• By Kevin E. Noonan

    Morocco Flag MapThe President of the EPO and the Minister of Industry, Trade, Investment and the Digital Economy of Morocco announced on January 19th that Morocco would permit EP applications and granted EP patents to be validated in that country beginning on March 1, 2015.  Upon request from an applicant, Morocco will validate a granted EP patents and recognize pending EP applications (which would then be eligible for validation upon grant) with the payment of a fee to the EPO to designate Morocco.  This route to patent protection is not retroactive, however, and will only be available to EP and PCT applications filed after March 1st.  Patents granted through such a route will have the same protections as in the other members of the European Patent Organization.

    This is the first non-European country to offer patent protection based on examination by the EPO.

    Hat tip to our foreign associates HGF.

    Image of Morocco flag map (above) from Mapsof.net under the Creative Commons Attribution-ShareAlike 1.0 Licence.

  • (Or, and then there was one)

    By Kevin E. Noonan

    MyriadAs discussed at the end of January, Myriad has given up its Quixotic quest to validate its BRCA gene testing franchise and has abandoned its several lawsuits (many of which were consolidated before the District of Utah under 28 U.S.C. § 1407 and captioned In Re: BRCA1- and BRCA2-Based Hereditary Cancer Test Patent Litigation; see "Panel on Multidistrict Litigation Consolidates Myriad Cases in Utah District Court").  With its agreement to dismiss actions (with prejudice) against Ambry Genetics, LabCorp, Invitae, and Pathway Genomics, the earlier settlement agreement reached with Gene-by-Gene (see "Gene-by-Gene Cries Uncle, Settles with Myriad Genetics"), and a separate settlement with Counsyl, the only actions remaining before the Utah court were against Quest and GenDx.

    Quest DiagnosticsUntil this week, when Quest and Myriad announced that this case has settled as well.  The terms are the same in this settlement as in the earlier, more recent ones:  Myriad's infringement allegations had been dismissed "with prejudice" and Quest has received a "covenant not to sue" by Myriad.  The only financial considerations announced were that each party would bear its own costs of the litigation.

    GeneDxThat leaves GeneDx, but that case is in a slightly different posture because GeneDx challenged Myriad's patents before the Patent Trial and Appeals Board under the inter partes review (IPR) provisions of the Leahy-Smith America Invents Act.  Such IPR actions can be settled, but once instituted can also be pursued to their conclusions sua sponte by the Board.  The patents at issue in that action are U.S. Patent Nos. 5,654,155; 5,753,441; 6,033,857; 6,051,379; 6,083,698; 6,951,721; 7,470,510; 7,563,571; 7,622,258; 7,670,776; and 7,838,237.

  • By Kevin E. Noonan

    Goodlatte, BobAs discussed in a prior post, Rep. Bob Goodlatte (R, VA-6th) and a bipartisan collection of sponsors* introduced a bill, once again entitled the "Innovation Act" (H.R. 3309 in the last Congress; H.R. 9 in this one) directed at "patent reform."  The prior post discussed the litigation provisions; this one will focus on the remaining portions of the bill.

    The bill is set out in ten sections:

    Sec. 1. Short title; table of contents.
    Sec. 2. Definitions.
    Sec. 3. Patent infringement actions.
    Sec. 4. Transparency of patent ownership.
    Sec. 5. Customer-suit exception.
    Sec. 6. Procedures and practices to implement recommendations of the Judicial Conference.
    Sec. 7. Small business education, outreach, and information access.
    Sec. 8. Studies on patent transactions, quality, and examination.
    Sec. 9. Improvements and technical corrections to the Leahy-Smith America Invents Act.
    Sec. 10. Effective date,

    With sections 3-5 being expressly directed to changes in pleadings requirements, "loser pays" provisions, patent ownership transparency, so-called "demand letters," and stays of litigation against customers in favor of lawsuits brought against manufacturers and suppliers.

    Of the remaining provisions of the bill, Sec. 6 relates to the Judicial Conference and how courts should implement "recommendations" of the Conference.  The Judicial Conference, governed by 28 U.S.C. § 331, is empowered to "make policy" with regard to how U.S. Courts are administered.  According to the Conference's website; these include:

    • Mak[ing] a comprehensive survey of the conditions of business in the courts of the United States;

    • Prepar[ing] plans for the assignment of judges to or from courts of appeals or district courts, where necessary;

    • Submit[ting] suggestions to the various courts in the interest of promoting uniformity of management procedures and the expeditious conduct of court business;

    • Exercis[ing] authority provided in chapter 16 of title 28 United States Codes for the review of circuit council conduct and disability orders filed under that chapter; and

    • Carry[ing] on a continuous study of the operation and effect of the general rules of practice and procedure in use within the federal courts, as prescribed by the Supreme Court pursuant to law.

    Sec. 6 of H.R. 9 directs the Conference to "develop rules and procedures to implement the issues and proposals described in paragraph (2) to address the asymmetries in discovery burdens and costs in any civil action arising under any Act of Congress relating to patents."  Using the mandatory "shall" throughout, the Section sets out the types of rules to be adopted with great specificity; for example (Sec. 6(a)(2)(A)):

    (A) DISCOVERY OF CORE DOCUMENTARY EVIDENCE.—Whether and to what extent each party to the action is entitled to receive core documentary evidence and shall be responsible for the costs of producing core documentary evidence within the possession or control of each such party, and whether and to what extent each party to the action may seek nondocumentary discovery as otherwise provided in the Federal Rules of Civil Procedure.
    (B) ELECTRONIC COMMUNICATION.—If the parties determine that the dis covery of electronic communication is appropriate, whether such discovery shall occur after the parties have exchanged initial disclosures and core documentary evidence and whether such discovery shall be in accordance with the following:
        (i) Any request for the production of electronic communication shall be specific and may not be a general request for the production of information relating to a product or business.
        (ii) Each request shall identify the custodian of the information requested, the search terms, and a time frame. The parties shall cooperate to identify the proper custodians, the proper search terms, and the proper time frame.
        (iii) A party may not submit production requests to more than 5 custodians, unless the parties jointly agree to modify the number of production requests without leave of the court.
        (iv) The court may consider contested requests for up to 5 additional custodians per producing party, upon a showing of a distinct need based on the size, complexity, and issues of the case.
        (v) If a party requests the discovery of electronic communication for additional custodians beyond the limits agreed to by the parties or granted by the court, the requesting party shall bear all reasonable costs caused by such additional discovery.
    (C) ADDITIONAL DOCUMENT DISCOVERY.—Whether the following should apply:
        (i) IN GENERAL.—Each party to the action may seek any additional document discovery otherwise permitted under the Federal Rules of Civil Procedure, if such party bears the reasonable costs, including reasonable attorney's fees, of the additional document discovery.
        (ii) REQUIREMENTS FOR ADDITIONAL DOCUMENT DISCOVERY.—Unless the parties mutually agree otherwise, no party may be permitted additional document disovery unless such a party posts a bond, or provides other security, in an amount sufficient to cover the expected costs of such additional document discovery, or makes a showing to the court that such party has the financial capacity to pay the costs of such additional document discovery.
        (iii) LIMITS ON ADDITIONAL DOCUMENT DISCOVERY.—A court, upon motion, may determine that a request for additional document discovery is excessive, irrelevant, or otherwise abusive and may set limits on such additional document discovery.
        (iv) GOOD CAUSE MODIFICATION.—A court, upon motion and for good cause shown, may modify the requirements of subparagraphs (A) and (B) and any definition under paragraph (3). Not later than 30 days after the pretrial conference under Rule 16 of the Federal Rules of Civil Procedure, the parties shall jointly submit any proposed modifications of the requirements of subparagraphs (A) and (B) and any definition under paragraph (3), unless the parties do not agree, in which case each party shall submit any proposed modification of such party and a summary of the disagreement over the modification.
        (v) COMPUTER CODE.—A court, upon motion and for good cause shown, may determine that computer code should be included in the discovery of core documentary evidence. The discovery of computer code shall occur after the parties have exchanged initial disclosures and other core documentary evidence.
    (D) DISCOVERY SEQUENCE AND SCOPE.—Whether the parties shall discuss and address in the written report filed pursuant to Rule 26(f) of the Federal Rules of Civil Procedure the views and proposals of each party on the following:
        (i) When the discovery of core documentary evidence should be completed.
        (ii) Whether additional document discovery will be sought under subparagraph11 (C).
        (iii) Any issues about infringement, invalidity, or damages that, if resolved before the additional discovery described in subparagraph (C) commences, might simplify or streamline the case, including the identification of any terms or phrases relating to any patent claim at issue to be construed by the court and whether the early construction of any of those terms or phrases would be helpful.

