• By John Cravero

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

    Pain Point Medical Systems, Inc. v. Blephex LLC

    PTAB Petition:  IPR2016-01670; filed August 24, 2016.

    PTAB Trial Instituted; entered March 1, 2017.

    Patent at Issue:  U.S. Patent No. 9,039,718 ("Method and device for treating an ocular disorder," issued May 26, 2015) claims a method of treating an eye for an ocular disorder with a swab operably connected to an electromechanical device, wherein the eye has an eyelid margin and includes a removable debris, the method comprising; effecting movement of the swab relative to the electromechanical device, the swab having at least a portion thereof configured to access an inner edge portion of the eyelid margin; while the swab is being moved by the electromechanical device, contacting a portion of the eye between the eyelashes and the inner edge of the eyelid margin that includes the removable debris with the swab thereby impacting the debris with the swab to remove debris from the eye.

    Petitioner Pain Point Medical Systems, Inc. DBA MiBo Medical Group is challenging the '718 patent on four grounds as obvious under 35 U.S.C. § 103(a) (grounds 1-3) and unpatentable in view of the prosecution history of U.S. Patent Application No. 13/949,365 (ground 4).  View the petition here.  Administrative Patent Judges Meredith C. Petravick, Scott A. Daniels (author), and Scott C. Moore issued a decision instituting inter partes review of whether claims 1–11 and 14–17 of the '718 patent are unpatentable under 35 U.S.C. § 103(a) as obvious over AlgerBrush II, Seminara, and Stevens; whether claims 1-11 and 14-17 are unpatentable under 35 U.S.C. § 103(a) as obvious over AlgerBrush II and Hamburg; and whether claims 1-11 and 14-17 are unpatentable under 35 U.S.C. § 103(a) as obvious over Yamaura and Stevens.

    Related Matters:  According to the petition, the '718 patent is also at issue in the following litigation:  Blephex LLC v. Pain Point Medical Systems, Inc., 3:16-cv-00410-N (N.D. Tex.).


    Oticon Medical AB v Cochlear Bone Anchored Solutions AB

    PTAB Petition:  IPR2017-01018; filed March 3, 2017.

    Patent at Issue:  U.S. Patent No. 7,043,040 ("Hearing aid apparatus," issued May 9, 2006) claims a bone-conducting bone-anchored hearing aid apparatus for sound transmission from one side of a patient's head to the patient's cochlea on another side of the patient's head for rehabilitation of unilateral hearing loss.

    Petitioners Oticon Medical AB, Oticon Medical LLC, and William Demant Holding A/S are challenging the '040 patent on four grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, the '040 patent is involved in the following litigation:  Cochlear Ltd. et al. v Oticon Medical AB et al., No. 1:16-cv-01700 (D. Co.).  The petitioners concurrently filed a petition for an inter partes review of the '040 patent on different grounds (IPR2017-01019; filed 03/03/2017).


    Oticon Medical AB v Cochlear Bone Anchored Solutions AB

    PTAB Petition:  IPR2017-01019; filed March 3, 2017.

    Patent at Issue:  U.S. Patent No. 7,043,040 ("Hearing aid apparatus," issued May 9, 2006) claims a bone-conducting bone-anchored hearing aid apparatus for sound transmission from one side of a patient's head to the patient's cochlea on another side of the patient's head for rehabilitation of unilateral hearing loss.

    Petitioners Oticon Medical AB, Oticon Medical LLC, and William Demant Holding A/S are challenging the '040 patent on two grounds as anticipated under 35 U.S.C. § 102(b) (ground 1) or as obvious under 35 U.S.C. § 103(a) (ground 2).  View the petition here.

    Related Matters:  According to the petition, the '040 patent is involved in the following litigation:  Cochlear Ltd. et al. v Oticon Medical AB et al., No. 1:16-cv-01700 (D. Co.).  The petitioners concurrently filed a petition for an inter partes review of the '040 patent on different grounds (IPR2017-01018; filed 03/03/2017).


    Fresenius Kabi USA, LLC v. Hospira, Inc.

    PTAB Petition:  IPR2017-01054; filed March 8, 2017.

    Patent at Issue:  U.S. Patent No. 8,242,158 ("Dexmedetomidine premix formulation," issued December 25, 2012) claims a ready to use liquid pharmaceutical composition for parenteral administration to a subject, comprising dexmedetomidine or a pharmaceutically acceptable salt thereof at a concentration of about 4 μg/mL disposed within a sealed glass container.

    Petitioner Fresenius Kabi USA, LLC is challenging the '158 patent on three grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, the '158 patent is involved in the following litigations:  Hospira Inc. v. Fresenius Kabi USA, LLC, 1:16-cv-00651 (N.D. Ill.); and Hospira Inc. v. Amneal Pharmaceuticals LLC, 1:15-cv-00697-RGA (D.Del.).  According to the petition, the '158 patent is the subject of inter partes review IPR2016-01577 (Petitioner Amneal Pharmaceuticals LLC; filed 08/10/2016; instituted 02/09/2017; pending).  The petitioners concurrently filed petitions for inter partes review of U.S. Patent Nos. 8,338,470 (IPR2017-01055; filed 03/08/2017; pending) and 8,455,527 (IPR2017-01056; filed 03/08/2017; pending).


    Fresenius Kabi USA, LLC v. Hospira, Inc.

    PTAB Petition:  IPR2017-01055; filed March 8, 2017.

    Patent at Issue:  U.S. Patent No. 8,338,470 ("Dexmedetomidine premix formulation," issued December 25, 2012) claims a ready to use liquid pharmaceutical composition for parenteral administration to a subject, comprising dexmedetomidine or a pharmaceutically acceptable salt thereof at a concentration of about 0.005 to about 50 μg/mL disposed within a sealed glass container.

    Petitioner Fresenius Kabi USA, LLC is challenging the '470 patent on three grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, the '470 patent is involved in the following litigations:  Hospira Inc. v. Fresenius Kabi USA, LLC, 1:16-cv-00651 (N.D. Ill.); and Hospira Inc. v. Amneal Pharmaceuticals LLC, 1:15-cv-00697-RGA (D.Del.).  According to the petition, the '470 patent is the subject of inter partes review IPR2016-01578 (Petitioner Amneal Pharmaceuticals LLC; filed 08/10/2016; instituted 02/09/2017; pending).  The petitioners concurrently filed petitions for inter partes review of U.S. Patent Nos. 8,242,158 (IPR2017-01054; filed 03/08/2017; pending) and 8,455,527 (IPR2017-01056; filed 03/08/2017; pending).


    Fresenius Kabi USA, LLC v. Hospira, Inc.

    PTAB Petition:  IPR2017-01056; filed March 8, 2017.

    Patent at Issue:  U.S. Patent No. 8,455,527 ("Methods of treatment using a dexmedetomidine premix formulation," issued June 4, 2013) claims a method of providing sedation to a patient in need thereof, the method comprising administering to the patient an effective amount of a composition, wherein the composition comprises dexmedetomidine or a pharmaceutically acceptable salt thereof at a concentration of about 0.005 to about 50 μg/mL, wherein the composition is a ready to use liquid pharmaceutical composition for parenteral administration to the patient disposed within a sealed glass container.

    Petitioner Fresenius Kabi USA, LLC is challenging the '527 patent on three grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, the '527 patent is involved in the following litigations:  Hospira Inc. v. Fresenius Kabi USA, LLC, 1:16-cv-00651 (N.D. Ill.); and Hospira Inc. v. Amneal Pharmaceuticals LLC, 1:15-cv-00697-RGA (D.Del.).  According to the petition, the '527 patent is the subject of inter partes review IPR2016-01579 (Petitioner Amneal Pharmaceuticals LLC; filed 08/10/2016; instituted 02/09/2017; pending).  The petitioners concurrently filed petitions for inter partes review of U.S. Patent Nos. 8,242,158 (IPR2017-01054; filed 03/08/2017; pending) and 8,338,470 (IPR2017-01055; filed 03/08/2017; pending).

