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  • More Instances of Tribal Sovereign Immunity Shielding Patents from PTAB Invalidation

    By Kevin E. Noonan –

    Late this summer, Allergan entered into an agreement with the St. Regis Mohawk Nation to assign its rights in several Orange Book-listed patents involved in inter partes review proceedings, with the aim of having those proceedings dismissed based on the tribe's invoking sovereign immunity (see "Allergan Avails Itself of Sovereign Immunity").

    To recap, the 11th amendment to the Constitution reads:

    The judicial power of the United States shall not be construed to extend to any suit in law or equity, commenced or prosecuted against one of the United States by citizens of another state, or by citizens or subjects of any foreign state.

    The concept of sovereign immunity stems from British common law, banning lawsuits against the king.  Although not explicitly stated in the Amendment, the Supreme Court has interpreted 11th Amendment immunity to extend to actions of a citizen against the state in which she resides.  Hans v. Louisiana, 134 U.S. 1 (1890).  The rationale behind the immunity conferred by the Amendment is that the "States entered the federal system with their sovereignty intact," Blatchford v. Native Village of Noatak, 501 U.S. 775 (1991), and that "the sovereign immunity of the States neither derives from nor is limited by the terms of the Eleventh Amendment.  Rather, . . . the States' immunity from suit is a fundamental aspect of the sovereignty which the States enjoyed before the ratification of the Constitution, and which they retain today," Alden v. Maine, 527 U.S. 706 (1999).  However, the immunity is not absolute.  It can be waived, and many states (as well as the federal government) have waived sovereign immunity in suits for tort and contract.  Certain U.S. Constitutional provisions trump the immunity, such as the Bankruptcy Clause and the 14th Amendment.  However, patent law does not fall within any federal law exemption, and the Supreme Court has decided expressly that States enjoy sovereign immunity against suits for patent infringement.  Florida Prepaid Postsecondary Education Expense Board v. College Savings Bank, 527 U.S. 627 (1999).

    This type of immunity has been determined to be available to the various tribes of Native Americans, which have also been held to enjoy sovereign immunity, albeit with certain limitations that do not apply to the States.  The immunity stems from common law rather than by statute or Act of Congress, Turner v. United States, 28 U.S. 354 (1919), and has been applied both to state action and private suit.  United States v. United States Fidelity & Guaranty Co., 309 U.S. 506 (1940); Puyallup Tribe, Inc. v. Department of Game of State of Washington, 433 U.S. 165 (1977); and Kiowa Tribe of Oklahoma v. Mfg. Technologies, Inc., 523 U.S. 751, 755 (1998).

    Allergan has not been alone in entering into such arrangements; on August 1st, SRC (Cray) Labs LLC transferred patent rights to the tribe, and on October 18th the tribe (with SRC named a co-plaintiff as exclusive licensee of the asserted patents) filed a patent infringement lawsuit in the Eastern District of Virginia against Amazon.com, Inc., Amazon Web Services, and VADATA, claiming infringement of the following patents:

    U.S. Patent No. 6,434,687 (System and method for accelerating web site access and processing utilizing a computer system incorporating reconfigurable processors operating under a single operating system image);

    U.S. Patent No. 7,149,867 (System and method of enhancing efficiency and utilization of memory bandwidth in reconfigurable hardware);

    U.S. Patent No. 7,225,324 (Multi-adaptive processing systems and techniques for enhancing parallelism and performance of computational functions);

    U.S. Patent No. 7,620,800 (Multi-adaptive processing systems and techniques for enhancing parallelism and performance of computational functions); and

    U.S. Patent No. 9,153,311 (System and method for retaining DRAM data when reprogramming reconfigurable devices with DRAM memory controllers)

    The subject matter claimed in these patents(as disclosed to defendants) is shown in the following illustrations, included in the complaint:

    Image 1

    Image 2
    According to the complaint, the Tribe granted SRC an exclusive license with the right to sue third parties for infringement.  Paragraph 31 of the complaint includes an important cavet relevant to the question of sovereign immunity;

    Para. 31. By filing this lawsuit, the Tribe has not expressly or impliedly waived its sovereign immunity to any inter partes review proceeding involving the patents asserted in this case or any other patent assigned to the Tribe.

    The complaint also provides justifications, based on lack of taxing power and "disproportionately high levels of unemployment and poverty, not to mention a severe lack of employment opportunities" for the assignment and licensing arrangement, consistent with the arguments made to the PTAB and the District Court in the Allergan case (see "Mohawk Nation Exercises Sovereign Immunity in Inter Partes Review").

    Defendants' accused infringing devices include SCR's Field Programmable Gate Arrays ("FPGAs").  The complaint alleges three meetings between SRC and Amazon without the parties coming to an agreement.

    Published reports inform that "dozens and dozens of tribes" are pursuing such arrangements, according to David Pridham, chief executive of Dominion Harbor Group as quoted by Reuters (see "Tech entity has tribal patent deal similar to Allergan's").  One example of tribes other than the St. Regis Mohawk Nation is the Mandan, Hidatsa and Arikara Nation, that sued Apple on patents licensed to Prowire and MEC Resources.  The patent-in-suit is U.S. Patent No. 6,137,390 ("Inductors with Minimized EMI Effect and the Method of Manufacturing the Same"); Claims 1 and 11 are representative:

    1.  An inductor with enhanced inductance comprising:
        (a) a magnetic core;
        (b) an electrically conducting coil wound about said magnetic core;
        (c) a magnetic resin layer compression-molded to embed at least a portion of an outer periphery of said electrically conducting coil;
        (d) wherein said magnetic resin layer contains a magnetic powder dispersed in a polymer resin.

    11.  A method for making inductors with enhanced inductance comprising the steps of:
        (a) winding an electrically conducting coil about a magnetic core;
        (b) forming a magnetic resin layer by compression molding to embed at least a portion of an outer periphery of said electrically conducting coil;
        (c) wherein said magnetic resin matrix contains a magnetic powder dispersed in a polymer resin.

    Prowire owns the '390 patent by assignment from Fuco Technology Co., Ltd., which obtained the patent from Industrial Technology and Research Institute of Taiwan, and itself assigned to MEC Resources, which is owned by the tribe.  Prowire alleged in its complaint (filed before transfer of patent ownership to the tribe) that Apple products, including its iPad line, infringed claims 1 and 11 of the '390 patent.  The procedural posture of this case is slightly different than the Mohawk cases; litigation was on-going between Apple and Prowire, with the District Court granting Prowire's unopposed motion to substitute parties to name MEC Resources, on August 29th.  Two weeks later, on September 15th, the Delaware court transferred the case to the Northern District of California, saying:

    Parsing through sworn facts, we carefully consider whether another venue is more appropriate to timely resolve a dispute over property created in California or Taiwan between citizens from states other than Delaware.  While this Court welcomes the chance to resolve complex patent disputes with proper venue, when a Californian asks to transfer venue in a case brought by a Texan, we carefully evaluate the facts and apply our court of appeals' guidance.  Having applied this guidance and rejecting the claim the California citizen waived the convenience of venue argument by waiting until after we ruled on dispositive motions, we enter the accompanying Order granting the California citizen's motion to transfer to the far more convenient district court in the Northern District of California.

    The basis for transfer was the District Court's application of Third Circuit law, specifically Jumara v. State Farm Ins. Co., 55 F.3d 873, 879 (3d Cir. 1995), and its balance of private and public factors regarding venue:

    Private interests are "the plaintiffs choice of forum; the defendant's preference; whether the claim arose elsewhere; the convenience of the parties; the convenience of the expected witnesses; and the location of the books and records.  The relevant public interests are: 'the enforceability of the judgment; practical considerations that could make the trial easy, expeditious, or inexpensive; the relative administrative difficulty in the two fora resulting from court congestion; the local interest in deciding local controversies at home; [and] the public policies of the fora.'"  Applying these factors to the sworn facts, we are compelled to transfer venue.

    These cases are on-going, and to date none of the patents in either lawsuit have been challenged before the PTAB by inter partes review or otherwise.

