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  • Conference & CLE Calendar

    CalendarMay 24, 2017 – "Antitrust Issues in ANDA Patent Litigation" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

    May 25, 2017 – "Evolving PTAB Trial Practice: Navigating Complex Procedural Rules — Strategically Using Routine and Additional Discovery, Requests for Joinder, and Motions to Amend" (Strafford) – 1:00 to 2:30 pm (EDT)

    May 25, 2017 – "Double Patenting: Defeating Double Patenting Rejections and Avoiding Terminal Disclaimers" (Strafford) – 1:00 to 2:30 pm (EDT)

    June 1, 2017 – "Obviousness Standard: Leveraging Latest PTO and Court Guidance — Overcoming Challenges of Obviousness and Attacks on Patent Validity" (Strafford) – 1:00 to 2:30 pm (EDT)

    June 1, 2017 – "Post-Grant Patent Office Proceedings After the AIA: Lessons from the First Five Years" (West LegalEdcenter) – 12:00 to 1:00 pm (EDT)

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

    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 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)

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

  • Webinar on Obviousness Standard

    Strafford #1Strafford will be offering a webinar/teleconference entitled "Obviousness Standard: Leveraging Latest PTO and Court Guidance — Overcoming Challenges of Obviousness and Attacks on Patent Validity" on June 1, 2017 from 1:00 to 2:30 pm (EDT).  Barry J. Herman of Womble Carlyle Sandridge & Rice and Jon L. Schuchardt of Dilworth IP will provide patent counsel with guidance on the evolving obviousness standard, including how the Federal Circuit's treatment of obviousness issues is changing, how the Patent Trial and Appeal Board (PTAB) handles obviousness in the increasingly popular inter partes review (IPR) proceedings, and whether the standard for patentees to prevail on non-obviousness under Section 103 is more confusing than ever.  The webinar will review the following topics:

    • How have recent Federal Circuit decisions affected application of the obviousness standard?
    • What level of "unexpected results" is needed to demonstrate patentability in light of recent decisions?
    • How can practitioners leverage recent decisions in which the Federal Circuit has insisted upon more thorough, reasoned explanations of the PTO’s obviousness conclusions?
    • What are the most effective strategies for both patentees and petitioners in prevailing on obviousness assertions in an IPR proceeding, and how will that strategy play out at the Federal Circuit?

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

  • Webcast on Post-Grant Patent Proceedings

    West LegalEdcenterWest LegalEdcenter will be offering a live webcast entitled "Post-Grant Patent Office Proceedings After the AIA: Lessons from the First Five Years" on June 1, 2017 from 12:00 to 1:00 pm (EDT).  Amol Parikh and Brian A. Jones of McDermott Will & Emery LLP will focus on the evolution of Post-Grant Patent Office proceedings, recent reforms, current trends, and potential changes that may occur in the near future.

    The registration fee for the webcast is $195.  Those interested in registering for the webinar, can do so here.

  • Seminar on Patent Prosecution

    Strafford #1Strafford will be offering a full day seminar on "Patent Prosecution: FTO Opinions, Examiner Interactions, Patent Drafting and More" on June 6, 2017 from 8:30 am to 5:30 pm (EDT).  The seminar will offer presentations on the following topics:

    • Freedom-to-Operate Opinions
    • USPTO Examiner Count System and Examiner Interview Strategies
    • Reflections on PTAB and Where is Patent Law Heading
    • Overcoming 101 Rejections
    • Drafting Patent Applications to Withstand PTAB Scrutiny
    • Conflicts in Patent Prosecution (Ethics)

    A live webcast of the seminar is also being offered.  The seminar will be rebroadcast on June 8, 2017 from 8:30 am to 5:10 pm PDT.

    The registration fee for the seminar is $1,497.  Those interested in registering for the webinar, can do so here.

  • Webinar on Biotech Patents and Section 101 Rejections

    Strafford #1Strafford will be offering a webinar/teleconference entitled "Biotech Patents and Section 101 Rejections: Meeting Patent Eligibility Requirements — Leveraging Recent Decisions and USPTO Guidance to Overcome Rejections" on June 8, 2017 from 1:00 to 2:30 pm (EDT).  Denise M. Kettelberger of Patterson Thuente Pedersen and Katherine M. Kowalchyk of Merchant & Gould will provide guidance for patent counsel for overcoming § 101 rejections for biotech patents, review recent case law and USPTO guidance on § 101 patent eligibility, and offer strategies to address § 101 rejections.  The webinar will review the following topics:

    • The impact of the Mayo, Myriad, and Ariosa decisions on recent USPTO and Federal Circuit decisions addressing §101 rejections for biotech and other technological patents;
    • Problems with the USPTO guidance documents and Examiner Training;
    • Potential strategies to overcome §101 rejections;
    • Robust patent specification and claim drafting tips.

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

  • PTAB Life Sciences Report — Part II

    By John Cravero —

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

    Argentum Pharmaceuticals LLC. v. Alcon Research, Ltd.

    PTAB Petition:  IPR2017-01053; filed March 10, 2017.

    Patent at Issue:  U.S. Patent No. 8,268,299 ("Self preserved aqueous pharmaceutical compositions," issued May 1, 2012) claims a multi-dose, self-preserved ophthalmic composition, comprising: zinc ions at a concentration of 0.04 to 0.4 mM; and borate and polyol, the borate being present in the composition at a concentration of 0.1 to 2.0% w/v and the polyol being present in the composition at a concentration of 0.25 to 2.5% w/v, the polyol comprising propylene glycol in the composition at a concentration of 0.25 to 1.25% w/v and sorbitol in the composition at a concentration of 0.05 to 0.5% w/v; wherein: (i) the composition has a concentration of anionic species less than 15 mM; and (ii) the composition exhibits sufficient antimicrobial activity to allow the composition to satisfy USP 27 preservative efficacy requirements.