  • CalendarMay 9, 2017 – "eCommerce Modernization (eMod) Update" (U.S. Patent and Trademark Office) – 12:00 to 1:00 pm (ET)

    May 10-11, 2017 - Post-Grant PTO Proceedings Conference*** (American Conference Institute) – New York, NY

    May 11, 2017 – "Protecting IP Rights in Joint Development Agreements and Strategic Alliances — Structuring JDAs to Apportion Contributed, Joint and Derivative IP; Planning for Involuntary Early Endings; Avoiding Unintended Consequences" (Strafford) – 1:00 to 2:30 pm (EDT)

    May 11, 2017 – "After Laches: Equitable Estoppel Redux?" (Intellectual Property Owners Association) – 2:00 to 3:00 pm (ET)

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

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

  • ACI - American Conference InstituteAmerican Conference Institute (ACI) will be holding is 8th Annual Summit on Biosimilars on June 12-14, 2017 in New York, NY.  Patent Docs author Dr. Kevin Noonan is a co-chair of this conference.  ACI faculty will help attendees:

    • Explore the changes in place and potential changes to come for biosimilars as a result of the new U.S. administration;
    • Compare and contrast the various pathways taken by the currently approved biosimilars;
    • Compile a robust package of evidence supporting interchangeability;
    • Review the Supreme Court Sandoz v. Amgen case, including the arguments presented, predictions for or analysis of the decision, and the potential impact on the industry;
    • Examine the institution and denial of IPR petitions for biosimilars;
    • Consider strategies for choosing the best suffixes for naming biosimilars;
    • Analyze the FDA's draft guidance for labeling biosimilars; and
    • Ascertain how payors will deal with biosimilars.

    In particular, ACI's faculty will offer presentations on the following topics:

    • Policy and Politics of Biosimilars under the New Administration
    • Case Study: Reviewing the First 18 Months of Biosimilars and a Look Ahead
    • Demystifying the Demonstration of Interchangeability in View of FDA's Draft Guidance
    Amgen v. Sandoz: Where are we Now?
    • Patent Portfolio Management in Light of Life Techs. Corp. and Extraterritorial Reach of U.S. Patents
    • Untangling the Inner Workings of IPRs for Biosimilars
    • Shall we Dance: Mastering the "Steps" of the BPCIA While Avoiding Common Pitfalls
    • A Biosimilar by Any Other Name. . . Has a Distinguishing Suffix
    • Ensuring Labeling Compliance and Assessing Impact of Labeling on Product Liability Litigation
    • The Judges Speak: Inside Perspectives on Biosimilar Litigation
    • The Price is Right: Or is it? Dissecting Pricing and Reimbursement Issues for Biosimilars
    • Examining the Ethics and Professional Responsibility Concerns for the Biosimilars Industry

    In addition, two post-conference workshops will be offered on June 14, 2017, from 9:00 am to 12:00 noon and 2:00 to 5:00 pm, respectively.  The first workshop is entitled "Product Patentability Workshop: Navigating through § 101 and § 112 Challenges for Biologics," and the second workshop is entitled "Biosimilars around the World: Examining Challenges and Strategies for Creating an International Biosimilar Portfolio."

    An agenda for the conference can be found here, and additional information regarding the workshops can be found here.  A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.

    The early-bird registration fee if paid before May 19, 2017 is $2,095 (conference alone), $2,695 (conference and one workshop), and $3,295 (conference and both workshops).  Special rates are available for in-house counsel (see brochure).  Patent Docs readers are entitled to a 10% discount off of registration using discount code P10-999-PTD17.  Those interested in registering for the conference can do so here, by e-mailing CustomerService@AmericanConference.com, by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.

    Patent Docs is a media partner of ACI's 8th Annual Summit on Biosimilars.

  • 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 May 9, 2017.  Lisa Tran, Communications Manager for eCommerce, and Richard Fernandez, eMod Project Manager, will provide an "eCommerce Modernization (eMod) Update" on the Office's efforts to improve the overall electronic patent application process.  The update will include information about Patent Center, a new tool in development to replace both the Electronic Filing System (EFS-Web) and the Patent Application Information Retrieval system (PAIR), and a discussion concerning the eMod Text Pilot Program for filing in text, upcoming text filing features available to all EFS-Web registered users, and how the public can participate in the eMod Project.

    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.

  • IPO #2The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "After Laches: Equitable Estoppel Redux?" on May 11, 2017 from 2:00 to 3:00 pm (ET).  Roger Cook of Kilpatrick Townsend & Stockton LLP, Ann Fort of Eversheds Sutherland LLP, and David Kelley of Ford Global Technologies LLC will focus on a point mentioned by both the majority and the dissent in the U.S. Supreme Court decision in SCA Hygiene v. First Quality – that equitable estoppel can protect against some of the consequences that may ensue from the court's decision, problems described by the majority as "unscrupulous patentees inducing potential targets of infringement suits to invest in the production of arguably infringing products."  The panel will explore whether equitable estoppel defense can indeed be used in many fact scenarios where laches previously applied.

    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.

  • By Kevin E. Noonan

    U.S. Trade RepresentativeOn April 28th, Ambassador Robert Lighthizer, U.S. Trade Representative (USTR), issued the 2017 Special 301 Report.  According to the USTR website, "[t]he 2017 Special 301 Report underscores the Administration's key trade priority of ensuring that U.S. owners of IP have full and fair opportunity to use and profit from their IP around the globe.  The theft of IP has resulted in distorted markets and unfair trade practices that harm American workers, innovators, service providers, and small and large businesses," language much more combative and less conciliatory than the USTR has used in recent years.  Noting that this is the first Special 301 Report of the Trump Administration, Ambassador Lighthizer states that "[t]he Administration is committed to using all possible sources of leverage to encourage other countries to open their markets to U.S. exports of goods and services and provide adequate and effective protection and enforcement of U.S. IP rights," calling this "the top trade priority" of the new Administration.  The Report reflects the Administration's resolve to "aggressively defend Americans from harmful IP-related trade barriers."  He backs up these assertions with statistics, such as there being 45.5 million American jobs that depend (directly or indirectly) on IP-intensive industries.  The differences between the Trump Administration and those that have preceded it are illustrated by the bluntness of the language and lack of finesse in stating its intentions:

    The Report reflects the resolve of this Administration to call out foreign countries and expose the laws, policies, and practices that fail to provide adequate and effective IP protection and enforcement for U.S. inventors, creators, brands, manufacturers, and service providers.  The identification of the countries and IP-related market access barriers in this Report and steps necessary to address those barriers are a critical component of the Administration's aggressive efforts to defend Americans from harmful IP-related trade barriers.

    Clearly, the intent is to "take names" although the efficacy of attempts to fulfill the other part of that memorable phrase remains to be seen.

    As it has done for the past several years, the Report highlights China as a country in which both "[l]ongstanding and new IP concerns merit attention," including with respect to "coercive technology transfer requirements, structural impediments to effective IP enforcement, and widespread infringing activity" (enumerated as "trade secret theft, rampant online piracy and counterfeiting, and high levels of physical pirated and counterfeit exports to markets around the globe").

    The USTR also cites India for what he calls "lack of sufficient measurable improvements to its IPR framework" and "new issues that have negatively affected U.S. right holders over the past year, particularly with respect to patents, copyrights, trade secrets, and enforcement."

    New this year is a citation to Canada and Mexico (U.S. NAFTA partners) for "lack of adequate authority for customs officials to seize and destroy counterfeit and pirated goods at the border" in a more general comment on "troubling trends in counterfeiting and piracy." These trends include "[d]igital piracy of U.S. movies, music, books, software and other works."  The European Union is cited, as it has previously, for "negative market access aspects" of its policies regarding geographical indications.

    The Report also announces that the USTR has closed "Out-of-cycle" reviews of Pakistan and Spain, "who have both undertaken improvements in recent years":   Pakistan "has maintained positive momentum in its efforts to reform its IP regime," whereas Spain "has strengthened its criminal laws for IP infringement and demonstrated a continued commitment to tackling online piracy."  Out-of-Cycle reviews will continue for Colombia and Tajikistan and the USTR will commence an Out-of-Cycle review for Kuwait.

    The Report is promulgated pursuant to Section 182 of the Trade Act of 1974, as amended by the Omnibus Trade and Competitiveness Act of 1988 and the Uruguay Round Agreements Act (enacted in 1994).  The Trade Representative is required under the Act to "identify those countries that deny adequate and effective protection for IPR or deny fair and equitable market access for persons that rely on intellectual property protection."  The Trade Representative has implemented these provisions by creating a "Priority Watch List" and "Watch List."  Placing a country on the Priority Watch List or Watch List is used to indicate that the country exhibits "particular problems . . . with respect to IPR protection, enforcement, or market access for persons relying on intellectual property."  These watch lists are reserved for countries having "the most onerous or egregious acts, policies, or practices and whose acts, policies, or practices have the greatest adverse impact (actual or potential) on the relevant U.S. products."