    Also mandated by the bill is the elimination of Form 18 in the Appendix to the Federal Rules of Civil Procedure relating to the form of a complaint for patent infringement (which the Judicial Conference has already decided will be accomplished by December 2015).  These provisions are set forth in such detail here to illustrate the extent to which Congress is attempting to specify how courts implement the changes in the statute, and this very specificity has motivated members of the judiciary to question whether it constitutes an overreach by one co-equal branch over another.  (It is particularly telling that in Sec. 6(c)(2) the bill provides that the Supreme Court "may" (not "shall") prescribe a new Form for patent complaints, but even here Rep. Goodlatte cannot resist the urge to specify how the Court should do so.)

    This section also amends Title 11 of the U.S.C. § 1522, to enable a licensee wherein a foreign representative has rejected or repudiates the license to "make the election and exercise the rights described in section 365(n)."  The provisions of Section 6 are to take effect upon enactment of the bill into law.

    Section 7 contains a variety of purported benefits to small businesses to be administered by the Patent and Trademark Office, including "educational" resources "to address concerns arising from patent infringement" (Sec. 7(a)(1)) (although it is unclear how the PTO will provide education on patent litigation, which is not under its purview); "outreach" between the Office and the Small Business Administration and the Minority Business Development Agency to "provide education and awareness on abusive patent litigation practices (Sec. 7(a)(2)); creating a "user-friendly" portion of the PTO website (does this imply that the remainder of the website is not user-friendly?) "to notify the public when a patent case is brought in Federal court," including the information specified by the assignment transparency provisions of this bill (Sec. 7(b)(1)), in a format that is "searchable by patent number, patent art area and entity" (Sec. 7(b)(2)).  All of this is to be achieved "[u]sing existing resources," which seems a tall order insofar as the Office is now to become a clearinghouse for patent litigation information from the district courts.

    Section 8 also provides for additional "studies," here directed to:

    • "ensure greater transparency and accountability in patent transactions occurring on the secondary market" (Sec. 8(a)(1)(A));

    • "examine the economic impact that the patent secondary market has on the United States" (Sec. 8(a)(1)(B));

    • "examine licensing and other oversight requirements that may be placed on the patent secondary market, including on the participants in such markets, to ensure that the market is a level playing field and that brokers in the market have the requisite expertise and adhere to ethical business practices" (Sec. 8(a)(1)(C)); and

    • "examine the requirements placed on other markets" (Sec. 8(a)(1)(D)).

    These studies are to be performed by the Director "in consultation with" the Secretaries of the Commerce and Treasury Departments, the Chairman of the Securities and Exchange Commission, and "the heads of other relevant agencies, and interested parties," raising the issue of exactly who these "interested parties" may be and how their interest is to be communicated to the officials performing the study.  The results of this study are to be provided to the Judiciary Committees of the House and Senate not later than 18 months after enactment of the bill.

    Another study set out in Section 8 (Sec. 8(b)(1) et seq.) is directed to patents owned by the U.S., related to how these patents are licensed (and sold, although it is not clear that patents assigned to the U.S. can be sold) and litigated, and to provide recommendations regarding "whether there should be  restrictions placed on patents acquired from the United States Government" (an issue supposedly settled by enactment of the Bayh-Dole Act 35 years ago).  The results of this study are due no later than one year after enactment of the bill into law.

    The GAO is directed to perform a study on patent quality, including how patents are examined, classified, searched (particularly directed to whether "off-the-shelf" searching software purportedly used abroad could be used by the Office to improve patent quality) and whether there are examination protocols in place to prevent "double patenting" "through filing by applicants in multiple art areas"; whether the bill's attention is drawn to different entities each obtaining a patent on the same invention or a single entity obtaining more than one patent on the same invention is unclear)(Sec. 8(c)(1) et seq.).  The results of this study are due no later than one year after enactment of the bill into law.

    There is also a judicial study contained in Section 8, wherein the Director of the Administrative Office of the United States Courts, the Director of the Federal Judicial Center and the PTO Director are to "examine the idea of developing a pilot program for patent small claims procedures in certain judicial districts within the existing patent pilot program mandated by Public Law 111–349." (Sec. 8(d)(1) et seq.)  The results of this study are due no later than one year after enactment of the bill into law.

    Having proposed provisions to restrict the use of demand letters earlier in the bill, Section 8 paradoxically mandates a study by the Director on "the prevalence of the practice of sending patent demand letters in bad faith and the extent to which that practice may, through fraudulent or deceptive practices, impose a negative impact on the marketplace."  (Sec. 8(e)(1) et seq.)  No doubt unintentionally (or perhaps not; after all, the "demand letter" provisions are driven more by politics than sound policy), enacting a remedy before obtaining the results of the study suggest either that these results are a forgone conclusion or that the Representative has made up his mind irrespective of the facts.  The results of this study are due no later than one year after enactment of the bill into law.

    Returning to the theme of patent quality, this Section also requires the GAO to conduct a study on patent quality for business method patents.  (Sec. 8(f)(1) et seq.)  Rather than having the GAO assess the Office's examination policies, however, this study is aimed at business method patent litigation, specifically the "volume and nature" of such litigation, wherein the "quality" of such patents will be judged by how often their validity is upheld and infringement is found.  The results of this study are due no later than one year after enactment of the bill into law.

    Finally, Section 8 also contains a provision for the Director to conduct a study to determine "the impact of legislation [purportedly, this legislation] on the ability of individuals and small businesses to protect exclusive rights to inventions and discoveries."  (Sec. 8(g)(1) et seq.)  The Director is instructed to enlist the assistance of the Secretary of Commerce, the Director of the Administrative Office of the United States Courts, the Director of the Federal Judicial Center, "the heads of other relevant agencies, and interested parties," to examine the impact of the substantive provisions of the bill (sections 3-5) on the patent rights of "individuals and small businesses owned by women, veterans, and minorities."  The results of this study are due no later than two years after enactment of the bill into law (the bill's sponsors apparently believing that it will take that long for any deleterious effects to arise).

    All the studies mandated by Section 8 are to be performed "using existing resources."

    Section 9 of the bill turns to "improvements and technical corrections" to the AIA, the most significant of which contained in Section 9(b), wherein the Patent Trial and Appeal Board is required to employ in post-grant proceedings the same standards for claim construction as are used by district courts.  Enactment of these provisions would reverse both the PTAB and the majority opinion by the Federal Circuit in In re Cuozzo Speed Technologies (and in the process vindicate Judge Newman's dissent recognizing both the intent of Congress in enacting the post-grant provisions of the AIA and the limitations on PTO rulemaking contrary to that intent).  On the other hand, Section 9(a) also strikes the estoppel provisions with regard to patent challenges that "reasonably could have been raised," opening the door for patentee harassment and multiplicity of challenges in the PTO and the courts.  These provisions will come into force immediately upon enactment of the bill into law.

    Section 9(c)(1) et seq. codifies the judicially created obviousness-type double patenting doctrine (without changing the doctrine substantively):

    § 106. Prior art in cases of double patenting
        A claimed invention of a patent issued under section 151 (referred to as the 'first patent') that is not prior art to a claimed invention of another patent (referred to as the 'second patent') shall be considered prior art to the claimed invention of the second patent for the purpose of determining the nonobviousness of the claimed invention of the second patent under section 103 if—
        (1) the claimed invention of the first patent was effectively filed under section 102(d) on or before the effective filing date of the claimed invention of the second patent;
        (2) either—
            ''(A) the first patent and second patent name the same individual or individuals as the inventor; or
            (B) the claimed invention of the first patent would constitute prior art to the claimed invention of the second patent under section 102(a)(2) if an exception under section 102(b)(2) were deemed to be inapplicable and the claimed invention of the first patent was, or were deemed to be, effectively filed under section 102(d) before the effective filing date of  the claimed invention of the second patent; and
        (3) the patentee of the second patent has not disclaimed the rights to enforce the second patent independently from, and beyond the statutory term of, the first patent.

    Patents subject to this section 106 would not be invalidated by a patent filed under Section 3(n)(1) of the AIA (i.e., a "transition" application).

    These amendments become effective one year after enactment of the bill into law.