    Petitioners Argentum Pharmaceuticals LLC; Intelligent Pharma Research LLC; APS GP LLC; APS GP Investors LLC; and KVK-Tech, Inc. are challenging the '299 patent on four grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, the '299 patent is involved in the following litigations:  Alcon Research Ltd. v. Mylan Pharmacuticals, Inc., 1:13-cv-01332 (D. Del.); Alcon Research Ltd. v.Wockhardt Ltd., 1:13-cv-02040 (D. Del.); Alcon Research Ltd. v. Micro Labs Ltd., 1:14-cv-00014 (D. Del.); Alcon Research Ltd. v. Watson Laboratories, Inc., 1:14-cv-00647 (D. Del.); Alcon Research Ltd. v. Akorn, Inc., 1:15-cv-00479 (D. Del.); and Alcon Research Ltd. v. Lupin Ltd., 1:15-cv-00621 (D. Del.); Apotex Corp. v. Alcon Research, Ltd.  According to the petition, the '299 patent was involved in inter partes review IPR2013-00428 (Apotex Corp.; filed 07/15/2013; instituted 01/02/2014; terminated through settlement 7/21/2014).


    Argentum Pharmaceuticals LLC. v. Novartis AG.

    PTAB Petition:  IPR2017-01063; filed March 10, 2017.

    Patent at Issue:  U.S. Patent No. 9,006,224 ("Neuroendocrine tumor treatment," issued May 1, 2012) claims a method for treating pancreatic neuroendocrine tumors, comprising administering to a human subject in need thereof a therapeutically effective amount of 40-O-(2-hydroxyethyl)-rapamycin as a monotherapy and wherein the tumors are advanced tumors after failure of cytotoxic chemotherapy.

    Petitioners Argentum Pharmaceuticals LLC; Intelligent Pharma Research LLC; APS GP LLC; APS GP Investors LLC; and KVK-Tech, Inc. are challenging the '224 patent on four grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, the '224 patent is involved in the following litigations:  Novartis Pharm. Corp. et al. v. Par Pharm., Inc., 1:14-cv-1289-RGA (D. Del.); Novartis Pharm. Corp. et al. v. Par Pharm., Inc., 1:14-cv-1494-RGA (D. Del.); Novartis Pharm. Corp. et al. v. Par Pharm., Inc., 1:15-cv-78-RGA (D. Del.); Novartis Pharm. Corp. et al. v. Par Pharm., Inc., 1:15-cv-475-RGA (D. Del.); Novartis Pharm. Corp. et al. v. Par Pharm., Inc., 1:15-cv-1050-RGA (D. Del.).  According to the petition, the '224 patent is involved in inter partes review Roxane Labs., Inc. v. Novartis AG, IPR2016-1461 (Roxane Laboratories, Inc.; filed 07/19/2016; institution denied 02/13/2017).


    Abiomed, Inc. v. Maquet Cardiovascular, LLC

    PTAB Petition:  IPR2017-01025; filed March 11, 2017.

    Patent at Issue:  U.S. Patent No. 7,022,100 ("Guidable intravascular blood pump and related methods," issued April 4, 2006) claims an intravascular blood pump system comprising an intravascular blood pump having a cannula coupled thereto, the intravascular blood pump including a rotor and a guide mechanism adapted to guide the intravascular blood pump and cannula to a predetermined location within the circulatory system of a patient.

    Petitioners Abiomed, Inc., Abiomed R&D, Inc., and Abiomed Europe GmbH are challenging the '100 patent on two grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, the '100 patent is the subject of a declaratory judgment action for non-infringement captioned Abiomed, Inc. v. Maquet Cardiovascular, LLC, 1-16-cv-10914 (MA.D.).  According to the petition, the Petitioners are concurrently filing inter partes reviews against two U.S. patents related to the '100 patent, U.S. Patent Nos. 8,888,728 (IPR2017-1026; Abiomed, Inc.; filed 03/11/2017; pending) and 9,327,068 (IPR2017-1028; Abiomed, Inc.; filed 03/11/2017; pending, and IPR2017-01029; Abiomed, Inc.; filed 03/11/2017; pending).


    Abiomed, Inc. v. Maquet Cardiovascular, LLC

    PTAB Petition:  IPR2017-01026; filed March 11, 2017.

    Patent at Issue:  U.S. Patent No. 8,888,728 ("Guidable intravascular blood pump and related methods," issued November 18, 2014) claims an intravascular blood pump system comprising a rotor having a rotor hub tapering in the distal direction, at least one blade extending radially outward from the rotor hub, the hub has a distal end extending distally beyond the most distal portion of the blade and a shroud within which the rotor is rotatably disposed; a cannula extending from the shroud and comprising an outer cannula surface, the outer cannula surface having a substantially circular cross-section along a portion of its length; a first lumen in fluid communication with the intravascular blood pump and operatively arranged to deliver purge fluid to the intravascular blood pump; and a guide mechanism configured as a second lumen having a proximal end and a distal end, the guide mechanism adapted to guide a distal portion of said intravascular blood pump system to a predetermined location within the circulatory system of a patient.

