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  • Senators Let FDA Know Their Intent Regarding Data Exclusivity Provisions of PPACA

    By Kevin E. Noonan —

    Senate Seal Members of Congress having sent their letter to the Food and Drug Administration on December 21st (see "Representatives Send Letter to FDA to Explain Data Exclusivity Provisions of Biosimilars Legislation"), on January 7th, it was the Senate's turn.  In their letter, Senators Kay Hagan (D-NC), Orrin Hatch (R-UT), Michael Enzi (R-WY), and John Kerry (D-MA) address the same provisions of the Act and give the Agency substantially the same message as to their "intent" in passing the legislation that their House colleagues did two weeks earlier.

    Agency action that prompted the Senators' letter was the portion of the Public Notice in the Federal Register requesting public input (significantly from the innovator and biosimilar communities) regarding the meaning of the term "exclusivity" in the statute (Patient Protection and Affordable Care Act (P.L. 111-148)):

    What factors should the agency consider in determining whether a modification to the structure of the licensed reference biological product results in a change in safety, purity, or potency, such that a subsequent Biologic License Application (BLA) may be eligible for a second 12-year period of marketing exclusivity?

    FDA Like their colleagues in the House of Representatives, the Senators assert that "[t]he Act does not provide market exclusivity for innovator products."  Rather, the exclusivity referenced in the Act is data exclusivity, "which prohibits FDA from allowing another manufacturer of a highly similar biologic to rely on the Agency's prior finding of safety, purity and potency for the innovator product," qualified by the phrase "for a limited period of time."  The Senators, like the MOCs, make the distinction that the biosimilar manufacturer is not prohibited from "developing its own data to justify FDA approval of [its own BLA] rather than an abbreviated application that relies on the prior approval [and data] of a reference product."

    The letter also reminds the Agency that the Act does prohibit it from granting more than one period of data exclusivity to the innovator (but not, of course, to the putative follow-on biologic manufacturer who undertakes filing its own BLA, which upon award would benefit from its own 12-year data exclusivity period).  This is clear from the qualifiers "from the same company" included in the letter's synopsis of these provisions of the Act:

    The Act explicitly precludes any period of data exclusivity for the following:

    o   A supplement to a BLA; or
    o   A subsequent BLA (from the same company) for a non-structural change that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device, or strength; or
    o   A subsequent BLA (from the same company) for a structural change that does not result in a change in safety, purity or potency.

    Like the letter from the House members, the Senators' letter closes with a statement that "the Act provides incentives for innovators to research and develop new treatments for patients," including an innovator company that "modifies an approved product to produce a change in safety, purity or potency [presumably, for the better]."  Approval of such a "new [drug] product" will not change the data exclusivity for the "first-generation" product (which will expire "as usual"), but will be entitled to its own 12-year data exclusivity period like all new biologic drug products.

    While it might be easy to dismiss this letter (like the MOC's earlier letter) as unadorned politics (particularly since both letters are not binding on the agency or a reviewing court in implementing or interpreting the statute), it does reflect bipartisan consensus on these issues.  The letters proffer a definition of "exclusivity" that attempts to prevent "evergreening" while fostering innovation, and to encourage an alternative path for biosimilar approval for those biologic drugs having sufficient market profit potential to justify the effort and expense of avoiding the innovator's data exclusivity by producing its own.  The combination of interpretations may also encourage development of "bio-betters," but that may also require the FDA to make decisions on questions such as the meaning of the terms "highly similar" and "interchangeable" that (unlike the meaning of "exclusivity") Congress has left to the agency's discretion and the exercise of its expertise.

  • George Will on Innovation

    By Kevin E. Noonan —

    Will, George George Will, conservative icon, wrote an Op-Ed piece in The Washington Post last week extolling the virtues (and the necessities) of innovation and government support for it ("Rev the scientific engine").

    He takes issue with some of his conservative brethren that, in view of what he terms the "excesses" of the various economic stimulus packages of the past few years, now oppose government expenditures that would support "innovation."  What America needs is "internal improvements," he says, in the form of support for scientific and engineering research and education.  He notes the decline in such support in the form of declining federal government support for research in engineering and the physical sciences, which dropped by more than 50% between 1970-1995 (which he characterizes as "America has been consuming its seed corn") and state support for science education, which was at its lowest levels since before Ronald Reagan was President before the economic meltdown at the end of the Bush administration.  (Curiously he fails to mention that the American technological Renaissance occurred during the Clinton administration.)  He also notes that countries like South Korea (38%) and China (47%) award a far higher percentage of their undergraduate degrees in science than does the U.S. (16%).

