Patent Law Weblog

recent posts

about

  • 2017 BIO International Convention — Docs @ BIO

    BIO International Convention_shortIn less than two weeks, the Biotechnology Innovation Organization (BIO) will be kicking off its annual BIO International Convention in San Diego, CA — the Convention takes place on June 19-22, 2017.  Founded in 1993, BIO is a nonprofit association seeking supportive biotechnology policies on behalf of biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations.  The BIO International Convention serves to educate the public and policymakers about biotechnology, while fostering partnering meetings and other business development activities to keep the biotech industry growing.

    Descriptions of the Convention's 125+ Breakout Sessions and six Super Sessions can be obtained here.  Among the sessions that may be of interest to Patent Docs readers are:

    San DiegoMonday, June 19

    The Evolution of Technology Transfer in Support of Economic Engagement  (Translational Research Track) — 1:45 to 2:45 pm (Room 6D)

    Tuesday, June 20

    The State of Biotechnology Patenting in the United States, and Future Directions (Intellectual Property Track) — 10:45 am to 12:00 pm (Room 1B) — panel includes Patent Docs author Dr. Kevin Noonan of McDonnell Boehnen Hulbert & Berghoff LLP

    Innovation and the Human Microbiome: Patent Eligibility and IP Protection (Intellectual Property Track) — 1:45 to 2:45 pm (Room 1B)

    Building Value Through International IP Protection: Obtaining, Extending, Protecting and Challenging Patents on the World Stage (Intellectual Property Track) — 3:00 to 4:00 pm (Room 1B)

    Of Rats and Men: The Success Story of Human Therapeutic Antibodies Produced in the Omnirat (Intellectual Property Track) — 4:00 to 5:00 pm (Room 7B)

    Subject-Matter Eligibility: Where Do We Go Now? (Intellectual Property Track) — 4:15 to 5:15 pm (Room 1B)

    Wednesday, June 21

    Brexit: What Might it Mean for Patent Prosecution, Litigation and Transactions in Europe? (Intellectual Property Track) — 10:45 am to 12:00 pm (Room 1B)

    The Trade and Investment Policies of the Trump Administration (Super Session) — 12:15 to 1:30 pm (Room 6A)

    Keeping it Under Wraps: Protecting, Asserting and Creating Value from Your Trade Secret (Intellectual Property Track) — 1:45 to 2:45 pm (Room 1B)

    Modulating Our Immune System to Fight Disease (Next Generation Biotherapeutics Track) — 1:45 to 2:45 pm (Room 6C)

    Biosimilars IP Litigation: Where We've Been and Where We're Heading (Intellectual Property Track) — 3:00 to 4:00 pm (Room 1B)

    Microbiome 2.0: Going Beyond Bugs as Drugs (Next Generation Biotherapeutics Track) — 4:15 to 5:15 pm (Room 6C)

    Thursday, June 22

    Precision Medicine: Regulatory and Reimbursement Challenges  (Personalized Medicine & Diagnostics Track) — 9:00 to 10:30 am (Room 6D)

    Will the Challenges of Delivering the Personalized Genetic Medicines of Tomorrow Outweigh the Promise of Today? (Next Generation Biotherapeutics Track) — 9:00 to 10:30 am (Room 6C)

    The Scientific American WorldVIEW Super Session: Wrapping Up and Looking Forward (Super Session) — 1:00 to 2:15 pm (Room 6A)

    As part of the Convention, more than 1,800 biotech companies, organizations, and institutions will participate in the BIO Exhibition.  A searchable list of exhibitors can be found here.  Information regarding registration and pricing can be obtained here.  Patent Docs authors Donald Zuhn, Kevin Noonan, and Andrew Williams, and Patent Docs contributors Josh Rich and Grant Drutchas will be attending BIO as part of the MBHB contingent, and will be reporting on a few of the sessions listed above.  Patent Docs readers who may be attending BIO are encouraged to stop by the MBHB booth (#1728).

    BIO - Good Times on Tap 2011In addition, the Docs will be attending the MBHB reception at Dublin Square Irish Pub (554 4th Ave., San Diego) on Tuesday, June 20 from 8:00 pm to 1:00 am.  Additional information about the reception, including invitations for the event, can be picked up at the MBHB booth.