    The USTR reviewed  "more than 100" of this country's trading partners and identified eleven countries on a "Priority Watch List" (the same number as last year) and another 23 countries on the "Watch List" (just like last year), all relating to deficiencies in intellectual property protection in these countries.  The Priority Watch List in the 2017 Report cites the same countries as in the 2016 Report (Algeria, Argentina, Chile, China, India, Indonesia, Kuwait, Russia, Thailand, Ukraine, and Venezuela).  Countries on this list "present the most significant concerns this year regarding insufficient IP protection or enforcement or actions that otherwise limited market access for persons relying on intellectual property protection."  On the Watch List this year are Barbados, Bolivia, Brazil, Bulgaria, Canada, Columbia, Costa Rica, Dominican Republic, Ecuador, Egypt, Greece, Guatemala, Jamaica, Lebanon, Mexico, Pakistan, Peru, Romania, Switzerland, Turkey, Turkmenistan, Uzbekistan, and Vietnam.

    The Report also notes the USTR's continued efforts to enhance public engagement.  In addition to written comments (from 57 interested parties, including 16 trading partner governments), there was a public hearing on March 8, 2017 that heard testimony from "representatives of foreign governments, industry, and non-governmental organizations" (where the comments and a transcript of the hearing are available on the USTR website).

    The Report identifies "foreign trading partners where IP protection and enforcement has deteriorated or remained at unacceptable levels and where market access for Americans who rely on IP protection has been unfairly compromised." For almost all countries mentioned in the Report, "IP enforcement is lacking," based on (a) "[in]adequate or [in]effective border enforcement against counterfeit and pirated goods"; (b) copyright piracy in Argentina, China, Greece, Mexico, Romania, Russia, Switzerland, Tajikistan, Thailand, Turkmenistan, Ukraine, Uzbekistan, Venezuela and Vietnam; (c) restrictive patentability criteria in Argentina, Canada, India, and Indonesia and "[in]adequate and [in]effective protection for regulatory test or other data submitted by pharmaceutical and agricultural chemical producers"; (d) inadequate trade secret protection in China and India; and (e) negative market access effects on regulatory agencies in the European Union.

    The Report contains two Sections (on "Developments in Intellectual Property Rights Protection and Enforcement" and "Country Reports") and two Annexes on particular issues (the statutory bases of the Report, and government technical assistance and capacity building efforts).  In Section I, the Report reiterates its raison d'etre, that:

    Intellectual Property (IP) infringement, including trademark counterfeiting and copyright piracy, causes significant financial losses for right holders and legitimate businesses around the world. It undermines U.S. comparative advantages in innovation and creativity, to the detriment of American businesses and workers. In its most pernicious forms, IP infringement endangers the public. Some counterfeit products, including semiconductors, automobile parts, and medicines, pose significant risks to consumer health and safety. In addition, trade in counterfeit and pirated products often fuels cross-border organized criminal networks and hinders sustainable economic development in many countries. Because fostering innovation and creativity is essential to U.S. economic growth, competitiveness, and the support of an estimated 45 million U.S. jobs that directly or indirectly rely on IP-intensive industries, USTR works to protect American innovation and creativity with all the tools of U.S. trade policy, including through this Report.

    It then reviews "Initiatives for Strengthen IP Protection and Enforcement Internationally," citing "important developments in 2016 and early 2017."  These include a pilot program in China for specialized IP courts and recognition in China of trade secrets as being eligible for IP protection.  In Honduras, the Report cites attempts to prevent unauthorized retransmission of satellite signals and rogue cable providers, and India is cited for eliminating certain administrative patent (dis)incentives. Brazil is commended for taking "significant steps" to reduce a backlog of patent and trademark examination.  In the Arab world, Kuwait and the United Arab Emirates are mentioned for adopting legislation related to improvements in copyright protection and criminal penalties for IP infringement, respectively; Kuwait has also acceded to the Patent Cooperation Treaty. With regard to collective action, the Report notes that Kenya became the 56th member of the 1991 Act of the International Union for the Protection of New Varieties of Plants Convention (UPOV 91), directed to protecting breeders' rights and incentivize plant-breeding activities.  Also, 95 nations are parties to World Intellectual Property Organization (WIPO) Performances and Phonograms Treaty (WPPT) and the WIPO Copyright Treaty (WCT).

    The Report contains once again this year a subsection on "best practices" among U.S. trading partners, including "cooperation and coordination," with positive developments in this regard including in Paraguay related to the activities of the National Directorate for Intellectual Property (DINAPI); in Malaysia with regard to its Special Anti-Piracy Task Force for "deterring and preventing networks that distribute counterfeit and infringing goods"; and in Thailand for establishing an interagency IP enforcement committee and subcommittee, led by both the Prime Minister and his Deputy.  Brazil and Malaysia are also mentioned for creating specialized IP enforcement units.  Even putatively IP-cognizant and supportive countries, like the UK, are mentioned for conducting IP educational campaigns.

    With regard to government activities, the Report discusses "innovative mechanisms that enable government and private sector right holders to donate or license pharmaceutical patents voluntarily and on mutually-agreed terms and conditions," including WIPO's Medicines Patent Pool and the WIPO Re:Search Consortium directed to neglected tropical diseases.  Government compliance with IP rights in software "can set the right example for private enterprises" (citing Mexico) as well as adopting "best practices" for government officials in this regard.  Several multilateral initiatives are also discussed, including activities of the World Trade Organization (WTO) such as discussions on "Intellectual Property and Innovation: Sustainable Resource and Low Emission Technology Strategies" (the U.S., EU, Japan, Switzerland, Canada, and Taiwan), "Intellectual Property and Innovation: Regional Innovation Models" (the U.S., Australia, the EU, Japan, Switzerland and Taiwan) and "Intellectual Property and Innovation: Inclusive Innovation and Micro-, Small-, and Medium-Sized Enterprises" (the U.S., Australia, the EU, Japan, Switzerland and Taiwan). Bilateral and regional initiatives discussed in the Report include the U.S.-India Trade Policy Forum, Trade and Investment Framework Agreements (TIFAs) between the United States and more than 50 trading partners, endorsement of a set of "Best Practices in Trade Secret Protection and Enforcement Against Misappropriation" by Asia-Pacific Economic Cooperation (APEC) Leaders and Ministers, and continued engagement with members of the Caribbean Community and Common Market regarding "inadequate and ineffective copyright protection and enforcement."

    In a section entitled "IP Protection and Enforcement and Related Market Access Challenges," the Report discusses topics including border control and criminal enforcement against counterfeiting of trademarked goods (including "semiconductors and other electronics, chemicals, automotive and aircraft parts, medicines, food and beverages, household consumer products, personal care products, apparel and footwear, toys, and sporting goods").  The Report states that such counterfeit goods harm "consumers, legitimate producers, and governments," particularly with regard to pharmaceutical and biologic drug products.  The Report enunciates particular concern for such activities in China, India, Indonesia, Russia, Peru, Lebanon and Guatemala, and alleges that 90% of all counterfeit drugs entering the U.S. come from China, Hong Kong, India and Singapore.  While commending Singapore for coordinated actions with U.S. Customs and Border Protection agents against such trafficking, the Report states more generally that "[m]any countries [] do not provide penalties that deter criminal enterprises engaged in global trademark counterfeiting operations" and that "[e]ven when such enterprises are investigated and prosecuted, the penalties imposed often are low, making such penalties merely "the cost of doing business." Accordingly, the Report "urges" U.S. trading partners to "undertake more effective criminal and border enforcement against the manufacture, import, export, transit, and distribution of counterfeit goods."

    The Report next turns to online and broadcast piracy of copyrighted works, citing the "increased availability of broadband Internet connections around the world" as being a "boon" to the U.S economy and foreign trade.  But while advances in technology have enabled U.S. creative producers to better distribute copyrighted materials it has also made the Internet "an extremely efficient vehicle for disseminating infringing content, thus competing unfairly with legitimate e-commerce and distribution services that copyright holders and online platforms use to deliver licensed content."  Illicit camcording is a particular concern in the Report, with stakeholders reporting a "significant increase" in pirated movies in the year since the last Special 301 Report (almost doubled in Mexico and India).  Changes in the law in individual trading partner countries is suggested, illustrated by the necessity in some countries for law enforcement to observe someone camcording a motion picture and illegally distributing it.  Added to the camcording problem are variety of ways to steal copyrighted content directly from legitimate providers, such as "stream-ripping" of live sports programming and online piracy of games and prerecorded content.  Rights enforcement capability as well as government action across multiple jurisdictions are mentioned as important needs, as are government actions to prevent domestic "safe havens" for online copyright infringers.  Other aspects of copyright enforcement contained in the Report are royalty payment and administration regimes including collective management organizations (CMO), which the Report states are "flawed or non-operational" in many countries (Argentina, India and the UAE, specifically).