    Washington Post He argues that "[t]he prerequisites for economic dynamism are ideas" in this century, as much as roads and canals were necessities earlier in our history.  However, he sees a risk in an era of ("curdled") populism, that there will be political resistance to supporting the "elites" (at least scientific ones) that are responsible for the breakthrough discoveries that must be made for research to translate to economic benefits.  This is because "[n]inety-nine percent of the discoveries are made by 1 percent of the scientists," he says, citing Nobel Laureate Julius Axelrod.  As a consequence, as part of making intelligent, pro-prosperity choices, Mr. Will argues that Congressional Republicans should be "defending research spending that sustains collaboration among complex institutions — corporations' research entities and research universities."  This is because "[r]esearch, including in the biological sciences, that yields epoch-making advances requires time horizons that often are impossible for businesses, with their inescapable attention to quarterly results."

    Along the way he cites Margaret Thatcher and Abraham Lincoln (who was, after all, a Republican), but most tellingly he cites Richard Levin from Yale for an important economic point:  "Would Japan's growth have lagged since 1990 'if Microsoft, Netscape, Apple and Google had been Japanese companies'"?  Culturally, the last twenty years have seen the world change from one in which everyone had a Walkman® to one where everyone has an iPod®, and where Amgen, Genentech, Biogen-Idec, and dozens of other U.S. companies drove the biotechnology revolution.  Mr. Will credits investment for driving this prosperity, and in citing Lincoln he acknowledges (however tacitly) the importance of patents in supporting such investment.  His point is not to defend the patent system but to support government support for research; unstated but nonetheless true is that one cannot thrive without the other.

  • Representatives Send Letter to FDA to Explain Data Exclusivity Provisions of Biosimilars Legislation

    By Kevin E. Noonan —

    Eshoo, Anna Members of Congress (Rep. Anna G. Eshoo (D-CA) (at right), Rep. Jan Inslee (D-WA), and Rep. Joe Barton (R-TX)) who sponsored the follow-on biologics portion of the comprehensive health care reform bill past year (Patient Protection and Affordable Care Act (H.R. 3590, now P.L. 111-148)) have sent a letter to the Food and Drug Administration, purportedly to explain the "legislative intent" of the data exclusivity provisions of the bill.

    Those provisions read as follows:

    SEC. 7002. APPROVAL PATHWAY FOR BIOSIMILAR BIOLOGI CAL PRODUCTS.

    (a) LICENSURE OF BIOLOGICAL PRODUCTS AS BIO- SIMILAR OR INTERCHANGEABLE.—Section 351 of the Public Health Service Act (42 U.S.C. 262) is amended—

    (7) EXCLUSIVITY FOR REFERENCE PRODUCT.—

    ''(A) EFFECTIVE DATE OF BIOSIMILAR APPLICATION APPROVAL.—Approval of an application under this subsection may not be made effective by the Secretary until the date that is 12 years after the date on which the reference product was first licensed under subsection (a).

    This portion of the bill would preclude a biosimilar application from being approved "until the date that is 12 years after the date on which the reference product was first licensed."  This provision has been described by several commentators as providing a 12-year "market exclusivity" term for innovator biologic drugs.  Not so, say these MOCs; responding to the following question posed by the Agency in public hearings regarding implementation of the new law:

    What factors should the agency consider in determining whether a modification to the structure of the licensed reference biological product results in a change in safety, purity, or potency, such that a subsequent Biologic License Application (BLA) may be eligible for a second 12-year period of marketing exclusivity?

    FDA Their letter states that P.L.111-148 does not provide a market exclusivity period.  Instead, the bill provides 12 years of data exclusivity.  The differences between these two types of exclusivity are "significant and critical," because the intent of these legislators was to "prohibit[] the FDA from allowing another manufacturer to rely on the data of an innovator to support approval of another product."  The law was not intended to "prohibit or prevent another manufacturer from developing its own data to justify FDA approval of a similar of competitive product."  This interpretation would encourage biologic drug competitors (presumably using the innovator's FDA submission as a roadmap) to submit their own data in support of an independent biologic license application (BLA) pursuant to Sec. 351 of the Public Health Service Act.