  • Biosimilars Update — Pfizer’s Proposed Epogen®/Procrit® Biosimilar Recommended for Approval

    By Andrew Williams —

    PfizerOn May 25, 2017, the FDA's Oncologic Drug Advisory Committee recommended approval of biologics license application ("BLA") 125545 submitted by Hospira Inc., a Pfizer company, for Retacrit, a proposed biosimilar to Amgen Inc.'s Epogen/Procrit (epoetin alfa).  According to a press release from Pfizer, the committee "recommended approval of the Company's proposed epoetin alfa biosimilar across all indications."  Pfizer had sought approval for treatment of anemia due to Chronic Kidney Disease (CKD), for treatment of anemia due to zidovudine in HIV-infective patients, for treatment of anemia in patients with non-myeloid malignancies, and to reduce the need for allogenic RBC transfusions among patients with perioperative hemoglobin.  If ultimately approved, Retacrit would become the sixth biosimilar in the U.S.  And if the experience with the previous five biosimilars is any indication, the FDA should be expected to approve the present application in the next couple of months.  Retacrit would also be the second biosimilar for Pfizer, which began selling Celltrion's biosimilar INFLECTRA® in late 2016.  As Pfizer's representative Diem Nguyen said in the press release:  "Following the approval and launch of INFLECTRA® (infliximab-dyyb) in 2016, this positive recommendation — a first for a proposed ESA [erythropoiesis-stimulating agent] biosimilar — marks an important milestone for Pfizer's U.S. biosimilars portfolio."

    The Retacrit application would also represent the longest delay between submission and approval.  BLA 125545 was originally submitted in December 2014, and according to a Complaint filed by Amgen in September 2015, the application was accepted sometime on or before February 23, 2015.  But on October 27, 2015, Pfizer announced that it had received a complete response letter (CRL) from the FDA that required more evidence to support approval.  According to Pfizer's FDA Advisory Committee Briefing Document, the CRL "requested additional data and sensitivity analysis to align with the most current FDA expectations and to ensure the robustness of the data demonstrating biosimilarity of Epoetin Hospira to the Epogen/Procrit reference product."  This included information in the categories of:  manufacturing process, analytical, clinical pharmacology, clinical efficacy, and clinical immunogenicity.  In response, Pfizer obtained the additional scientific evidence, which it summarized in the following figure that it said "establishes the biosimilarity of Epoetin Hospira to the Epogen/Procrit reference product."

    Image
    Marketing of the drug will likely be delayed because of the requirement to give the 180-day notice of commercial marketing.  In anticipation, though, Amgen filed a motion for preliminary injunction on May 26, 2017, because (as it alleged in the original underlying Complaint (at paragraph 66)):  "Hospira has indicated that it intends to violate the statute by categorically refusing to provide Amgen with a legally operative notice of commercial marking under 42 U.S.C. § 262(l)(8)(A)."  Of course, according to the Federal Circuit's Amgen v. Sandoz ruling, Hospira cannot give notice until after the FDA has approved the product.  But this requirement may change this month when the Supreme Court issues its decision in the Sandoz v. Amgen case.  The Delaware Court also denied Amgen's request for discovery related to Hospira's manufacturing process that was not supplied during the patent dance.  The appeal from that decision was heard by the Federal Circuit in April 2017, and an opinion is expected within the next few months.

    As a reminder, both this author and Kevin Noonan will be attending the American Conference Institute's 8th Annual Summit on Biosimilars next week, June 12-14, 2017 in New York, NY.  Dr. Noonan is co-chair of the conference and will be on a panel reviewing the first 18 months of biosimilars (and looking ahead).  If you are attending, please say hello.  As a reminder, Patent Docs readers are entitled to a 10% discount off of registration using discount code P10-999-PTD17, but hurry because registration is closing soon.

  • USPTO Director Michelle Lee Reported to Have Resigned

    By Kevin E. Noonan —

    Lee MichelleSeveral news outlets are reporting that Michelle Lee, Undersecretary of Commerce and Director of the U.S. Patent and Trademark Office, has resigned.  Director Lee submitted a her resignation to the Trump Administration in January but almost immediately withdrew it, and has remained as a holdover from the Obama Administration since that time.

    Director Lee was appointed by President Obama in 2015, having served as Director of the Office's Silicon Valley satellite office, and before that as Deputy General Counsel and Head of Patents and Patent Strategy at Google.  Under her watch the USPTO implemented many of the provisions of the America Invents Act and instituted programs intended to improve patent quality and efficient examination (see "USPTO Launches Enhanced Patent Quality Initiative" and "USPTO Holds Patent Quality Symposium").