  • Bioquark Seeks to Reverse Brain Death

    By Donald Zuhn —

    BioquarkLast year, two biotech companies announced that they had received institutional review board (IRB) approval for a study focused on the clinical intervention of brain death in humans.  The study, entitled "Non-randomized, Open-labeled, Interventional, Single Group, Proof of Concept Study With Multi-modality Approach in Cases of Brain Death Due to Traumatic Brain Injury Having Diffuse Axonal Injury" (ClinicalTrials.gov Identifier NCT02742857), brought together Bioquark Inc., a Philadelphia-based life sciences company that develops proprietary combinatorial biologic products for both the regeneration and repair of human organs and tissues, as well as the reversion of a range of chronic degenerative diseases, and Revita Life Sciences, an Indian biotechnology company that develops stem cell therapies targeting areas of significant unmet or poorly met medical need.

    The trial is part of Bioquark's ReAnima Project, which is described in the following video:

    As initially posted on ClinicalTrials.gov (and as updated last June), the study was expected to enroll an initial 20 subjects, declared to be brain dead from a traumatic brain injury having diffuse axonal injury on MRI, and be conducted at Anupam Hospital in Rudrapur, Uttarakhand India, where Revita is headquartered.  The study, which was expected to be initiated in July 2017 and completed in July 2018, had as its primary outcome the reversal of brain death as noted in clinical examination or electroencephalography (EEG).  A report on STAT last summer, however, indicated that the study was experiencing some difficulties due to lack of regulatory approval in India, and that Bioquark may be looking for a new study location in Latin America.

    In the press release announcing the study's approval, Bioquark and Revita noted that while human beings lack substantial regenerative capabilities in the central nervous system, many non-human species, such as amphibians, planarians, and certain fish, can repair, regenerate, and remodel substantial portions of their brain and brain stem even after critical life-threatening trauma.  In addition to providing insight into human brain death, Bioquark President Dr. Sergei Paylian expects the study to "have important connections to future therapeutic development for other severe disorders of consciousness, such as coma, and the vegetative and minimally conscious states, as well as a range of degenerative CNS conditions, including Alzheimer's and Parkinson's disease."

    A check of the U.S. Patent & Trademark Office patent application full text (AppFT) database identified one published application assigned to Bioquark, U.S. Patent Application Publication No. US 2014/0030244, entitled "Extracts Isolated From Electroporated Amphibian Oocytes And Use Thereof In Treating Diseases And Disorders."  However, the published application, which is directed to a method for preparing a pharmaceutical composition comprising extracts of activated amphibian oocytes that can be used, inter alia, for the treatment of traumatic brain injury, was abandoned for failure to pay the issue fee.  No other Bioquark or ReAnima Advanced Biosciences published U.S. applications or issued U.S. patents were identified.

  • Merck Sharp & Dohme Corp. v. Hospira, Inc. (Fed. Cir. 2017)

    By Kevin E. Noonan –

    The Federal Circuit continues its explication of the law of obviousness post-KSR Int'l. v. Teleflex Inc. (and Judge Pauline Newman continues to disagree with her brethren in some regards) in a decision handed down last Friday, in Merck Sharp & Dohme Corp. v. Hospira, Inc.

    The case arose in an ANDA litigation between innovator Merck and generic drug manufacturer Hospira over the antibiotic ertapenem, sold by Merck under the brand name Invanz®.  The drug, known to be chemically unstable, has the following structure:

    Image 1
    The molecule's instability arises from two aspects and from two different chemical reactions:  hydrolysis of the beta-lactam nitrogen indicated by the arrow on the left, and dimerization of the pyrrolidine nitrogen on the right.  The prior art taught that the dimerization reaction could be inhibited and the molecule stabilized by forming a carbon dioxide adduct after reaction with carbon dioxide under basic conditions.

    The claimed invention is directed to minimizing both dimerization and hydrolysis, resulting in the stabilized form of ertapenem sold by Merck as its Invanz® product.  One of the patents-in-suit (and the subject of this appeal) is U.S. Patent No. 6,486,150; claim 21 is representative of the asserted claims:

    21.  A process for preparing a final formulation product of a compound of formula Ia,

    Image 2
    or its pharmaceutically acceptable salt, or hydrates wherein, R4, R5, and R6 are independently:
        (a) hydrogen
        (b) (C1–C6)-alkyl, or
        (c) alkali-metal or alkali earth-metal
    wherein the alkali-metal or alkali earth metal is sodium, potassium, lithium, cesium, rubidium, barium, calcium or magnesium;
    comprising the steps of:
        (1) charging a solution of carbon dioxide source having a pH range of about 6.0 to about 12.0 into a reaction vessel;
        (2) adding an effective amount of a mole ratio of a base and an active ingredient into the reaction vessel containing the solution of carbon dioxide source to maintain pH at about 6.0 to about 9.0 and a temperature range of about –3° C. to about 15° C.; [and]
        (3) lyophilizing the solution of Step (2) to yield the final formulation product of a compound of formula Ia with less than about 10% of moisture content.

    MerckMerck asserted claims 21-34 of the '150 patent and U.S. Patent No. 5,952,323; the District Court found the asserted claims of the latter patent not invalid and infringed.  The District Court found the asserted claims of the '150 patent would also be infringed but were invalid for obviousness over the '323 patent in combination with PCT publication WO 98/18800.  According to the District Court, although none of the three recited steps of the claimed process were disclosed in the prior art, the "recipe" for the final stabilized ertapenem formulation was disclosed, and the three recited steps were conventional manufacturing steps that were the product of routine experimentation.  Specific conditions known in the prior art were:

    • That formation of a carbon dioxide adduct is pH dependent and occurs between pH 6.0 and pH 9.0;
    • That the pH could be adjusted using sodium hydroxide; and
    • The adduct could be produced by lyophilization.

    Although the temperature range limitation was not expressly taught by the cited art, the District Court found that it was known in the art that low temperatures minimized degradation, and as a consequence the skilled worker would want to keep the temperature as low as possible without freezing.

    With regard to the objective indicia of non-obvious, the District Court held that although there was evidence of commercial success and copying, the evidence was not strong enough to overcome the "strong prima facie case of obviousness" established by the defendant.  With regard to commercial success, the strength of the evidence was diminished because Merck was the exclusive licensee of the patent on ertapenem itself — US. Patent No. 5,478,820.  And with regard to copying, Hospira adduced evidence that it attempted five different processes to produce stabilized ertapenem before choosing the method that, if valid, would have infringed the '150 patent.

    The Federal Circuit affirmed in an opinion by Judge Lourie joined by Judge Hughes, Judge Newman dissenting, setting forth a pithy statement of what constitutes obviousness:

    Obviousness is a question of law, based on underlying factual findings, including what a reference teaches, whether a person of ordinary skill in the art would have been motivated to combine references, and any relevant objective indicia of nonobviousness.  Apple Inc. v. Samsung Elecs. Co., 839 F.3d 1034, 1047–48, 1051 (Fed. Cir. 2016) (en banc).

    The District Court, according to Merck, based its decision on the grounds that the skilled worker would have relied on "knowledge, creativity, and common sense" to arrive at the claimed invention, which considerations, according to Merck, should be limited to the question of whether there was a motivation to combine prior art references and not the ultimate question of whether an invention is obvious.  As Merck explained the prior art, It was focused on the dimerization basis for instability, not hydrolysis, and "pH values favorable for reducing dimerization result in increased hydrolysis, and vice versa," thus precluding the required reasonable expectation of success.

    HospiraHospira argued that the skilled worker would have performed adduct formation as recited in the claims, to minimize subjecting the unstable ertapenem compound to conditions that would cause it to degrade.  The panel majority found no clear error in the District Court's finding that the prior art taught:  1) minimizing dimerization by forming the carbon dioxide adduct of ertapenem at pH 6.0–9.0; 2) that sodium hydroxide could be used to adjust the pH; and 3) that the final adduct was to be obtained using "standard lyophilization techniques" (the claim recites no particular lyophilization methods or conditions).

    The fact that the prior art was silent as to methods for minimizing hydrolysis was not persuasive because the solution recited in the claims "constitutes nothing more than conventional manufacturing steps that implement principles disclosed in the prior art."

    It was undisputed that the combination of the '323 patent and the '800 PCT publication taught exposing ertapenem to carbon dioxide in a solution having pH between 6.0 and 9.0 followed by lyophilization, and that minimizing the temperature would have been a routine precaution.  The opinion states the majority's basis for finding deficient Merck's arguments against its claims being obvious:

    Merck's purported solution for minimizing both hydrolysis and dimerization was to create the carbon dioxide solution first, at the pH range disclosed in the prior art; then simultaneously add the ertapenem and a base to the solution, in order to maintain the pH range taught by the prior art; maintain a low temperature during the process; and lyophilize the final product to contain less than 10% moisture content.  The only elements of that process that were not expressly disclosed in the prior art are emphasized in italics above—namely, the order of the steps, the simultaneous addition of base, the specific temperature range, and a final moisture content of less than 10%.  But, as the court found, those are all experimental details that one of ordinary skill would have utilized via routine experimentation, armed with the principles disclosed in the prior art.

