• Calendar

    April 5-6, 2011 – International Patent Forum 2011 (Managing Intellectual Property) – London, UK

    April 6-9, 2011 – 26th Annual Intellectual Property Law Conference (American Bar Association Section of Intellectual Property Law) – Arlington, VA

    April 7, 2011 – "The Oral Argument in Myriad" (Intellectual Property Owners Association) – 2:00 PM (ET)

    April 13-15, 2011 – Intellectual Property Counsels Committee (IPCC) Spring Conference & Meeting (Biotechnology Industry Organization) – Seattle, WA

    April 15, 2011 – 2nd Annual John Marshall Law School Review of Intellectual Property Law Symposium – Chicago, IL

    April 27, 2011 – 27th Annual Joint Patent Practice Seminar (Connecticut, New Jersey, New York, and Philadelphia Intellectual Property Law Associations) – New York, NY

    April 29, 2011 – Ethics in the Practice of Intellectual Property Law (John Marshall Law School Center for Intellectual Property Law) – Chicago, IL

    May 3-4, 2011 – Paragraph IV Disputes*** (American Conference Institute) – New York, NY

    June 7-8, 2011 – Biosimilars*** (American Conference Institute) – New York, NY

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

  • IPO #2 The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "The Oral Argument in Myriad" on Thursday, April 7, 2011 beginning at 2:00 PM (ET).  The IPO webinar will discuss and analyze the April 4th Federal Circuit oral argument in Association of Molecular Pathology v. U.S. Patent and Trademark Office.  The panel, which includes Donald Dunner of Finnegan, Henderson, Farabow, Garrett & Dunner, LLP; Patent Docs author Dr. Kevin Noonan of McDonnell Boehnen Hulbert & Berghoff LLP; and Ed Reines of Weil, Gotshal & Manges, LLP, will garner evidence from the oral argument on where the CAFC is heading and discuss possible outcomes.  The registration fee for the webinar is $120 (government and academic rates are available upon request).  Those interested in registering for the webinar, can do so here.

  • New York #1 American Conference Institute (ACI) will be holding a conference on Biosimilars on June 7-8, 2011 in New York, NY.  ACI faculty will help attendees:

    • Understand the FDA's current position on the implementation of a biosimilar pathway and strategically position companies to protect or increase market share;
    • Determine what level of clinical data biosimilar applicants must provide to prove safety and efficacy;
    • Evaluate the impact that the 12-year exclusivity period will have on competition and research and development;
    • Assess the financial viability of biosimilars in light of potential regulatory hurdles and forecast potential profit margins; and
    • Develop proactive strategies and plans in preparation for the eventuality of biosimilar patent disputes.

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

    • Update on current FDA position and initiatives regarding biosimilars;
    • Predicting, preparing and positioning for the FDA's implementation of the biosimilar pathway;
    • Scrutinizing the financial viability of biosimilars and making the business case for or against follow-on biologics;
    • No two biologics are alike: Defining biosimilarity and meeting the heightened standard of interchangeability under the statute — to be presented in part by Patent Docs author Dr. Kevin Noonan;
    • Debating the practical implications of a 12-year exclusivity period: Striking a balance between innovator and biosimilar interests;
    • Branding and promotional considerations for biosimilars;
    • Learning from the global development of biosimilars: Enforcement and risk management strategies to protect your biologic on the international stage;
    • An overview of the statutory dispute resolution mechanisms: Analyzing the practical impact of linking the FDA approval process with the patent resolution process;
    • Developing proactive procedures and strategies now for the eventual flood of biosimilar litigation: Early considerations to best position yourself;
    • Developing proactive procedures and strategies now for the eventual flood of biosimilar litigation: Prevailing through preparedness;
    • Ascertaining the type and volume of clinical data necessary to establish biosimilarity;
    • Structuring a patent portfolio strategy to protect IP in light of FOB legislation; and
    • Alternative routes to market for biosimilars: Evaluating the benefits of using the abbreviated pathway.

    A pre-conference primer, entitled "Biologics Science 101: Understanding and Deconstructing the Complicated Scientific Principles Behind Biosimilar," will be offered from 2:00 pm to 5:00 pm on June 6, 2011.  In this in-depth and interactive primer, scientists on the front lines of research and development and the thought-leaders who are guiding the FDA on the relevant scientific considerations will maximize your understanding of the science to put you in the best position to determine actual costs of biosimilar research and development and to prepare for protecting your intellectual property at the patenting and litigation stages.  In addition, a post-conference master class, entitled "In-Depth Breakdown of the Biosimilar Framework in the EU," will be offered from 9:00 am to 12:00 pm on June 9, 2011.