    Section 9(e) provides clarification of limits to patent term adjustment, specifically as shown:

    (B) Guarantee of no more than 3-year application pendency.— Subject to the limitations under paragraph (2), if the issue of an original patent is delayed due to the failure of the United States Patent and Trademark Office to issue a patent within 3 years after the actual filing date of the application under section 111 (a) in the United States or, in the case of an international application, the date of commencement of the national stage under section 371 in the international application, the term of the patent shall be extended 1 day for each day after the end of that 3-year period until the patent is issued, not including
        (i) any time consumed by continued examination of the application requested by the applicant consumed after continued examination of the application requested by the applicant under section 132 (b);
        (ii) any time consumed by a proceeding under section 135 (a), any time consumed by the imposition of an order under section 181, or any time consumed by appellate review by the Patent Trial and Appeal Board or by a Federal court; or
        (iii) any delay in the processing of the application by the United States Patent and Trademark Office requested by the applicant except as permitted by paragraph (3)(C).,
    the term of the patent shall be extended 1 day for each day after the end of that 3-year period until the patent is issued
    .

    These amendments will become effective upon enactment.

    Likewise, the bill contains (Sec. 9(h)) technical corrections to the following provisions of the AIA:

    35 U.S.C. §102(b)(1)(a):

        (b) Exceptions.—
            (1)
    Disclosures made 1 year or less before the effective filing date of the claimed invention.— A disclosure made 1 year or less before the effective filing date of a claimed invention shall not be prior art to the claimed invention under subsection (a)(1) if—
                (A) the disclosure was made by the inventor or joint inventor or by another the inventor or joint inventor or another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor; or

    35 U.S.C. §115(a):

    (a) Naming the Inventor; Inventor's Oath or Declaration.— An application for patent that is filed under section 111 (a) or commences the national stage under section 371 shall include, or be amended to include, the name of the inventor for any invention claimed in the application. Except as otherwise provided in this section, each individual who is the inventor or a joint inventor of a claimed invention in an application for patent shall execute may be required to execute an oath or declaration in connection with the application.

    35 U.S.C. §119(e)(1):

    (e)(1) An application for patent filed under section 111 (a) or section 363 for an invention disclosed in the manner provided by section 112 (a) (other than the requirement to disclose the best mode) in a provisional application filed under section 111 (b), by an inventor or inventors named that names the inventor or a joint inventor in the provisional application, shall have the same effect, as to such invention, as though filed on the date of the provisional application filed under section 111 (b), if the application for patent filed under section 111 (a) orsection 363 is filed not later than 12 months after the date on which the provisional application was filed and if it contains or is amended to contain a specific reference to the provisional application. No application shall be entitled to the benefit of an earlier filed provisional application under this subsection unless an amendment containing the specific reference to the earlier filed provisional application is submitted at such time during the pendency of the application as required by the Director. The Director may consider the failure to submit such an amendment within that time period as a waiver of any benefit under this subsection. The Director may establish procedures, including the payment of a surcharge, to accept an unintentionally delayed submission of an amendment under this subsection during the pendency of the application.

    35 U.S.C. §120:

    An application for patent for an invention disclosed in the manner provided by section 112 (a) (other than the requirement to disclose the best mode) in an application previously filed in the United States, or as provided by section 363, which names [an] the inventor or a joint inventor in the previously filed application shall have the same effect, as to such invention, as though filed on the date of the prior application, if filed before the patenting or abandonment of or termination of proceedings on the first application or on an application similarly entitled to the benefit of the filing date of the first application and if it contains or is amended to contain a specific reference to the earlier filed application. No application shall be entitled to the benefit of an earlier filed application under this section unless an amendment containing the specific reference to the earlier filed application is submitted at such time during the pendency of the application as required by the Director. The Director may consider the failure to submit such an amendment within that time period as a waiver of any benefit under this section. The Director may establish procedures, including the payment of a surcharge, to accept an unintentionally delayed submission of an amendment under this section.

    35 U.S.C. §291(b):

    (b) Filing Limitation.— An action under this section may be filed only before the end of the 1-year period beginning on the date of the issuance of the first patent containing a claim to the allegedly derived invention and naming an individual alleged to have derived such invention as the inventor or a joint inventor.

    While enactment is almost assured, several of Rep. Goodlatte's co-sponsors have voiced opposition to (or at least skepticism over) at least some of the provisions of the bill.  Thus, there remains significant opportunity to convince our representatives to drop or modify the provisions that have the capacity to do the most harm to patentees and the patent system.

    *Rep. Peter DeFazio (D, OR-4th), Rep. Darrell Issa (R, CA-49th), Rep. Jerrold Nadler (D, NY-10th), Rep. Lamar Smith (R, TX-21st), Rep. Zoe Lofgren (D, CA-19th),  Rep. Steve Chabot (R, OH-1st), Rep. Anna Eshoo (D, CA-18th), Rep. Randy Forbes (R, VA-4th), Mr. Pedro Pierluisi (D, Representative for Puerto Rico), Rep. Jason Chaffetz (R, UT-3rd), Rep. Hakeem Jeffries (D, NY-8th), Rep. Tom Marino (R, PA-10th), Rep. Blake Farenthold (R, TX-27th), Rep. George Holding (R, NC-13th), Rep. Bill Johnson (R, OH-6th), Rep. Jared Huffman (D, CA-2nd), Rep. Mike Honda (D, CA-17th), and Rep. Rick Johnson (D, WA-2nd)

  •         By Sherri Oslick

    Gavel About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases.

    Novartis Pharmaceuticals Corp. et al. v. Roxane Laboratories Inc.
    1:15-cv-00128; filed February 5, 2015 in the District Court of Delaware

    • Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis AG
    • Defendant:  Roxane Laboratories Inc.

    Infringement of U.S. Patent Nos. 5,665,772 ("O-alkylated Rapamycin Derivatives and Their Use, Particularly as Immunosuppressants," issued September 9, 1997), 7,297,703 ("Macrolides," issued November 20, 2007), and 7,741,338 (same title, issued June 22, 2010) following a Paragraph IV certification as part of Roxane's filing of an ANDA to manufacture a generic version of Novartis' Afinitor® (everolimus, used for the treatment of: postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole; adults with progressive neuroendocrine tumors of pancreatic origin that are unresectable, locally advanced or metastatic; adults with advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib; adults with renal angiomyolipoma and tuberous sclerosis complex, not requiring immediate surgery; and pediatric and adult patients with tuberous sclerosis complex who have subependymal giant cell astrocytoma that requires therapeutic intervention but cannot be curatively resected).  View the complaint here.

    Orexo AB v. Actavis Laboratories FL, Inc. et al.
    3:15-cv-00826; filed February 4, 2015 in the District Court of New Jersey

    • Plaintiff:  Orexo AB
    • Defendants:  Actavis Laboratories FL, Inc.; Andrx Corp.; Actavis, Inc.; Actavis Pharma, Inc.

    Infringement of U.S. Patent Nos. 6,759,059 ("Fentanyl Composition for the Treatment of Acute Pain," issued July 6, 2004), 6,761,910 ("Pharmaceutical Composition For The Treatment Of Acute Disorders," issued July 13, 2004), and 7,910,132 (same title, issued March 22, 2011) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Orexo's  Abstral® (fentanyl citrate sublingual tablets, used for the management of breakthrough pain in cancer patients).  View the complaint here.

    Medac Pharma Inc. et al. v. Antares Pharma Inc.
    1:15-cv-00120; filed February 3, 2015 in the District Court of Delaware

    • Plaintiffs:  Medac Pharma Inc.; Medac Gesellschaft Fur Klinische Speziialpraparate GmbH
    • Defendant:  Antares Pharma Inc.

    Declaratory judgment of noninfringement and invalidity of U.S. Patent No. 8,945,063 ("Hazardous Agent Injector System," issued February 3, 2015) based on Medac's manufacture and sale of its Rasuvo® Injector product (methotrexate injection, used to treat certain adults with severe, active rheumatoid arthritis, and children with active polyarticular juvenile idiopathic arthritis (pJIA), after treatment with other medicines including non‑steroidal anti‑inflammatory (NSAIDS) have been used and did not work well and to control the symptoms of severe, resistant, disabling psoriasis in adults when other types of treatment have been used and did not work well).  View the complaint here.

    Teva Pharmaceuticals USA Inc. et al. v. Amneal Pharmaceuticals LLC
    1:15-cv-00124; filed February 3, 2015 in the District Court of Delaware

    • Plaintiffs:  Teva Pharmaceuticals USA Inc.; Teva Pharmaceutical Industries Ltd.; Teva Neuroscience Inc; Yeda Research and Development Co Ltd.
    • Defendant:  Amneal Pharmaceuticals LLC

    Infringement of U.S. Patent Nos. 8,232,250 ("Low Frequency Glatiramer AcetateTherapy," issued July 31, 2012) and 8,399,413 (same title, issued March 19, 2013) following a Paragraph IV certification as part of Amneal's filing of an ANDA to manufacture a generic version of Teva's Copaxone® (glatiramer acetate injection, used for the reduction or frequency of relapses in patients with relapsing-remitting multiple sclerosis).  View the complaint here.