    The letter also emphasizes that the bill prohibits "evergreening" by innovators, specifically that "no product, under any circumstances, can be granted 'bonus' years of data exclusivity for mere improvements on a product."  New products, termed "next generation" by the letter's signatories, are not within the definition of evergreening — such a new product (having "significant changes in safety, purity or potency") is considered a "new biologic [that] will receive its own 12-year period of data exclusivity" (emphasis in original).  However the letter positively asserts that while its authors "care deeply about patient access to biologics," they "also care about the advancement of science and our ability to treat the most complex diseases."  Thus, they warn that "[a]ny proposal to limit the definition of a 'new' product, and thus one which is entitled to its own period of data exclusivity has the potential to stifle innovation and negatively impact patient care," which they oppose.

    While certain to be helpful in guiding the agency on interpreting the statute according to Congressional intent, the letter is not in any way binding on how the Agency decides to promote its regulations.  There is a long tradition of skepticism by legal scholars and judges about the validity of any "intent" asserted for Congress in passing legislation.  And executive agencies have the capacity (indeed, the duty) to interpret their enabling statutes and are granted (by courts) substantial deference in these determinations.  So while the letter from these members of Congress is certainly deserving of consideration, stakeholders and their opinions, as well as Agency expertise, are likely to play an even more important role in shaping the eventual contours of follow-on biologic drug policy.

  • BIO Survey Shows Support for DNA-Based Patents Despite Some Reservations

    By Donald Zuhn —

    Biotechnology Industry Organization (BIO) A survey commissioned by the Biotechnology Industry Organization (BIO) shows that 89% of respondents believe patents provide the protection, time, and funding researchers to work on major technological discoveries, and therefore, are a "good thing."  The survey also showed that while 51% respondents had reservations about DNA-based patents, those respondents could support them because such patents allow biotech companies to work on treatments and cures for deadly diseases.

    The results of the survey were summarized in the December issue of BIO's e-newsletter BIOtech NOW.  The survey, which was conducted by Public Opinion Strategies, assessed the views of 400 "elite" voters, which were defined as voters having a college degree, a household income of more than $75,000, and who closely follow current events.

    According to the article in BIOtech NOW, the survey highlighted the need for DNA patent proponents to explain to the public that:

    • further research can still take place during the life of the patent;
    • when the patent expires, it's freely available to the public;
    • the opposition has already inserted "gene patents" and "human gene patents" into the vernacular of this debate, terms that produce the negative reactions;
    • it would be helpful to adopt alternative terms, such as "genome sequence patents," "DNA-based patents" or "DNA patents."

  • Court Report

    By Sherri Oslick —

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

    Aventis Pharma S.A. et al. v. Accord Healthcare Inc. USA
    1:11-cv-00018; filed January 6, 2011 in the District Court of Delaware

    • Plaintiffs:  Aventis Pharma S.A.; Sanofi-Aventis U.S. LLC
    • Defendant:  Accord Healthcare Inc. USA

    Infringement of U.S. Patent Nos. 5,714,512 ("Compositions Containing Taxane Derivatives," issued February 3, 1998) and 5,750,561 (same title, issued May 12, 1998) following a Paragraph IV certification as part of Accord's filing of an ANDA to manufacture a generic version of Aventis' Taxotere® (docetaxel, used to treat breast, lung, prostate, gastric, and head and neck cancers).  View the complaint here.


    App Pharmaceuticals, LLC v. Navinta LLC et al.
    3:11-cv-00063; filed January 6, 2011 in the District Court of New Jersey

    • Plaintiff:  APP Pharmaceuticals, LLC
    • Defendants:  Navinta LLC; Sandoz Inc.; Sandoz AG

    Infringement of U.S. Patent Nos. 5,670,524 ("Methods and Compositions for the Treatment of Pain Utilizing Ropivacaine," issued September 23, 1997) and 5,834,489 (same title, issued November 10, 1998) following defendants' filing of an ANDA to manufacture a generic version of APP's Naropin® (ropivacaine hydrochloride injection product, used for the production of regional or local anesthesia for surgery and for acute pain management).  View the complaint here.


    Pronova BioPharma Norge AS v. Apotex Corp. et al.
    1:11-cv-00012; filed January 5, 2011 in the District Court of Delaware

    • Plaintiff:  Pronova BioPharma Norge AS
    • Defendants:  Apotex Corp.; Apotex Inc.

    Infringement of U.S. Patent No. 7,732,488 ("Pharmaceutical Composition Comprising Low Concentrations of Environmental Pollutants," issued June 8, 2010) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Pronova's Lovaza® (omega-3-acid ethyl esters, used to reduce triglyceride levels in adult patients with very high triglyceride levels).  View the complaint here.