    Petitioners Abiomed, Inc., Abiomed R&D, Inc., and Abiomed Europe GmbH are challenging the '728 patent on three grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, the '728 patent is the subject of a declaratory judgment action for non-infringement captioned Abiomed, Inc. v. Maquet Cardiovascular, LLC, 1-16-cv-10914 (MA.D.).  According to the petition, the Petitioners are concurrently filing a second inter partes review against the '728 patent (IPR2017-1027; Abiomed, Inc.; filed 03/11/2017; pending) and inter partes reviews against two U.S. patents related to the '728 patent, U.S. Patent Nos. 7,022,100 (IPR2017-1025; Abiomed, Inc.; filed 03/11/2017; pending, and 9,327,068 IPR2017-1027; Abiomed, Inc.; filed 03/11/2017; pending).


    Abiomed, Inc. v. Maquet Cardiovascular, LLC

    PTAB Petition:  IPR2017-01027; filed March 11, 2017.

    Patent at Issue:  U.S. Patent No. 8,888,728 ("Guidable intravascular blood pump and related methods," issued November 18, 2014) claims an intravascular blood pump system comprising a rotor having a rotor hub tapering in the distal direction, at least one blade extending radially outward from the rotor hub, the hub has a distal end extending distally beyond the most distal portion of the blade and a shroud within which the rotor is rotatably disposed; a cannula extending from the shroud and comprising an outer cannula surface, the outer cannula surface having a substantially circular cross-section along a portion of its length; a first lumen in fluid communication with the intravascular blood pump and operatively arranged to deliver purge fluid to the intravascular blood pump; and a guide mechanism configured as a second lumen having a proximal end and a distal end, the guide mechanism adapted to guide a distal portion of said intravascular blood pump system to a predetermined location within the circulatory system of a patient.

    Petitioners Abiomed, Inc., Abiomed R&D, Inc., and Abiomed Europe GmbH are challenging the '728 patent on three grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, the '728 patent is the subject of a declaratory judgment action for non-infringement captioned Abiomed, Inc. v. Maquet Cardiovascular, LLC, 1-16-cv-10914 (MA.D.).  According to the petition, the Petitioners are concurrently filing a second inter partes review against the '728 patent (IPR2017-01026; Abiomed, Inc.; filed 03/11/2017; pending) and inter partes reviews against two U.S. patents related to the '728 patent, U.S. Patent Nos. 7,022,100 (IPR2017-01025; Abiomed, Inc.; filed 03/11/2017; pending) and 9,327,068 (IPR2017-01028; Abiomed, Inc.; filed 03/11/2017; pending, and IPR2017-01029; Abiomed, Inc.; filed 03/11/2017; pending).


    Abiomed, Inc. v. Maquet Cardiovascular, LLC

    PTAB Petition:  IPR2017-01028; filed March 11, 2017.

    Patent at Issue:  U.S. Patent No. 9,327,068 ("Guidable intravascular blood pump and related methods," issued May 3, 2016) claims method for perfusing a patient with an intravascular blood pump system, the intravascular blood pump system.

    Petitioners Abiomed, Inc., Abiomed R&D, Inc., and Abiomed Europe GmbH are challenging the '068 patent on three grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, the '068 patent is the subject of a declaratory judgment action for non-infringement captioned Abiomed, Inc. v. Maquet Cardiovascular, LLC, 1-16-cv-10914 (MA.D.).  According to the petition, the Petitioners are concurrently filing a second inter partes review against the '068 patent (IPR2017-1028; Abiomed, Inc.; filed 03/11/2017; pending) and inter partes reviews against two U.S. patents related to the '068 patent, U.S. Patent Nos. 7,022,100 (IPR2017-1025; Abiomed, Inc.; filed 03/11/2017; pending) and 8,888,728 (IPR2017-01026; Abiomed, Inc.; filed 03/11/2017; pending).


    Abiomed, Inc. v. Maquet Cardiovascular, LLC

    PTAB Petition:  IPR2017-01029; filed March 11, 2017.

    Patent at Issue:  U.S. Patent No. 9,327,068 ("Guidable intravascular blood pump and related methods," issued May 3, 2016) claims method for perfusing a patient with an intravascular blood pump system, the intravascular blood pump system.

    Petitioners Abiomed, Inc., Abiomed R&D, Inc., and Abiomed Europe GmbH are challenging the '068 patent on two grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, the '068 patent is the subject of a declaratory judgment action for non-infringement captioned Abiomed, Inc. v. Maquet Cardiovascular, LLC, 1-16-cv-10914 (MA.D.).  According to the petition, the Petitioners are concurrently filing a second inter partes review against the '068 patent (IPR2017-1028; Abiomed, Inc.; filed 03/11/2017; pending) and inter partes reviews against two U.S. patents related to the '068 patent, U.S. Patent Nos. 7,022,100 (IPR2017-1025; Abiomed, Inc.; filed 03/11/2017; pending) and 8,888,728 (IPR2017-01026; Abiomed, Inc.; filed 03/11/2017; pending).

  • EasyWeb Innovations, LLC v. Twitter, Inc. (Fed. Cir. 2017)

    Message Publishing Patents Found Invalid under 35 U.S.C. § 101

    By Joseph Herndon —

    In a recent decision by the U.S. Court of Appeals for the Federal Circuit, the Court held all asserted claims of five U.S. patents to be invalid under 35 U.S.C. § 101 because the claims recite patent-ineligible subject matter.