    Cephalon Inc. et al. v. Unimark Remedies Ltd.
    1:15-cv-00117; filed February 2, 2015 in the District Court of Delaware

    • Plaintiffs:  Cephalon Inc.; Teva Sante SAS
    • Defendant:  Unimark Remedies Ltd.

    Infringement of U.S. Patent No. 7,132,570 ("Method for the Production of Crystalline Forms of Optical Enantiomers of Modafinil," issued November 7, 2006) following a Paragraph IV certification as part of Unimark's filing of an ANDA to manufacture a generic version of Cephalon's Nuvigil® (armodafinil, used to improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome, narcolepsy, and shift work sleep disorder).  View the complaint here.

    Cosmo Technologies Ltd. et al. v. Par Pharmaceutical Inc.
    1:15-cv-00116; filed February 2, 2015 in the District Court of Delaware

    • Plaintiffs:  Cosmo Technologies Ltd.; Santarus Inc.
    • Defendant:  Par Pharmaceutical Inc.

    Infringement of U.S. Patent Nos. 7,410,651 ("Controlled Release and Taste Masking Oral Pharmaceutical Composition," issued August 12, 2008), 7,431,943 (same title, issued October 7, 2008), 8,293,273 (same title, issued October 23, 2012), 8,784,888 (same title, issued July 22, 2014), 8,895,064 (same title, issued November 25, 2014), and RE43,799 (same title, issued November 13, 2012) following a Paragraph IV certification as part of Par's filing of an ANDA to manufacture a generic version of Santarus' Uceris® (budesonide, used to treat mildly to moderately active ulcerative colitis).  View the complaint here.

    Sanofi-Aventis U.S. LLC et al. v. Actavis LLC et al.
    3:15-cv-00776; filed February 2, 2015 in the District Court of New Jersey

    • Plaintiffs:  Sanofi-Aventis U.S. LLC; Aventis Pharma S.A.; Sanofi
    • Defendants:  Actavis LLC; Actavis Elizabeth LLC

    Infringement of U.S. Patent Nos. 5,847,170 ("Taxoids, Their Preparation and Pharmaceutical Compositions Containing Them" issued December 8, 1998) and 7,241,907 ("Acetone Solvate of Dimethoxy Docetaxel and its Process of Preparation" issued July 10, 2007) following a Paragraph IV certification as part of Actavis' filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) (for another dosage form) to manufacture a generic version of Sanofi's Jevtana® (cabazitaxel injection, used in combination with prednisone for the treatment of patients with hormonerefractory metastatic prostate cancer previously treated with a docetaxel-containing treatment regimen).  View the complaint here.

    Bayer HealthCare LLC et al. v. Mylan Pharmaceuticals Inc. et al.
    1:15-cv-00114; filed January 30, 2015 in the District Court of Delaware

    • Plaintiffs:  Bayer HealthCare LLC; Bayer HealthCare Pharmaceuticals Inc.; Onyx Pharmaceuticals Inc.
    • Defendants:  Mylan Pharmaceuticals Inc.; Mylan Inc.

    Infringement of U.S. Patent Nos. 8,618,141 ("Aryl Ureas with Angiogenesis Inhibiting Activity," issued December 31, 2013) and 8,877,933 ("Thermodynamically Stable Form of a Toslyate Salt," issued November 4, 2014) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Bayer's Nexavar® (sorafenib tosylate, used to treat certain types of cancer).  View the complaint here.

    Celgene Corp. et al. v. Lannett Holdings, Inc. et al.
    2:15-cv-00697; filed January 30, 2015 in the District Court of New Jersey

    • Plaintiffs:  Celgene Corp.; Children's Medical Center Corp.
    • Defendants:  Lannett Holdings, Inc.; Lannett Co., Inc.

    Infringement of U.S. Patent Nos. 6,045,501 ("Methods for Delivering a Drug to a Patient While Preventing the Exposure of a Foetus or Other Contraindicated Individual to the Drug," issued April 4, 2000), 6,315,720 ("Methods for Delivering a Drug to a Patient While Avoiding the Occurrence of an Adverse Side Effect Known or Suspected of Being Caused by the Drug," issued November 13, 2001), 6,561,976 ("Methods for Delivering a Drug to a Patient While Preventing the Exposure of a Foetus or Other Contraindicated Individual to the Drug," issued May 13, 2003), 6,561,977 ("Methods for Delivering a Drug to a Patient While Restricting Access to the Drug by Patients for Whom the Drug May be Contraindicated," issued May 13, 2003), 6,755,784 (same title, issued June 29, 2004), 6,869,399 (same title, issued March 22, 2005), 7,141,018 (same title, issued November 28, 2006), 7,230,012 ("Pharmaceutical Compositions and Dosage Forms of Thalidomide," issued June 12, 2007), 7,435,745 ("Methods and Compositions for Inhibition of Angiogenesis," issued October 14, 2008), 7,874,984 ("Methods for Delivering a Drug to a Patient While Preventing the Exposure of a Foetus or Other Contraindicated Individual to the Drug," issued January 25, 2011), 7,959,566 ("Methods for Delivering a Drug to a Patient While Restricting Access to the Drug by Patients for Whom the Drug May be Contraindicated," issued June 14, 2011), 8,204,763 ("Methods for Delivering a Drug to a Patient While Preventing the Exposure of a Foetus or Other Contraindicated Individual to the Drug," issued June 19, 2012), 8,315,886 ("Methods for Delivering a Drug to a Patient While Restricting Access to the Drug by Patients for Whom the Drug May be Contraindicated," issued November 20, 2012), 8,589,188 ("Methods for Delivering a Drug to a Patient While Preventing the Exposure of a Foetus or Other Contraindicated Individual to the Drug," issued November 19, 2013), and 8,626,531 ("Methods for Delivering a Drug to a Patient While Restricting Access to the Drug by Patients for Whom the Drug May be Contraindicated," issued January 7, 2014) following a paragraph IV certification as part of Lannett's filing of an ANDA to manufacture a generic version of Celgene's Thalomid® (thalidomide, used to treat multiple myeloma and erythema nodosum leprosum).  View the complaint here.

    Shionogi & Co., Ltd. et al. v. Apotex Corp. et al.
    3:15-cv-00668; filed January 30, 2015 in the District Court of New Jersey

    • Plaintiffs:  Shionogi & Co., Ltd.; Shionogi Inc.
    • Defendants:  Apotex Corp.; Apotex Inc.

    Infringement of U.S. Patent No. 8,247,402 ("Crystal Form of Pyrrolidylthiocarbapenem Derivative," issued August 21, 2012) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Shionogi's Doribax® (doripenem injection, used to treat complicated intra-abdominal infections and complicated urinary tract infections, including pyelonephritis).  View the complaint here.

  • CalendarFebruary 12, 2015 – "USPTO Section 101 Guidelines:  Part 1" (American Intellectual Property Law Association) – 12:30 – 2:15 pm (Eastern)

    February 12, 2015 – "Overcoming Sect. 101 Rejections Post-Alice Corp. — Leveraging USPTO Guidance and Recent Decisions to Meet Sect. 101 Patent Eligibility Requirements" (Strafford) – 1:00 to 2:30 pm (EST)

    February 12, 2015 – "Ex Parte Reexam: New Tactics, Old Tool" (Intellectual Property Owners Association) – 2:00 to 3:00 pm (ET).

    February 19, 2015 - "Readjusting the USPTO 101 Guidance for Life Science Inventions to Alice and Public Input: Are We There Yet?" (American Intellectual Property Law Association) – 12:30 – 2:00 pm (Eastern)

    February 25, 2015 – "Prevailing Before the PTAB 'Death Squad': Practical Considerations for Petitioners and Patent Holders" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

    February 26, 2015 – "Coordinating Post-Grant Patent Opposition in Europe and the U.S. — Navigating Timing, Grounds for Opposition, Discovery, and Amendments to Maximize Protection in Both Jurisdictions" (Strafford) – 1:00 to 2:30 pm (EST)

    March 4-5, 2015 – Medical Device Patents (American Conference Institute) – Chicago, IL

    March 5-6, 2015 – Advanced Patent Law Seminar (Chisum Patent Academy) – Cincinnati, OH

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

  • IPO #2The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Ex Parte Reexam: New Tactics, Old Tool" on February 12, 2015 beginning at 2:00 pm (ET).  Matthew Berkowitzof Kenyon & Kenyon LLP, Mollybeth Kocialski of Oracle Corporation, and Lissi Mojica of Dentons US LLP will analyze the new, post-AIA, role for ex parte reexamination.