  • Conference & CLE Calendar

    Calendar

    January 11, 2011 – Gene Patenting — Defining a Potentially Pivotal Moment in Biotech (Foley & Lardner LLP) – 12:00 to 1:00 pm (EST)

    January 12, 2011 – New USPTO Guidelines and the Obviousness Standard for Patents (Strafford) – 1:00 – 2:30 PM (EST)

    January 21, 2011 – Patents, Innovation and Job Creation: A Virtuous Circle (Innovation Alliance) – Washington, DC

    January 25, 2011 – Understanding Obviousness in a Post-KSR World:  Practical Applications for Compliance with the Recent USPTO Guidelines (Technology Transfer Tactics) – 1:00 – 2:30 PM (EST)

    January 26-27, 2011 – The Life Sciences Lawyer's Guide to Patent Term Adjustment and Patent Term Extensions*** (American Conference Institute) – New York, NY

    January 31 – February 1, 2011 – Medical Device Patent Litigation*** (American Conference Institute) – New York, NY

    February 16-17, 2011 – Life Sciences Collaborative Agreements and Acquisitions*** (American Conference Institute) – New York, NY

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

  • ACI Medical Device Patent Litigation Conference

    New York #2 American Conference Institute (ACI) will be holding a conference on Medical Device Patent Litigation from January 31 to February 1, 2011 in New York, NY.  Topics of discussion at the conference will include:

    • Satisfying the four-prong test set forth in eBay and obtaining a permanent injunction;
    • Effectively opposing injunction requests;
    • Developing an unassailable reasonable royalty analysis;
    • Contesting the plaintiff's proffer of "comparable" licenses;
    • Recognizing the implications of Hatch-Waxman regulations on medical device patent litigation; and
    • Enforcing and challenging the validity of method patents in the device context post-Bilski.

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

    • Positioning your case for success — Early case strategies and tactical considerations;
    • Asserting invalidity defenses and advancing persuasive infringement claims;
    • Balancing risks and navigating the interplay between re-examination and litigation;
    • Presenting an effective Markman case — Winning strategies for managing a pivotal point in patent litigation;
    • Injunctive relief: Strategies for obtaining and opposing injunctions;
    • Developing a damages case and defenses in the wake of recent federal circuit decisions: Calculating and proving damages and minimizing damages liability;
    • View from the Bench: Judicial perspectives on medical device patent litigation;
    • Managing and reducing costs associated with patent litigation;
    • Patent litigation for drug and device combination products: Preparing for the intersection between medical devices and Hatch-Waxman litigation;
    • Successfully asserting and challenging claims of inequitable conduct in the crowded field of medical device patents; and
    • Restructuring patent marking practices following the recent surge of false marking litigation.

    A pre-conference workshop on "FDA Regulatory Process Primer: Understanding Regulatory Processes for Devices and Their Interplay with Patent Litigation," will be offered from 8:00 to 11:30 am on January 31, 2011, and a post-conference workshop on "Settlement and Licensing Strategies — Developing a Solid Licensing Plan and Drafting Sound Licensing Agreements," will be offered from 9:00 am to 12:00 pm on February 2, 2011.

    The agenda for the Pharma/Biotech Collaborative Agreements conference 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 Institute The registration fee for the conference is $2,295 (conference alone), $2,895 (conference and one workshop), or $3,495 (conference and both workshops).  Those registering by January 11, 2011 will receive a $200 discount.  Those interested in registering for the conference can do so here, 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 Medical Device Patent Litigation conference.

  • Web Conference on Gene Patenting

    Foley & Lardner Foley & Lardner LLP will be hosting a web conference entitled "Gene Patenting — Defining a Potentially Pivotal Moment in Biotech" on Tuesday, January 11, 2011 from 12:00 to 1:00 pm (Eastern).  The web conference will be moderated by Harold C. Wegner of Foley & Lardner LLP, and will include the following panelists:  Patent Docs author Kevin Noonan, Ph.D. of McDonnell Boehnen Hulbert & Berghoff LLP; Associate Professor Joshua D. Sarnoff of DePaul University College of Law; Hans Sauer, Ph.D., Associate General Counsel for Intellectual Property for the Biotechnology Industry Organization (BIO); and Jacqueline D. Wright Bonilla, Ph.D. of Foley & Lardner LLP.

    Issues to be discussed will include:

    • Is DNA a 35 U.S.C. § 101 "composition of matter"?

    • What exactly is a "gene patent," and what does it mean to assert that such technology is patent-ineligible?

    • Are other statutory requirements (such as non-obviousness) more appropriate gatekeepers for obtaining patents directed to this subject matter?

    • Does the Justice Department's distinction supporting patent-eligibility of some DNA compositions, but not isolated "product-of-nature" DNA, make legal and scientific sense?

