.N.J.).  Petitioner concurrently filed petitions for inter partes review of U.S. Patent Nos. 9,173,859 (IPR2016-01566; filed 08/10/2016; institution denied 02/03/2017); 8,846,695 (IPR2016-01564; filed 08/10/2016; instituted 01/31/2017; pending); and 8,853,156 (IPR2016-01565; filed 08/10/2016; instituted 02/09/2017; pending).


    Carefusion Corp. v. Baxter International, Inc.

    PTAB Petition:  IPR2016-01463; filed July 19, 2016.

    PTAB Trial Instituted; entered February 6, 2017.

    Patent at Issue:  U.S. Patent No. 6,231,560 ("Method and apparatus for automatically controlling the level of medication," issued May 15, 2001) claims a method for automatically controlling the level of a patient's medication administered from a programmable infusion pump.

    Petitioners Carefusion Corporation and Becton, Dickinson and Company are challenging the '560 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 Richard E. Rice (author), Robert J. Weinschenk, and Amanda F. Wieker issued a decision instituting inter partes review of whether claims 1–3, 6, 7, and 16 of the '560 patent are obvious under 35 U.S.C. § 103(a) over Bollish; and claims 1–3, 6, 7, and 16 are obvious under 35 U.S.C. § 103(a) over Bollish and TITRATOR.

    Related Matters:  According to the petition, the '560 patent is the subject the litigation:  Baxter Int'l, Inc. v. CareFusion Corp., No. 1:15-cv-09986 (N.D. Ill.).

  • Signatories Ask President to Exempt USPTO from Hiring Freeze

    By Donald Zuhn —

    Washington - White House #3In a letter sent to President Trump earlier this month, a group of twenty companies, organizations, and individuals expressed concern about the effect of the President's January 23, 2017 hiring freeze on the U.S. Patent and Trademark Office and innovation in the United States.  The group noted that the USPTO is not supported by taxpayer dollars, but instead operates entirely on user fees.  The Group also noted that from 2010-2014, $409.8 million in user fees were diverted from the USPTO to general government spending.  According to the group's letter, as a result of this fee diversion, the hiring freeze essentially amounts to a tax on America's inventors that is diverted from USPTO operations to general government spending, and "[t]axing inventors in this way thwarts innovation and harms the economy."

    The group also contends that fee diversion, coupled with the hiring freeze, also limits the USPTO's ability to hire new examiners, which "will stymie efforts to improve the total patent pendency rate which is currently 25.6 months, down from 27.4 months just two years ago."  The letter suggests that increasing the pendency rate by decreasing the number of patent examiners "will be a boon to our foreign competitors," and specifically to China, which the group points out is granting patents at a faster rate than the U.S.  Noting that the U.S. fell from first in 2016 to ten in 2017 in rankings of patent system strength released by the U.S. Chamber of Commerce's Global Intellectual Property Center, the letter contends that "[t]he United States should have the best patent system in the world, and not allowing the USPTO to hire needed examiners will cause the U.S. to fall farther behind."

    The letter concludes by expressing appreciation for the President's efforts to "put America first," and asking the President to "keep this purpose in mind in exempting the USPTO from the hiring freeze and asking Congress to permanently end the practice of USPTO fee diversion."

    The following companies, organizations, and individuals were signatories on the letter:  Alliance of U.S. Startups & Inventors for Jobs (USIJ); Bernard Shay, Entrepreneur and Patent Attorney; Bi-Level Technologies; Biotechnology Innovation Organization (BIO); Earlens Corporation; ExploraMed Development, LLC; IEEE-USA; InterDigital Inc.; Kenneth Stanwood, CTO, Wi-LAN Inc.; Licensing Executives Society (USA and Canada), Inc.; Medical Device Manufacturers Association (MDMA); Miramar Labs, Inc.; National Venture Capital Association (NVCA); NeoTract, Inc.; Nuelle, Inc.; Peter A. Socarras, Senior Director, Intellectual Property, Nevro Corp.; Qool Therapeutics, Inc.; Small Business Technology Council; Susan Schmitt, Esquire; and The Innovation Alliance.

