• By Sherri Oslick —

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

    Alkermes Pharma Ireland Ltd. et al. v. Torrent Pharmaceuticals Ltd. et al.
    1:11-cv-01009; filed October 21, 2011 in the District Court of Delaware

    • Plaintiffs:  Alkermes Pharma Ireland Ltd.; Jazz Pharmaceuticals Inc.
    • Defendants:  Torrent Pharmaceuticals Ltd.; Torrent Pharma Inc.

    Infringement of U.S. Patent No. 7,456,462 ("Multiparticulate Controlled Release Selective Serotonin Reuptake Inhibitor Formulations," issued December 16, 2008), licensed to Jazz Pharmaceuticals, following a Paragraph IV certification as part of Torrent's filing of an ANDA to manufacture a generic version of Jazz's Luvox® CR (fluvoxamine maleate, used to treat social anxiety disorder and obsessive compulsive disorder).  View the complaint here.


    Fred Hutchinson Cancer Research Center et al. v. Branhaven, LLC

    3:11-cv-00710; filed October 21, 2011 in the Eastern District of Virginia

    • Plaintiffs:  Fred Hutchinson Cancer Research Center; Argus Genetics, LLC; Mars, Inc.
    • Defendant:  Branhaven, LLC; Scidera, INC.; Scidera Canine, LLC

    Infringement of U.S. Patent No. 7,729,863 ("Methods and Materials for Canine Breed Identification," issued June 1, 2010) based on defendants' use, sale, and offers to sell its dog breed identification services (Canine Heritage XL Breed Test).  View the complaint here.


    Janssen Pharmaceuticals, Inc. v. Sun Pharma Global FZE et al.

    2:11-cv-06089; filed October 17, 2011 in the District Court of New Jersey

    • Plaintiff:  Janssen Pharmaceuticals, Inc.
    • Defendants:  Sun Pharma Global FZE; Sun Pharmaceutical Industries, Inc.

    Infringement of U.S. Patent No. 6,214,815 ("Triphasic Oral Contraceptive," issued April 10, 2001) following a Paragraph IV certification as part of Sun's filing of an ANDA to manufacture a generic version of Ortho-McNeil's Ortho Tri-Cyclen® Lo (norgestimate and ethinyl estradiol, used for oral contraception).  View the complaint here.


    Novo Nordisk Inc. et al. v. Sandoz Inc.

    3:11-cv-06106; filed October 14, 2011 in the District Court of New Jersey

    • Plaintiffs:  Novo Nordisk Inc.; Novo Nordisk A/S
    • Defendant:  Sandoz Inc.

    Infringement of U.S. Patent No. 6,677,358 ("NIDDM Regimen," issued January 13, 2004) following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of Novo Nordisk's Prandin® (repaglinide, used to treat non-insulin dependent diabetes mellitus in combination with metformin).  View the complaint here.


    Alcon Pharmaceuticals, Ltd. vs. Perrigo Co.

    4:11-cv-00732; filed October 14, 2011 in the Northern District of Texas

    • Plaintiff:  Alcon Pharmaceuticals, Ltd.
    • Defendants:  Perrigo Co; Perrigo Israel Pharmaceuticals Ltd.

    Infringement of U.S. Patent No. 7,977,376 ("Olopatadine Formulations for Topical Nasal Administration," issued July 12, 2011) following a Paragraph IV certification as part of Perrigo's filing of an ANDA to manufacture a generic version of Alcon's Patanase® (olopatadine hydrochloride, used to treat seasonal allergic rhinitis).  View the complaint here.


    Noven Pharmaceuticals, Inc. v. Watson Laboratories, Inc. et al.

    2:11-cv-05997; filed October 13, 2011 in the District Court of New Jersey

    • Plaintiff:  Noven Pharmaceuticals, Inc.
    • Defendants:  Watson Laboratories, Inc.; Watson Pharmaceuticals, Inc.

    Infringement of U.S. Patent Nos. 6,210,705 ("Compositions and Methods For Treatment of Attention Deficit Disorder and Attention Deficit/Hyperactivity Disorder With Methylphenidate," issued April 3, 2001) and 6,348,211 (same title, issued February 19, 2002) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of Noven's Daytrana® (transdermal methylphenidate delivery system, used to treat attention deficit disorder and attention deficit/hyperactivity disorder).  View the complaint here.