    Director Lee has been rumored to be under consideration for other positions in the Trump Administration, but there have been no reports that any offers for such positions have been extended or are forthcoming.

  • Viveve, Inc. v. Thermigen, LLC (E.D. Tex. 2017)

    District Court Denies Motion to Dismiss for Lack of Patent Eligible Subject Matter

    By Donald Zuhn —

    District Court for the Eastern District of TexasEarlier this year, in Viveve, Inc. v. Thermigen, LLC, District Judge Rodney Gilstrap of the U.S. District Court for the Eastern District of Texas denied the Motion to Dismiss Pursuant to Fed. R. Civ. P. 12(b)(6) and 35 U.S.C. § 101 filed by Defendants Thermigen, LLC; ThermiAesthetics, LLC; and Dr. Red Alinsod, M.D. ("Thermigen").  In denying Thermigen's motion, the District Court determined that the patent asserted by Plaintiff Vivive, Inc. against Thermigen is not directed to a natural law or phenomenon.

    In October 2016, Vivive filed a complaint against Thermigen for infringement of U.S. Patent No. 8,961,511, which is directed to a method for remodeling female genital tissue by applying heat to certain target tissue.  According to the '511 patent, the tissue to be remodeled is tightened as "a consequence of thermal denaturation of collagen as well as a longer term healing response in the tissue that includes an increased deposition of collagen."  The '511 patent also discloses that the claimed method provides an alternative to the prior art, which indicated that such remodeling required invasive surgical procedures.

    In response to Vivive's complaint, Thermigen filed its motion to dismiss, arguing that the '511 patent is directed to non-patentable subject matter.  In particular, Thermigen asserted that the '511 patent is directed to the natural phenomenon that collagen is remodeled through exposure to heat, which Thermigen contended is a phenomenon that allegedly has previous, well known applications in treating tissue generally, and that the claimed method simply applies this phenomenon to a discrete area of the human body.

    In deciding whether the asserted claims of the '511 patent are directed to patent-ineligible subject matter, the District Court noted that in Mayo Collaborative Servs. v. Prometheus Labs., Inc. and Alice Corp. Pty. Ltd. v. CLS Bank Int'l, the Supreme Court set forth a two-step test for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent eligible applications of those concepts.  In the first step, the court determines whether the claims are directed to a law of nature, natural phenomenon, or abstract idea.  If the answer to this question is "no," then the inquiry is over and the claims pass muster under § 101.  However, if the answer is "yes," then the court must determine whether the elements of the claim individually, or as an ordered combination, transform the nature of the claim into a patent-eligible application.

    In denying Thermigen's motion to dismiss, the District Court determined that "the '511 patent is not invalid as claiming unpatentable subject matter," finding that Thermigen's arguments "fail at step one [because] the '511 is not directed to a natural law or phenomenon," and further, that "even if [the '511 patent] were directed to a natural law or phenomenon, . . . under step two of the Mayo framework, the '511 patent improves an existing process for bringing about the tightening of female genital tissue."  With respect to the step one inquiry, the District Court agreed with Vivive's argument that remodeling is a process comprising a doctor's application of specific concrete steps to specific tissue under particularized conditions, which is simply predicated on the ability of collagen to be physically transformed by heat, rather than being a law of nature.

    The District Court also noted that the Federal Circuit recently took up the patentability of similar method claims in Rapid Litigation Management Ltd. v. Cellzdirect, Inc.  In that case, the Federal Circuit addressed whether method claims covering a process for subjecting hepatocyte liver cells to multiple freeze-thaw cycles used to preserve the cells for later use was directed to a law of nature.  In Rapid Litigation Management, the Federal Circuit observed "[t]hat one way of describing the process is to describe the natural ability of the subject matter to undergo the process [which] does not make the claim 'directed to' that natural ability" (emphasis in original), adding that "[i]f that were so, we would find patent-ineligible methods of, say, producing a new compound (as directed to the individual components' ability to combine to form the new compound), treating cancer with chemotherapy (as directed to cancer cells' inability to survive chemotherapy), or treating headaches with aspirin (as directed to the human body's natural response to aspirin)."