    The registration fee for the webinar is $130 (government and academic rates are available upon request).  Those interested in registering for the webinar can do so here.

  • By Kevin E. Noonan

    Goodlatte, BobAs expected by almost everyone (and anticipated by several groups who urged him not to do so; see "Pro-Patent Coalition Writes Letter to the House and Senate Judiciary Committees" and "Big Ten Lobbies Congress to Tread Lightly on "Patent Reform""), Rep. Bob Goodlatte (R, VA-6th), joined by Rep. Peter DeFazio (D, OR-4th), Rep. Darrell Issa (R, CA-49th), Rep. Jerrold Nadler (D, NY-10th), Rep. Lamar Smith (R, TX-21st), Rep. Zoe Lofgren (D, CA-19th),  Rep. Steve Chabot (R, OH-1st), Rep. Anna Eshoo (D, CA-18th), Rep. Randy Forbes (R, VA-4th), Mr. Pedro Pierluisi (D, Representative for Puerto Rico), Rep. Jason Chaffetz (R, UT-3rd), Rep. Hakeem Jeffries (D, NY-8th), Rep. Tom Marino (R, PA-10th), Rep. Blake Farenthold (R, TX-27th), Rep. George Holding (R, NC-13th), Rep. Bill Johnson (R, OH-6th), Rep. Jared Huffman (D, CA-2nd), Rep. Mike Honda (D, CA-17th), and Rep. Rick Johnson (D, WA-2nd) (in other words, a true bipartisan bill) today introduced his "Innovation Act" bill in substantially the same form as in the last Congress (H.R. 3309).  The bill is "bipartisan" for the same reason the Smith-Leahy America Invents Act (the AIA) was bipartisan — it is a bill whose provisions can be spun as being "a jobs bill" or one that "protects American innovation" by members on both sides of the aisle, and is sufficiently arcane that most members of the public will not be overly concerned about it.  Which is too bad, because the evidence is mounting that most of the provisions are unnecessary or could be accomplished by a much more limited bill directed at actual abuses of the patent system.  But if the same lineup of lobbying groups representing industries who need not rely on patents spends about as much money and is opposed by a fractured coterie of industries that actually do depend on patents, then passage is certain in the House, and likely also in the Republican-controlled Senate.  It is also a certainty that the President will sign such a bill; Mr. Obama has shown neither any understanding nor any affection for the patent system that would make him inclined to wield his veto pen.

    The bill addresses two broad areas of the law:  patent litigation and "prosecution," that is some aspects of how the Patent Office has implemented certain provisions of the AIA.  The bill is set out in ten sections:

    Sec. 1. Short title; table of contents.
    Sec. 2. Definitions.
    Sec. 3. Patent infringement actions.
    Sec. 4. Transparency of patent ownership.
    Sec. 5. Customer-suit exception.
    Sec. 6. Procedures and practices to implement recommendations of the Judicial Conference.
    Sec. 7. Small business education, outreach, and information access.
    Sec. 8. Studies on patent transactions, quality, and examination.
    Sec. 9. Improvements and technical corrections to the Leahy-Smith America Invents Act.
    Sec. 10. Effective date.

    Five of these sections are substantive, and the bill also contains mandates for several "studies" on the patent system (similar to the "study" on second opinion genetic diagnostic testing in the AIA that still has not seen the light of day, almost three years after it was due).

    The patent litigation provisions once again focus on the "burden" on (presumably) innocent infringers imposed by being named as a defendant in an infringement suit.  These include heightened pleadings requirements set forth in Sec. 3(A)(1)(a), including that in any infringement action the plaintiff must identify:

    ''(1) An identification of each patent allegedly infringed.
    ''(2) An identification of each claim of each patent identified under paragraph (1) that is allegedly infringed.
    '(3) For each claim identified under paragraph (2), an identification of each accused process, machine, manufacture, or composition of matter (referred to in this section as an 'accused instrumentality') alleged to infringe the claim.
    ''(4) For each accused instrumentality identified under paragraph (3), an identification with particularity, if known, of—
        ''(A) the name or model number of each accused instrumentality; or
        ''(B) if there is no name or model number, a description of each accused instrumentality.
    ''(5) For each accused instrumentality identified under paragraph (3), a clear and concise statement of—
        ''(A) where each element of each claim identified under paragraph (2) is found within the accused instrumentality; and
        ''(B) with detailed specificity, how each limitation of each claim identified under paragraph (2) is met by the accused instrumentality.
    ''(6) For each claim of indirect infringement, a description of the acts of the alleged indirect infringer that contribute to or are inducing the direct infringement.
    ''(7) A description of the authority of the party alleging infringement to assert each patent identified under paragraph (1) and of the grounds for the court's jurisdiction.
    ''(8) A clear and concise description of the principal business, if any, of the party alleging infringement.
    ''(9) A list of each complaint filed, of which the party alleging infringement has knowledge, that asserts or asserted any of the patents identified under paragraph (1).
    ''(10) For each patent identified under paragraph (1), whether a standard-setting body has specifically declared such patent to be essential, potentially essential, or having potential to become essential to that standard-setting body, and whether the United States Government or a foreign government has imposed specific licensing requirements with respect to such patent.

    It will be appreciated that some or much of the facts necessary to fulfill these requirements may not be available prior to discovery, and for at least some of these instances the bill provides (in Sec. 3(A)(1)(b)) that a plaintiff can describe the information generally, with an explanation of why more specific information could not be adduced ("was not readily accessible") despite efforts to do so (wherein the substance of these efforts must also be plead).  Complaints containing confidential information can be filed under seal upon motion, which if denied entitle the party to "seek to file" an amended complaint (Sec. 3(A)(1)(c)).  And, as in the last version of the Innovation Act, ANDA litigation brought under 35 U.S.C. § 271(e)(2) are not subject to these requirements.

    Another litigation-specific part of the bill (Sec. 3(b)(1)(a) et seq.), and the section that was responsible for Sen. Harry Reid (D-NV) refusing to bring the bill to the Senate floor, involves fee-shifting against a "non-prevailing party" "unless the court finds that the position and conduct of the nonprevailing party or parties were reasonably justified in law and fact or that special circumstances (such as severe economic hardship to a named inventor) make an award unjust."  While couched in seemingly innocuous language, Sen. Reid appreciated (purportedly spurred on by the trial lawyers lobby) that these provisions constitute a sea change in the presumptions under U.S. law (this section begins with the phrase "The court shall award [such fees and "other expenses"]. . . ) that parties bear their own costs unless there is evidence that one party acted fraudulently or recklessly in bringing or defending against a lawsuit.  In addition, the bill contains indemnification provisions that may make one co-plaintiff (or, more rarely, co-defendant) liable for such an award in the event that one or more of the parties cannot satisfy the award (Sec. 3(b)(1)(b)).  The bill also discourages a patentee from offering a covenant not to sue as a means to settle infringement litigation, making such an offer an admission that the patentee is the "non-prevailing party" and thus a risk for an award of fees and costs to the accused infringer (Sec. 3(b)(1)(c)).

    Curiously, this section of the bill also contains a provision that Sec. 273 of the Code be amended by striking sections (f) and (g); while this is seemingly not related to the other provisions, it does materially affect the effects of this section on the assertion of the "prior user rights" defense:

    (a) In General.— A person shall be entitled to a defense under section 282 (b) with respect to subject matter consisting of a process, or consisting of a machine, manufacture, or composition of matter used in a manufacturing or other commercial process, that would otherwise infringe a claimed invention being asserted against the person if—
        (1) such person, acting in good faith, commercially used the subject matter in the United States, either in connection with an internal commercial use or an actual arm's length sale or other arm's length commercial transfer of a useful end result of such commercial use; and
        (2) such commercial use occurred at least 1 year before the earlier of either—
            (A) the effective filing date of the claimed invention; or
            (B) the date on which the claimed invention was disclosed to the public in a manner that qualified for the exception from prior art under section 102 (b).

    * * *

    (f) Unreasonable Assertion of Defense.— If the defense under this section is pleaded by a person who is found to infringe the patent and who subsequently fails to demonstrate a reasonable basis for asserting the defense, the court shall find the case exceptional for the purpose of awarding attorney fees under section 285.
    (g) Invalidity.— A patent shall not be deemed to be invalid under section
    102 or 103 solely because a defense is raised or established under this section.