    TwitterEasyWeb sued Twitter for infringement of the following five patents directed to a message publishing system:  U.S. Patent Nos. 7,032,030; 7,596,606; 7,685,247; 7,689,658; and 7,698,372.  The patents are generally directed to allowing any person or organization to easily publish a message on the Internet.  According to the specification of the '247 patent, at the time of the invention (priority filing date of March 11, 1999), publishing a message on the Internet was a daunting task because of cost, limitations in existing software, and a lack of technical knowledge.  The patents sought to address this problem by inventing a message publishing system that accepts messages in multiple ways, such as by fax, telephone, or email, verifies the message was sent by an authorized sender, and converts and publishes the message on the Internet.

    Namely, the message is received and converted from a first format (e.g., fax) to a second format, with the second format preferably being one or more webpages.  The message is stored within an Internet web server, and is retrieved from the storage area when a request for the message has been received from a requester.  The message is then transmitted to the requester over the Internet.

    The parties agreed that claim 1 of the '247 patent is representative:

    1.  A message publishing system (MPS) operative to process a message from a sender in a first format, comprising:
        a central processor;
        at least one sender account;
        at least one storage area configured to store at least a first portion of the message; and
        software executing in the central processor to configure the processor so as to:
            identify the sender of the message as an authorized sender based on information associated with the message in     comparison to data in the sender account, wherein the identification is dependent upon the first format;
            convert at least a second portion of the message from the first format to a second format; and
            publish the converted second portion of the message so as to be viewable in the second format only if the sender has     been identified as an authorized sender.

    EasyWeb sued Twitter for patent infringement in the U.S. District Court for the Eastern District of New York.  At the District Court, Twitter moved for summary judgment of non-infringement and ineligibility under 35 U.S.C. § 101.  The District Court granted the motion, finding that the patents are directed towards ineligible subject matter, or in the alternative that Twitter did not infringe any of the patents.

    On appeal, the Federal Circuit followed the Supreme Court's two-step framework for determining patent-eligibility under § 101.  First, a determination is made as to whether the claims at issue are directed to a patent-ineligible concept.  Second, if the claims are directed to patent-ineligible subject matter, the court considers the elements of each claim both individually and as an ordered combination to determine whether the additional elements transform the nature of the claim into a patent-eligible application.

    Beginning with the first step, the Federal Circuit concluded that claim 1 is directed to an abstract idea.  The Federal Circuit summarily noted that claim 1 merely recites "familiar concepts of receiving, authenticating, and publishing data", and as explained in a number of prior cases, claims involving data collection, analysis, and publication are directed to an abstract idea.  The Federal Circuit referred to Elec. Power Grp. v. Alstom S.A. (Fed. Cir. 2016), which held that "collecting information, analyzing it, and displaying certain results of the collection and analysis" are "a familiar class of claims 'directed to' a patent-ineligible concept."

    In addition, because Claim 1 simply recites use of generic computer technology to perform data collection, analysis, and publication rather than reciting an improvement to a particular computer technology, the Federal Circuit easily found claim 1 to be directed to the abstract idea of receiving, authenticating, and publishing data.

    Turning to the second step, the Federal Circuit found that claim 1 did not contain an inventive concept sufficient to transform the nature of the claim into a patent-eligible application.  Again, the Federal Circuit summarily stated that the "elements of claim 1 simply recite an abstract idea or an abstract idea executed using computer technology" with no explanation.

    EasyWeb argued that an inventive concept arises from the ordered combination of steps in claim 1, but the Federal Circuit disagreed.  The Federal Circuit stated that Claim 1 "recites the most basic of steps in data collection, analysis, and publication and they are recited in the ordinary order."  The Federal Circuit concluded by finding that "all the claims are directed to the abstract idea of receiving, authenticating, and publishing data, and fail to recite any inventive concepts sufficient to transform the abstract idea into a patent eligible invention."

    It's easy to understand the Federal Circuit's opinion with respect to the first and last functions in claim 1 (e.g., to identify the sender of the message and publish the converted second portion of the message), but the Federal Circuit did not comment at all on the middle step to "convert at least a second portion of the message from the first format to a second format."  At least in that step, some data processing occurs that is not encompassed by the alleged abstract idea of receiving, authenticating, and publishing data as characterized by the Court.  That is not to say that the broad feature of "converting data" from a first format to a second format is new in any way, but it at least recites more than found in the prior cases where claims were held to be abstract because the claims only recited "collecting information, analyzing it, and displaying certain results of the collection and analysis."  It would seem that converting data is distinguished over the more generic "analyzing" data.  Clearly, though, if claim 1 recited more details for how the conversion was performed, the claim would be stronger and more likely to withstand § 101 challenges.  But the fact that the Federal Circuit ignored this feature and summarily rejected all claims is disappointing.

    EasyWeb Innovations, LLC v. Twitter, Inc. (Fed. Cir. 2017)
    Nonprecedential disposition
    Panel:  Circuit Judges Lourie, Moore, and Hughes
    Opinion by Circuit Judge Hughes

  • AIPLA Proposes Legislative Changes to 35 U.S.C. § 101

    By Kevin E. Noonan —

    AIPLA #1Like the Intellectual Property Owners (see "What to Do about Section 101? IPO Provides Its Answer") and the IP Law Section of the American Bar Association (see "ABA IP Law Section Sends Section 101 Revision Proposal to USPTO Director Lee") have done earlier this year, the American Intellectual Property Lawyers Association (AIPLA) has announced its proposal to amend Section 101 of the Patent Act to adapt, revise, and correct how the law has been changed by a series of U.S. Supreme Court cases of recent vintage (and a certain degree of infamy).  The AIPLA's proposal is as follows:

    35 U.S.C. § 101—Inventions Patentable

    (a) Eligible Subject Matter.—Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain shall be entitled to a patent therefor, subject only to the conditions and requirements of set forth in this title.