    Schering Corp. et al. v. Actavis Inc. et al.

    2:11-cv-06067; filed October 13, 2011 in the District Court of New Jersey

    • Plaintiffs:  Schering Corp.; MSP Singapore Company LLC
    • Defendants:  Actavis Inc.; Actavis Group HF

    Infringement of U.S. Patent Nos. RE42,461 ("Hydroxy-Substituted Azetidinone Compounds Useful as Hypocholesterolemic Agents," issued June 14, 2011) and 5,846,966 ("Combinations of Hydroxy-Aubstituted Azetidinone Compounds and HMG CoA Reductase Inhibitors," issued December 8, 1998), both licensed to MSP, following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of MSP's Vytorin® (ezetimibe and simvastatin, used to treat hyperlipidemia).  View the complaint here.


    Warner Chilcott Co., LLC et al. v. Watson Pharmaceuticals, Inc. et al.

    2:11-cv-05989; filed October 12, 2011 in the District Court of New Jersey

    • Plaintiffs:  Warner Chilcott Co., LLC; Warner Chilcott (US), LLC
    • Defendants:  Watson Pharmaceuticals, Inc.; Watson Laboratories, Inc. – Florida; Watson Pharma, Inc.

    Infringement of U.S. Patent Nos. 7,645,459 ("Dosage Forms of Bisphosphonates," issued January 12, 2010) and 7,645,460 ("Dosage Forms of Risedronate" issued January 12, 2010) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of Warner Chilcott's Atelvia (risedronate sodium delayed-release, used to treat osteoporosis in women after menopause).  View the complaint here.

  • Calendar

    October 31, 2011 – Leahy-Smith America Invents Act (U.S. Patent and Trademark Office) – 1:00 pm (EDT)

    November 1, 2011 – Patent Reform: Advanced Prior Art under the AIA (Intellectual Property Owners Association) – 2:00 – 3:00 PM (ET)

    November 2-4, 2011 – Intellectual Property Counsels Committee (IPCC) Fall Conference & Meeting (Biotechnology Industry Organization) – New York, NY

    November 2-4, 2011 – Biotechnology from the Ground Up (Management Forum and JNB Marketing & Events) – San Diego, CA

    November 4, 2011 – Patent Law Symposium 2011 (Intellectual Property Law Association of Chicago) – Chicago, IL

    November 9, 2011 – Optimizing Relations with the USPTO: All the Questions You Always Wanted to Ask and Could Never Get Answers For (Association of Intellectual Property Firms) – 12:30 – 1:30 PM (EST)

    November 15, 2011 – Patent Reform: First to File Provisions (Strafford) – 1:00 – 2:30 PM (EST)

    November 17, 2011 – The America Invents Act: Key Facts You Need To Know Now About Provisions that Are Already Law (American Bar Association) – 1:00 – 2:30 pm (Eastern)

    November 18, 2011 – The US Patent Reform Congress (IBC Legal Conferences) – London, UK

    November 30 to December 1, 2011 – Advanced Forum on Biotech Patents*** (American Conference Institute) – Boston, MA

    December 1, 2011 – Biotechnology/Chemical/ Pharmaceutical (BCP) Customer Partnership Meeting (U.S. Patent and Trademark Office) – 9:00 am – 5:15 pm

    December 5-7, 2011 – Drug and Medical Device Litigation*** (American Conference Institute) – New York, NY

    December 6-7, 2011 – Paragraph IV Disputes*** (American Conference Institute) – San Francisco, CA

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

  • USPTO SealThe U.S. Patent and Trademark Office will be hosting a free public webinar on the Leahy-Smith America Invents Act on October 31, 2011 at 1:00 pm (EDT).  The panel for the webinar will include David Kappos, USPTO Director; Teresa Stanek Rea, USPTO Deputy Director; Robert L. Stoll, Commissioner for Patents; Bernard Knight, USPTO General Counsel; and James D. Smith, BPAI Chief Administrative Patent Judge, who will outline the agency's implementation plans and answer a selection of questions submitted during the session.  Questions should be submitted in advance to aia_townhallquestions@uspto.gov.  The webinar can be accessed here.  Participants should enter their name and e-mail address, if prompted.  If a password is required, participants should enter the meeting password: 123456 and click "Join."  Additional information regarding the webinar, including phone numbers for participating in the audio conference only, can be found here.