    In the instant case, the District Court determined that "the Federal Circuit's reasoning and holding in Rapid Litigation Management [is] controlling in the present case," and that "[l]ike the court in Rapid Litigation Management, here the Court is presented with a method patent comprising concrete steps, premised upon a discovery of natural law rendering the relevant subject matter amenable to certain processes."  While the claimed method in Rapid Litigation Management was based upon the ability of hepatocytes to be frozen and thawed multiple times, the District Court found that the claimed method in the instant case is based upon the ability of collagen to be denatured by heat.  The District Court also noted that like the claimed method in Rapid Litigation Management, the claimed method in the instant case provides certain advantages over the prior art.  The Court further noted that "[t]he '511 patent stands in stark contrast to those patents which the Federal Circuit has invalidated as directed to a natural law or natural phenomenon," such as Genetic Techs., Ltd. v. Merial L.L.C. and Ariosa Diagnostics, Inc. v. Sequenom, Inc., wherein "the patents typically encompass the pure observation or identification of the natural law at issue."

    With respect to step two of the Mayo/Alice inquiry, the District Court noted that even if it "was persuaded that the '511 patent was 'directed to' a natural law or natural phenomenon (which it is not), the '511 patent recites an inventive concept, rendering it subject matter patent eligible."  In particular, the Court determined that "the claims of the '511 patent recite an improved treatment technique that is inventive over known techniques in the prior art," finding that "[w]hile the denaturation of collagen through application of heat was known and used for medical and cosmetic purposes in the prior art (see '511 patent, 1:39–61), the only known methods for tightening the relevant tissue required invasive surgical procedures which carried with them the risk of scarring."  According to the Court, this constituted an improvement over the prior art.  The Court also noted that one of the Defendants, Dr. Red Alinsod, had referred to the claimed method as "a fairly new concept" that was "game changing"; the Court stated that "Defendants cannot honestly extoll the 'game changing' virtues of the process at issue in the marketplace, yet argue in the courtroom that the same procedure lacks an inventive element."

    Having decided that the answer to step one of the Mayo/Alice inquiry was "no," and further, that the claims of the '511 patent also recite an inventive concept, the District Court denied Thermigen's Motion to Dismiss Pursuant to Fed. R. Civ. P. 12(b)(6) and 35 U.S.C. § 101.

    Memorandum Opinion and Order by District Judge Gilstrap

  • Conference & CLE Calendar

    CalendarJune 6, 2017 – "Patent Prosecution: FTO Opinions, Examiner Interactions, Patent Drafting and More" (Strafford) – 8:30 am to 5:30 pm (EDT)

    June 6, 2017 – "The Decline in Research: Should We Worry?" (The Center for Innovation Policy at Duke Law) – 11:15 am to 1:00 pm (ET), Capitol Visitor Center, Washington, DC

    June 8, 2017 – "Biotech Patents and Section 101 Rejections: Meeting Patent Eligibility Requirements — Leveraging Recent Decisions and USPTO Guidance to Overcome Rejections" (Strafford) – 1:00 to 2:30 pm (EDT)

    June 8, 2017 – "Pharma Lessons from the PTAB: Litigation and Prosecution" (Intellectual Property Owners Association) – 2:00 to 3:00 pm (ET)

    June 12-14, 2017 – Summit on Biosimilars*** (American Conference Institute) – New York, NY

    June 13, 2017 – European biotech patent law update (D Young & Co) – 4:00 am, 7:00 am, and 12:00 pm (ET)

    June 13, 2017 – Patent Quality Chat webinar series (U.S. Patent and Trademark Office) – 12:00 to 1:00 pm (ET) on 

    June 14, 2017 – "Laying Your Claim: Best Practices for Patent Claim Construction in a Post-Teva World" (Dilworth IP) – 1:00 to 2:00 pm (EDT)

    June 15, 2017 – "ITC as a PTAB Antidote: Navigating Competing Administrative Trial Strategies & Pitfalls — Threading the New Patent Monetization Needle" (Strafford) – 1:00 to 2:30 pm (EDT)

    June 15, 2017 – "TC Heartland: A Deep-Dive into Next-Level Issues for Companies in an Integrated Economy" (Foley & Lardner) – 7:00 to 8:00 pm (CDT)

    August 10-11, 2017 – Advanced Patent Law Seminar (Chisum Patent Academy) – Seattle, WA