    (b) Sole Exceptions to Subject Matter Eligibility.—A claimed invention is ineligible under subsection (a) only if the claimed invention as a whole exists in nature independent of and prior to any human activity, or can be performed solely in the human mind.

    (c) Sole Eligibility Standard.—The eligibility of a claimed invention under subsections (a) and (b) shall be determined without regard to the requirements or conditions of sections 102, 103, and 112 of this title, the manner in which the claimed invention was made or discovered, or whether the claimed invention includes an inventive concept.

    Like the earlier proposals, the AIPLA's proposed revision establishes an affirmative right ("shall be entitled to") rather than merely the possibility ("may obtain") to a patent should the statutory requirements be met; this may merely reflect the embattled state of patenting that members of the AIPLA perceive in the face of persistent criticism of patents from many sources.

    The second and new subparagraph (b) reflects the desire to cabin by statutory specificity what the implicit judicial exceptions involve, here either things that can be accomplished by solely mental steps or that are found in nature absent the "hand of man" (which, no doubt, can be supplied in ways that would vindicate Justice Breyer's apprehension about misapplication of the draftman's art).

    Finally, new subparagraph (c) is directed to an attempt to recreate the doctrinal wall between patent eligibility under Section 101 and patentability under the substantive statutory sections (§§ 102, 103, and 112).

    The AIPLA's proposal is embedded in an eighteen page "position paper" reviewing the historical and legislative provenance of patent eligibility and how the Supreme Court has "distorted" the inquiry (and its own precedent, e.g., Diamond v. Diehr) to impose its own views of what subject matter is beyond Congress's Article I power to grant a patent.  The document also sets forth evidence of the uncertainty that these decisions have engendered and how its proposal is intended to rectify the situation.  Specifically:

    The Legislative Proposal is intended to eliminate the current two-part test for eligibility.  It introduces an objective and evidence-based approach to the limited question of eligibility, and commits any policy concerns about overbreadth in patent claims to the conditions of patentability.  In particular, the Legislative Proposal recognizes that concerns for the existence of a so-called "inventive concept" were eliminated with the creation of the nonobviousness requirement in Section 103 by the 1952 Patent Act.  In sum, the Legislative Proposal is intended to provide a clear test that will result in appropriately broad eligibility and that will minimize the uncertainty and unpredictability discouraging investment in research and development.

    The proposal and supporting document is yet another example of dedicated patent professionals addressing what is widely viewed as an error in how patent eligibility is being applied in the USPTO and the courts (see Judge Linn's "concurrence" in Ariosa v. Sequenom and Judge Lourie's and Judge Dyk's (joined by Judge Moore) concurrences and Judge Newman's dissent in the Federal Circuit's denial of Sequenom's petition for rehearing en banc).  We will all have to see what good it does.

  • USPTO Files Response Brief in In re Janssen Biotech, Inc. & New York University

    By Grantland Drutchas —

    JanssenThe U.S. Patent and Trademark Office has now filed its response brief in In re: Janssen Biotech, Inc., New York University, No. 2017-1257 (Fed. Cir.), the Federal Circuit appeal involving U.S. Patent No. 6,284,471/Reexamination Control No. 90/012,851 ("Reexam appeal").  This is a parallel appeal to Janssen's appeal from its District Court action against Celltrion involving the '471 patent, Janssen Biotech, Inc. v. Celltrion Healthcare Co., Ltd., No. 2017-1120 (Fed. Cir.) ("Janssen v. Celltrion").  Notably, however, Janssen (and New York University) previously argued in the parallel Janssen v. Celltrion appeal that this PTO appeal controlled:  "Because the '471 Patent was amended in reexamination, a decision favorable to Janssen in the co-pending appeal would supersede the district court's ruling, which was based on the un-amended form of the '471 Patent."  As such, this Reexam appeal is the one to watch.

    Both this appeal and the Janssen v. Celltrion appeal involve obviousness-type double patenting (or "ODP"), an issue which presents real risks for pharmaceutical manufacturers who have sought to broaden their patent estates to cover all possible uses of patented compositions.  The ODP doctrine is an attempt to enforce the quid pro quo that is at the core of the patent system:  that, in exchange for a patent, an inventor must fully disclose his invention and promise to permit free use of it at the end of his patent term.  Gilead Sciences, Inc. v. Natco Pharma Ltd., 753 F. 3d 1208, 1212 (Fed. Cir. 2014).  The ODP doctrine prevents an applicant from obtaining several sequential patents on the same invention, including obvious modifications of the invention.  In such cases, a terminal disclaimer should be used to preserve the validity of the later-expiring patent by aligning its expiration date with that of the earlier-expiring patent.  Id. at 1217

    At issue in both of these appeals is (1) whether the claims of the '471 patent (as amended in the reexamination) are subject to the "safe harbor" of 35 U.S.C. § 121 to avoid the ODP issue altogether, and (2) if not, how the test for ODP should be applied, either under a "one-way test," or a "two-way test."

    Under the "safe harbor" provision of 35 U.S.C. § 121, a restriction requirement from the PTO acts as a sort of estoppel with respect to a divisional application filed in response to that requirement:  neither of the patents that result directly from the restriction requirement can be used as an ODP reference against the other patent.