    The panel majority found no error with regard to the District Court's determination that the objective indicia did not rebut obviousness as found based on the asserted references.  Nevertheless, the opinion states that just because there was another patent for which Merck was the exclusive licensee wasn't enough to properly discount evidence of commercial success.  As the opinion explains, there are frequently a bundle of patents protecting a commercial product, due in part to USPTO decisions during prosecution (restriction requirements, for example), as well as improvements in a product or process.  Thus, the existence of "multiple patents do not necessarily detract from evidence of commercial success of a product or process, which speaks to the merits of the invention, not to how many patents are owned by a patentee."  But here, the panel majority did not understand there to be clear error in the District Court's determination that the evidence of commercial success was not sufficient to overcome Hospira's prima facie case of obviousness.

    On the question of evidence of copying, neither the District Court nor the panel majority was persuaded by Hospira's contention that copying was not relevant in the ANDA litigation context (because the FDA requires a generic drug manufacturer to copy an approved drug).  In this case, the panel majority noted that the FDA does not "require the generic manufacturer to copy the NDA holder's process of manufacturing the drug."  But the panel agreed with the District Court that Merck's evidence of copying did not overcome Hospira's prima facie case of obviousness.

    Judge Newman dissented, saying that "[i]t is time to remedy our inconsistent treatment of the procedures and burdens in applying the evidentiary factors of obviousness" by returning to the "statutory rigor" imposed by the Supreme Court in Graham v. John Deere Co., 383 U.S. 1 (1966).  In her view, the Court mandated in Graham that all of the Graham factors ("(1) the scope and content of the prior art; (2) the differences between the claimed invention and the prior art; (3) the level of ordinary skill in the field of the invention; and (4) objective ("secondary") considerations such as commercial success, failure of others, and long-felt need") are to be considered, particularly with regard to their effect on the analysis of the other factors.  Judge Newman appreciates that the Federal Circuit has "properly" applied the Graham factors in certain cases (including Apple Inc. v. Samsung Electronics Co., 839 F.3d 1034, 1048 (Fed. Cir. 2016) (en banc); In re Cyclobenzaprine Hydrochloride, 676 F.3d 1063, 1077 (Fed. Cir. 2012); and Leo Pharmaceutical Products, Ltd. v. Rea, 726 F.3d 1346, 1357–58 (Fed. Cir. 2013), and in her view this approach was validated by the Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 399 (2007).  But she recognizes that some Federal Circuit cases have adopted the position used by the District Court and the panel majority here, that the objective indicia are to be used to rebut a prima facie obviousness determination based on consideration of the other three factors.  Doing so shifted "the placement and [] burden of proof" improperly according to Judge Newman's dissent.

    The proper role of the objective indicia, according to Judge Newman, was to be used as "independent evidence of non-obviousness," citing Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc., 520 F.3d 1358, 1365 (Fed. Cir. 2008), and reiterates the Federal Circuit's earlier observation that the "objective indicia 'may often be the most probative and cogent evidence in the record," and are 'to be considered as part of all the evidence, not just when the decision-maker remains in doubt after reviewing the art,'" citing Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1538–39 (Fed. Cir. 1983).  Judge Newman cites several cases to illustrate her point that the Federal Circuit has strayed from this proper use of the objective indicia, including Cubist Pharmaceuticals, Inc. v. Hospira, Inc., 805 F.3d 1112, 1130 (Fed. Cir. 2015); Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd., 719 F.3d 1346, 1353 (Fed. Cir. 2013); Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356, 1364 (Fed. Cir. 2012); Otsuka Pharmaceutical Co. v. Sandoz, Inc., 678 F.3d 1280, 1296 (Fed. Cir. 2012); Tokai Corp. v. Easton Enterprises, Inc., 632 F.3d 1358, 1370 (Fed. Cir. 2011); Wyers v. Master Lock Co., 616 F.3d 1231, 1246 (Fed. Cir. 2010); Muniauction, Inc. v. Thomson Corp., 532 F.3d 1318, 1327 (Fed. Cir. 2008); Aventis Pharma Deutschland GmbH v. Lupin, Ltd., 499 F.3d 1293, 1302 (Fed. Cir. 2007); and Ormco Corp. v. Align Tech., Inc., 463 F.3d 1299, 1311 (Fed. Cir. 2006).

    While consistent with earlier application of the Graham factors, Judge Newman somewhat ironically neglected to mention the Federal Circuit's decision (from which she also dissented) in Pharmastem Therapeutics, Inc. v. Viacell, Inc. (Fed. Cir. 2007), a case decided close upon the Supreme Court's KSR decision.  In that case, the panel majority (Judges Proust and Bryson) ignored exceptionally strong evidence on objective reasons for finding the claimed invention nonobvious, similarly relying on "strong prima facie" evidence that the prior art (which did not disclose the claimed methods or hematopoietic stem cell compositions) rendered the claims obvious.

    This practice needs reform, because in Judge Newman's view:

    It is time to restore conformity to precedent, in the interest of stability of practice and procedure, and predictability and fairness of result.  I would reestablish the proper analytic criteria under the four Graham factors, and would remand to the district court to apply the correct law.

    Merck Sharp & Dohme Corp. v. Hospira, Inc. (Fed. Cir. 2017)
    Panel: Circuit Judges Newman, Lourie, and Hughes
    Opinion by Circuit Judge Lourie; dissenting opinion by Circuit Judge Newman

  • PTAB Life Sciences Report

    By John Cravero —

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

    Complete Genomics, Inc. v. Illumina Cambridge Ltd.

    PTAB Petition:  IPR2017-02172; filed October 5, 2017.

    Patent at Issue:  U.S. Patent No. 7,566,537 ("Labelled nucleotides," issued July 28, 2009) claims a method of labeling a nucleic acid molecule, the method comprising incorporating into the nucleic acid molecule a nucleotide or nucleoside molecule, wherein the nucleotide or nucleoside molecule has a base that is linked to a detectable label via a cleavable linker and the nucleotide or nucleoside molecule has a ribose or deoxyribose sugar moiety, wherein the ribose or deoxyribose sugar moiety comprises a protecting group attached via the 2' or 3' oxygen atom, and said protecting group can be modified or removed to expose a 3' OH group and the protecting group comprises an azido group.

    Petitioners Complete Genomics, Inc.; BGI Shenzhen Co., Ltd.; BGI Groups USA Inc.; BGI Genomics Co., Ltd.; and BGI Americas Corp. are are challenging the '537 patent on one ground as being obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, the '537 patent has been the subject of the following lawsuits: Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359 (Fed. Cir. 2016) (appeal from IPR2013-00517); Ilumina Cambridge Ltd. v. Intelligent Bio-Systems, Inc., 638 Fed. Appx. 999 (Fed. Cir. 2016) (unpublished) (appeals from IPR2013-00128 and IPR2013-00266); Trustees of Columbia University in the City of New York v. Illumina, Inc., 620 Fed. Appx. 916 (Fed. Cir. 2015) (unpublished) (appeals from IPR2012-00006, IPR2012- 00007, and IPR2013-00011); Trustees of Columbia University in the City of New York v. Illumina, Inc., 1:12-cv-00376-GMS (D. Del.); Illumina, Inc. et al. v. Qiagen, NV et al., 3-16-cv-02788 (N.D. Cal.); IPR2013-00517 (Intelligent Bio-Systems, Inc.; filed 08/19/2013; instituted 02/13/2014; determined not unpatentable 02/11/2015); IPR2013-00518 (Intelligent Bio-Systems, Inc.; filed 08/19/2013; instituted 02/13/2014; determined not unpatentable 02/11/2015).  Petitioner concurrently filed a second petition for inter partes review of the '537 patent (IPR2017-02174; filed October 5, 2017; pending) challenging the '537 patent on different grounds.


    Complete Genomics, Inc. v. Illumina Cambridge LTD.

    PTAB Petition:  IPR2017-02174; filed October 5, 2017.