  • USPTO Building FacadeThe U.S. Patent and Trademark Office has announced the agenda for the next biotechnology/chemical/ pharmaceutical (BCP) customer partnership meeting to be held on December 1, 2011.  The proposed agenda is as follows:

    Morning Session

    • Meet & Greet and Opening Remarks (9:00 – 9:45 am EDT):  Jackie Stone, George Elliott, and Remy Yucel, Directors, Technology Center 1600

    • Patent Reform Legislation (AIA) (9:45 – 11:15 am):  Janet Gongola, Patent Reform Coordinator

    • Break (11:15 – 11:30 am)

    • Track I Briefing (11:30 am – 12:30 pm):  Krista Zele, SPE, Art Unit 2453

    • Lunch (12:30 – 1:30 pm)

    Afternoon Session

    • Professional Responsibility for IP Practitioners (1:30 – 2:30 pm):  William Covey, Office of Enrollment and Discipline

    • Break (2:30 – 3:00 pm)

    • TC1600 35 U.S.C. § 112 Supplemental Guideline Training (3:00 – 4:00 pm):  Bennett Celsa, QAS, TC1600

    • Therasense and Duty of Candor (4:00 – 5:00 pm):  Hans Sauer, Associate General Counsel for Intellectual Property

    • Closing Remarks/Discussion (5:00 – 5:15 pm):  Jackie Stone, George Elliott, and Remy Yucel, Directors, Technology Center 1600

    The meeting can be attended in person at the USPTO's Madison Auditorium, 600 Dulany Street, Alexandria, VA, or viewed online here (select the "enter as guest" option).  The Patent Office asks that non-USPTO employees login using their e-mail addresses.  Those wishing to attend the meeting should contact Cecilia Tsang by phone at 571-272-0562, by fax at 571-273-0562, or by e-mail at Cecilia.Tsang@uspto.gov by November 25, 2011 to confirm their attendance.  Additional information regarding the BCP customer partnership meeting can be found here.

  • ABAThe American Bar Association (ABA) Section of Intellectual Property Law, Section of Intellectual Property Law Young Lawyers Action Group, and Center for Continuing Legal Education will be offering a live webinar entitled "The America Invents Act: Key Facts You Need To Know Now About Provisions that Are Already Law" on November 17, 2011 from 1:00 – 2:30 PM (Eastern).  David Postolski of the Innovation Division of Cantor Fitzgerald, LP (moderator), Orion Armon of Cooley LLP, Ann N. Cathcart Chaplin of Fish & Richardson, and Christa Zado of Cisco Systems, Inc. (representing the Coalition for Patent Fairness), will offer in-depth analysis of the AIA provisions that became effective, including:

    • Prior user rights;
    • Joinder limitations;
    • USPTO fee increases;
    • Tax strategies within prior art;
    • Best mode changes;
    • Virtual marking;
    • False marking litigation restrictions;
    • New standards for petitioning for inter partes reexamination; and
    • New best mode requirements.

    In particular, the panelists will provide in-depth explanation regarding each change in the law and how the changes affect the planning, strategy, and budgets of patent owners, applicants and litigants, with a special emphasis placed on how these provisions impact litigation proceedings.

    The registration fee for the webcast is $95 for members of any of the sections sponsoring the webinar, $99 for government attorneys, $150 for ABA members, and $195 for the general public (for group fee options, please visit the event website).  Those interested in registering for the webinar, can do so here or by calling 800-285-2221.

  • By Kevin E. Noonan —

    President Signs HR1249_cropAnother significant change effected by the Leahy-Smith America Invents Act relates to the power of an assignee, or someone who has obligated an inventor to assign, to file an application without obtaining an oath or declaration (or even permission or knowledge) of the inventor, raising an interesting Constitutional question as discussed below.

    This change is effected by Section 4 of the Act, which amends 35 U.S.C. § 115.  As in the current version of § 115, new § 115(a) provides that an application requires the name of the inventor or inventors and an oath or declaration stating that the application was made (or was authorized to be made) by the affiant/declarant, and that the individual believes himself/herself to be the original sole or joint inventor of the claimed invention (§ 115(b)).  In the first of several delegations of authority from the statute to the Director, § 115(c) gives the Director the right to "specify additional information relating to the inventor and the invention that is required to be included in an oath or declaration."