    If the safe harbor does not apply, then the PTO and courts must apply either a one-way test or two-way test for ODP.  In the one-way test, the only question is whether the claimed subject matter in the later-expiring patent is obvious over that of the earlier-expiring patent.  In the two-way test, the examiner (or patent challenger) must show that the subject matter of the claims of both patents would be obvious over the other, and thus is a much more difficult obstacle for the examiner (or patent challenger) to overcome.  Although there are a number of pitfalls, the two-way test applies if (i) the later-expiring patent was filed before the earlier-expiring patent and (ii) the applicant could not avoid separate filings (by filing conflicting claims in the earlier-filed application) and (iii) the PTO was solely responsible for the delay in prosecution of the later-expiring patent.  If all three are true, the two-way test applies; if any one is false, then the one-way test applies.

    In its briefs in both appeals, Janssen made many of the same arguments supporting reversal of the District Court and the PTO decisions.  There are two significant differences in the two appeals, however.  First, the PTO has argued an alternative ground for rejecting the § 121 safe harbor, specifically the lack of "consonance."  Second, and perhaps more damning, Janssen has to contend in this Reexam appeal with the PTO's finding that the PTO was not solely responsible for the delay in prosecution of the '471 patent.  In the District Court decision on appeal in Janssen v. Celltrion, Judge Wolf did not rule on this last issue, finding a potential issue of fact.

    The PTO's brief relied heavily on three facts, the first two of which are undisputed:  (1) that the applicant filed the '093 application, which issued as the '471 patent, as a CIP application, not a divisional application (although they tried to fix this retroactively); (2) that claim 1 of the '471 patent is not patentably distinct from the claims of appellees' '272 and '195 reference patents; and (3) that the PTO had found that Janssen was partially responsible for the delay caused in the '903 application prosecution which caused the '471 patent to issue after its siblings, the '272 and '195 patents.  PTO Response Brief, Slip op. at 18-19, 23 (note that the page numbering used here is the court's page numbering at the top of the page in the slip opinion, rather than the brief's page numbering at the bottom).

    With respect to the § 121 safe harbor issue, the PTO followed a long line of cases — Pfizer, Inc. v. Teva Pharms. USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008); Amgen Inc. v. F. Hoffman-LaRoche Ltd., 580 F.3d 1340 (Fed. Cir. 2009); Amgen v. HLR, and G.D. Searle LLC v. Lupin Pharms., Inc., 790 F.3d 1349 (Fed. Cir. 2015) (id. at 29-34), and a long-standing PTO practice (id.  at 34-38), in holding that because the applicants filed the '093 application as a CIP application, not a divisional application, the '471 patent was not entitled to § 121's safe harbor.  Indeed, the single largest chunk of the PTO's argument is directed to reminding the Federal Circuit of what exactly it held in those three decisions.  That is, under these prior decisions, applicants' belated attempt to re-cast the filing as a divisional is too little, too late.  As Searle made clear, "Janssen cannot 'retroactively alter the nature' of the original '093 CIP application" to make it a divisional application after-the fact.  Id. at 20.  Because Janssen filed the '093 application as a CIP of two applications, and included subject matter and claims not supported by the disclosure of the '413 application where the restriction requirement was made, "there is no way that the '093 application can be considered a divisional of the '413 application in 'form' or in 'substance.'"  Id. at 20.

    A second, alternative argument that the PTO made for denying appellees the § 121 safe harbor was that the claims at issue in the ODP rejection did not maintain "consonance."  That is, issued claims in the three patents involved in the ODP rejection are not consonant with the restricted claims in the '413 application because they did not maintain the independent and distinct inventions that prompted the restriction requirement.  The PTO provided several reasons, including:  (a) the issued claims in the '195 patent and '272 patent are not limited to TNF-α, whereas claims that were the subject of the restriction requirement were limited to TNF-α; and (b) claims 1 and 9 of the '471 patent are not only broader than the original Group I claims of the restriction requirement but they are also directed to subject matter not disclosed in the '413 application where the restriction was made. 

    Notably, for Janssen to prevail on the § 121 safe harbor issue it must establish that the PTO erred on both of these two grounds.  It appears unlikely to succeed with either.

    Regarding the § 121 safe harbor argument, Janssen argued a number of equities that the PTO's brief dismissed.  With respect to Janssen's argument that its added disclosure — disclosed but not eventually claimed — in the '093 application benefited the public, for example, the PTO noted that Janssen could have filed both a CIP and a divisional application and given the same benefit without losing its divisional designation.  With respect to Janssen's argument that it relied to its detriment on the Examiner's withdrawal of an ODP objection, because it could have filed a divisional while the parent application was still pending, the PTO argued that the timing is unlikely because Janssen did not file a divisional application during the two years that the examiner's ODP objection was pending.  And with respect to Janssen's argument that it relied on a non-precedential decision in a reexamination, the PTO noted that the decision was both not binding and in any event preceded Searle.  Id. at 45-47.

    With respect to the second issue on appeal, the PTO argued that Janssen was not entitled to the two-way ODP test because (a) the application that led to the '471 and '272 patents were filed on the same day, and the MPEP clearly states that where "both applications are filed on the same day, only a one-way determination of distinctness is needed" and (b) Janssen was partially responsible for the "delay" that caused the '471 patent to issue after the '272 and '195 reference patents.  These examples of delay cited by the PTO included (i) the applicant waited ten months to file a preliminary amendment that included immunoreceptor claims from the other parent application (not supported by the '413 application where the original restriction requirement was made) — which then prompted a further restriction requirement; (ii) that, by contrast, Janssen took specific steps in the '195 and '272 applications explicitly designed to expedite prosecution; (iii) after receiving a final rejection in May, 1996, Janssen waited six months, until October, 1996 to file a Notice of Appeal; and then (iv) Janssen waited another six months, until May, 1997 to reopen prosecution by filing a 37 C.F.R. § 1.129(a) amendment.  Id. at 52-54.