    (in other words, "unreasonable" assertion of the defense is no longer a per se violation that would invoke the "special case" provisions of the statute, and a patent could be deemed invalid under Sec. 102 or Sec. 103 of the statute "solely" because the defense had been plead).

    These provisions are immediately effective upon enactment and apply to any complaint filed "on or after the first day of the 6-month period ending on that effective date."

    This section also contains provisions (Sec. 3(c)) for retroactive joinder, in cases where the non-prevailing party cannot satisfy the fees and expenses award, that would permit a prevailing party to join "an interested party" upon a showing that the non-prevailing party "has no substantial interest in the subject matter at issue other than asserting such patent claim in litigation"; these provisions are clearly directed at patent aggregation entities and other non-practicing entities, although it might be difficult to make the required showing against some NPEs (like universities, for example).  Such joinder has an actual notice requirement and a "get out of jail free" provision, wherein the party to be joined can escape liability by "renounce[ing], in writing and with notice to the court and the parties to the action, any ownership, right, or direct financial interest (as described in paragraph (4)) that the interested party has in the patent or patents at issue."  "Interested parties" are defined in this section of the statute to include assignees, licensees with the right to enforce the patent in suit, or anyone else having a direct financial interest in the patent, but not counsel "if the sole basis for the financial interest of the attorney or law firm in the patent or patents at issue arises from the attorney or law firm's receipt of compensation reasonably related to the provision of the legal representation" (which, while good news does enable a party to argue that the compensation is not reasonable and thus that there is sufficient "financial interest" to justify a court imposing liability on counsel).

    The limits on discovery (Sec. 3(d) et seq.) contained in H.R. 3309 are also contained in this bill, including limitations until after the court has performed claim construction (with provisions for a court to exercise discretion regarding expanding the scope of discovery if necessary for claim construction and under "special circumstances"); this section also exempts from the discovery limitations discovery directed to a motion for a preliminary injunction to avoid "competitive harm" (Sec. 3(d)(1)(b)(4)) or if at least one plaintiff and one defendant stipulate that they wish to be exempt from these limitations.

    The next portion of Section 3 sets forth a "sense of the Congress" that "it is an abuse of the patent system and against public policy for a party to send out purposely evasive demand letters to end users alleging patent infringement" (Sec. 3(e)).  Accordingly, the following part of Section 3 provides that willful infringement cannot be established merely by sending a demand letter, but must include the type of information required in the earlier portions of Section 3 for filing a complaint. (Sec. 3(f) et seq.)

    Section 4 of the bill contains the requirements for "transparency" in patent ownership, wherein a plaintiff must disclose to all adverse parties, the court and the Patent and Trademark Office the assignee(s) of the patents in suit, any licensee empowered to sublicense or enforce the patents, any other entity having a "financial interest" in the patents, and the "ultimate parent entity" of any of the aforesaid parties; this provision seemingly is intended to prevent litigation by proxy, and also contains the exemption for ANDA litigation under 35 U.S.C. § 271(e)(2) found in Section 3 of the bill.  These requirements are on-going (Sec. 4(d)) and "failure to comply" will prevent a successor from recovering fees and expenses under 35 U.S.C. § 285 or increased damages under 35 U.S.C. §284.  These provisions are effective "upon the expiration of the 6-month period beginning on the date of the enactment."

    The bill also contains provisions (in Sec. 5) that permit an infringement action against a "covered customer" to be stayed in favor of an action against the manufacturer of the article sold to the customer upon motion consented to by both customer and manufacturer.

    The remaining Sections of the bill will be discussed in a separate post.

  • Federal Circuit Sides with Patent Office in First IPR Final Written Decision Review

    By Andrew Williams

    Federal Circuit SealEarlier today, the Federal Circuit decided the first appeal from the Patent Trial and Appeal Board ("PTAB" or "Board") related to an inter partes review ("IPR") Final Written Decision.  As we have previously reported, the In re Cuozzo Speed Technologies, LLC. case was the first appeal of the first IPR Final Written Decision for the first IPR ever filed.  As such, the significance of this case rested not only on the how the Court would address the substance of the present case, but on what the Federal Circuit would say regarding some of the more contentious rules promulgated by the Patent Office for these proceedings.  Specifically, the 2-1 decision, which was written by Judge Dyk and joined by Judge Clevenger, affirmed the Board's use of the Broadest Reasonable Interpretation (BRI) standard for claim construction, and agreed with the Office that any aspect of the decision to institute the IPR is not reviewable.  With regard to the substance of the case, the Federal Circuit also affirmed the Board's cancellation of the claims at issue as obvious over the cited art (although not necessarily as specifically cited in the petition).  Judge Newman dissented, in part, because she believed that several rulings of the Court were contrary to the legislative intent behind the creation of the PTAB and IPR proceedings.

    We described the technology at issue in this case in a previous post (see "The First IPR Decision — A Win for the Patent Challenger").  Put simply, the claimed technology is directed to indicating speed limits at particular locations on GPS units.  A GPS receiver is used to track the location of a vehicle, and the speed limit indicator correlates the vehicle's position with a database containing the speed limit for that location.  As the database is accessed, the colored filter adjusts so that speeds above the legal speed are displayed in red, and legal speeds are displayed in white.  Claim 10 reads as follows:

    10.    A speed limit indicator comprising:
        a global positioning system receiver;
        a display controller connected to said global positioning system receiver, wherein said display controller adjusts a colored display in response to signals from said global positioning system receiver to continuously update the delineation of which speed readings are in violation of the speed limit at a vehicle's present location; and
        a speedometer integrally attached to said colored display.

    USPTO SealOne of the first issues resolved by the Court was whether it could even review the Board's decision to institute an IPR proceeding in the first place.  Importantly, the Federal Circuit held that the statute barred such a review, even when the institution is contrary to the requirements outlined by the statute.  In this case, the Board instituted the review on grounds not specifically identified in the petition, even though all of the art the Board cited could found therein.  The Federal Circuit's decision, however, was not so nuanced.  Instead, it went on to state that even if the Board went beyond the statute and instituted an IPR based on a prior public use (which is not permitted by the statute), such an action would not be appealable.  The Court did suggest that mandamus might be available when the Board exceeds its authority, but even that was not certain.  A petitioner would first need to establish that mandamus relief was not barred by the statute, and then it would need to demonstrate a clear and indisputable right to the issuance of a writ, and that the writ was appropriate under the circumstances.  The Court indicated that none of these had been demonstrated in this case.

    The problem with the Court's analysis, however, is that the cited case law related to other Patent Office procedures in which examination of an application takes place.  For example, it cites In re Hiniker Co., 150 F.3d 1362, 1367 (Fed. Cir. 1998), approvingly, even though that case was directed to a reexamination proceeding.  The Court had found that a defect in the decision to institute was cured by the final decision.  Basically, the defective petition was irrelevant because "a proper petition could have been drafted."  First, the petition was only cured in that case because the examiner searched the prior art — something the Board continually reminds stakeholders it will not do in an IPR proceeding.  Judge Newman even pointed out that the Board has consistently claimed that an IPR is not a patent examination, but rather "a trial, adjudicatory in nature [which] constitutes litigation," citing Google Inc. v. Jongerius Panoramic Techs, LLC, IPR2013-00191, Paper No. 50 at 4 (PTAB Feb. 13, 2014).  Moreover, the Court's rationale does not fit the hypothetical of a review instituted on prior public use.  In such a case, a proper petition could not have been drafted — and yet such decision would not have been appealable.

    Of course, the issue that has probably been the most closely watched from this case was whether the adoption of the "broadest reasonable interpretation" by the PTAB was proper.  The Federal Circuit believed that it was.  Nevertheless, as readers of this blog are aware, the use of this standard has been strongly criticized and is generally disfavored by the patent community.  As Judge Newman pointed out in dissent, IPR proceedings before the PTAB were meant to be a surrogate for district court litigations on validity.  She complained that this goal has not been realized because of the use of these two different standards of claim construction.  One of the justifications for the adoption of this standard by the Patent Office has been that a patentee can amend its claims in an IPR proceeding.  As Judge Newman noted, however, the ability to amend claims has been almost entirely illusory.  In over two years, only two sets of claim amendment motions have been granted by Board (see "PTAB Update — The Board Grants Its Second Motion to Amend (At Least in Part)").