    Trademarks and impediments to obtaining and enforcing them in some countries make up the next topic in the Report, with Argentina, Brazil, India, Malaysia and the Philippines having "slow" opposition proceedings and Russia and Panama having no administrative opposition proceedings. Even registering (i.e., making a record of) trademarks is problematic in some countries, with "unnecessary administrative and financial burdens" imposed on owners and there being unnecessary difficulties in maintaining and enforcing trademarks (albeit without naming any countries where these and other difficulties contained in the Report have arisen).  There are also issues with cybersquatting and particularly with country code top-level domain names (ccTLDs) for U.S. rights holders.  The governments of China, Macedonia, Pakistan, Panama, Paraguay, South Korea, Taiwan, Tajikistan, Thailand, Turkmenistan, Ukraine and Vietnam are named for unlicensed use of software, and the Report cites a commercial value for such illicit use of software at $52 billion worldwide.

    Trade secrets also raise issues for American industry, spanning "a wide variety of industry sectors, including information and communications technologies, services, pharmaceuticals, manufacturing, and environmental technologies."  Evidence for risk to U.S. companies of trade secret misappropriation comes from a variety of sources according to the Report, including the U.S. Office of the National Counterintelligence Executive (ON- CIX), which has identified China and India as countries posing particular impediments to obtaining effective remedies against trade secret thieves.  The problem is even more critical in Brazil, Indonesia and Nigeria, where companies can be compelled to disclose, inter alia, source code protected as a trade secret. Despite recognizing these challenges, the Report also commends China, the EU, Kazakhstan and Taiwan for strengthening or "working to strengthen" their trade secret protection regimes.

    There is increasing evidence that in some countries governments are incentivizing domestic indigenous innovation that can require U.S. companies to give up IP rights as the price of market entry.  Examples of such policies cited in the Report are:

    • Requiring the transfer of technology as a condition for obtaining regulatory approvals or otherwise securing access to a market, or for allowing a company to continue to do business in the market;

    • Directing state owned enterprises (SOEs) in innovative sectors to seek non-commercial terms from their foreign business partners, including with respect to the acquisition and use or licensing of IP;

    • Providing national firms with an unfair competitive advantage by failing to effectively enforce foreign-held IP, including patents, trademarks, trade secrets, and copyright;

    • Failing to take meaningful measures to prevent or deter cyber-intrusions and other unauthorized activities;

    • Requiring use of, or providing preferences to, products or services that contain locally- developed or owned IP, including with respect to government procurements;

    • Manipulating the standards development process to create unfair advantages for national firms, including with respect to the terms on which IP is licensed; and

    • Requiring the submission of unnecessary or excessive confidential business information for regulatory approval purposes and failing to protect such information appropriately.

    Countries identified in the Report as employing at least one of these practices include China, India, and Nigeria.

    Market barriers to pharmaceuticals and medical devices make up a separate portion of the Report, there the USTR maintains that "[m]easures including those that are discriminatory, nontransparent, or otherwise trade-restrictive, have the potential to hinder market access in the pharmaceutical and medical device sector, and potentially result in higher healthcare costs," citing Brazil and India for adding tariffs in the form of taxes on imported medicines. Other market access restrictions cited in the Report include "unreasonable regulatory approval delays and non-transparent reimbursement policies" that can "impede a company's ability to enter the market, and thereby discourage the development and marketing of new drugs and other medical products."  Algeria, Austria, Belgium, China, Columbia, Czech Republic, Ecuador, Hungary, Italy, Lithuania, New Zealand, Portugal, Romania, South Korea, Taiwan and Turkey have policies regarding pharmaceutical and medical device market access that raise concerns in the Report (specific examples of which are set forth for each country).

    The last specific areas of concern discussed in the Report are geographical indications, with the policies of the EU in this regard being "particularly concerning."

    Section I of the Report ends by mentioning the role of intellectual property and the environment and intellectual property and health as areas of concern raised by stakeholders in their comments.  In India, for example, compulsory licensing of "green" technology "will discourage, rather than promote, investment in and dissemination of green technology innovation, including those technologies that contribute to climate change adaptation and mitigation." The Report contains an affirmation of the provisions regarding IP and public health set forth in the Doha Declaration and pledges not to "impede its trading partners from taking measures necessary to protect public health." And the final portion of the Report discusses efforts at dispute resolution of IP matters under the GATT/TRIPS provisions as they are implemented by the WTO.

    Section II of the Report is a detailed, country-by-country discussion for each country on the Priority Watch List and the Watch List, relating to the activities (or lack thereof) of each country that results in placement of that country on these lists.

    As it has for the past several years (and across otherwise very different Administrations), the U.S. Trade Representative Special 301 Report provides insights into both the concerns of U.S. IP rights holders and the Administration's intentions to work with, cajole, coerce, or threaten other countries to increase protection for IP rights of U.S. IP rights holders.  The substance of the Report is similar to Reports issued during the Obama Administration, but there is less recognition of areas where our trading partners have rectified lapses in IP protection and more emphasis on protecting American rights (albeit less pugnaciously than might have been expected from this Administration).  Ironically, much of what the Report espouses was contained in the Trans-Pacific Partnership Agreement from which the President withdrew as one of the first acts of the new Administration (see "Why President Trump Is Wrong about Trans-Pacific Partnership Agreement").  As with last year's Report, however, the tone and tenor of this Report is robustly assertive regarding IP rights and America's intention to negotiate international agreements and confront its trading partners in ways that protect American innovation and commercial interests.

  • By John Cravero

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

    InnoPharma Licensing, LLC v AstraZeneca AB

    PTAB Petition:  IPR2017-00900; filed February 17, 2017.

    Patent at Issue:  U.S. Patent No. 8,329,680 ("Formulation," issued December 11, 2012) claims a method for treating a hormonal dependent benign or malignant disease of the breast or reproductive tract comprising administering intramuscularly to a human in need of such treatment a formulation comprising: about 50 mgml-1 of fulvestrant; about 10% w/v of ethanol; about 10% w/v of benzyl alcohol; about 15% w/v of benzyl benzoate; and a sufficient amount of castor oil vehicle; wherein the method achieves a therapeutically significant blood plasma fulvestrant concentration of at least 2.5 ngml-1 for at least four weeks.

    Petitioners InnoPharma Licensing, LLC, InnoPharma, Inc., and Pfizer Inc. are challenging the '680 patent on four grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, the '680 patent is involved in litigations captioned AstraZeneca Pharms. LP. v. Agila Specialties, Inc., No. 1:15-cv-06039 (D.N.J.); AstraZeneca Pharms. LP v. InnoPharma, Inc., No. 1:16-cv-894 (D.N.J.); AstraZeneca Pharms. LP v. InnoPharma Licensing LLC, No. 1:16-cv-1962 (D.N.J.); AstraZeneca Pharms. LP v. Sandoz Inc., No. 1:14-cv-03547 (D.N.J.); AstraZeneca Pharms. LP v. Sagent Pharms., Inc., No. 1:14-cv-05539 (D.N.J.) and 1:14-cv-7358-EEC (N.D. Ill.); AstraZeneca Pharms. LP v. Glenmark Pharms. Inc., USA, No. 1:15-cv-615 
(D.N.J.); AstraZeneca Pharms. LP v. Teva Pharms. USA, Inc., No. 1:15-cv-7889 (D.N.J.); AstraZeneca Pharms. LP v. Mylan Pharms. Inc., No. 1:15-cv-7009 (D.N.J.); AstraZeneca Pharms. LP v. Dr. Reddy's Laboratories, Inc., No. 1:17-cv-926 (D.N.J.); AstraZeneca Pharms. LP v. Mylan Institutional LLC, No. 1:16-cv-4612 (D.N.J.).  Also, the '680 patent was the subject of IPR2016-01325 (Mylan Pharmaceuticals; filed 06/29/2016; institution denied 12/14/2016).


    InnoPharma Licensing, LLC v AstraZeneca AB

    PTAB Petition:  IPR2017-00904; filed February 17, 2017.

    Patent at Issue:  U.S. Patent No. 6,774,122 ("Formulation," issued August 10, 2004) claims a method of treating a hormonal dependent benign or malignant disease of the breast or reproductive tract by administration to a human in need of such treatment an intra-muscular injection of a pharmaceutical formulation comprising fulvestrant, a mixture of 10% weight of ethanol per volume of formulation, 10% weight of benzyl alcohol per volume of formulation and 15% weight of benzyl benzoate per volume of formulation and a sufficient amount of a castor oil vehicle, whereby a therapeutically significant blood plasma fulvestrant concentration of at least 2.5 ngml-1 is attained for at least 2 weeks after injection.