    If there are points for brevity, the PTO got all this done in only 10,627 of the 14,000 words allotted.

    • Brief for Appellee – Director of the United States Patent and Trademark Office
    • Opening Brief for Janssen Biotech Inc. and New York University

  • 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.

    Mylan Pharmaceuticals, Inc. v. Cosmo Technologies Ltd.

    PTAB Petition:  IPR2017-01034; filed March 9, 2017.

    Patent at Issue:  U.S. Patent No. 8,784,888 ("Controlled Release and Taste Masking Oral Pharmaceutical Compositions," issued June 22, 2014) claims a controlled release oral pharmaceutical composition consisting essentially of: (1) a tablet core consisting essentially of: a) budesonide in an amount effective to treat intestinal inflammatory disease; and b) a macroscopically homogeneous composition comprising at least one lipophilic excipient, at least one amphiphilic excipient, and at least one hydrogel-forming hydrophilic excipient other than a gum, wherein said budesonide is dispersed in said macroscopically homogeneous composition; and (2) a coating on said tablet core, said coating consisting essentially of a gastro-resistant film.

    Petitioners Mylan Pharmaceuticals, Inc., Mylan Laboratories Ltd., Mylan Inc., and Mylan N.V. are challenging the '888 patent on three grounds as 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 '888 patent is the subject of the following litigations:  Cosmo Technologies Ltd. et al. v. Mylan Pharmaceuticals Inc., 16-cv-00152 (D. Del.); Cosmo Technologies Ltd. et al. v. Mylan Pharmaceuticals Inc., 16-cv-00040 (N.D.W.Va.); Cosmo Technologies Ltd. et al. v. Lupin Ltd. et al, 15-cv-00669 (D. Del.); Cosmo Technologies Ltd. et al. v. Alvogen Pine Brook, Inc., 15-cv-00193 (D. Del.); Cosmo Technologies Ltd. et al. v Actavis Laboratories FL, Inc., 15-cv- 01312 (D.N.J.); Cosmo Technologies Ltd. et al. v Actavis Laboratories FL, Inc., 15- cv-00164 (D. Del.); Cosmo Technologies Ltd. et al. v. Par Pharmaceutical, Inc., 15-cv-00116 (D. Del.).  Petitioner concurrently filed a petition for inter partes review of U.S. Patent No. 9,320,716 (IPR2017-01035; filed 03/09/2017; pending).


    West-Ward Pharmaceuticals International Ltd. v. Novartis AG

    PTAB Petition:  IPR2017-01078; filed March 13, 2017.

    Patent at Issue:  U.S. Patent No. 9,006,224 ("Neuroendocrine tumor treatment," issued April 14, 2015) claims a method for treating pancreatic neuroendocrine tumors, comprising administering to a human subject in need thereof a therapeutically effective amount of 40-O-(2-hydroxyethyl)-rapamycin as a monotherapy and wherein the tumors are advanced tumors after failure of cytotoxic chemotherapy.

    Petitioners West-Ward Pharmaceuticals International Ltd., Hikma Pharmaceuticals PLC, Roxane Laboratories, Inc., and West-Ward Pharmaceuticals Corp. are challenging the '224 patent on four grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, the '224 patent is the subject of the following litigations:  Novartis Pharm. Corp. v. Breckenridge Pharm., Inc., 14-1043-RGA (D. Del.); Novartis Pharm. Corp. v. Roxane Labs., Inc., 14-1196-RGA (D. Del.); Novartis Pharm. Corp. v. Par Pharm., Inc., 14-1289-RGA (D. Del.); Novartis Pharm. Corp. v. Par Pharm., Inc., 14-1494-RGA (D. Del.); Novartis Pharm. Corp. v. Par Pharm., Inc., 15-78-RGA (D. Del.); Novartis Pharm. Corp. v. Par Pharm., Inc., 15-475-RGA (D. Del.); Novartis Pharm. Corp. v. Par Pharm., Inc., 15-1050-RGA (D. Del.); Novartis Pharm. Corp. v. Roxane Labs., Inc., 14-1508-RGA (D. Del.); Novartis Pharm. Corp. v. Roxane Labs., Inc., 15-128-RGA (D. Del.); and Novartis Pharm. Corp. v. Breckenridge Pharm., Inc., 16-431-RGA (D. Del.).  The '224 patent is also the subject of inter partes reviews IPR2016-01461 (Roxane Labs., Inc.; filed 07/19/2016; Institution denied 02/13/2017); IPR2017-01063 (Argentum Pharm. LLC; filed 03/10/2017; pending); and IPR2016-01479 (Par Pharm., Inc.; filed 07/22/2016; Instituted 02/15/2017; pending).


    Celltrion, Inc. v. Biogen Inc.

    PTAB Petition:  IPR2017-01093; filed March 15, 2017.

    Patent at Issue:  U.S. Patent No. 8,329,172 ("Combination therapies for B-cell lymphomas comprising administration of anti-CD20 antibody," issued December 11, 2012) claims a method of treating low grade B-cell non-Hodgkin's lymphoma in a human patient comprising administering to the patient chemotherapy consisting of CVP therapy to which the patient responds, followed by rituximab maintenance therapy, wherein the maintenance therapy comprises four weekly administrations of rituximab at a dose of 375 mg/m2 every 6 months, and wherein the maintenance therapy is provided for 2 years.

    Petitioners Celltrion, Inc.; Celltrion Healthcare Co., Ltd.; and Teva Pharmaceuticals International GmbH are challenging the '172 patent on four grounds as anticipated under 35 U.S.C. § 102(b) (grounds 1 and 2) or as obvious under 35 U.S.C. § 103(a) (grounds 3 and 4).  View the petition here.