    In any event, the Court held that adoption of this standard was consistent with the legislative history, even though its strongest pronouncement was that it "can be inferred that Congress impliedly adopted the existing rule of adopting the broadest reasonable construction."  Judge Newman disagreed with this assessment.  Instead, she pointed to the difference in language used in the various part of the statute — reexaminations, interferences, and reissues refer to the "patentability" of claims, while the IPR statute uses the word "validity."  Certainly, the difference in wording cannot be ignored, because this distinction must be significant.  Finally, the Court also noted that adoption of this standard was within the rulemaking authority of the PTO as established by the statute, and a Chevron analysis dictates deference in this case.  Judge Newman argued that the intention of Congress was clear, albeit the exact opposite of how it was interpreted by the Patent Office and the majority.

    With regard to whether this case contained any significant comments about whether the PTAB is properly handling motions for claim amendments, the holding is fairly limited.  Both the statute and the rules prohibit claim amendments that broaden the scope of the claims.  The Federal Circuit cited cases in the reissue and reexamination context when it clarified that a claim is "broader in scope than the original claims if it contains within its scope any conceivable apparatus or process which would not have infringed the original patent."  Because the proposed claim amendment in this case would have encompassed a new embodiment, the Court affirmed the denial of the motion to amend.

    For anyone practicing before the PTAB looking for a take home lesson, it would probably be that you should not leave any of your cards on the proverbial table.  An unsuccessful challenger or defender of a patent before the PTAB should not look to the Federal Circuit for an easy reversal.  This case makes clear the Federal Circuit's willingness to defer to the PTAB on issues of both substance and procedure.  This result should not be surprising, however, and may be pragmatic, especially in view of the deluge of IPR appeals that the Court is anticipating in the very near future.

    In re Cuozzo Speed Technologies, LLC (Fed. Cir. 2015)
    Panel: Circuit Judges Newman, Clevenger, and Dyk
    Opinion by Circuit Judge Dyk; dissenting opinion by Circuit Judge Newman

  • By Donald Zuhn

    USPTO Building FacadeIn a forum held January 21 on the U.S. Patent and Trademark Office's Alexandria campus, Office representatives discussed the Interim Guidance on Patent Subject Matter Eligibility, which was released in December, and received additional input from the public regarding that guidance.  The forum, which ran almost four and a half hours, began with some opening remarks by Drew Hirshfeld, Deputy Commissioner for Patent Examination Policy at the USPTO, and then Raul Tamayo, Senior Legal Advisor in the Office of Patent Legal Administration at the USPTO, followed Mr. Hirshfeld's presentation with an overview of the Interim Guidance.  The remainder of the forum was devoted to two groups of public presentations — in which the presenters were essentially divided into those on the life sciences side (group one) and those on the hi-tech side (group two) — and an "open participation/question/answer" session, in which attendees were allowed to give statements or ask questions of USPTO representatives participating in the forum.

    Leading off the forum, Mr. Hirshfeld provided a few highlights regarding changes to the Interim Guidance relative to the Myriad/Mayo guidance that was released by the Office in March.  First, he noted that the Interim Guidance "narrows the funnel" in that the new guidance applies only to claims that are directed to (or recite) a judicial exception, as opposed to claims that involve a judicial exception.  Mr. Hirshfeld also noted that the Interim Guidance permits applicants to establish subject matter eligibility using markedly different characteristics other than just structure.  He suggested that by removing the 12-factor test from the Myriad/Mayo guidance, the Office had made the Interim Guidance less complex than the Office's earlier guidance.  Finally, he pointed out that the Office had responded to public feedback, and would be providing more examples, including examples that were not based on actual claims discussed in the case law.  Before turning the lectern over to Mr. Tamayo, Mr. Hirshfeld reminded attendees that the development of the guidance was an iterative process, and that the Office would continue to collect and evaluate comments from the public, and make changes to the guidance where necessary.

    Mr. Tamayo's overview of the Interim Guidance also focused on the changes the Office had made to the subject matter eligibility analyses set forth in the Myriad/Mayo guidance and the Preliminary Examination Instructions released by the Office in June (a copy of Mr. Tamayo's presentation can be obtained here).  By presenting a "comprehensive view" of subject matter eligibility, combining the previously separate analyses for claims reciting abstract ideas (Alice/Bilski) and claims reciting natural products (Myriad/Mayo), Mr. Tamayo suggested that this represented a change in itself.  According to Mr. Tamayo, the best overview of the Interim Guidance was provided by the flowchart in the guidance (click on flowchart to expand):

    2014-12-16 Flowchart
    He noted that the examination procedure set forth in the flowchart relied on the two-step test set forth in Mayo, which the Court then applied in Alice.  Mr. Tamayo explained that there was "nothing new" about the first step in the flowchart (i.e., whether the claim is directed to a statutory class of subject matter), which had "been around for a while."  The second step of the Interim Guidance test, divided on the flowchart into Steps 2A and 2B, set forth the two-step framework of Mayo/Alice.  Mr. Tamayo noted that the examination procedure outlined in the Interim Guidance's flowchart also constituted a change from the Office's prior guidance.

    As Mr. Hirshfeld had discussed earlier, Mr. Tamayo indicated that a further change to the Interim Guidance could be found in Step 2A, which requires an analysis of whether the claim is directed to a judicial exception, as opposed to the Myriad/Mayo guidance which applied to claims that recited or involved a judicial exception.  Mr. Tamayo also indicated that by "directed to," the Office means "sets forth" or "describes."  The Interim Guidance itself states that "[a] claim is directed to a judicial exception when a law of nature, a natural phenomenon, or an abstract idea is recited (i.e., set forth or described) in the claim" (emphasis added), so it would appear that claims involving a judicial exception will be exempt from consideration under the new guidance.  How the Office will distinguish in practice between claims that are directed to, recite, set forth, or describe a judicial exception and those that "merely" involve a judicial exception is not entirely clear.

    With respect to claims directed to nature-based products, Mr. Tamayo noted that such claims "require closer scrutiny," and that in another change in the new guidance, this scrutiny would take place during Step 2A.  In yet another change, Mr. Tamayo noted that nature-based products would be scrutinized using markedly different characteristics other than just structure, which had been the sole focus of the Myriad/Mayo guidance.  He also explained that the Office had looked to Federal Circuit and Supreme Court decisions to compile a non-exhaustive list of the types of characteristics that could be considered in assessing whether there is a marked difference, including biological or pharmacological functions or activities, chemical and physical properties, phenotype, and structure and form (see slide 12 below from Mr. Tamayo's presentation).

    Slide12
    Moving on to Step 2B, Mr. Tamayo indicated that this step addressed the question of whether any limitation (or limitations) in the claim ensured that the claim as a whole amounts to something that is significantly more than the judicial exception itself.  Mr. Tamayo then provided a list of examples of limitations that either qualified or did not qualify as amounting to something that is significantly more than the judicial exception (see slides 15 and 16 below from Mr. Tamayo's presentation).

    Slide15

    Slide16
    Mr. Tamayo concluded his presentation by noting one last change in the new guidance:  a streamlined eligibility analysis, which the Interim Guidance explains "can be used for a claim that may or may not recite a judicial exception but, when viewed as a whole, clearly does not seek to tie up any judicial exception such that others cannot practice it" (see slide 19 below from Mr. Tamayo's presentation).  Whether the streamlined eligibility analysis will play a role in the Office's eligibility analyses, however, remains to be seen.

    Slide19
    Highlights from the public presentations will be provided in subsequent posts.

    For additional information regarding this topic, please see:

    • "USPTO Issues Post-Alice Abstract Idea Examples," January 28, 2015
    • "Impact of Interim Guidance on Business Method and Software Claims," December 17, 2014
    • "USPTO Issues Interim Guidance on Subject Matter Eligibility," December 16, 2014
    • "USPTO to Release Revised Subject Matter Eligibility Guidance," December 15, 2014

  • It seems that Orwell was right: all pigs are equal, but some are more equal than others.

    By Kevin E. Noonan

    The question of how diverse different breeds of domesticated animals may be has begun to be addressed with the completion of many "genome projects" directed towards household animals like dogs and cats.  Pigs are animals that are extremely important economically both historically and today, and that come in many different breeds throughout the world.  This species (Sus scrofu) arose from the common ancestor with wild boars about 1.2 million year ago, and then diverged into European pigs and Chinese pigs.  This was not a speciation event but a population one (similar in its way with the divergence between human races), which in pigs occurred sometime in the Pleistocene and possibly related to the last large glaciation event in the Northern Hemisphere (about 130,000 years ago).  These events were complete long before pigs were domesticated by humans, in both China and the Middle East, about 10,000 years ago.  China has almost one-third of the breeds of pigs in the world (~100 breeds), with there being a recognized difference in phenotype between pigs in the north and south of the country, inter alia, differences in thermoregulatory mechanisms that have adapted these pigs to their different environments.