    Petitioners InnoPharma Licensing, LLC, InnoPharma, Inc., and Pfizer Inc. are challenging the '122 patent on three grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, the '122 patent is involved in litigations captioned AstraZeneca Pharms. LP. v. Agila Specialties, Inc., No. 1:15-cv-06039 (D.N.J.); AstraZeneca Pharms. LP v. InnoPharma, Inc., No. 1:16-cv-894 (D.N.J.); AstraZeneca Pharms. LP v. InnoPharma Licensing LLC, No. 1:16-cv-1962 (D.N.J.); AstraZeneca Pharms. LP v. Sandoz Inc., No. 1:14-cv-03547 (D.N.J.); AstraZeneca Pharms. LP v. Sagent Pharms., Inc., No. 1:14-cv-05539 (D.N.J.) and 1:14-cv-7358-EEC (N.D. Ill.); AstraZeneca Pharms. LP v. Glenmark Pharms. Inc., USA, No. 1:15-cv-615 
(D.N.J.); AstraZeneca Pharms. LP v. Teva Pharms. USA, Inc., No. 1:15-cv-7889 (D.N.J.); AstraZeneca Pharms. LP v. Mylan Pharms. Inc., No. 1:15-cv-7009 (D.N.J.); AstraZeneca Pharms. LP v. Dr. Reddy's Laboratories, Inc., No. 1:17-cv-926 (D.N.J.); AstraZeneca Pharms. LP v. Mylan Institutional LLC, No. 1:16-cv-4612 (D.N.J.).  Also, the '122 patent was the subject of IPR2016-01316 (Petitioner Mylan Pharmaceuticals Inc.; filed 06/29/2016; terminated through settlement 01/10/2017); and US Pat. No. 8,329,680, a continuation of the '122 patent, was the subject of IPR2016-01325 (Mylan Pharmaceuticals; filed 06/29/2016; institution denied 12/14/2016).


    InnoPharma Licensing, LLC v AstraZeneca AB

    PTAB Petition:  IPR2017-00905; filed February 17, 2017.

    Patent at Issue:  U.S. Patent No. 8,466,139 ("Formulation," issued June 18, 2013) claims a method for treating a hormonal dependent benign or malignant disease of the breast or reproductive tract comprising administering intramuscularly to a human in need of such treatment a formulation comprising: about 50 mgml-1 of fulvestrant; a mixture of from 17-23% w/v of ethanol and benzyl alcohol; 12-18% w/v of benzyl benzoate; and a sufficient amount of castor oil vehicle; wherein the method achieves a blood plasma fulvestrant concentration of at least 2.5 ngml-1 for at least two weeks.

    Petitioners InnoPharma Licensing, LLC, InnoPharma, Inc., and Pfizer Inc. are challenging the '139 patent on three grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, the '139 patent is involved in litigations captioned AstraZeneca Pharms. LP. v. Agila Specialties, Inc., No. 1:15-cv-06039 (D.N.J.); AstraZeneca Pharms. LP v. InnoPharma, Inc., No. 1:16-cv-894 (D.N.J.) ("the First InnoPharma Action"); AstraZeneca Pharms. LP v. InnoPharma Licensing LLC, No. 1:16-cv-1962 (D.N.J.) (part of the Consolidated Fulvestrant Action); AstraZeneca Pharms. LP v. Sandoz Inc., No. 1:14-cv-03547 (D.N.J.); AstraZeneca Pharms. LP v. Sagent Pharms., Inc., No. 1:14-cv-05539 (D.N.J.) and 1:14-cv-7358-EEC (N.D. Ill.); AstraZeneca Pharms. LP v. Glenmark Pharms. Inc., USA, No. 1:15-cv-615 
(D.N.J.); AstraZeneca Pharms. LP v. Teva Pharms. USA, Inc., No. 1:15-cv-7889 (D.N.J.); AstraZeneca Pharms. LP v. Mylan Pharms. Inc., No. 1:15-cv-7009 (D.N.J.); AstraZeneca Pharms. LP v. Dr. Reddy's Laboratories, Inc., No. 1:17-cv-926 (D.N.J.); AstraZeneca Pharms. LP v. Mylan Institutional LLC, No. 1:16-cv-4612 (D.N.J.).  Also, the '139 patent was the subject of IPR2016-01326 (Petitioner Mylan Pharmaceuticals Inc.; filed 06/29/2016; terminated through settlement 01/10/2017); and US Pat. No. 8,329,680, a parent of the '139 patent, was the subject of IPR2016-01325 (Mylan Pharmaceuticals; filed 06/29/2016; institution denied 12/14/2016).


    Celltrion, Inc. v Genentech, Inc.

    PTAB Petition:  IPR2017-00959; filed February 21, 2017.

    Patent at Issue:  U.S. Patent No. 8,591,897 ("Anti-ERBB2 antibody adjuvant therapy," issued November 26, 2013) claims a method of adjuvant therapy comprising administering to a human subject with nonmetastatic HER2 positive breast cancer, following definitive surgery, anthracycline/cyclophosphamide (AC) based chemotherapy, followed by sequential administration of a taxoid and trastuzumab or an antibody that blocks binding of trastuzumab to HER2.

    Petitioners Celltrion, Inc., Celltrion Healthcare Co. Ltd., and Teva Pharmaceuticals International GmbH are challenging the '897 patent on three grounds as anticipated under 35 U.S.C. § 102(b) (grounds 1 and 2) or as obvious under 35 U.S.C. § 103(a) (ground 3).  View the petition here.

    Related Matters:  According to the petition, the '897 patent is not involved in any other matters.


    Celltrion, Inc. v Biogen, Inc.

    PTAB Petition:  IPR2016-01614; filed August 15, 2016.

    PTAB Trial Instituted, entered February 24, 2017.

    Patent at Issue:  U.S. Patent No. 7,820,161 ("Treatment of autoimmune diseases," issued October 21, 2010) claims a method of treating rheumatoid arthritis in a human comprising: (a) administering to the human more than one intravenous dose of a therapeutically effective amount of rituximab; and (b) administering to the human methotrexate.

    Petitioner Celltrion, Inc. is challenging the '161 patent on three grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.  Administrative Patent Judges Francisco C. Prats, Erica A. Franklin (author), and Sheridan K. Snedden issued a decision instituting inter partes review of whether claims 1–3, 5–7, and 9–11 are unpatentable under 35 U.S.C. § 103(a) as obvious over Edwards, the Rituxan® Label, O'Dell, and Kalden.

    Related Matters:  According to the petition, the '161 patent was the subject of IPR2015-00415 (Boehringer Ingelheim Pharmaceuticals, Inc.; filed 12/15/2014; instituted 07/17/2015; terminated 10/01/2015 pursuant to a Request for Adverse Judgment by petitioner); and IPR2015-01744 (Celltrion, Inc.; filed 08/17/2015; terminated 10/06/2015 pursuant to a Motion to Dismiss filed by petitioner).


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

    PTAB Petition:  IPR2017-00983; filed February 28, 2017.

    Patent at Issue:  U.S. Patent No. 8,657,827 ("Surgical tools for arthroplasty," issued February 25, 2014) claims patient-specific surgical tool for use in surgically repairing a joint of a patient.

    Petitioner Smith & Nephew, Inc. is challenging the '827 patent on six grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, the '827 patent is the subject of a litigation captioned ConforMIS, Inc. v. Smith & Nephew, Inc., No. 1:16-cv-10420-IT (D. Mass.).  Petitioner is concurrently filing a petition for inter partes review of claims 50-64 of the '827 patent (IPR2017-00984).  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); 7,534,263 (IPR2017-00544; filed 12/27/2016; pending) and (IPR2017-00545; filed 12/27/2016; pending); and 8,062,302 (IPR2017-00779; filed 01/26/2017; pending).


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

    PTAB Petition:  IPR2017-00984; filed February 28, 2017.

    Patent at Issue:  U.S. Patent No. 8,657,827 ("Surgical tools for arthroplasty," issued February 25, 2014) claims patient-specific surgical tool for use in surgically repairing a joint of a patient.

    Petitioner Smith & Nephew, Inc. is challenging the '827 patent on four grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, the '827 patent is the subject of a litigation captioned ConforMIS, Inc. v. Smith & Nephew, Inc., No. 1:16-cv-10420-IT (D. Mass.).  Petitioner is concurrently filing a petition for Inter Partes Review of claims 50-64 of the '827 patent (IPR2017-00983).  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); 7,534,263 (IPR2017-00544; filed 12/27/2016; pending) and (IPR2017-00545; filed 12/27/2016; pending); and 8,062,302 (IPR2017-00779; filed 01/26/2017; pending).


    Arthrex, Inc.
    v KFx Medical, LLC

    PTAB Petition:  IPR2016-01697; filed August 31, 2016.

    PTAB Trial Instituted, entered February 28, 2017.