    It is in new § 115(d) that the effects of the changes begin to become evident.  Section 115(d)(1) provides that an assignee ("the applicant") can file an application in the name of an inventor who is deceased, "under legal incapacity" or "cannot be found after diligent effort" (Section 115(d)(2)(A)), or who is "under an obligation to assign" but has refused to do so (Section 115(d)(2)(B)).  The substitute statement under these circumstances must contain the identification of the individual, "set forth the circumstances representing the permitted basis for the filing of the substitute statement in lieu of the oath or declaration" and (again) "any additional information, including any showing, required by the Director (Section 115(d)(3)).

    New § 115(e) permits the "required statements" of §§ 115(b) and (c) to be included in the assignment document, and new § 115(f) prohibits the Director from issuing a Notice of Allowance unless there has been submitted "each required oath or declaration under subsection (a) or has filed a substitute statement under subsection (d) or recorded an assignment meeting the requirements of subsection (e)."  This language suggests that the assignment document might be substituted for the oath/declaration to satisfy the requirements under circumstances other than those where the inventor is unable, unavailable, or unwilling to sign (provided the assignment document is signed).  Since assignment documents are traditionally not constrained by the limitations of oaths or declarations (i.e., that neither the application nor the oath/declaration can be altered after the oath/declaration is signed), there is at least the possibility (particularly in view of the latitude given the Director) for assignments to be accepted under circumstances where an inventor (or, more likely, a co-inventor) is unaware that an application has been filed.  Similar possibilities exist for later-filed applications (continuations, divisionals, or continuations-in-part), since new § 115(g) provides that a new oath/declaration need not be filed if in the earlier application an oath/declaration pursuant to new § 115(a) (according to § 115(g)(1)(A)), a substitute statement under new § 115(d) (according to § 115(g)(1)(B)),  or an assignment under new § 115(e) (according to § 115(g)(1)(C)) has been filed, although the Director is empowered to require that the "applicant" file a copy of such documents (§ 115(g)(2)).

    New § 115(h)(1) further provides that "[a]ny person making a statement required under this section may withdraw, replace or otherwise correct the statement at any time" pursuant to regulations established by the Director "under which any such additional statements shall be filed."  In addition, "the Director may not  . . . require that any individual [] make any additional oath, declaration or other statement" once that individual has fulfilled the requirements of §§ 115(a) or (e) (i.e., the assignment shall be sufficient under this section) (§ 115(h)(2)).  This part of the statute also has an express "savings clause" (§ 115(h)(3) permitting any irregularities in the oath or declaration to be cured by such "corrective statements."  New § 115(i) contains the provision that "any willful false statement made in such declaration or statement is punishable under section 1001 of title 18 by fine or imprisonment of not more than 5 years, or both."

    In addition to certain conforming amendments under Section 4(b)(1), the Act amends current 35 U.S.C. § 118 (filing by other than inventor) as follows:

    A person to whom the inventor has assigned or is under an obligation to assign the invention may make an application for patent.  A person who otherwise shows sufficient proprietary interest in the matter may make an application for patent on behalf of and as agent for the inventor on proof of the pertinent facts and a showing that such action is appropriate to preserve the rights of the parties.  If the Director grants a patent on an application filed under this section by a person other than the inventor, the patent shall be granted to the real party in interest and upon such notice to the inventor as the Director considers to be sufficient.

    Section 4(b)(2) amends 35 U.S.C. § 251 to permit the applicant (assignee) to file a reissue application (and presumably sign the oath/declaration attesting that the patent for reissue is defective).

    In keeping with the reflection of the statute-writing process, Section 4(c) revises 35 U.S.C. § 112 to replace paragraph designations with subsections; thus, § 112, 1st paragraph, is changed to § 112(a), § 112, 2nd paragraph, is changed to § 112(b), etc.  There is no indication why this change has been included in the bill.  Section 4(d) contains conforming amendments to §§ 111(b)(1)(A) and (b)(2) to reflect these amendments to § 112.

    The effective date of these provisions is "1 year after the date of the enactment of this Act [i.e., September 16, 2012] and shall apply to patent applications that are filed on or after that effective date" under Section 4(e).