    Patent at Issue:  U.S. Patent No. 7,566,537 ("Labelled nucleotides," issued July 28, 2009) claims a method of labeling a nucleic acid molecule, the method comprising incorporating into the nucleic acid molecule a nucleotide or nucleoside molecule, wherein the nucleotide or nucleoside molecule has a base that is linked to a detectable label via a cleavable linker and the nucleotide or nucleoside molecule has a ribose or deoxyribose sugar moiety, wherein the ribose or deoxyribose sugar moiety comprises a protecting group attached via the 2' or 3' oxygen atom, and said protecting group can be modified or removed to expose a 3' OH group and the protecting group comprises an azido group.

    Petitioners Complete Genomics, Inc.; BGI Shenzhen Co., Ltd.; BGI Groups USA Inc.; BGI Genomics Co., Ltd.; and BGI Americas Corp. are are challenging the '537 patent on two grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, the '537 patent has been the subject of the following lawsuits:  Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359 (Fed. Cir. 2016) (appeal from IPR2013-00517); Ilumina Cambridge Ltd. v. Intelligent Bio-Systems, Inc., 638 Fed. Appx. 999 (Fed. Cir. 2016) (unpublished) (appeals from IPR2013-00128 and IPR2013-00266); Trustees of Columbia University in the City of New York v. Illumina, Inc., 620 Fed. Appx. 916 (Fed. Cir. 2015) (unpublished) (appeals from IPR2012-00006, IPR2012- 00007, and IPR2013-00011); Trustees of Columbia University in the City of New York v. Illumina, Inc., 1:12-cv-00376-GMS (D. Del.); Illumina, Inc. et al. v. Qiagen, NV et al., 3-16-cv-02788 (N.D. Cal.); IPR2013-00517 (Intelligent Bio-Systems, Inc.; filed 08/19/2013; instituted 02/13/2014; determined not unpatentable 02/11/2015); IPR2013-00518 (Intelligent Bio-Systems, Inc.; filed 08/19/2013; instituted 02/13/2014; determined not unpatentable 02/11/2015).  Petitioner concurrently filed a second petition for inter partes review of the '537 patent (IPR2017-02172; filed October 5, 2017; pending) challenging the '537 patent on different grounds.


    ABS Global, Inc. v. Cytonome/ST, LLC

    PTAB Petition:  IPR2017-02162; filed October 5, 2017.

    Patent at Issue:  U.S. Patent No. 9,446,912 ("Multilayer hydrodynamic sheath flow structure," issued September 20, 2016) claims a flow structure for suspending a particle in a sheath fluid, comprising: a primary flow channel provided within a substrate and configured to convey fluid in a downstream direction; and a sheath fluid distribution system including: a first sheath fluid channel in fluid communication with the primary flow channel at a first sheath fluid introduction region for injecting sheath fluid into the primary flow channel in a first direction away from a first wall of the primary flow channel; and a second sheath fluid channel in fluid communication with the primary flow channel at a second sheath fluid introduction region for injecting sheath fluid into the primary flow channel in a second direction away from a second wall of the primary flow channel, wherein the second sheath fluid introduction region is located downstream from the first sheath fluid introduction region, and wherein a width of the primary flow channel at the first sheath fluid introduction region is greater than a width of the primary flow channel at the second sheath fluid introduction region.

    Petitioners ABS Global, Inc. and Genus plc are challenging the '912 patent on three grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or obvious under 35 U.S.C. § 103(a) (grounds 2 and 3).  View the petition here.

    Related Matters:  According to the petition, the '912 patent is the subject of the following litigation:  Cytonome/ST, LLC v. ABS Global, Inc, Genus plc, et al., Case No. 3:17-cv-00446 (W.D. Wis.).


    ABS Global, Inc. v. Cytonome/ST, LLC

    PTAB Petition:  IPR2017-02097; filed October 6, 2017.

    Patent at Issue:  U.S. Patent No. 8,529,161 ("Multilayer hydrodynamic sheath flow structure," issued September 10, 2013) claims a microfluidic system comprising: a primary flow channel for flowing a sample having one or more particles suspended in a suspension medium; a primary adjustment region including a first set of one or more inlets intersecting the primary flow channel and adapted for introducing additional suspension medium into the primary flow channel, whereby the sample is adjusted in at least a first direction; and a secondary adjustment region downstream of the primary alignment region and including a second set of one or more inlets intersecting the primary flow channel downstream of the first set of one or more inlets and adapted for introducing additional suspension medium whereby the sample is adjusted in at least a second direction different from the first direction.

    Petitioners ABS Global, Inc. and Genus plc are challenging the '161 patent on two grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or obvious under 35 U.S.C. § 103(a) (ground 2).  View the petition here.

    Related Matters:  According to the petition, the '912 patent is the subject of the following litigation:  Cytonome/ST, LLC v. ABS Global, Inc, Genus plc, et al., Case No. 3:17-cv-00446 (W.D. Wis.).


    ABS Global, Inc. v. XY, LLC

    PTAB Petition:  IPR2017- 02184; filed October 10, 2017.

    Patent at Issue:  U.S. Patent No. 7,208,265 ("Method of cryopreserving selected sperm cells," issued April 24, 2007) claims a method of cryopreserving sex-selected sperm cells, comprising: a. obtaining sperm cells from a species of a non-human male mammal; b. sorting said sperm cells, without the presence of protective compounds in seminal plasma, and based upon sex-type to provide a collection of sex-selected sperm cells obtained using flow cytometry or fluorescence-activated cell sorting; c. cooling said sex-selected sperm cells; d. suspending said sex-selected sperm cells in an extender to provide a concentration of sperm cells of about 5 million per milliliter of extender to about 10 million per milliliter of extender; and e. freezing said sex-selected sperm cells in said extender.

    Petitioners ABS Global, Inc. and Genus plc are challenging the '265 patent on two grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, the '265 patent is the subject of the following litigation:  Cytonome/ST, LLC v. ABS Global, Inc, Genus plc, et al., Case No. 3:17-cv-00446 (W.D. Wis.), and XY, LLC et al. v. Trans Ova Genetics, LC, Case No. 1:17-cv-00944 (D. Colo.).

  • Conference & CLE Calendar

    CalendarOctober 30, 2017 – "Post Grant Review Strategy – Choose Wisely" (Cardinal IP) – 3:00 to 4:00 pm (CT), Chicago, IL.

    October 31, 2017 – "Divided Patent Infringement and Inducement: Protecting IP Rights and Allocating Liability" (Strafford) – 1:00 to 2:30 pm (EDT)

    November 2-3, 2017 – Summit on IP Due Diligence*** (American Conference Institute) – Philadelphia, PA

    December 4, 2017 – "Aqua Products, Inc. v. Matal, Answers or More Questions?" – Part II (Federal Circuit Bar Association) – 1:00 to 2:00 pm

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

  • ACI Summit on IP Due Diligence

    ACIAmerican Conference Institute (ACI) will be holding its Summit on IP Due Diligence on November 2-3, 2017 in Philadelphia, PA.  This conference will be unique because a mock fact pattern will lay the foundation for the sessions of both days.  ACI faculty will help attendees:

    • Assess patent scope, validity, and enforceability in light of current patent rules and regulations
    • Apply recent case law, legislation, and influence of post-grant proceedings into due diligence practices
    • Explore the patent landscape by conducting effective freedom to operate analyses
    • Uncover potential ownership and inventorship inconsistencies
    • Protect attorney-client privilege while avoiding contamination during the review

    The conference will offer presentations on the following topics:

    • Preparing the Due-Diligence Checklist and Forming your Team
    • Analyzing the Current Patent Landscape: AIA, Post-Grant Proceedings, Evolving Jurisprudence, and the Effects on Patent Strength
    • Uncovering Red Flag in Ownership and Inventorship
    • Diving into the Patent Portfolio: Examining the Scope, Patentability, Validity, and Enforceability
    • Focusing on Freedom to Operate: Analyzing the Market
    • Deals Gone Wild: Real-Life Horror Stories of IP Due Diligence Missteps
    • Show Me the Money: Strategies to Overcome Valuation Challenges — to be presented in part by Patent Docs author Andrew Williams
    • Pursuing Trade Secret Protection in the Current Anti-Patent Climate
    • Attorney-Client Privilege, Contamination and Ethical Challenges

    In addition, one post-conference workshop on "Best Practices for Managing the Entire Due Diligence Process from Both Sides' Perspectives" will be offered on November 3, 2017 from 2:00 to 5:00 pm.