    Patent at Issue:  U.S. Patent No. 9,044,226 ("System and method for attaching soft tissue to bone," issued June 02, 2015) claims a bone implant, comprising a substantially hollow cylinder; and a method of fixating a bone implant within bone.

    Petitioner Arthrex, Inc. is challenging the '226 patent on seven grounds as anticipated under 35 U.S.C. § 102(b) (ground 1) and obvious under 35 U.S.C. § 103(a) (grounds 2-7).  View the petition here.  Administrative Patent Judges Lora M. Green, Josiah C. Cocks (author), and Richard H. Marschall issued a decision instituting inter partes review of whether claims 1-20 are unpatentable under 35 U.S.C. § 103(a) as obvious over Meridew, Pietrzak or Goble, Fucci or Schmieding, and Anspach.

    Related Matters:  According to the petition, the '226 patent is the subject of a litigation captioned Arthrex, Inc. v. Joseph Tauro et al., No: 3:15-cv-06580 (D.N.J.).


    Arthrex, Inc.
    v KFx Medical, LLC

    PTAB Petition:  IPR2016-01698; filed August 31, 2016.

    PTAB Trial Instituted, entered February 28, 2017.

    Patent at Issue:  U.S. Patent No. 8,926,663 ("System and method for attaching soft tissue to bone," issued January 6, 2015) claims a bone implant, comprising a substantially hollow cylinder; and a method of fixating a bone implant within bone.

    Petitioner Arthrex, Inc. is challenging the '663 patent on seven grounds as anticipated under 35 U.S.C. § 102(b) (ground 1) and obvious under 35 U.S.C. § 103(a) (grounds 2-7).  View the petition here.  Administrative Patent Judges Lora M. Green, Josiah C. Cocks, and Richard H. Marschall (author)issued a decision instituting inter partes review of whether claims 1-18 are unpatentable under 35 U.S.C. § 103(a) as obvious over Meridew, Pietrzak or Goble, Fucci or Schmieding, and Anspach.

    Related Matters:  According to the petition, the '663 patent is the subject of a litigation captioned Arthrex, Inc. v. Joseph Tauro et al., No: 3:15-cv-06580 (D.N.J.).

  • By Kevin E. Noonan

    Duke UniversityLast week, the Federal Circuit completed its review of a series of patents relating to treating Pompe disease and invalidated by inter partes review before the U.S. Patent and Trademark Office's Patent Trial and Appeal Board (PTAB), in Duke University v. BioMarin Pharmaceutical Inc.

    The drug recited in the challenged clams of the patent-at-issue, U.S. Patent 7,056,712, covers (as did two other patents, U.S. Patent Nos. 7,351,410 and 7,655,226, previously invalidated by the PTAB) methods for administering acid α-glucosidase ("GAA") used as an enzyme replacement therapy for treating glycogen storage disease type II (Pompe disease).  This disease is caused by GAA deficiency, resulting in an accumulation of glycogen in tissues such as the heart and skeletal muscle.  Pompe disease is treated by administering to the patient a therapeutically effective amount of the protein (a recombinant human version of this protein (rhGAA)), produced in precursor form in Chinese hamster ovary (CHO) cell cultures.  The drug is marketed by Genzyme, the patent owner of the two related patents involved in these IPR proceedings.

    BiomarinBioMarin Pharmaceutical Inc. filed IPR petitions against these three patents in 2013.  The PTAB determined that the claims of the two Genzyme patents were obvious in view of various combinations of references.  The PTAB further determined that the claims of the Duke patent were either anticipated or obvious in view of similar cited art.

    The '712 patent claims are supported by a disclosure directed to treating the most serious (infantile) form of the disease.  Two independent claims are representative:

    1.  A method of treating glycogen storage disease type II in a human individual having glycogen storage disease type II, comprising administering to the individual a therapeutically effective amount of human acid α-glucosidase periodically at an administration interval, wherein the human acid α-glucosidase was produced in chinese [sic] hamster ovary cell cultures.

    20.  A method of treating cardiomyopathy associated with glycogen storage disease type II in an human individual having glycogen storage disease type II, comprising administering to the individual a therapeutically effective amount of human acid α-glucosidase periodically at an administration interval, wherein the human acid α-glucosidase was produced in chinese [sic] hamster ovary cell culture.

    In addition, and important for this appeal, two dependent claims were also invalidated:

    9.  The method of claim 1, wherein the human acid α-glucosidase is a precursor of recombinant human acid α-glucosidase that has been produced in chinese [sic] hamster ovary cell cultures." (emphasis in opinion)

    19.  The method of claim 1, [wherein the human acid α-glucosidase is administered in conjunction with an immunosuppressant and] "wherein the immunosuppressant is administered prior to any administration of human acid α-glucosidase to the individual." (emphasis in opinion).

    Altogether, claims 1-9, 11, 12, 15, and 18-21 of the '712 patent were invalidated by the PTAB.  All claims were found invalid for being anticipated by U.S. Patent 7,351,410 and/or obvious over the combination of PCT Publication WO 97/05771 with a scientific journal publication (Van Hove) that disclosed purification of precursor rhGAA, either alone or in combination with other references, including one to Brady et al. that disclosed using neutralizing antibody production in patients given Ceredase to manage Gaucher's disease (another lysosomal storage disorder).

    With regard to dependent claims 9 and 19, the Board interpreted the "precursor" limitation in claim 9 to include methods using administration of combinations of precursor and other forms of rhGAA, and that the timing of administration of immunosuppressants recited in claim 19 was prior to the first administration of rhGAA to a patient.

    The '410 patent and '771 application both disclosed methods for producing rhGAA in transgenic animals as well as using rhGAA for treating Pompe disease by enzyme replacement therapy.  In addition, both references disclosed recombinant production in CHO cells as an alternative source to transgenic animals.  Both also disclosed precursor forms of rhGAA as well as smaller intermediate and mature forms, and disclosed that administrating the precursor form is preferred.  Specifically with regard to the grounds for finding the '712 claims invalid, the '410 patent teaches that GAA from transgenic animals, human urine, and rhGAA from CHO cells are equivalently efficient for treating Pompe disease.  Moreover, the '410 patent teaches a method for purifying "large quantities" of rhGAA from CHO cells.

    The PTAB found claims 1-9, 12, 15, 20, and 21 were anticipated by the '410 patent.  The Board rejected Duke's arguments regarding differences between transgenic animal-derived human GAA and CHO cell-derived rhGAA based on disclosure in the '410 patent that GAA from these disparate sources were equivalent for treating Pompe disease.  With regard to claim 9, the Board found that the '410 patent disclosed treating Pompe disease with mixtures of GAA that were predominantly (>50%) comprised of the precursor form.

    Alternatively, the Board found that all challenged claims were obvious over the combination of the '410 patent and the '771 application, with or without further consideration of the Brady reference.  The Board's conclusions paralleled the reasoning for anticipation, finding the disclosures in the cited references would have provided the required reasonable expectation of success from the combination.  The Board also held that, for claim 19 the Brady reference taught immunosuppression on the first day of GAA administration "in an 'effort to immunosuppress the patient' and reduce neutralizing antibodies in the individual," which was enough to support its obviousness determination.

    Finally, the Board was not persuaded by any of the evidence regarding Duke's assertion of the objective indicia of non-obviousness (long-felt need, failure of others, unexpected results, licensing, commercial success, praise, and industry acceptance), due to a perceived failure to establish a nexus between the claims and any of the indicia.

    The Board granted rehearing to reconsider the obviousness determination of claim 19 over the Brady reference, and held that "Brady does not disclose administering immunosuppressant prior to any and all administration of hGAA, as required by claim 19."  Nevertheless, two of the Administrative Patent Judges still found the claim obvious, based on expert testimony of BioMarin's expert and their own determination that "[t]he choice of administering immunosuppressant before an adverse immune response develops in a patient, or after a patient has experienced an adverse immune response, are predictable variations producing the same result—prevention of an adverse immune response to foreign protein."  The remaining APJ was unconvinced, saying that "[w]hile [BioMarin expert] Dr. Pastores' conclusory statements may indicate what 'could be' done if 'there is a high incidence' of antibody response, he does not explain, nor provide evidence showing, what an ordinary artisan would have done in this regard prior to the filing date of the '712 patent, or what one would have understood in relation to incidents of 'high antibody titers' in response to exogenous enzyme therapy" (emphasis in opinion).

    The Federal Circuit affirmed the Board with regard to all claims except claims 9 and 19, in an opinion by Judge Lourie joined by Judges O'Malley and Taranto.  The Court's analysis focused on independent claims 1 and 20 (because Duke had not argued that dependent claims 2-8, 12, 15, and 21 were independently patentable) with regard to anticipation, and found that there was substantial evidence supporting the Board's conclusion that these claims were anticipated by the '410 patent.  The panel was not convinced by the distinction Duke attempted to draw between the hGAA produced in the milk of transgenic animals and the rhGAA produced in CHO cells.  This result was based on the disclosure in the '410 patent specification, which was so "sufficiently clear and on point to constitute substantial evidence to support the Board's anticipation findings," so much so that expert testimony was not required, according to the opinion.