    For additional information regarding this topic, please see:

    • "AIA Overview: Supplemental Examination," October 26, 2011
    • "AIA Overview: Changes to Provisions Relating to Third Party Submissions of Prior Art," October 24, 2011
    • "AIA Overview: Changes to Inter Partes Re-examination," October 23, 2011
    • "AIA Overview: Post-grant Review Provisions," October 20, 2011
    • "AIA Overview: Prior User Rights Defense," October 19, 2011
    • "AIA Overview: First-Inventor-to-File Provisions," October 11, 2011
    • "USPTO Seeking Comment on AIA Mandated Studies," October 10, 2011
    • "USPTO Implements AIA Changes to Inter Partes Reexamination," September 28, 2011
    • "USPTO Implements Prioritized Examination Track under AIA," September 26, 2011
    • "President Signs AIA into Law; USPTO Begins Implementation of Act," September 20, 2011

  • By Donald Zuhn —

    NVCALast week, the National Venture Capital Association (NVCA), a trade association representing the U.S. venture capital industry, released the results of its MoneyTree Report on venture funding for the third quarter of 2011.  The NVCA quarterly study, which the group conducts with PriceWaterhouseCoopers using data from Thomson Reuters, indicates that venture capitalists invested $6.95 billion in 876 deals during the third quarter, which constituted a 12% decrease in dollars and a 14% decrease in deals as compared with the second quarter of 2011 when $7.9 billion was invested in 1,015 deals (the NVCA revised its second quarter numbers, adding $400 million in funding and 49 deals to the totals for the last quarter).  Although venture funding and the number of deals dropped in the third quarter, the NVCA noted that the totals for the first three quarters of 2011 ($21.2 billion invested in 2,725 deals) represented a 20% increase in dollars and a 3% increase in deals over the first three quarters of 2010.

    Dollars Invested
    The Life Sciences sector (biotechnology and medical devices) saw an 18% decrease in dollars and a 21% decrease in deals in the third quarter — the sector's worst showing since the first quarter of 2005.  The biotech industry alone received $1.1 billion via 96 deals, which marked an 18% decrease in dollars and a 20% decrease in deals as compared to the second quarter of 2011.  In terms of dollars invested, the biotechnology industry placed second (to the software industry, which collected $2.0 billion for its best quarter since the fourth quarter of 2001) among the industries tracked by the NVCA.  The Life Sciences sector was not alone, as the NVCA report noted that of the seventeen sectors its tracks, fourteen experienced decreases in dollars invested in the third quarter.

    Dollars by Sector Tracy Lefteroff, the global managing partner of the venture capital practice at PwC US noted that "[c]hallenges in the regulatory environment for Life Sciences companies are prompting VCs to look to other industries to put their money to work for a faster return on their investment," and as a result, "over the past two quarters, we've seen a clear shift in Life Sciences investments from Seed/Early Stage companies over to more Later Stage companies."  While "VCs are continuing to support the companies in their pipeline," Ms. Lefteroff noted that they "appear to be curbing their investments in new Life Sciences companies."  NVCA president Mark Heesen, stated that "[p]ublic policy challenges in the life sciences and clean technology sectors are impacting investment levels this quarter as is the IPO market that basically came to a screeching halt in August."  Noting that "[v]enture fundraising levels are the lowest they have been in nearly a decade," Mr. Heesen suggested that "it is reasonable to expect investment levels to decline in the coming years."

    For additional information regarding this and other related topics, please see:

    • "Life Sciences Venture Funding up 37% in Second Quarter," August 1, 2011
    • "VentureSource Reports 35% Increase in 1Q Venture Funding," April 26, 2011
    • "NVCA Reports Modest Gains in First Quarter Venture Funding," April 19, 2011

    • "NVCA Reports 31% Drop in Venture Funding for Third Quarter," October 17, 2010

    • "NVCA Reports 34% Increase in Venture Funding for Second Quarter," July 22, 2010

    • "NVCA Report Shows First Quarter Drop in Venture Funding," April 20, 2010

    • "Biotech/Pharma Financing Improving, R&D Spending Up," August 31, 2009
    • "NVCA Study Shows Increase in Third Quarter Venture Funding," October 23, 2009

    • "First Quarter Venture Capital Funding at 12-Year Low," April 23, 2009

    • "NVCA Study Shows Decline in 2008 Investment; BIO Study Predicts Biotech Rebound in 2009," February 16, 2009

    • "NVCA Predicts Another Slow Year for Venture-backed Businesses in 2009," December 18, 2008

  • By Kevin E. Noonan —

    President Signs HR1249_cropOne provision in the Leahy-Smith America Invents Act (AIA) that appears to benefit (or at least be intended to benefit) patentees is the Supplemental Examination revision set forth in Section 12.