  • Conference & CLE Calendar

    CalendarApril 18, 2017 – "The Defend Trade Secrets Act at (Almost) One" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

    April 18, 2017 – "A Patent Exhaustion Doctrine for the 21st Century" (Intellectual Property Law Association of Chicago Patent Committee – 4:00 to 6:00 pm (CT), Chicago, IL

    April 19, 2017 – "The Intersection of the PTO Practice and the Courts" (Federal Circuit Bar Association and Wayne State University) – Wayne State University McGregor Memorial Conference Center, Detroit, MI – 9:00 am to 5:00 pm (ET)

    April 19, 2017 – "Patent Eligibility: Navigating the Supreme Court's 2016 Decisions and Its Impacts" (The Knowledge Group) – 3:00 to 4:30 pm (EST)

    April 20, 2017 – "Settlement Agreements as Comparables: New Comprehensive Analysis from the Federal Circuit" (Intellectual Property Owners Association) – 2:00 to 3:00 pm (ET)

    April 20, 2017 – "Double Patenting: Defeating Double Patenting Rejections and Avoiding Terminal Disclaimers" (Strafford) – 1:00 to 2:30 pm (EDT)

    April 26, 2017 – Post-argument discussion on Sandoz Inc. v. Amgen Inc. (American University Washington College of Law Program on Information Justice & Intellectual Property) – beginning at 4:30 pm (Eastern), American University Washington College of Law, Washington, DC

    April 27, 2017 – "Navigating Section 112 Issues in IPR Proceedings: Using Section 112 as a Sword or a Shield — Addressing Section 112 Issues in IPR Petitions, Establishing Priority or Earlier Critical Date of Asserted Reference, and More" (Strafford) – 1:00 to 2:30 pm (EDT)

    April 27, 2017 – 33rd Annual Joint Patent Practice Seminar (Connecticut, New Jersey, New York, and Philadelphia Intellectual Property Law Associations) – New York, NY

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

  • 33rd Annual Joint Patent Practice Seminar

    JPPThe Connecticut, New Jersey, New York, and Philadelphia Intellectual Property Law Associations will be holding their 33rd Annual Joint Patent Practice Seminar on April 27, 2017 in New York, NY.  The seminar will consist of six panels:  USPTO Practice, PTAB, Supreme Court/Foreign Practice, Licensing, Litigation, and Pharma/Life Sciences, with each panel addressing a series of cases and topics.  An agenda for each of the panels can be found here.

    A featured morning address will be given between 8:35 and 9:15 am by Drew Hirshfeld, Commissioner of Patents, U.S. Patent and Trademark Office.  In addition, Nathan Kelley, Acting Chief Administrative Judge, USPTO Patent Trial and Appeal Board, will provide "An Update from the Solicitor's Office," and Markus Meier, Assistant Director, U.S. Federal Trade Commission will provide an "FTC Update on Stopping Pharmaceutical Reverse-Payment Agreements."  Hon. Richard Linn, Circuit Judge, U.S. Court of Appeals for the Federal Circuit will provide a keynote address.

    The registration fee for the conference is $480.  Those interested in registering for the conference can do so here.

  • Washington College of Law Post-Argument Discussion of Sandoz Inc. v. Amgen Inc.

    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 Sandoz Inc. v. Amgen Inc. case beginning at 4:30 pm (Eastern) on April 26, 2017 at the American University Washington College of Law in Washington, DC.  The panel discussion will be moderated by Prof. Jonas Anderson, American University Washington College of Law, with a panel consisting of Jennifer Thomas of Hyman, Phelps & McNamara, PC, representing Pharmaceutical Care Management Association, et al. on amicus brief; Donald Ware of Foley Hoag LLP, representing Biotechnology Innovation Organization on amicus brief; and Prof. Hans Sauer, Biotechnology Innovation Organization, Deputy General Counsel for amicus BIO.

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

  • Webcast on Patent Eligibility

    The Knowledge GroupThe Knowledge Group will offer a live webcast entitled "Patent Eligibility: Navigating the Supreme Court's 2016 Decisions and Its Impacts" on April 19, 2017 from 3:00 to 4:30 pm (EST).  Kenneth H. Sonnenfeld of King & Spalding LLP, Jo Dale Carothers of Weintraub Tobin, and Eli Mazour of Harrity & Harrity, LLP will provide an overview to help attendees understand the critical elements of the impacts of recent Supreme Court rulings on the general perspective of patent eligibility, and also provide an in-depth discussion of the 2016 SC decisions and their specific aftermath in 2017 and beyond.  The panel will cover the following topics:

    • Overview of Significant 2016 Patent Eligibility Decisions:
        – Amphastar Pharmaceuticals, Inc. v. Momenta Pharmaceuticals, Inc.
        – Sequenom v. Ariosa
        – Cuozzo Speed Technologies, LLC v. Lee
        – Halo Electronics, Inc. v. Pulse Electronics, Inc.
    • In-depth Discussion of 35 U.S.C. § 271(e)(1)
    • The Scope of "Safe Harbor" in Patent After Hatch-Waxman
    • Recent Patent Eligibility Cases
    • Significant Insights on the Possible Impacts of 2016 Decisions in 2017
    • Trends at the PTAB and patent prosecution strategies related to patent eligibility of software-related inventions

    The registration fee for the webcast is $299 (standard rate).  Those interested in registering for the webinar can do so here.

