• New York #2American Conference Institute (ACI) will be holding the next session of its FDA Boot Camp conference on March 10-11, 2015 in New York, NY.  ACI faculty will help attendees:

    • Master the basics of the application and approval processes for drugs, biologics, and devices;
    • Comprehend the structure of the FDA and the roles of the three major agency centers:  CDER, CBER, and CDHR;
    • Develop a practical working knowledge of clinical trials for drugs and biologics and the clearance process for devices;
    • Learn how devices are classified, monitored, and regulated;
    • Appreciate the complexities of pharmaceutical IP and the regulatory balance between brand name and generic products;
    • Recognize the pivotal role of labeling in the drug and biologics approval process;
    • See the importance of cGMPs to the post-approval regulatory process; and
    • Navigate the protocols of adverse events monitoring, signal detection, product withdrawals, and recalls.

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

    • Brief Overview of FDA Practice
    • The Nature of the Approval Process
    • Understanding the Clinical Trial Process for Drugs and Biologics
    • Drugs and Biologics: Labeling
    • Patent and IP Overview for Drugs and Biologics: Understanding The Connection Between FDA Regulation and IP and Related Mechanisms Under Hatch-Waxman and BPCIA
    • Part 1 — Patents, Trademarks and Other IP Protections and Mechanisms
    • Part 2 — Hatch-Waxman and BPCIA Overview
    • The Drug Supply Chain Security Act — Summarizing the Act and Its Effect on FDA Practice
    • cGMPs: Drugs and Biologics (Current Good Manufacturing Practices)
    • Medical Devices: Classifications, the Essentials of the Premarket Review Process, and Post-Market Requirements and Concerns
    • Using FDA's Citizen Petition Process and Litigation to Achieve Market Success
    • How to Respond to FDA: Best Practices, Tips, Tricks, and Pitfalls to Avoid
    • Adverse Events Monitoring, Pharmacovigilance and Risk Management, and Recalls

    A pre-conference workshop on the "Fundamentals of FDA Regulatory Law" and "Resolving Ethical Challenges Encountered During the Drug Approval Process" will be offered on March 9, 2015 from 1:00 to 5:00 pm.  Two post-conference master classes will be offered on March 11, 2015.  The first master class is entitled "Hatch-Waxman and BPCIA: Overview of Biosimilars and Life Cycle Planning for Drugs and Biologics,"  and the second master class is entitled "Post-Approval Marketing Guidance and Preemption Protocols."

    An agenda for the conference can be found here, and additional information regarding the workshop and master classes 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.

    ACI - American Conference InstituteThe registration fee is $2,295 (conference alone), $2,895 (conference and workshop or conference or one master class), or $3,495 (conference, workshop, and one master class).  Those interested in registering for the conference can do so here, by e-mailing CustomerService@AmericanConference.com, by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.

    Patent Docs is a media partner of ACI's FDA Boot Camp conference.

  • D Young & CoD Young & Co will be offering its next European biotech patent law update on February 25, 2015.  The 45-minute webinar will be offered at three times: 3:00 am, 6:00 am, and 11:00 am (ET).  D Young & Co European Patent Attorney Simon O'Brien will provide an essential update and live Q&A on EPO biotechnology case law.

    While there is no fee to participate, attendees must register in advance.  Those wishing to register can do so here.

  • JMLSThe John Marshall Law School Center for Intellectual Property Law will be holding its 59th Annual Intellectual Property Law Conference on February 27, 2015 in Chicago, IL.  The conference will consist of the following sessions:

    • Recent Developments in Intellectual Property Law
    • Keynote speaker — Lisa K. Jorgenson, Executive Director, American Intellectual Property Law Association

    The conference's afternoon patent track will consist of sessions on:

    • Creative Use of Jury Research in Patent Cases
    • Drafting Successful Applications for Life Science and Business Method Patents
    • Patent Damages
    • Strategies in Post-Grant Proceedings for Biotech/Pharma and Financial Services

    Additional information about the conference, including a complete list of speakers, can be found here.  Those interested in registering for the conference online can do so here; the registration fee is $195 (general rate), $95 (government, judicial, and academic rate), or free (JMLS students).

  • Strafford #1Strafford will be offering a webinar/teleconference entitled "Structuring Patent Indemnification Provisions After the AIA — Allocating Infringement Risk While Accounting for AIA Changes to PTAB Estoppel and Statutory Bar Requirements" on February 19, 2015 from 1:00 to 2:30 pm (EST).  C. Andrew Keisner of Davis & Gilbert and Robert E. Krebs of Nixon Peabody will prepare counsel to IP owners, licensees and licensors to protect their interests by allocating patent infringement risks during negotiations of indemnification provisions in a patent license or vendor contract, and examine the impact of the AIA on indemnification and discuss indemnity issues in litigation.  The webinar will review the following questions:

    • How has the AIA impacted indemnity and how should patent counsel account for the changes when structuring indemnification provisions?
    • When does an indemnification clause create privity under the IPR statutes?
    • What approaches should counsel use to protect a client's interests when negotiating an indemnification provision?

    The registration fee for the webinar is $297 ($362 for registration and CLE processing).  Those interested in registering for the webinar, can do so here.

  • 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.