    August 14-15, 2017 – Advanced Patent Law Seminar (Chisum Patent Academy) – Seattle, WA

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

  • IPO Webinar on Pharma Lessons from the PTAB

    IPO #2The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Pharma Lessons from the PTAB: Litigation and Prosecution" on June 8, 2017 from 2:00 to 3:00 pm (ET).  Eldora Ellison of Sterne Kessler Goldstein & Fox, PLLC; Cynthia Lambert Hardman of Goodwin Procter LLP; and Kerry Taylor of Knobbe, Martens, Olson & Bear LLP will spell out winning strategies specific to the biopharmaceutical industry for both patent owners and challengers, and will also highlight lessons for patent prosecutors that emerge from PTAB practice.  Topics to be discussed include:

    • The role of objective indicia of nonobviousness. Pharma patents do put up a better fight at the PTAB than other technologies: last year, a third of biotech/pharma claims survived PTAB trials, almost three times the survival rate of electrical/computer claims;
    • The surge in PGRs challenges to pharma patents on Section 112 grounds of indefiniteness and enablement;
    • The relationship between district court Hatch-Waxman litigation and PTAB challenges;
    • How to inoculate continuations or divisionals of challenged patents to relevant prior art.

    The registration fee for the webinar is $135 (government and academic rates are available upon request).  Those interested in registering for the webinar can do so here.

  • USPTO Patent Quality Chat Webinar Series

    USPTO SealThe U.S. Patent and Trademark Office will be offering the next webinar in its Patent Quality Chat webinar series from 12:00 to 1:00 pm (ET) on June 13, 2017.  Greg Vidovich, Associate Commissioner for Patent Quality, and Jim Dwyer, Director, Office of Patent Quality Assurance will be discussing the latest evolution of the Office's patent quality metrics that divides them into:

    1.  Product indicators, focusing on correctness and clarity;
    2.  Process indicators, tracking efficiency and consistency; and
    3.  Perception indicators, validating our first two indicators.

    Instructions for viewing the webinar can be found here.

    Additional information regarding the Patent Quality Chat webinar series can be found on the USPTO's Patent Quality Chat webpage.

  • Chisum Patent Academy Patent Law Seminar

    The Chisum Patent Academy will be offering the next session of its Advanced Patent Law Seminar on August 10-11 and August 14-15, 2017 in Seattle, WA.  The seminar is co-taught by Donald Chisum, author of the treatise Chisum on Patents (LexisNexis), and Janice Mueller, who was a tenured full Professor at the University of Pittsburgh School of Law from 2004-2011.  The registration fee for the seminar is $1,600; a maximum of ten registrations will be accepted for the seminar.  Those interested in registering for either seminar can do so here.  Additional information regarding the seminar can be obtained here or by e-mailing info@chisum.com.

    Chisum Patent Academy

  • Web Conference on TC Heartland

    Foley & LardnerFoley & Lardner will be offering a web conference entitled "TC Heartland: A Deep-Dive into Next-Level Issues for Companies in an Integrated Economy" on June 15, 2017 from 7:00 to 8:00 pm (CDT).  Pavan K. Agarwal, Kevin J. Malaney, and Liane M. Peterson of Foley & Lardner LLP will address such next-level issues as:

    • Determining venue for multinational corporations, as well as cases involving multiple parties residing in diverse locations
    • Potential impact on Hatch-Waxman pharmaceutical ANDA and biosimilar cases
    • Possible effects on cases brought by non-practicing entities
    • How the decision may affect pending lawsuits.

    While there is no cost to participate in the program, advance registration is required.  Those interested in attending the webinar can register here.

  • Congressional Briefing on Decline in Research

    Washington - Capitol #3The Center for Innovation Policy at Duke Law will be hosting a Congressional briefing on "The Decline in Research: Should We Worry?" from 11:15 am to 1:00 pm (ET) on June 6, 2017 at the Capitol Visitor Center in Washington, DC.  Sen. Chris Coons (D-DE), Co-chair, Senate Competitiveness Caucus, will provide opening remarks, and Wesley Cohen, Duke Fuqua Business School will moderate a panel consisting of Ashish Arora, Duke Fuqua Business School; Steven Freilich, University of Delaware; Stephen Merrill, Duke Law School; Arti Rai, Duke Law School; and Pian Shu, Harvard Business School.

    Additional information regarding the briefing can be found here.  Those interested in registering for the conference can do so here.