  • University of California/Berkeley Appeals Adverse CRISPR Decision by PTAB

    By Kevin E. Noonan —

    University of California-BerkleyIn February, the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office rendered judgment that there was no interference-in-fact between the claims in interference between the Regents of the University of California/Berkeley and the Broad Institute.  Yesterday, UC/Berkeley filed a Notice of Appeal at the Federal Circuit, challenging the PTO's decision.

    The University's position is set out in a press release posted on-line saying that "[u]ltimately, we expect to establish definitively that the team led by Jennifer Doudna and Emmanuelle Charpentier was the first to engineer CRISPR-Cas9 for use in all types of environments, including in non-cellular settings and within plant, animal and even human cells," according to their spokesman, Edward Penhoet, associate dean of biology at Berkeley, professor emeritus of molecular and cell biology, and a special adviser on CRISPR to the University of California president and Berkeley chancellor.  The press release also states that the University will continue to pursue related applications both in the U.S. and abroad, for "CRISPR-Cas9 technology and its application in non-cellular and cellular settings, including eukaryotic cells."  Recently, the European Patent Office announced its intention to grant the University an EP patent on May 10, 2017.

    Former Solicitor General Don Verrilli will be lead counsel for the University.

    For its part, the Broad also issued a press release setting forth its position:

    UCB has filed a Notice of Appeal asking the United States Court of Appeals for the Federal Circuit, based in Washington DC, to review the recent decision by the PTAB (Patent Trial and Appeals Board) that there is no interference between the Broad Institute, MIT and Harvard claims concerning the use of the CRISPR system in eukaryotic cells and the patent application of UCB because the claims are patentably distinct.

    Given that the facts have not changed, we expect the outcome will once again be the same.

    We are confident the Federal Circuit will affirm the PTAB decision and recognize the contribution of the Broad, MIT and Harvard in developing this transformative technology.

    Importantly, the Federal Circuit does not independently weigh the facts determined by the PTAB.  To overturn the PTAB decision, the Court would need to decide that the PTAB committed an error of law or lacked substantial evidence to reach its decision.  Given the careful and extensive factual findings in the PTAB's decision, this seems unlikely.

    Broad InstituteRegardless of the likelihood that the PTAB's decision might be reversed, the matter will not be resolved even if the Federal Circuit sends the case back to the Board.  The Office determined only that there was no interference-in-fact between the parties' claims-in-interference (see "PTAB Decides CRISPR Interference in Favor of Broad Institute — Their Reasoning"), not the substantive questions of priority and patentability raised by the parties in their preliminary motions.  The PTAB's reasoning was based on the University's failure to establish that the Broad's claims would have been obvious in view of the University's application, because inter alia the University had not established that there would have been a reasonable expectation of success that the CRISPR technology would be effective in eukaryotic cells in view of the University's disclosure of the technology's use in prokaryotic cells.  The Federal Circuit's review of this question under Dickinson v. Zurko would be to give the PTAB's factual determinations deference under the substantial evidence standard, and to review de novo the ultimate legal question of obviousness.

    Should the University prevail, the case would be remanded to the PTAB for further proceedings.  These would include a determination of which group of inventors had priority (where the Broad is junior party and would bear the burden of establishing earlier invention).  Any further PTAB action should also include rendering decisions on several motions submitted by both parties (see "CRISPR Interference Motions Set").

    Should the University's appeal fail, however the status quo will remain:  the Broad will maintain its extensive CRISPR patent portfolio and the University's patent application (reciting claims broader than the Broad's and encompassing CRISPR without regard to the cells in which it is practiced) should grant as a patent in due course.  Under these circumstances a third party wishing to practice the technology in eukaryotic cells (encompassing everything from yeast to man) would need a license from both the University and the Broad (absent the parties coming to an agreement on how their overlapping technologies will be licensed).  This circumstance cannot fail to retard commercial adoption of the techniques, providing further impetus for some sort of settlement to be forged.