    The agenda for the IP Due Diligence Summit can be found here.  More information regarding the workshop 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 registration fee is $2,295 (conference alone), $2,895 (conference and workshop).  Patent Docs readers are entitled to a 10% discount off of registration using discount code P10-999-PTD18.  Those interested in registering for the conference can do so here, by e-mailing CustomerService@AmericanConference.com, or by calling 1-888-224-2480.

    Patent Docs is a media partner of ACI's Summit on IP Due Diligence.

  • USPTO News Briefs

    By Donald Zuhn —

    USPTO Releases Beta Version of Citation List

    Global DossierIn a Patent Alert e-mail distributed last month, the U.S. Patent and Trademark Office announced that it has released a beta version of the Citation List, as part of the Global Dossier Initiative.  The Citation List service, which can be accessed here, provides a comprehensive listing of relevant citations in related applications that share a common priority claim.  The Office noted that subsequent versions of the Citation List will introduce additional features, such as viewing the citation publication documents and incorporating additional data sources to enhance the comprehensiveness and consistency of citation data.

    In the fall of 2015, the USPTO announced the launch of Dossier Access, the first of a set of business services to be developed as part of the Global Dossier Initiative (see "USPTO Launches Dossier Access").  The Global Dossier Initiative is a collaborative project of the IP5 Offices — the European Patent Office (EPO), Japan Patent Office (JPO), Korean Intellectual Property Office (KIPO), State Intellectual Property Office of the People's Republic of China (SIPO), and USPTO — which aims to modernize the global patent system by providing a single portal/user interface for stakeholders.


    USPTO Extends AFCP 2.0 and QPIDS Programs

    In a Patent Alert e-mail distributed last month, the U.S. Patent and Trademark Office noted that both the After-Final Consideration Pilot 2.0 (AFCP 2.0) program and Quick Path IDS (QPIDS) pilot program have been extended to September 30, 2018.

    The AFCP, which was implemented in April 2012 (see "USPTO to Assess After Final Consideration Pilot Program"), modified in May 2013 (see "USPTO News Briefs"), and extended since then provides examiners with a limited amount of non-production time — three hours for utility and reissue applications — to consider responses filed following a final rejection.  The requirements for participating in the AFCP 2.0 are as follows:

    (1) a transmittal form that requests consideration under AFCP 2.0 (the Office suggests that applicants use form PTO/SB/434);
    (2) a response under 37 CFR 1.116, including an amendment to at least one independent claim that does not broaden the scope of the independent claim in any aspect;
    (3) a statement that the applicant is willing and available to participate in any interview initiated by the examiner concerning the accompanying response (according to the Office, "willing and available" means that the applicant is able to schedule the interview within ten (10) calendar days from the date the examiner first contacts the applicant);
    (4) any necessary fees (e.g., a request filed more than three months after the mailing of a final rejection must include the appropriate fee for an extension of time under 37 C.F.R. § 1.136(a)); and
    (5) the required papers must be filed via the EFS-Web.

    Additional information regarding the AFCP 2.0 program can be found on the Office's AFCP 2.0 webpage.

    The QPIDS pilot program, also implemented in 2012 (see "USPTO Announces Quick Path Information Disclosure Statement (QPIDS) Pilot Program") and extended since then, allows applicants to have an Information Disclosure Statement (IDS) considered after the issue fee has been paid and without having to file a Request for Continued Examination (RCE).  To be eligible to participate in the pilot program, an application must be an allowed utility or reissue application for which the issue fee has been paid and the patent has not yet issued, and a QPIDS submission must be made electronically via the EFS-Web.  A QPIDS submission must include the following:

    • a transmittal form that designates the submission as a QPIDS submission (e.g., form PTO/SB/09);
    • an IDS accompanied by a timeliness statement set forth in 37 CFR 1.97(e), with the IDS fee set forth in 37 CFR 1.17(p);
    • a Web-based ePetition to withdraw from issue under 37 CFR 1.313(c)(2), with the petition fee set forth in 37 CFR 1.17(h); and
    • an RCE, which will be treated as a "conditional" RCE, with the RCE fee under 37 C.F.R. 1.17(e).

    Additional information regarding the QPIDS pilot program can be found on the Office's QPIDS webpage.


    Cash Not Accepted

    Cash Not AcceptedEarlier this month, the U.S. Patent and Trademark Office published a notice in the Federal Register (82 Fed. Reg. 46042) noting that the USPTO will no longer accept cash as payment for products and services for which fees are required.  The new policy will take effect on November 1, 2017.  The notice indicates that the change is intended to streamline the fee collection process and implement the Department of the Treasury's directive to agencies to adopt a no-cash policy.  The notice also indicates that in the past three fiscal years, the Office has collected at least $3 billion in net revenue each year, of which less than $14,000 per year has been in the form of cash payments.


    USPTO Announces New EFS-Web and Private PAIR Feature

    EFS-WebIn a Patent Alert e-mail distributed last month, the U.S. Patent and Trademark Office announced that all EFS-Web-registered and Private PAIR users will now be able to file structured text via EFS-Web and access structured text submissions, structured text Office actions, and XML downloads via Private PAIR.

    A Quick Start Guide for text intake in EFS-Web can be found here.  According to the Guide, application parts can now be submitted in DOCX format.  Additional requirements for such submissions can be found on page 6 of the Guide.

    A Quick Start Guide regarding new Private PAIR enhancements can be found here.  Among the enhancements will be the option to download XML or DOCX versions of PDF documents.


    USPTO Changes Electronic Retrieval Method for Japanese Priority Documents

    In a notice published in the Official Gazette earlier this month, the U.S. Patent and Trademark Office noted that the electronic retrievals of priority documents between the USPTO and the Japan Patent Office (JPO) will be managed via the World Intellectual Property Organization (WIPO) Digital Access Service (DAS).  For applications filed on or after October 1, 2017, Applicants who wish to have Japanese priority documents electronically retrieved must provide the WIPO DAS access code associated with the priority application along with the country, application number, and filing date of that application.  For applications filed prior to October 1, 2017, the WIPO DAS access code will not be required, but the Office is encouraging applicants to voluntarily provide the WIPO DAS access code for Japanese priority documents.  The certified copy requirement will be considered to be satisfied when a Japanese priority document is retrieved electronically via the WIPO DAS service during pendency of the U.S. application.  According to the notice, the Office will include the WIPO DAS access code on filing receipts.  The Office also reminds applicants that they bear the ultimate responsibility for ensuring that the priority document is filed by the time limit set forth in 37 C.F.R. § 1.55.

    Image of Cash not accepted sign at North Avenue Beach in Chicago derived from image by Marco Verch, from the Wikimedia Commons under the Creative Commons Attribution 2.0 Generic license.

  • PTAB Life Sciences Report

    By John Cravero —

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

    Sun Pharmaceuticals Industries, Ltd. v. Novartis AG

    PTAB Petition:  IPR2017-01929; filed August 16, 2017.

    Institution of Inter Partes Review:  entered October 2, 2017.

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

    Petitioners Sun Pharmaceutical Industries, Ltd., Sun Pharmaceutical Industries, Inc., and Sun Pharma Global FZE are challenging the '405 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).  Petitioners also seek joinder with IPR2017-00854 through Motions for Joinder under 35 U.S.C. § 315(c) and 37 C.F.R. §§ 42.22 and 42.122(b).  View the petition here and the Motion for Joinder here.  Administrative Patent Judges Lora M. Green, Christopher M. Kaiser, and Robert A. Pollock (author) issued a decision instituting inter partes review of whether claims 1-6 are unpatentable under 35 U.S.C. § 103 over the combination of Kovarik and Thomson; claims 1–6 are unpatentable under 35 U.S.C. § 103 over the combination of Chiba, Kappos 2005, and Budde; and claims 1–6 are anticipated under 35 U.S.C. § 102 by Kappos 2010.  The Judges also ordered IPR2017-01929 and IPR2017-00854 joined, administratively terminated IPR2017-01929 under 37 C.F.R. § 42.72, and ordered all further filings in the joined proceedings shall be made in Case IPR2017-00854 (Petitioners, Apotex Inc.; filed 02/03/2017; instituted 07/18/2017; pending).

    Related Matters:  According to the petition, the '405 patent is involved in IPR2017-01550 (Argentum Pharmaceuticals LLC; filed 06/09/2017; instituted and joined to IPR2017-00854 08/09/2017; pending).


    Pfizer Inc. v. Genentech, Inc.