    Nature GeneticsNow a group led by researchers from Jiangxi Agricultural College* has sequenced genomes of 69 pigs (Sus scrofa) from different parts of China, specifically 15 geographically distinct regions, as reported in Nature Genetics ("Adaptation and possible ancient interspecies introgression in pigs identified by whole-genome sequencing," Nature Genetics (2015) (Published online 26 January 2015)).  These pigs were members of eleven "geographically diverse" breed plus three populations of wild boar, which included the breeds Bamaxiang, Wuzhishan, and Luchuan and southern Chinese wild boars (comprising the southern population); and Erhualian, Hetao, Laiwu, Min, Tibetan (Gansu), Tibetan (Sichuan) Tibetan (Tibet), and Tibetan (Yunnan) breeds and the northern Chinese wild boar (comprising the northern population; although the Tibetan pigs are at similar latitudes as the southern populations their elevation is closer in climate to the northern pigs).

    The types of studies reported by the Jiangxi group have been used (on pigs and other species) to identify "genomic signature of selection" indicative of domestication (wherein both natural selection and artificial (human) selection has been at work).  This work extends that to individuals in distinct populations within a species to identify such signatures related to geographic condition-related adaptations.

    While there were a variety of interesting results to this study, one broad conclusion these authors made is that pigs have adapted to a hot and wet vs. a cold and dry climate that is unique to China in view of its geographic range.

    The statistics of the genomic DNA sequencing from these 69 pigs is as follows:

    • Greater than 25-fold coverage of the pig genomes, 95% genome coverage;
    • About 41 million (40,820,483) SNPs were detected, with 21 million of these that are not in the reference pig genomic database;
    • 26.6 million of these SNPs were intergenic;
    • 188,664 SNPs were exonic;
    • About 500,000 SNPs were intronic (the authors interpret the non-exonic SNPs as indicating that regulatory variants were involved in the observed genetic adaptations);
    • An average of 13.3 million SNPs were detected per individual, with Chinese wild boar showing the highest average (14.5 million); wild boars also had the highest number of population-specific SNPs (767,770);
    • An average of 794 "loss-of-function" mutations in each pig breed but only 3 breed-specific LOF variants, including "a nonsense mutation in the PKD1L3 gene in Laiwu pigs, a splice-site mutation in the IFLTD1 gene in Luchuan pigs and a splice-site mutation in the SKIL gene in Min pigs";
    • 5,663,829 indels (insertion/deletion events) and 44,170 structural variations;
    • 2,000,000 copies of tRNA-derived short interspersed repeat (SINEs) distributed in the chromosomes in such a way that suggested these elements were "an important source of genetic diversity in pigs."

    Pig genes associated with geographically relevant diversity (i.e., differences between "northern" breeds and "southern" breeds) included genes involved in blood coagulation and circulation (TBC1D8, KIF2B, VPS13A, and GNA14); vasculature development (FZD10), neural tube closure (SUFU), cellular chloride ion homeostasis (ABCC2), and hair development (DCAF17).

    Locus-specific branch-length analyses revealed 774 "sweep" regions implicating 219 genes with population-related reductions in heterozygosity and recombination.  These regions comprised on average 51kb on pig autosomes and one large ~14 Mb sweep in the X chromosome.  On the autosomes, the strongest sweep signal from chromosome 15 spanning 300 kb, comprising the locus for the DCAF17 gene.  This region was found to be "nearly devoid of genetic variability" and the hair development gene DCAF17 showed "clear allelic imbalance" between the two pig populations.  This was consistent with the authors' hypothesis that the pig population genomes had adapted to the climate in which the different pig breeds were found in China, and with the observed phenotypes of sparse hair in southern pigs and dense, insulating hair in northern pigs.

    These studies also implicated 219 genes in these sweep regions, and the authors reported finding missense mutations in 10 of these 219 genes.  One particular gene, the VPS13A gene that encodes chorein, was found to have two nonsynonymous substitutions; the significance of this finding is that chorein was recently characterized as a key regulator of the secretion and aggregation of blood platelet and showed "marked" allelic differences between the two populations, with the authors "hypothesiz[ing] that the VPS13A missense mutations might contribute to reducing the risk of thrombosis by modulating platelet counts and blood viscosity in southern Chinese pigs in hot environments."

    Gene Ontology (GO) analysis identified a significant over-representation in these 219 genes of genes involved in biological processes that contribute to the maintenance of thermostatic status during heat or cold stress.  These processes were related to hair cell differentiation (ATOH1, JAG1 and RAC1) and hair follicle maturation (BARX2 and TBC1D); forebrain neuron differentiation (DLX1, DLX2, RAC1, ROBO1 and SALL1); kidney development (BMP4, BMP7, MYC, SALL1, SPRY1 and KLHL3); energy metabolism and blood circulation, including artery development (BMP4, CITED2 and JAG1) and embryonic heart tube development (CITED2, INVS, RYR2, SUFU and TBC1D8), among others.

    Also of interest was the large sweep region (~14 Mb) detected on the X chromosome identified by LSBL analyses as having suppressed heterozygosity/low recombination rate and complete linkage disequilibrium.  This region was found to contain a total of 84,373 LSBL outlier SNPs over the 14 Mb span, with 74,515 SNPs with "extreme differences in allele frequencies" between the northern and southern pig populations.  Interestingly, all northern pigs had the northern pig haplotype, including ones that were otherwise phenotypically diverse.  This sweep region was embedded in a larger region of the X chromosome (48 Mb) that was found to have a low recombination rate.  There was no evidence detected of structural variation (such as one or more inversions that would make meiotic pairing unlikely or impossible and thus suppress recombination frequency) in this region.  The region comprises the X chromosome centromere and reduced GC content, both of which had been associated with reduced recombination in other species.  Unique to the pigs in this study was a greater extent of repeat sequences in this region, specifically enriched for 6 kb poly(T) sequences.  Haplotype analysis showed "three major groups of haplotypes in the 48-Mb region:  one in European pigs (domestic breeds and wild boars) and northern Chinese wild boars; a highly differentiated one in southern Chinese pigs (domestic breeds and wild boars) and a third haplogroup  in northern Chinese domestic pigs, which appeared to be a recombinant between the other two haplogroups."

    The authors concluded that this sweep was caused by natural selection, in part because there was a strong reduction in heterozygosity (10-15 fold reduction in nucleotide variability, compared with two-fold reductions between different Sus species) in this region in both northern and southern pigs, despite the fact that the two groups were themselves highly divergent.  The age of this sweep was determined by these authors to be ~0.13 million years, around the time of the last glaciation event, perhaps reflecting population bottlenecks at that time.

    Another unique finding in this study was evidence for ancient interspecies introgression being involved in the establishment of the sweep, with divergence between the two populations happening ~8.5 million years ago (alternatively the authors hypothesized that two different haplotypes arose in two subpopulations of a species ancestral to S. scrofa).  As explained in the report:

    "To explore the introgression hypothesis, we further analyzed whole-genome sequence data for one  Phacochoerus species (African warthog; P. africanus) and four Sus species, including bearded pig (Sus barbatus), Celebes warty pig (Sus celebensis), Java warty pig (Sus verrucosus) and Visayan warty pig (Sus cebifrons)," finding the northern haplotype to be distinct from all other Sus haplotypes, and that further analysis suggested that "the northern haplotype was likely introgressed from a (possibly) extinct Sus species and may have spread through the northern Chinese population as well as the European pig population, before the split with wild boars ~1.2 million years ago."

    Alternatively this haplotype:

    [M]ight have been caused by gene flow between wild boars of northern China and Europe during the Pleistocene era after their divergence, a hypothesis supported by an excess of derived similarity between European and northern Chinese wild boars on the autosomes as reported previously.

    The authors assert that this is the first report showing genetic adaptation to local climate conditions, and that "the adaptive haplotype in the northern Chinese populations was likely introduced from another divergent Sus species, providing the first evidence, to our knowledge, that inter-species introgression has driven adaptation in a mammal."  They also acknowledged their good fortune by noting that "[i]f the introgressed segment had not fallen in a region with such a strong reduction in recombination rate, we would likely never have detected the signal of introgression as introgression fragments in other systems degenerate quickly, owing to recombination."

    * The researchers were from Key Laboratory for Animal Biotechnology of Jiangxi Province and the Ministry of Agriculture of China, Jiangxi Agricultural University, Nanchang, China; GI-Tech, BGI-Shenzhen, Shenzhen, China; Department of Integrative Biology, University of California, Berkeley, Berkeley, California, USA.