    For additional information regarding this topic, please see:

    • "PTAB Decides CRISPR Interference in Favor of Broad Institute — Their Reasoning," February 16, 2017
    • "PTAB Decides CRISPR Interference — No interference-in-fact," February 15, 2017
    • "Guest Post — The Patient Side of the CRISPR Patent Battle," December 19, 2016
    • "CRISPR Interference Motions Set," March 23, 2016
    • "CRISPR Interference Declared," January 28, 2016

  • USPTO Forms Working Group on Regulatory Reform

    By Donald Zuhn —

    USPTO SealLast month, the U.S. Patent and Trademark Office posted a notice on its website announcing the formation of a Working Group on Regulatory Reform "to consider, review, and recommend ways that USPTO regulations can be improved, revised, and streamlined."  Members of the Working Group will be familiar with all of the agency's regulations, and will also represent the USPTO on the Department of Commerce's Regulatory Reform Task Force.  The Office notes that the Working Group, which will be led by Nicolas Oettinger, Senior Counsel for Regulatory and Legislative Affairs in the USPTO's Office of General Counsel, will be seeking public input for any rulemaking that would revise or eliminate regulations.  Stakeholders wishing to submit suggestions to improve, revise, and streamline USPTO regulations can do so by e-mailing those suggestions to RegulatoryReformGroup@uspto.gov.

    According to the Office notice, the formation of the Working Group implements two Executive orders issued by President Trump — Executive Order 13771, entitled "Presidential Executive Order on Reducing Regulation and Controlling Regulatory Costs," (January 30, 2017), and Executive Order 13777, entitled "Presidential Executive Order on Enforcing the Regulatory Reform Agenda" (February 24, 2017).

    Executive Order 13771 states that "it is important that for every one new regulation issued, at least two prior regulations be identified for elimination, and that the cost of planned regulations be prudently managed and controlled through a budgeting process."  The Executive Order further states that "[u]nless prohibited by law, whenever an executive department or agency (agency) publicly proposes for notice and comment or otherwise promulgates a new regulation, it shall identify at least two existing regulations to be repealed."

    Executive Order 13777 requires that each agency designate an agency official as its Regulatory Reform Officer (RRO) by April 25, 2017, and also establish a Regulatory Reform Task Force.  Pursuant to the Executive Order, each Regulatory Reform Task Force shall "evaluate existing regulations . . . and make recommendations to the agency head regarding their repeal, replacement, or modification, consistent with applicable law," and "[a]t a minimum, . . . shall attempt to identify regulations" that:

    (i)    eliminate jobs, or inhibit job creation;
    (ii)   are outdated, unnecessary, or ineffective;
    (iii)  impose costs that exceed benefits;
    (iv)   create a serious inconsistency or otherwise interfere with regulatory reform initiatives and policies;
    (v)    are inconsistent with the requirements of section 515 of the Treasury and General Government Appropriations Act, 2001 (44 U.S.C. 3516 note), or the guidance issued pursuant to that provision, in particular those regulations that rely in whole or in part on data, information, or methods that are not publicly available or that are insufficiently transparent to meet the standard for reproducibility; or
    (vi)   derive from or implement Executive Orders or other Presidential directives that have been subsequently rescinded or substantially modified.

    Each Regulatory Reform Task Force shall also provide a report to the agency head by May 25, 2017, detailing the agency's progress toward, inter alia, "identifying regulations for repeal, replacement, or modification."

  • PTAB Life Sciences Report — Part IV

    By John Cravero —

    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:  IPR2017-00778; filed January 26, 2017.

    Patent at Issue:  U.S. Patent No. 8,062,302 ("Surgical tools for arthroplasty," issued November 22, 2011) claims patient-specific surgical tool for use in surgically repairing a joint of a patient.

    Petitioner Smith & Nephew, Inc. is challenging the '302 patent on three grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, the '302 patent is the subject of litigation in ConforMIS, Inc. v. Smith & Nephew, Inc., No. 1:16-cv-10420-IT (D. Mass.).  Petitioner is concurrently filing two additional petitions for inter partes review of the '302 patent (IPR2017-00779 and IPR2017-00780).  Also, Petitioner filed petitions requesting inter partes review of related ConforMIS patents:  U.S. Patent Nos. 9,055,953 (IPR2016-01874; filed 09/21/2016; pending); 9,216,025 (IPR2017-00115; filed 10/20/2016; pending) and (IPR2017-00307; filed 11/21/2016; pending); 8,377,129 (IPR2017-00372; filed 11/30/2016; pending); 8,551,169 (IPR2017-00373; filed 11/30/2016; pending); 9,295,482 (IPR2017-00487; filed 12/14/2016; pending) and (IPR2017-00488; filed 12/14/2016; pending); 7,981,158 (IPR2017-00510; filed 12/20/2016; pending) and (IPR2017-00511; filed 12/20/2016; pending); and 7,534,263 (IPR2017-00544; filed 12/27/2016; pending) and (IPR2017-00545; filed 12/27/2016; pending).