    PTAB Petition:  IPR2018-00016; filed October 3, 2017.

    Patent at Issue:  U.S. Patent No. 7,846,441 ("Treatment with anti-ErbB2 antibodies," issued December 7, 2010) claims a method for the treatment of a human patient with a malignant progressing tumor or cancer characterized by overexpression of ErbB2 receptor, comprising administering a combination of an intact antibody which binds to epitope 4D5 within the ErbB2 extracellular domain sequence and a taxoid, in the absence of an anthracycline derivative, to the human patient in an amount effective to extend the time to disease progression in said human patient, without increase in overall severe adverse events.

    Petitioner Pfizer Inc. is challenging the '441 patent on two grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, the '441 patent is involved in inter partes review IPR2017-00731 (Hospira, Inc.(subsidiary of Pfizer); filed 01/20/2017; denied 07/27/2017; rehearing requested 08/25/2017; pending); Celltrion, Inc. (IPR2017-01121; filed 03/21/2017; pending).  Petitioner also identified that related European patent EP 1,037,926 B1 was invalidated as obvious in the following proceedings: (1) Hospira UK, Ltd. v. Genentech, Inc., No. HP-2014-000034, [2015] EWHC (HC) 1796 (Pat), (Jun. 24, 2015), aff’d Hospira UK, Ltd. v. Genentech, Inc., No.A3 2015 3238, [2016] EWCA Civ 1185 (Nov. 30, 2016); and (2) Decision to Revoke European Patent EP 1,037,926, Application No. 98,963,840.8 (Jun. 13, 2016).


    Hologic, Inc. v. Enzo Life Sciences, Inc.

    PTAB Petition:  IPR2018-00019; filed October 4, 2017.

    Patent at Issue:  U.S. Patent No. 6,221,581 ("Processes for detecting polynucleotides, determining genetic mutations or defects in genetic material, separating or isolating nucleic acid of interest from samples, and useful compositions of matter and multihybrid complex compositions," issued April 24, 2001) claims a process for detecting a nucleic acid of interest.

    Petitioners Hologic and Gen-Probe Inc. are challenging the '581 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, the '581 patent is presently the subject of the following patent infringement lawsuits:  Enzo Life Scienced, Inc. v. Hologic, Inc., 1:16-cv-00894 (D. Del.); and Enzo Life Scienced, Inc. v. Digene Corp., 1:02-cv-00212 (D. Del.).


    Celltrion, Inc. v Genentech, Inc.

    PTAB Petition:  IPR2017-01139; filed March 24, 2017.

    Institution of Inter Partes Review:  entered October 4, 2017.

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

    Petitioners Celltrion, Inc., Celltrion Healthcare Co. Ltd., and Teva Pharmaceuticals International GmbH are challenging the '196 patent on one ground as obvious under 35 U.S.C. § 103(a).  View the petition here.  Administrative Patent Judges Zhenyu Yang (author), Christopher G. Paulraj, and Robert A. Pollock issued a decision instituting inter partes review of whether claims 1–3, 5, 7, 9–11, and 17–33 of the '196 patent are obvious over the combination of Slamon, Watanabe, Baselga, and Pegram.

    Related Matters:  According to the petition, the '196 patent is the subject of inter partes reviews IPR2017-00804 (Hospira, Inc; filed 01/30/2017; instituted 07/27/2017; pending).  Also, Petitioners concurrently filed a petition for inter partes review of related U.S. Patent No. 7,371,379 (IPR2017-01140; filed 03/24/2017; pending) which is also the subject of IPR 2017-00805 (Hospira, Inc.; filed 01/30/2017; instituted 07/27/2017; pending).


    Celltrion, Inc. v Genentech, Inc.

    PTAB Petition:  IPR2017-01121; filed March 21, 2017.

    Institution of Inter Partes Review:  entered October 4, 2017.

    Patent at Issue:  U.S. Patent No. 7,846,441 ("Treatment with anti-ErbB2 antibodies," issued December 7, 2010) claims a method for the treatment of a human patient with a malignant progressing tumor or cancer characterized by overexpression of ErbB2 receptor, comprising administering a combination of an intact antibody which binds to epitope 4D5 within the ErbB2 extracellular domain sequence and a taxoid, in the absence of an anthracycline derivative, to the human patient in an amount effective to extend the time to disease progression in said human patient, without increase in overall severe adverse events.

    Petitioners Celltrion, Inc., Celltrion Healthcare Co. Ltd., and Teva Pharmaceuticals International GmbH are challenging the '441 patent on one ground as being obvious under 35 U.S.C. § 103(a).  View the petition here.  Administrative Patent Judges Zhenyu Yang (author), Christopher G. Paulraj, and Robert A. Pollock issued a decision instituting inter partes review of whether claims 1–14 of the '441 patent are obvious over the combination of Baselga 1996, Seidman 1996, and the 1995 TAXOL PDR entry, and the knowledge of a person of ordinary skill in the art.

    Related Matters:  According to the petition, the '441 patent is involved in inter partes review IPR2017-00731 (Hospira, Inc.; filed 01/20/2017; institution denied; request for reconsideration filed 08/25/2017; pending).  Petitioner concurrently filed a petition for inter partes review of related U.S. Patent No. 7,892,549 (IPR2017-01122; filed 03/21/2017; instituted 10/04/2017) which is also the subject of IPR2017-00737 (Hospira, Inc.; filed 01/20/2017; instituted 07/27/2017; pending) and IPR2017-00739 (Hospira, Inc.; filed 01/20/2017; institution denied 07/27/2017).


    Celltrion, Inc. v Genentech, Inc.

    PTAB Petition:  IPR2017-01122; filed March 21, 2017.

    Institution of Inter Partes Review:  entered October 4, 2017.

    Patent at Issue:  U.S. Patent No. 7,892,549 ("Treatment with anti-ErbB2 antibodies," issued February 22, 2011) claims a method for the treatment of a human patient with breast cancer that overexpresses ErbB2 receptor, comprising administering a combination of an antibody that binds ErbB2, a taxoid, and a further growth inhibitory agent to the human patient in an amount effective to extend the time to disease progression in the human patient, wherein the antibody binds to epitope 4D5 within the ErbB2 extracellular domain sequence.

    Petitioners Celltrion, Inc., Celltrion Healthcare Co. Ltd., and Teva Pharmaceuticals International GmbH are challenging the '549 patent on one ground as being obvious under 35 U.S.C. § 103(a).  View the petition here.  Administrative Patent Judges Zhenyu Yang, Christopher G. Paulraj, and Robert A. Pollock (author) issued a decision instituting inter partes review of whether claims 1–11 and 14–17 of the ’549 Patent are obvious over the combination of Baselga 1996, Seidman 1996, Pegram, and the 1995 TAXOL PDR entry, and the knowledge of a person of ordinary skill in the art.

    Related Matters:  According to the petition, the '549 patent is involved in inter partes reviews IPR2017-00737 (Hospira, Inc.; filed 01/20/2017; instituted 07/27/2017; pending) and IPR2017-00739 (Hospira, Inc.; filed 01/20/2017; institution denied 07/27/2017).  Petitioner concurrently filed a petition for inter partes review of related U.S. Patent No. 7,846,441 (IPR2017-01123; filed; pending) which is also the subject of IPR2017-00731 (Hospira, Inc.; filed 01/20/2017; pending).


    Celltrion, Inc. v Genentech, Inc.

    PTAB Petition:  IPR2017-01140; filed March 24, 2017.

    Institution of Inter Partes Review:  entered October 4, 2017.

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

    Petitioners Celltrion, Inc., Celltrion Healthcare Co. Ltd., and Teva Pharmaceuticals International GmbH are challenging the '379 patent on one ground as obvious under 35 U.S.C. § 103(a).  View the petition here.  Administrative Patent Judges Zhenyu Yang, Christopher G. Paulraj (author), and Robert A. Pollock issued a decision instituting inter partes review of whether claims 1–3, 5, 7, 9–11, 16–28, and 30–40 of the ’549 Patent are obvious over the combination of Slamon, Watanabe, Baselga ’96, and Pegram ’98.

    Related Matters:  According to the petition, the '379 patent is the subject of inter partes reviews IPR 2017-00805 (Hospira, Inc.; filed 01/30/2017; instituted 07/27/2017; pending).  Also, Petitioners concurrently filed a petition for inter partes review of related U.S. Patent No. 6,627,196 (IPR2017-01139; filed 03/24/2017; pending) which is also the subject of IPR2017-00804 (Hospira, Inc; filed 01/30/2017; instituted 07/27/2017; pending).