    This section revises 35 U.S.C. § 257 to include a new "Request for Supplemental Examination" that is limited to filings by the patent owner (§ 257(a)).  The Request permits the patentee to "consider, reconsider, or correct information believed [by the patent owner] to be relevant to the patent," by far the most extensive grounds for Patent Office reconsideration of all the avenues of reconsideration in the statute (ex parte reexamination, inter partes review, or post-grant review).  The statute provides that the supplemental examination must be considered by the Office within three months of filing the request, and be concluded by issuance of a certificate indicating "whether the information presented in the request raises a substantial new question of patentability" (SQP).  If the Director's determines that a SQP exists, then the Director will order reexamination (§ 257(b)).

    Re-examination is conducted pursuant to current ex parte re-examination practice (save the provisions of 35 U.S.C. § 304), i.e., by the examining corps and the Director "shall consider" each SQP raised in the request, "notwithstanding the limitations in chapter 30 relating to patents and printed publication or any other provision of such chapter [30]" (§ 257(b)).  The benefits of this supplemental examination are set forth in § 257(c), wherein a patent "shall not be held to be unenforceable" bsed on any information "that had not been considered, was inadequately considered, or was incorrect in a prior examination of the patent" that was considered by the Office during supplemental examination.  Moreover, the statute provides that either making or failing to make a request "shall not be relevant to enforceability of the patent under section 282" (§ 257(c)(1)).

    The statute provides several exceptions to this particular form of absolution, including that the benefits of filing a supplemental examination request "shall not apply to an allegation pled with particularity in a civil action" or to an allegation contained in a Paragraph 4 notice received by the patentee under the provisions of the Hatch-Waxman Act (§ 505(j)(2)(B)(iv)(II) of the Federal Food, Drug, and Cosmetic Act, codified at 21 U.S.C. § 355(j)(2)(B)(iv)(II)) before the filing of the supplemental examination request (§ 257(c)(2)(A)).  In addition, the protections afforded by § 257(c)(1) "shall not apply" to any section 337(a) action under the Tariff Act of 1930 or a civil action for patent infringement under 35 U.S.C. § 281 "unless the supplemental examination, and any reexamination ordered pursuant to the request, are concluded before the date on which the action is brought," thus preventing a patentee to attempt to inoculate itself from an inequitable conduct allegation after litigation has ensued (§ 257(c)(2)(B)).

    A significant limitation to the protections afforded by § 257(c)(1) is set forth in § 257(e), which excludes instances of "material fraud" from the provisions of § 257(c)(1).  If "material fraud" is found, the Director is empowered to take any action otherwise authorized (including cancelling a claim or claims under 35 U.S.C. § 307) and in addition is directed ("shall") to "refer the matter to the Attorney General for such further action as the Attorney General may deem appropriate" (although such referral "shall be treated as confidential, shall not be included in the file of the patent, and shall not be disclosed to the public unless the United States charges a person with a criminal offense in connection with such referral").  In this regard the statute "preclude[s] the imposition of sanctions based upon criminal or antitrust laws" (§ 257(f)(1)) or "to limit the authority of the Director to investigate issues of possible misconduct and impose sanctions for misconduct in connection with matters or proceedings before the Office" (§ 257(f)(2)).

    Fees and regulations are to be set by the Director ((§ 257(d)), with the express provision that the Office is entitled to collect fees associated with ex parte reexamination in addition to supplemental examination fees if reexamination is ordered pursuant to § 257(b).

    Section 12(c) of the AIA provides that the effective date of these provisions is "upon the expiration of the 1-year period beginning on the date of the enactment of this Act" (September 16, 2012) "and shall apply to any patent issued before, on, or after that effective date."

  • By Donald Zuhn —

    USPTO SealYesterday, the U.S. Patent and Trademark Office and European Patent Office announced the launch of a new website regarding the Cooperative Patent Classification (CPC) initiative.  The CPC project seeks to combine the best classification practices of both the U.S. and European systems with the aim of developing a joint IPC based classification system to be used for the search and examination of U.S. and EP patent applications.  The website was created to serve as EPO-EPCan informative resource on the progress of the CPC project for USPTO and EPO staff, as well as other patent offices worldwide and the user community.  The EPO press release regarding the website launch can be found here.