    Related Matters:  According to the petition, Petitioners concurrently filed petitions for inter partes review of related U.S. Patent Nos. 8,557,244 (IPR2017-01094; filed 03/15/2017; pending) and 9,296,821 (IPR2017-01095; filed 03/15/2017; pending).


    Celltrion, Inc. v. Biogen Inc.

    PTAB Petition:  IPR2017-01094; filed March 15, 2017.

    Patent at Issue:  U.S. Patent No. 8,557,244 ("Treatment of aggressive non-Hodgkins lymphoma with anti-CD20 antibody," issued October 15, 2013) claims a method of treating a patient with diffuse large cell lymphoma, comprising administering an unlabeled chimeric anti-CD20 antibody and CHOP (cyclophosphamide, hydroxydaunorubicin/doxorubicin, vincristine, and prednisone/prednisolone) chemotherapy to the patient, wherein the patient is >60 years old and has bulky disease (tumor >10 cm in diameter).

    Petitioners Celltrion, Inc.; Celltrion Healthcare Co., Ltd.; and Teva Pharmaceuticals International GmbH are challenging the '244 patent on four grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, Petitioners concurrently filed petitions for inter partes review of related U.S. Patent Nos. 8,329,172 (IPR2017-01093; filed 03/15/2017; pending) and 9,296,821 (IPR2017-01095; filed 03/15/2017; pending).


    Fluidigm, Corp. v. Board of Trustees of the Leland Stanford Junior University

    PTAB Petition:  IPR2017-00013; filed October 4, 2016.

    PTAB Trial Instituted; entered March 15, 2017.

    Patent at Issue:  U.S. Patent No. 7,563,584 ("Methods and compositions for detecting the activation state of multiple proteins in single cells," issued July 21, 2009) claims a method of detecting the activation state of at least a first and a second activatable protein in single cells, said method comprising the steps of: a) providing a population of cells comprising said first and said second activatable proteins, wherein said first and second activatable proteins are distinct proteins that each have at least an activated isoform, and a non-activated isoform; b) permeabilizing said population of cells; c) contacting said permeabilized population of cells with at least two distinguishably labeled activation state-specific antibodies, wherein a first of said at least two distinguishably labeled activation state-specific antibodies is specific for said activated isoform of said first activatable protein; and a second of said at least two distinguishably labeled activation state-specific antibodies is specific for said activated isoform of said second activatable protein; and d) using flow cytometry to detect binding of said first and said second distinguishably labeled activation state-specific antibodies to their corresponding activated isoform of said first and second activatable proteins in single cells of said population of cells, wherein said binding of said first distinguishably labeled activation state-specific antibody is indicative of the activation state of said first activatable protein, and said binding of said second distinguishably labeled activation state-specific antibody is indicative of the activation state of said second activatable protein.

    Petitioner Fluidigm Corp. is challenging the '926 patent on four grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.  Administrative Patent Judges Erica A. Franklin (author), Georgianna W. Braden, and Zhenyu Yang issued a decision instituting inter partes review of whether claims 1, 2, 4–6, 10–21, and 23–27 are unpatentable under 35 U.S.C. § 103(a) as obvious over Fleisher; whether claims 3, 7–9, and 22 are unpatentable under 35 U.S.C. § 103(a) as obvious over Fleisher and Belloc; whether 1, 2, 4–6, 10–21, and 23–27 are unpatentable under 35 U.S.C. § 103(a) as obvious over Darzynkiewicz and Yen; and whether claims 3, 7–9, and 22 are unpatentable under 35 U.S.C. § 103(a) as obvious over Darzynkiewicz, Yen, and Belloc.

    Related Matters:  According to the petition, the '926 patent is not involved in any judicial proceedings.


    Fluidigm, Corp. v. Board of Trustees of the Leland Stanford Junior University

    PTAB Petition:  IPR2017-00014; filed October 4, 2016.

    PTAB Trial Instituted; entered March 15, 2017.

    Patent at Issue:  U.S. Patent No. 7,695,926 ("Methods and compositions for detecting receptor-ligand interactions in single cells," issued April 13, 2010) claims a kit comprising a first activation-state specific antibody and a second activation-state specific antibody and instructions for use of the antibodies, wherein at least one of the antibodies is specific for a phosphorylation site, wherein said first activation state-specific antibody binds to an activation form of a first protein within the MAPK (mitogen activated protein kinase), AKT (homolog of V-akt murine thymoma viral oncogene), NFkB (nuclear factor kappa B), PKC (protein kinase C), STAT (signal transducers and activators of transcription) or WNT (Win gless/Int) signaling pathways, and said second activation state-specific antibody binds to an activation form of a second protein within the MAPK, AKT, NFkB, PKC, STAT or WNT signaling pathways, and wherein said first and second proteins are different proteins.

    Petitioner Fluidigm Corp. is challenging the '926 patent on three grounds as 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 Erica A. Franklin (author), Georgianna W. Braden, and Zhenyu Yang issued a decision instituting inter partes review of whether claims 1–5 and 11–12 are unpatentable under 35 U.S.C. § 102 as anticipated by Shen; whether claims 1-9 are unpatentable under 35 U.S.C. § 103(a) as obvious over Fleisher; and whether claims 1-9 are unpatentable under 35 U.S.C. § 103(a) as obvious over Darzynkiewicz and Yen.

    Related Matters:  According to the petition, the '926 patent is not involved in any judicial proceedings.