  • Smart Systems Innovations, LLC v. Chicago Transit Authority (Fed. Cir. 2017)

    By Michael Borella —

    Federal Circuit SealThree years ago, the Supreme Court's Alice Corp. v. CLS Bank Int'l case set forth a two-part test to determine whether claims are directed to patent-eligible subject matter under 35 U.S.C. § 101.  One must first decide 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 decide 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 typically patent-eligible.

    Since then, there has been much confusion and debate regarding the exact contours of patent eligibility.  Of late, however, clarity has been emerging, but not enough to disambiguate the Alice test.  Instead, it only helps us understand why different individuals can use the same test to come to radically different conclusions.  Particularly, when applying the test, the outcome is largely determined by (i) the level of abstraction at which one views the claims under part one, and (ii) whether one considers any improvements provided by the claimed invention under part two.  The present case illustrates how even Federal Circuit judges vary with respect to these points.

    Smart Systems brought an action against the Chicago Transit Authority (CTA) in the Northern District of Illinois, alleging infringement of its U.S. Patents Nos. 7,566,003, 7,568,617, 8,505,816, and 8,662,390.  The CTA moved for judgment on the pleadings, taking the position that all of the patents were ineligible under § 101 for being directed to an abstract idea and not claiming significantly more.  The District Court granted the motion.  Smart Systems appealed.

    The Federal Circuit panel unanimously agreed with the District Court that the '816 and '390 patents were invalid.  However, Judge Linn dissented from Judge Wallach's majority opinion regarding the '003 and '617 patents.  For sake of brevity, we will focus on where the panel disagreed.

    As described by Judge Linn:

    In conventional transit systems, access is rapidly provided through a turnstile by directly depositing the required fare using cash, tokens or some form of proprietary fare card.  Such systems generally do not use conventional bankcards.  Conventional bankcard transactions use a card reader in contact with the card's magnetic strip or imbedded chip to read the card number and other data at a merchant's location.  The read data is then transmitted over a telephone line or network to a merchant bank for verification of card validity and fund availability.  The merchant bank processes the received data and returns to the merchant an approval or disapproval message.

    According to Smart Systems, the latency in such conventional bankcard transactions and the lack of network connectivity in some transit control points render conventional bankcards impractical for point-of-access use in a transit system that requires rapid fare processing.

    [The Smart Systems patents] claim systems and methods for using a bank card directly at a physical gate or terminal to enter a mass transit system.  [They] disclose the use of a bankcard reader to scan a credit or bankcard and a processor to compare the scanned data against a locally-stored "white list" of approved transit accounts.  If the card owner is listed as an account-holder, access is granted without immediately having to establish network connectivity to process and charge the account, which can be done at a later time.  If the card owner is not listed as an account-holder, access is denied.

    Claim 14 of the '003 patent was considered representative:

    A method for validating entry into a first transit system using a bankcard terminal, the method comprising:
        downloading, from a processing system associated with a set of transit systems including the first transit system, a set of bankcard records comprising, for each bankcard record in the set, an identifier of a bankcard previously registered with the processing system, and wherein the set of bankcard records identifies bankcards from a plurality of issuers;
        receiving, from a bankcard reader, bankcard data comprising data from a bankcard currently presented by a holder of the bankcard, wherein the bankcard comprises one of a credit card and a debit card;
        determining an identifier based on at least part of the bankcard data from the currently presented bankcard;
        determining whether the currently presented bankcard is contained in the set of bankcard records;
        verifying the currently presented bankcard with a bankcard verification system, if the bankcard was not contained in the set of bankcard records; and
        denying access, if the act of verifying the currently presented bankcard with the bankcard verification system results in a determination of an invalid bankcard.

    Similarly, claim 13 of the '617 patent was also considered representative:

    A method for validating entry into a first transit system using a bankcard terminal, the method comprising:
        downloading, from a processing system associated with a set of transit systems including the first transit system, a list of bankcards comprising, for each bankcard in the list, a hash identifier of a bankcard previously presented, by a respective holder of the bankcard, to the processing system, wherein the bankcard comprises one of a credit card and a debit card;
        receiving, from a bankcard reader, bankcard data comprising data from a bankcard currently presented by a holder of the bankcard;
        determining an identifier based on at least part of the bankcard data from the currently presented bankcard;
        determining whether the currently presented bankcard is contained in the set of bankcard records;
        verifying the currently presented bankcard with a bankcard verification system, if the bankcard was not contained in the set of bankcard records; and
        denying access, if the act of verifying the currently presented bankcard with the bankcard verification system results in a determination of an invalid bankcard.

    Applying part one of the Alice test, the Court rapidly concluded that the claims were directed to an abstract idea.  Particularly, the Court found that the "patents involve acquiring identification data from a bankcard, using the data to verify the validity of the bankcard, and denying access to a transit system if the bankcard is invalid."  In the Court's view, the claimed inventions were no more than financial transactions applied to mass transmit.  Furthermore, the Court held that the claims merely involved the "collection, storage, and recognition of data," and did not improve an existing technological process.

    While Smart Systems argued that the claims embodied an improvement because they sped up processing at turnstiles, the Court disagreed.  The Court reasoned that precedents such as Enfish v. Microsoft, and DDR Holdings v. Hotels.com require that the patentee establish that the claimed invention is an improvement to computer technology, while McRO v. Bandai Namco Games requires that the patentee establish that the claimed invention is "directed to specific rules that improve a technological process."  The Court's narrow view of these cases — ones that ultimately found claims to be eligible under § 101 — appear to render them limited to their facts.  In contrast, the Court took a more expansive reading of cases finding claims involving financial transactions ineligible under § 101.  The Court noted that "regardless of whether the claims teach a financial transaction, when properly considered, it is evident that the claims are directed to the collection, analysis, and classification of information, and not access alone."

    Turning to part two of the Alice test, the Court focused on the additional elements of a processor, an interface, memory, and a hash identifier ("data extracted from a bankcard to create a digital fingerprint of the card that a bankcard terminal processor uses to identify the card in question").  The Court viewed these aspects as nothing more than generic computing elements.  Once more reading precedent that would otherwise help Smart Systems as being, for all intents and purposes, limited to its facts, the Court stated that the holdings of Diamond v. Diehr and DDR Holdings did not apply.  Diehr involved more than generic computer components and DDR Holdings was solving a problem particular to the Internet.

    Thus, Judge Wallach, joined by Judge Reyna, declared all claims invalid.

    Writing in dissent with respect to only the '003 and '617 patents, Judge Linn disagreed.  Notably, he began by observing that "[t]he majority commits the same error as the district court in engaging in a reductionist exercise of ignoring the limitations of the claims in question."  Judge Linn goes on to state that "the abstract idea exception is almost impossible to apply consistently and coherently," and that the Alice test is "indeterminate and often leads to arbitrary results."  As a consequence, "it can strike down claims covering meritorious inventions not because they attempt to appropriate a basic building block of scientific or technological work, but simply because they seemingly fail the Supreme Court's test."

    Judge Linn goes further, addressing one of the fundamental issues that makes the Alice test ambiguous.  He notes that recent Federal Circuit § 101 opinions state that, under part one, we are to both "examine the claims' character as a whole," and "look to capture the 'basic thrust' of the Asserted Claims."  These contradictory directives can lead to disparate outcomes based on who is evaluating the claims and what precedent they happen to be looking to for guidance.

    Judge Linn posed a series of questions: "But if we are not to re-characterize the claims, what are we supposed to do?  Are we not to ignore any limitations?  May we ignore some?  If so, which ones?  Which limitations matter and which do not?  What exactly is the task at hand under step one?"  Ultimately, he took the position that "[a] determination of what the claims are directed to is often aided by a consideration of the specification and its description of the problem to be solved and the discovered solution to that problem."

    Judge Linn's criticism of the majority is based on how its "determination turns wholly on the level of generality with which it describes the focus of the claims and is at such a high level of abstraction as to overlook and misstate what the inventors considered to be their invention."  To that point, Judge Linn found that the claims are directed to an access system rather than a financial transaction, and therefore are neither directed to a fundamental economic practice nor abstract.