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

    PTAB Petition:  IPR2017-00779; filed January 26, 2017.

    Patent at Issue:  U.S. Patent No. 8,062,302 ("Surgical tools for arthroplasty," issued November 22, 2011) claims patient-specific surgical tool for use in surgically repairing a joint of a patient.

    Petitioner Smith & Nephew, Inc. is challenging the '302 patent on three grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, the '302 patent is the subject of litigation in ConforMIS, Inc. v. Smith & Nephew, Inc., No. 1:16-cv-10420-IT (D. Mass.).  Petitioner is concurrently filing two additional petitions for inter partes review of the '302 patent (IPR2017-00778 and IPR2017-00780).  Also, Petitioner filed petitions requesting inter partes review of related ConforMIS patents:  U.S. Patent Nos. 9,055,953 (IPR2016-01874; filed 09/21/2016; pending); 9,216,025 (IPR2017-00115; filed 10/20/2016; pending) and (IPR2017-00307; filed 11/21/2016; pending); 8,377,129 (IPR2017-00372; filed 11/30/2016; pending); 8,551,169 (IPR2017-00373; filed 11/30/2016; pending); 9,295,482 (IPR2017-00487; filed 12/14/2016; pending) and (IPR2017-00488; filed 12/14/2016; pending); 7,981,158 (IPR2017-00510; filed 12/20/2016; pending) and (IPR2017-00511; filed 12/20/2016; pending); and 7,534,263 (IPR2017-00544; filed 12/27/2016; pending) and (IPR2017-00545; filed 12/27/2016; pending).


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

    PTAB Petition:  IPR2017-00780; filed January 26, 2017.

    Patent at Issue:  U.S. Patent No. 8,062,302 ("Surgical tools for arthroplasty," issued November 22, 2011) claims patient-specific surgical tool for use in surgically repairing a joint of a patient.

    Petitioner Smith & Nephew, Inc. is challenging the '302 patent on two grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, the '302 patent is the subject of litigation in ConforMIS, Inc. v. Smith & Nephew, Inc., No. 1:16-cv-10420-IT (D. Mass.).  Petitioner is concurrently filing two additional petitions for inter partes review of the '302 patent (IPR2017-00778 and IPR2017-00779).  Also, Petitioner filed petitions requesting inter partes review of related ConforMIS patents: U.S. Patent Nos. 9,055,953 (IPR2016-01874; filed 09/21/2016; pending); 9,216,025 (IPR2017-00115; filed 10/20/2016; pending) and (IPR2017-00307; filed 11/21/2016; pending); 8,377,129 (IPR2017-00372; filed 11/30/2016; pending); 8,551,169 (IPR2017-00373; filed 11/30/2016; pending); 9,295,482 (IPR2017-00487; filed 12/14/2016; pending) and (IPR2017-00488; filed 12/14/2016; pending); 7,981,158 (IPR2017-00510; filed 12/20/2016; pending) and (IPR2017-00511; filed 12/20/2016; pending); and 7,534,263 (IPR2017-00544; filed 12/27/2016; pending) and (IPR2017-00545; filed 12/27/2016; pending).


    Hospira, Inc. v. Genentech, Inc.

    PTAB Petition:  IPR2017-00804; filed January 30, 2017.

    Patent at Issue:  U.S. Patent No. 6,627,196 ("Dosages for treatment with anti-ErbB2 antibodies," issued September 30, 2003) claims a method for the treatment of a human patient diagnosed with cancer characterized by overexpression of ErbB2 receptor, comprising administering an effective amount of an anti-ErbB2 antibody to the human patient, the method comprising: administering to the patient an initial dose of at least approximately 5 mg/kg of the anti-ErbB2 antibody; and administering to the patient a plurality of subsequent doses of the antibody in an amount that is approximately the same or less than the initial dose, wherein the subsequent doses are separated in time from each other by at least two weeks.