    (In passing, the Court also rejected Duke's argument regarding the Board's assertion of invalidity based on "theories [] BioMarin never raised" in support of IPR initiation, saying that Duke had been given an opportunity to respond and illustrating once again the Court's reluctance to review IPR initiation questions raised by the parties to an IPR.)

    Turning to dependent claim 9, the Court addressed Duke's challenge to the Board's construction of the claim term "precursor" regarding the species of rhGAA recited in the '712 patent claims.  This question was decided de novo by the Federal Circuit, because only intrinsic evidence was considered by the Board.  The Court disagreed with the Board's construction, that the claim encompassed administration of GAA formulations comprising hGAA species in addition to the precursor form of the molecule.  Rather, the panel agreed with Duke that the term should be construed to mean "exclusively a precursor of recombinant hGAA that has been produced in CHO cell cultures," based on the structure of the language of the claim and the written description of the '712 specification.  This the cited art did not teach, according to the Court, and reversed the Board's finding that claim 9 was anticipated.

    With regard to obviousness, the issue as to claims 1-8, 12, 15, 20, and 21 was mooted by the Court's affirmance that these claims were anticipated as the Board held, and thus they were no longer discussed with regard to the panel's review of the PTAB's decision.  As to claim 9, the Court vacated the Board's decision because they did "not have the benefit of the Board's considered analysis whether claim 9 would have been obvious under the correct construction"; specifically, "the Board did not determine whether [the cited references] teach or suggest administering exclusively a precursor of rhGAA produced in CHO cell cultures."  The panel remanded the obviousness question to the Board for reconsideration based on the Court's construction of the term "precursor."  Further with regard to the claim 9 rejection, the Court also stated that:

    Duke also argues that there was no motivation to combine Reuser and Van Hove, there was no reasonable expectation of success from that combination, and its proffered objective indicia support a conclusion of nonobviousness.  On remand, the Board is to consider these arguments and provide a meaningful discussion of its analysis of them.

    And in a footnote, the Court said that "[n]otably, Duke's objections to the Board's treatment of its evidence of objective indicia of non-obviousness—including its failure to apply a presumption of nexus—appear well taken."

    For claim 19, the opinion states that the Court agreed with Duke that the PTAB had erred in finding that BioMarin had borne its burden of establishing obviousness.  The Court did not find substantial evidence that "the prophylactic administration of an immunosuppressant would have been a predictable variation of the use of immunosuppressant disclosed in Brady."  The panel said neither party disputed that the Board properly found that Brady reference not to disclose administering immunosuppressant prior to "any and all" occurrences of GAA administration, and that the Board had used expert testimony to "bridge the gap" in arriving at its obviousness determination.  However, the Federal Circuit found that testimony "falls short" of what was required "because it does not address what an ordinary artisan would have done or understood regarding prophylactic administration of immunosuppressants in the context of GAA enzyme replacement therapy prior to the priority date of the '712 patent. It merely suggests what 'could be' done 'if there is a high incidence' of antibody response" according to the panel, citing specific portions of that testimony to support its conclusion.  In addition, the opinion states that there was no evidence adduced by BioMarin to support the predicate that a "high incidence of patients" would develop high antibody titres as a result of rhGAA therapy.  Indeed, Brady affirmatively teaches that "[v]ery few patients with Gaucher disease who are treated with [enzyme replacement therapy] develop a neutralizing antibody to the exogenous enzyme" and refers to this phenomenon as "rare" according to the opinion.  The panel concludes that:

    [T]he evidence of record does not establish the conditions precedent (a high incidence of patients with high antibody titers to the enzyme) to the prophylactic administration of immunosuppressants according to the expert's testimony.  Such conclusory expert testimony cannot support an obviousness conclusion.

    In view of the Court's final decision regarding nonobviousness of Claim 19, it seems that Duke has a claim that would prevent BioMarin or other competitors from inducing infringement of rhGAA administration in the presence of an immunosuppressant administered prior to rhGAA administration (absent assertion of additional prior art).  And it is possible that the Board will not invalidate claim 9 on remand, thus permitting Duke (and its licensees) to have an exclusive position on rhGAA produced from CHO cells for treating Pompe disease.

    Duke University v. Biomarin Pharmaceutical Inc. (Fed. Cir. 2017)
    Nonprecedential disposition
    Panel: Circuit Judges Lourie, O'Malley, and Taranto
    Opinion by Circuit Judge Lourie

  • By Michael Borella

    Federal Circuit SealRecognicorp, owner of U.S. Patent No. 8,005,303, sued Nintendo for infringement in the U.S. District Court for the District of Oregon.  After a transfer to the U.S. District Court for the Western District of Washington and reexamination proceedings in the U.S. Patent and Trademark Office, Nintendo moved for judgment on the pleadings.  Particularly, Nintendo asserted that the patent's claims recited ineligible subject matter under 35 U.S.C. § 101.  The District Court agreed, and Recognicorp appealed to the Federal Circuit.

    The Supreme Court's Alice Corp. Pty. Ltd. v. CLS Bank Int'l case set forth a two-part test to determine whether claims are directed to patent-eligible subject matter.  One must first determine whether the claim at hand is directed to a judicially-excluded law of nature, a natural phenomenon, or an abstract idea.  If so, then one must further determine whether any element or combination of elements in the claim is sufficient to ensure that the claim amounts to significantly more than the judicial exclusion.  But generic computer implementation of an otherwise abstract process does not qualify as "significantly more."  On the other hand, a claimed improvement to a computer or technological process is not abstract.

    Claim 1 of the '303 patent recites:

    A method for creating a composite image, comprising:
        displaying facial feature images on a first area of a first display via a first device associated with the first display, wherein the facial feature images are associated with facial feature element codes;
        selecting a facial feature image from the first area of the first display via a user interface associated with the first device, wherein the first device incorporates the selected facial feature image into a composite image on a second area of the first display, wherein the composite image is associated with a composite facial image code having at least a facial feature element code and wherein the composite facial image code is  derived by performing at least one multiplication operation on a facial code using one or more code factors as input parameters to the multiplication operation; and
        reproducing the composite image on a second display based on the composite facial image code.

    As described by the Court, storing facial images in traditional file formats (e.g., bitmaps, JPEGs, and GIFs) is inefficient due to the large resulting file sizes, and compressing these files often decreases image quality.  The '303 patent, however, "solves this problem by encoding the image at one end through a variety of image classes that required less memory and bandwidth, and at the other end decoding the images."

    The District Court, prior to claim construction, stated that the claims are "directed to the abstract idea of encoding and decoding composite facial images using a mathematical formula."  The District Court made an analogy between the claimed invention and painting by numbers to support this conclusion.  Regarding part two of the Alice test, the District Court concluded that "the entirety of the '303 Patent consists of the encoding algorithm itself or purely conventional or obvious pre-solution activity and post-solution activity insufficient to transform the unpatentable abstract idea into a patent-eligible application."

    On review, the Federal Circuit generally agreed.  Considering part one of Alice, the Court characterized the invention as being directed to an even broader abstract idea — that of "encoding and decoding image data."  The Court acknowledged that the claim recites a specific type of encoding and decoding, but stated that encoding and decoding of information is "an abstract concept long utilized to transmit information."

    Recognicorp invoked Enfish v. Microsoft to support its position that "the district court mischaracterized the invention using an improperly high level of abstraction that ignored the particular encoding process recited by the claims."  But the Court disagreed in a conclusory fashion, stating that the claims are "clearly directed to encoding and decoding image data," and that "claim 1 does not claim a software method that improves the functioning of a computer."  This latter statement was made despite the Court implying that the invention solved a technical problem related to digital image encoding and transmission just a few pages earlier.  The only reasoning the Court used to support its holding was that claim 1 was similar to the claims of Digitech Image Technologies v. Electronics for Imaging, where an invention directed to organizing information through mathematical correlations was found to be abstract.

    Moving on to part two of Alice, the Court rebutted Recognicorp's argument that "facial feature element codes" and "pictorial entity symbols" in the claims (the latter not in claim 1) rendered the claims patent-eligible.  Particularly, the Court found these additional elements also to be abstract, and noted that adding more abstract elements to an abstract idea does not lift a claim over the § 101 hurdle.  The Court also noted that claim 1 did not require computer implementation, and could be performed by hand.  Another claim of the '303 patent did make use of a computer, but "it does exactly what we have warned it may not: tell a user to take an abstract idea and apply it with a computer."