    • What practical implications would a decision based on the DOJ distinction have for the biotech industry?

    • What alternate claim forms will be open?

    • Would an anti-eligibility ruling violate the Trade-Related Aspects of Intellectual Property Rights (TRIPS)?

    • Will the Federal Circuit dismiss the case for lack of jurisdiction under Medimmune v. Genentech?

    Those interested in attending the conference can do so here.  Additional information regarding the web conference can be found here.

  • Conference on Patents, Innovation & Job Creation

    Innovation Alliance The Innovation Alliance will be sponsoring a conference on "Patents, Innovation and Job Creation: A Virtuous Circle" on Friday, January 21, 2011 from 9:00 am to 1:35 pm at The Newseum, located at 555 Pennsylvania Ave., N.W. in Washington, DC.  The conference will provide discussions with inventors, entrepreneurs, business leaders, and industry experts on the economic value of patents and a vigorous USPTO.

    The agenda for the conference is as follows:

    • 9:00 — Address by Retired Federal Circuit Chief Judge Paul Michel

    • 9:45 — Panel on Job Creation and Innovation: How an Idea Can Create Jobs and Economic Growth — to be moderated by IPWatchdog's Gene Quinn

    • 11:15 — Panel on Patents in the Modern Innovation Economy — to be moderated by Kim Hart of Politico.com

    • 1:00 — Keynote Address by U.S. Patent and Trademark Office Director David Kappos

    Confirmed panelists include Robert Alt, The Heritage Foundation; Gregory J. Junemann, IFPTE, AFL-CIO; Lisa Kuuttila, STC.UNM; Bill Jones, Cummins-Allison Corp.; Harry J. Leonhardt, Amylin Pharmaceuticals; William J. Merritt, InterDigital; Hank Nothhaft, Tessera; and John Swart, Exemplar Genetics.

    Those interested in attending the conference should RSVP to info@innovationalliance.net.

  • EPO Exempts Some Applicants from Submitting Search Results under Rule 141(1) EPC

    By Donald Zuhn —

    EPO Last month, the European Patent Office (EPO) announced that in some circumstances, applicants would be exempted from filing a copy of search results under amended Rule 141(1) EPC.  Prior to the EPO's announcement, the new rule would have required applicants to provide a copy of the results of any search that was carried out on a priority application when filing a European application or when entering the regional phase in Europe, and If the results were unavailable upon filing, to provide the results "without delay after such results have been made available" (see "EPO Prepares to Roll out New Prior Art Search Disclosure Rules").  The requirement to provide search results applies to European and international applications filed on or after January 1, 2011.

    Pursuant to the EPO's recent announcement, applicants will be exempted from providing search results for a priority application when (1) the EPO drew up a certain type of search report on that application, or (2) the application is a first filing in Japan, the United Kingdom, or the United States.  The EPO explained that under amended Rule 141(2) EPC, a copy of the search results under Rule 141(1) EPC is deemed to be duly filed if it is available to the EPO and will be included in the file of the European patent application under conditions determined by the President of the EPO.  The notice indicates that in October, the President of the EPO decided that the EPO would include a copy of certain search results in the file of a European patent application where the EPO had drawn up the search report, thus exempting applicants in such cases from filing the search results themselves.  According to an earlier notice from the EPO, only the following search reports will apply:  European search reports under Article 92 EPC, international search reports under Article 15(1) PCT, international-type searches under Article 15(5) PCT, and search reports made on behalf of a national office on a national application in Belgium, Cyprus, France, Greece, Italy, Luxembourg, Malta, Netherlands, and Turkey.

    The second class of exempted applications is likely more relevant to U.S. practitioners and applicants.  The EPO noted that the Japan Patent Office (JPO), the United Kingdom Intellectual Property Office (UKIPO), and the United States Patent and Trademark Office (USPTO) had each agreed to provide the EPO with electronic copies of search results produced by their offices and covered by Rule 141(1) EPC.  As a result, the President of the EPO determined that the EPO would include these search results in the file of a European patent application, thus exempting applicants claiming the priority of a first filing made in Japan, the United Kingdom, or the United States from filing copies of the search results themselves.

    In a release posted on the Marks & Clerk website, the European IP firm notes that if an EP application claims priority from one or more applications filed with an office other than the USPTO, JPO, or UKIPO, search results will still need to be filed with the EPO.  In addition, the notice indicates that under amended Rule 141(1) EPC, the actual document issued by the patent office (as opposed to a list of references cited) must be filed with the EPO.