    Petitioners Hospira, Inc. and Pfizer Inc. are challenging the '196 patent on one ground as obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, Petitioner concurrently filed a petition for inter partes review of U.S. Patent No. 7,371,379.  According to the petition, the '196 patent is not involved in any other related judicial or administrative matters.


    Hospira, Inc. v. Genentech, Inc.

    PTAB Petition:  IPR2017-00805; filed January 30, 2017.

    Patent at Issue:  U.S. Patent No. 7,371,379 ("Dosages for treatment with anti-ErbB2 antibodies," issued May 13, 2008) claims a method for the treatment of a human patient diagnosed with cancer characterized by overexpression of ErbB2 receptor, comprising administering an effective amount of an anti-ErbB2 antibody to the human patient, the method comprising: administering to the patient an initial dose of at least approximately 5 mg/kg of the anti-ErbB2 antibody; and administering to the patient a plurality of subsequent doses of the antibody in an amount that is approximately the same or less than the initial dose, wherein the subsequent doses are separated in time from each other by at least two weeks; and further comprising administering an effective amount of a chemotherapeutic agent to the patient.

    Petitioners Hospira, Inc. and Pfizer Inc. are challenging the '379 patent on one ground as obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, Petitioner concurrently filed a petition for inter partes review of U.S. Patent No. 6,627,196.  According to the petition, the '379 patent is not involved in any other related judicial or administrative matters.


    Obalon Therapeutics, Inc. v. Polyzen, Inc.

    PTAB Petition:  IPR2017-00812; filed January 30, 2017.

    Patent at Issue:  U.S. Patent No. 7,682,306 ("Therapeutic intervention systems employing implantable balloon devices," issued March 23, 2010) claims a method of therapeutic intervention for treatment of a patient in need of such treatment, said method comprising introducing to a physiological locus of said patient a balloon formed from two vacuum thermoformed half-sections of a multilayer film comprising a layer of sealing film and at least one layer of thermoplastic polymer.

    Petitioner Obalon Therapeutics, Inc. is challenging the '306 patent on three grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, Petitioners concurrently filed a petition for inter partes review of related U.S. Patent Nos. Nos. 6,712,832 (filed 03/03/2017) and 7,883,491.  According to the petition, the '306 patent is not involved in any other related judicial or administrative matters.


    Obalon Therapeutics, Inc. v. Polyzen, Inc.

    PTAB Petition:  IPR2017-00813; filed January 30, 2017.

    Patent at Issue:  U.S. Patent No. 7,883,491 ("Extrusion laminate polymeric film article and gastric occlusive device comprising same," issued February 8, 2011) claims a gastric occlusive device comprising a layer of sealing film and at least one layer of thermoplastic polymer.

    Petitioner Obalon Therapeutics, Inc. is challenging the '491 patent on two grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, Petitioners concurrently filed a petition for inter partes review of related U.S. Patent Nos. Nos. 6,712,832 (filed 03/03/2017) and 7,682,306.  According to the petition, the '491 patent is not involved in any other related judicial or administrative matters.


    Mylan Pharmaceuticals, Inc. v. Boehringer Ingelheim International GmbH

    PTAB Petition:  IPR2016-01564; filed July 8, 2016.

    PTAB Trial Instituted; filed January 31, 2017.

    Patent at Issue:  U.S. Patent No. 8,846,695 ("Treatment for diabetes in patients with inadequate glycemic control despite metformin therapy comprising a DPP-IV inhibitor," issued September 30, 2014) claims a method for treating type 2 diabetes mellitus in a patient with inadequate glycemic control despite therapy with metformin comprising orally administering 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-a- mino-piperidin-1-yl)-xanthine to the patient in combination with metformin.

    Petitioners Mylan Pharmaceuticals, Inc., Mylan Laboratories Ltd., Mylan Inc., and Mylan N.V. are challenging the '695 patent on two grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.  Administrative Patent Judges Toni R. Scheiner, Brian P. Murphy, and Zhenyu Yang (author) issued a decision instituting inter partes review of claims 1–4 as obvious under 35 U.S.C. § 103(a) over Charbonnel or Hughes in view of the '940 Publication; and claims 1–4 as obvious under 35 U.S.C. § 103(a) over Nauck or Ahrén 2008 in view of the '940 Publication.

    Related Matters:  According to the petition, the '695 patent is the subject of litigation in Boehringer Ingelheim Pharmaceuticals Inc., et al. v. HEC Pharm Group, et al., No. 3:15-cv-05982-PGS-TJB (D.N.J.).