    Consequently, the Court concluded that there was no inventive concept in the claims, they failed the Alice test, and were invalid under § 101.

    For the better part of a year, it has been understood that an invention that improves the operation of a computer or another technology is not abstract under § 101, and one should review the specification to make this determination.  While this case does not exactly throw that notion under the bus, it may serve to narrow the holdings of Enfish and McRO v. Bandai Namco Games America.  Here, the Court refused to acknowledge the possibility that the claimed invention resulted in such an improvement, and did not analyze the specification in detail.

    Further, the disconnect between the Court's characterization of the claims under part one of Alice and the actual claimed invention is remarkable.  In the Court's view, there was no substantive difference between claim 1 and "Morse code, ordering food at a fast food restaurant via a numbering system, and Paul Revere's one if by land, two if by sea signaling system."  As many have noted, evaluating claims at such a high level does violence to the actual invention, which is the specific method recited by the claim.  Indeed, Enfish and McRo specifically warned against over-generalizing claims and reducing them to a subjective "gist" in part one of the Alice analysis.

    Taking a step back, claim 1 is broader in substance than it might appear at first blush, and perhaps that breadth and its lack of specificity regarding exactly how the encoding is performed doomed the claims to abstractness.  So all is not lost for image processing and data compression inventions.  Many will be clearly patent-eligible, especially ones that claim specific solutions to specific problems and result in a technological improvement.  But, as we have learned over the last several years, the proverbial devil is in the details.

    Recognicorp, LLC v. Nintendo Co. (Fed. Cir. 2017)
    Panel: Circuit Judges Lourie, Reyna, and Stoll
    Opinion by Circuit Judge Reyna

  • Acting as Lexicographers Saves Patent from Being Found Invalid

    By Joseph Herndon

    AppleIn a recent Federal Circuit decision, the Court highlighted an old rule in that the inventors may act as their own lexicographers to create a claim term and define the term accordingly.  Here, a U.S. patent directed to user interface functionality on a touchscreen device was saved due to a claim term "rubberbanding" being well-defined in the specification.

    Procedurally, in this case, an unidentified third party filed a request for ex parte reexamination of all claims of Apple's U.S. Patent No. 7,844,915, and the U.S. Patent and Trademark Office granted the request.  Based on its constructions of "scroll or gesture" and "rubberbanding" claim limitations, the Examiner rejected every claim of the '915 patent as anticipated or obvious in view of the prior art, and the Board affirmed.

    Apple appealed the Patent Trial and Appeal Board's decision rejecting all claims, contending that the Board erred by construing the claim limitations of "scroll or gesture" and "rubberbanding" too broadly.  The Federal Circuit agreed with Apple on the latter, but not the former.

    The '915 patent claims software that allows a touchscreen device to differentiate between a scroll operation and a gesture operation based on the number of detected input points or finger touches.  The '915 patent teaches that a single input point is interpreted as a scroll, whereas two or more input points are interpreted as a gesture.  Gestures may include zooming in, zooming out, or rotating an image on the screen.  Claim 1 recites a method that invokes the "scroll or gesture" limitation in dispute in this case:

    1.  A machine implemented method for scrolling on a touch-sensitive display of a device comprising:
        receiving a user input, the user input is one or more input points applied to the touch-sensitive display that is integrated with the device;
        creating an event object in response to the user input;
        determining whether the event object invokes a scroll or gesture operation by distinguishing between a single input point applied to the touch-sensitive display that is interpreted as the scroll operation and two or more input points applied to the touch-sensitive display that are interpreted as the gesture operation;
        issuing at least one scroll or gesture call based on invoking the scroll or gesture operation;
        responding to at least one scroll call, if issued, by scrolling a window having a view associated with the event object based on an amount of a scroll with the scroll stopped at a predetermined position in relation to the user input; and
        responding to at least one gesture call, if issued, by scaling the view associated with the event object based on receiving the two or more input points in the form of the user input.

    The '915 patent also describes an improved scrolling feature called "rubberbanding."  When a user scrolls past the edge of the content on the screen, a predetermined amount of blank space is displayed and then the content slides back to fit on the screen, resembling the motion of a taut rubber band when the tension is released from one end.  For example, if a user scrolls too far such that no content remains in the direction of the scroll — i.e., a user scrolls down when the screen is already displaying the most recent email at the top — the phone will show a predetermined amount of blank space above the most recent email and will slide the content back onto the screen at the end of the scroll.

    Claim 2 recites rubberbanding:  "The method as in claim 1, further comprising: rubberbanding a scrolling region displayed within the window by a predetermined maximum displacement when the scrolling region exceeds a window edge based on the scroll."

    "Scroll or Gesture"

    Both of Apple's arguments on appeal are rooted in claim construction.  First, Apple contended that the Board's construction of the phrase "two or more" in the scroll or gesture limitation is unreasonable in light of the claim structure and specification.  According to Apple, the '915 patent articulates a single rule for distinguishing between two categories of operations:  1) a "single" input point that is interpreted as a scroll operation; and 2) "two or more" input points that are interpreted as a gesture operation.  Apple claimed that the "or" in the phrase "two or more" does not create a distinction between two input points and more than two input points.  In other words, the phrase "two or more" must be interpreted as an atomic unit, meaning that two-, three-, four-, and five-input points must all be interpreted as gestures.

    In reaching a contrary conclusion, the Board explained that the broadest reasonable interpretation of the phrase "two or more" permits either two input points or more than two input points to be interpreted as a gesture operation.  Stated differently, the Board held that the claim language only requires detection of a scroll operation in response to a single input point and a gesture operation in response to one of the possible multi-input touches.  Thus, this included more than a single rule.  Because the prior art relied on by the Examiner both teach a single-input scroll and a two-input gesture, the Board rejected the claims.

    The Federal Circuit agreed with the Board's construction.  The pertinent claim language recites:  "distinguishing between a single input point . . . and two or more input points."  On its face, this language does not limit the invention such that all received user inputs must be categorized as either a scroll or a gesture as Apple contends.  Apple's construction would replace the word "or" with "and," thereby requiring all multi-input touches to be distinguished as gestures.  But this reading is too narrow.  The broadest reasonable interpretation of the word "or" in the phrase "two or more" creates alternatives for the gesture operation:  a gesture operation occurs if either two input points or more than two input points are detected.

    The Federal Circuit additionally noted that the claims use the open-ended transitional phrase "comprising" and thus the claims are broad enough to include user inputs that are categorized as something other than a scroll or a gesture, undermining Apple's suggestion that the claims are limited to a single rule.

    "Rubberbanding"

    Apple next argued that the Examiner's interpretation of "rubberbanding" was erroneous as covering sliding content forward at the end of a scroll (i.e., sliding in the same direction as the scroll).  Based on this construction, the Board rejected claims 2, 9, and 16 — which include the rubberbanding limitation — as obvious in view of other prior art of record.  Apple contended the Board erred in its claim construction because rubberbanding requires sliding the content backwards in the opposite direction of the scroll.

    The PTO argued on appeal that the broadest reasonable interpretation of rubberbanding is not limited to sliding content in a particular direction, much less requiring that the content must slide backwards, and that the concept of rubberbanding "simply seeks to control the movement of scrolled content."

    The Federal Circuit agreed with Apple here in that the Board's analysis rests on an incorrect interpretation of "rubberbanding".  As expressly defined in the specification, the key to the rubberbanding feature is sliding content in the opposite direction of the scroll — sliding content backwards — once the scroll has been completed.  Acting as lexicographers, the inventors of the '915 patent expressly defined rubberbanding in the specification as follows:

    Rubberbanding a scrolled region according to the method 300 occurs by a predetermined maximum displacement value when the scrolled region exceeds a display edge of a display device based on a scroll.  If a user scrolls content of the display making a region past the edge of the content visible in the display, then the displacement value limits the maximum amount for the region outside the content.  At the end of the scroll, the content slides back making the region outside of the content no longer visible on the display.

    The term "rubberbanding," as defined by the inventors, does not cover sliding content forward at the end of the scroll, and the Examiner did not cite any evidence to support the proposition that selecting the direction of the scrolling would be within the level of ordinary skill.  Thus, because the Federal Circuit found that the Board misinterpreted the rubberbanding limitation, the rejection of claims 2, 9, and 16 was vacated and the case was remanded for the Board to reconsider these claims in light of the proper interpretation of rubberbanding.

    In re Apple Inc. (Fed. Cir. 2017)
    Nonprecedential disposition
    Before Chief Judge Prost and Circuit Judges Dyk and Stoll
    Opinion by Circuit Judge Stoll