    Regarding part two of the Alice test, Judge Linn chided the majority for ignoring the advancement reflected in the claims, noting that "facilitating use of conventional bankcards to access mass transit is at the heart of the invention, much like the challenge of curing rubber was at the heart of the invention in Diehr."  He also found that the claimed "combination of a bankcard reader, a white list, and transit system access control" was "a different way of accessing a transit system by using a conventional bankcard without the need for immediate network connectivity and without the latency previously considered an inherent limitation on the use of ordinary bankcards."

    For these reasons, Judge Linn would have ruled claims of the '003 and '617 patents to be patent-eligible.

    The problems inherent in the Alice test are plain to see.  While the responsibility lies with the Supreme Court for setting forth an abstruse test that frequently produces contradictory outcomes, the burden is now on the Federal Circuit to agree within itself how the test is to be used in practice.  Are we to consider all claim elements in part one, or boil the language of the claim down to its gist or main idea?  If the answer is the latter, how do we prevent different evaluators from finding different main ideas in the same claim, as was the case here?  And, during the part two analysis, are we to consider evidence from the specification that the claimed invention is a technical improvement, or are we limited to finding such an improvement literally recited by the claims?

    Until these questions are answered definitively, the black mark of Alice will continue to stain patent law.

    Smart Systems Innovations, LLC v. Chicago Transit Authority (Fed. Cir. 2017)
    Panel: Circuit Judges Reyna, Linn, and Wallach
    Opinion by Circuit Judge Wallach; opinion dissenting in part and concurring in part by Circuit Judge Linn

  • Merck Sharp & Dohme B.V. v. Warner Chilcott Co. (Fed. Cir. 2017)

    By Kevin E. Noonan –

    MerckThe Supreme Court most recently revisited the proper standards for making an obviousness determination ten years ago, in KSR Int'l. Co. v. Teleflex. Inc.  While in some ways changing the obviousness standard, for example expanding the scope and relevance of analogous art, and clarifying other aspects, such as when being "obvious to try" can make a claim obvious, the Court's opinion was steadfast to established principles of patent law in other respects.  One of these latter principles is that the "pernicious effects of hindsight" should be avoided, for the distorting effect it can have on when an innovation is deserving of patent protection (and when it is not).

    Warner ChilcottThe District Court's failure to properly apply this principle of avoiding hindsight was the error that led the Federal Circuit on Friday to overturn a finding of obviousness in Merck Sharp & Dohme B.V. v. Warner Chilcott Co.  The invention related to an internally worn contraceptive device, sold by Merck under the brand name NuvaRing® as claimed in U.S. Patent No. 5,989,581, comprising an estrogen and a progesterone compound.  Contraception is effective when both compounds are delivered daily and consistently, but achieving this level of performance is the relevant challenge.  In the prior art, the two components (for Merck's device these are ethynyl estradiol (EE) and etonogestrel (ETO)) were combined in a single compartment which proved unsatisfactory so two compartment designs were used.  The invention claimed in the '581 patent provided both compounds in a single compartment wherein the polymer comprising the device contained supersaturated ETO.  Claims 4 and 11 were at issue, claim 4 being dependent on claim 1:

    1.  A drug delivery system comprising at least one compartment which comprises
        a thermoplastic polymer core . . . said core comprising a mixture of a steroidal progestogenic compound and a steroidal estrogenic compound in a ratio by weight that allows a direct release of both said progestogenic compound and said estrogenic compound in physiologically required amounts,
        said progestogenic compound being initially dissolved in said polymer core material in a degree of supersaturation of 1 to about 6 times of the amount by weight necessary for obtaining saturation concentration of said progestogenic compound  in said polymer core material at 25° C,
        said estrogenic compound being dissolved in said polymer core material in a concentration lower than that of said progestogenic compound . . . .

    4.  A drug delivery system according to claim 1, wherein the amount of progestogenic compound dissolved in the thermoplastic core material is 2 to 5 times the amount necessary for obtaining saturation concentration. (italics added)

    And claim 11 being dependent on claim 5:

    5.  A drug delivery system in a substantially ring shaped form and suitable for vaginal administration comprising at least one compartment which comprises
        a thermoplastic polymer core . . . said core comprising a mixture of a progestogenic steroidal compound and an estrogenic steroidal compound in a ratio by weight of 10 parts of the progestogenic compound to 1.5–5 parts of the estrogenic compound . . . .

    11.  A drug delivery system according to claim 5, wherein the core material comprises 0.55 to 0.8% by weight of etonogestrel and 0.12 to 0.18% by weight of ethinyl estradiol. (italics added)

    The important limitation recognized by the Federal Circuit is that the device comprises a single compartment that comprises both the progestogenic steroidal compound and the estrogenic steroidal compound (highlighted in italics above).

    The District Court determined that these claims were obvious over the prior art disclosure of PCT Publication No. WO97/02015.  This PCT application was also directed to contraceptive vaginal rings but expressly disclosed a two-compartment structure.  The specification of the '015 PCT application disparaged one-compartment versions, stating:

    These above-mentioned one-compartment rings have the disadvantage that, when loaded with more than one active substance, release patterns of these substances cannot be adjusted independently.  Such devices usually show suboptimum release patterns for the different substances, whereas it is generally preferred that all substances are released in a controlled rate and during a similar duration of time.  As a consequence the release ratio of the active substances undergoes a change after a period of time.

    Nevertheless, the District Court found that the worker of ordinary skill would have been "motivated" to optimize the ring disclosed in the '015 PCT to include a second compartment wherein that compartment released the contraceptive-effective amounts of ETO and EE (presumably so that both compartments contained both compounds, thus distinguishing prior art comprising two components each containing only one of the compounds).  The '015 PCT disclosed drug release rates encompassing those of Merck's claimed device and thus "it would have been obvious for a person of skill to derive the claimed ratios of progestin and estrogen."

    The Federal Circuit reversed, in an opinion by Judge Hughes, joined by Judges Linn and Dyk.  Taking the invalidated claims in order, the panel noted that the '015 PCT application disclosed a first compartment comprising EE alone and a second compartment a combination of EE and ETO.  The opinion disputes the District Court's finding that the '015 PCT application discloses a second compartment comprising 97% of the ring and includes ETO at a higher concentration than EE.  The '015 PCT application discloses ranges of these compounds ("between 30:1 and 1:30, but usually are between 15:1 and 1:1, and preferably are about 2:1.") and this can result in a ring wherein the second compartment comprises 97% of the ring.  However, this "hypothetical" ring is not disclosed and, according to the Federal Circuit is "outside of the usual or preferred range disclosed in PCT '015."  In addition, the panel opined that the District Court's interpretation would require the skilled worker to "pick a concentration of ETO from the high end of the disclosed range, but conversely select a concentration of EE from the low end of the range."  There is no disclosure in the '015 PCT application (the only art the District Court relied upon) that would suggest to the skilled worker to choose these concentrations.  The panel found that "the only way to arrive at the hypothetical ring is by using the '581 patent as a roadmap to piece together various elements of PCT '015."  And doing that, according to the Federal Circuit, is hindsight.

    This conclusion is supported for the panel by the disparagement of one-compartment embodiments expressly contained in the '015 PCT application's specification.  The opinion distinguishes the instructions from the Supreme Court's KSR opinion that the skilled work may sometimes "have 'good reason to pursue the known options' based on 'design need or market pressure.'"  But those instances involve ones where the skilled worker pursues "identified, predictable solutions," whereas here the skilled worker would have had to rely on putatively inoperative embodiments, which the very prior art the District Court relied upon provided devices having "sub-optimal release patterns."

    With regard to claim 11, which does not require effective amounts of both compounds to be released from one compartment, the amounts of the compounds are specified in the claim.  Warner-Chilcott argued persuasively to the District Court that the skilled worker would have been able to calculate these amounts based on the release rates disclosed in the '015 PCT application.  The Federal Circuit opinion points out that these release rates were disclosed in the '015 PCT application as being determined using a two-compartment device.  The opinion states that its reading of the '015 PCT application is that these disclosed release rates can be achieved because they are contained in two compartments.  Thus, for the panel the skilled worker would not have expected to be able to produce these release rates from a one-compartment device.

    This decision is nonprecedential, but provides a good example of how the Federal Circuit understands the proper avoidance of hindsight in considering whether a claim is obvious.

    Merck Sharp & Dohme B.V. v. Warner Chilcott Co. (Fed. Cir. 2017)
    Nonprecedential disposition
    Panel: Circuit Judges Dyk, Linn, and Hughes
    Opinion by Circuit Judge Hughes