    For additional information regarding this topic, please see:

    • "USPTO and EPO Agree to Principles of Joint Patent Classification System," February 14, 2011
    • "USPTO and EPO to Develop Joint Patent Classification System," October 25, 2010

  • By Kevin E. Noonan —

    Federal Trade Commission (FTC) SealThe Federal Trade Commission is nothing if not consistent.  Yet again, the Commission has released a Report on the negative effects of reverse payment (or, in Commission parlance, "pay-for-delay") agreements, in the face of competing studies (see "Generic Pharmaceutical Association Releases Report on Value of Pay-for-Delay Agreements") and well-reasoned appellate decisions (see "Second Circuit Denies En Banc Reconsideration in Cipro® Case") that, in the main, settlement agreements in ANDA litigation between branded and generic pharmaceutical companies are actually pro-competitive and result in generic drugs reaching the market sooner than they would in the absence of such agreements.

    Washington - Capitol #4The Commission's latest audience is the Congressional "Super Committee" on the budget (having failed to convince the judiciary up to and including the Supreme Court).  The ostensible reason is that banning reverse payment agreements would "reduce the deficit and lower [the] nation's health care costs" (a mantra of patent reform proponents with almost equally little factual basis).  Calling it a "recent anticompetitive trend," the Report characterizes reverse payment agreements as merely a way for branded pharmaceutical companies to delay generic entry, thus delaying "the introduction of lower-cost prescription drug alternatives for American consumers."  The FTC Chairman was quoted as saying that "[w]hile a lot of companies don't engage in pay-for-delay settlements, the ones that do increase prescription drug costs for consumers and the government each year.  Fortunately, Congress has the opportunity to fix this problem through the Joint Select Committee on Deficit Reduction — and save the government and American taxpayers billions of dollars," something the FTC has not been able to accomplish through litigation or the normal Congressional process (see "Sen. Kohl Introduces Bill to Prohibit Reverse Payments").  The Commission contends that the cost savings from a ban on reverse settlements would amount to $2.67 over 10 years due to savings from Medicare and Medicaid expenses.

    Under the Medicare Prescription Drug, Improvement and Modernization Act of 2003, settlements between innovator drug companies and generic competitors must be filed with the FTC.  The text of this Report is an update of the Report released earlier this year (May 2011) providing a synopsis of such agreements between 2003 and 2010.  The update adds data from 2011:  according to the Report, the FTC received information on 156 "final resolutions" of ANDA litigation between branded and generic drug makers.  Of these, 28 contained a combination of compensation to the generic pharmaceutical company and a restriction on the ability of the generic drug maker to market the generic drug.  These settlements "involved 25 different branded" drugs having annual sales of more then $9 billion in total.  Another 100 settlements contained restrictions on marketing the generic drug without any "explicit" compensation, while the remaining 28 settlements had neither compensation nor market restrictions.  Of particular interest were settlements involving "first" ANDA filers, who were potentially entitled to a 180-day market exclusivity period.  Of these 54 agreements, 18 (one-third) had provisions that both compensated the generic drug maker and restricted access to the marketplace, with 10 of the 18 having express provisions prohibiting the branded pharmaceutical company from competing with an "authorized generic" or contained an exclusive license from the branded pharmaceutical company that permitted the generic drug maker to produce an authorized generic drug.  Another 29 settlements restricted market access by the generic drug maker but provided no compensation.  As part of the Report, a Table was provided that integrated the 2011 data with the previously released data from 2004-2010:

    Table
    While the total number of settlements continues to increase, the percentage containing reverse payments is decreasing, particularly among first filers.  This trend seems to indicate that the scrutiny occasioned by FTC displeasure over these agreements (or the threat of antitrust litigation (from state as well as private "attorneys general"; see "Second Circuit Denies En Banc Reconsideration in Cipro® Case") is having the FTC's desired effect.  It is also possible that the real trend here is the overall increase in ANDA litigation settlements, which may indicate that the industry (both branded and generic) is coming to recognize that the Hatch-Waxman ANDA regime is wasteful of resources that might better be spent addressing deficiencies in the pharmaceutical pipeline (see "Maybe Hatch-Waxman Data Exclusivity Isn't So Good For Traditional Drugs After All").  It seems evident that the Commission will continue with its ideological idée fixe to ban reverse payment settlement agreements, regardless of whether they are either necessary or in the public interest.