    The agenda for the Biosimilars 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 either pre-conference primer or post-conference master class), or $3,495 (conference, pre-conference primer, and post-conference master class).  Those registering by April 15, 2011 will receive a $300 discount and those registering by May 13, 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 the Biosimilars conference.

  • JMLS The John Marshall Law School Center for Intellectual Property Law will be holding its "Ethics in the Practice of Intellectual Property Law" program from 9:00 am to 3:00 pm on April 29, 2011 in Chicago, IL.  The program will consist of the following sessions:

    • What IP Lawyers Should Know about the ARDC and Client Complaints
    Therasense — Does it Make Sense?  Has the Federal Circuit Finally Fixed the Law of Inequitable Conduct?
    • The Ethics of Deception
    • How to Have Fewer Clients and Yet Make More Money
    • Ethical Issues Relating to the Attorney Client Privilege in IP
    • Ethics in IP Licensing

    Additional information about the program, including a registration form, can be found here.  Those interested in registering for the program online can do so here; the registration fee is $195 (general rate) or $95 (government, judicial, and academic rate); attendees are eligible for 4 hours of professional responsibility CLE credit.

  • By Donald Zuhn

    On Wednesday, the House introduced its own version of the "America Invents Act" (H.R. 1249).  Although the legislation introduced in the House and the bill that was passed in the Senate earlier this month (S. 23) share the same name, the two bills are not identical (a discussion of the differences between the House and Senate bills can be found here). Since the House bill was introduced, patent organizations, industry groups, and members of the House have begun to line up in support of or opposition to the new legislation.

    Biotechnology Industry Organization (BIO) Earlier today, the Biotechnology Industry Organization (BIO) issued a press release in which BIO president and CEO Jim Greenwood "praise[d] House Judiciary Committee Chairman Lamar Smith (R-TX) for his introduction of a comprehensive patent reform bill similar to the bill adopted by the U.S. Senate earlier this month by a nearly unanimous vote."  Mr. Greenwood called the House legislation "a clear improvement over prior House versions of patent reform legislation" (readers may recall that the House passed a patent reform bill in September 2007; see "Patent 'Reform' Bill Passes House of Representatives").  He also noted that BIO was "pleased that the legislation will end, once and for all, the diversion of fees collected by the U.S. Patent and Trademark Office, allowing the agency to use all of its fees to hire more examiners, reduce the backlog of pending applications, and make other improvements to its operations."  With regard to the first-inventor-to-file provisions of the House bill, Mr. Greenwood suggested that the inclusion of this and "many other reforms" would "improve the patent system and enhance patent quality."

    The biotech industry group was not satisfied with everything in the House version of legislation, however.  Mr. Greenwood stated that "BIO has serious concerns with several significant changes made in the House bill regarding the inter partes review system," concluding that:

    Taken as a whole, these changes would make it easier to bring frivolous challenges to patents, harder for patent owners to enforce them, and more likely that patent owners will find themselves in duplicative and costly patent-related proceedings.  These changes negatively alter the carefully-crafted balance between patent owners and accused infringers that was achieved in the Senate bill — a bill that won support not only from 95 Senators, but from a wide range of industries, universities, and small businesses across the spectrum of American innovation.

    BIO was also concerned about "the inclusion of broader prior user rights in the House bill, and believes that this issue, coupled with the harmful inter partes review changes, could set back efforts to pass meaningful patent reform this year by undermining the broad coalition of American innovators currently supporting patent reform."  Noting that small biotech companies rely on IP to attract investment, Mr. Greenwood asserted that "[i]t is critical that patent reform legislation preserves and enhances the incentives necessary to sustain our nation's global leadership in biotechnology innovation and to spur the creation of high-wage, high-value jobs throughout the country."

    American Innovators for Patent Reform On Tuesday, nine organizations representing U.S. small businesses, startup entrepreneurs, independent inventors, and technical professionals sent a letter to each member of the House "to clarify [their] objections to the House version of the America Invents Act, in its current form," and highlight "troubling provisions pertaining to matters that are critical to small businesses." The organizations signing onto the letter included the American Innovators for Patent Reform, CONNECT, IEEE-USA, IP Advocate, National Association of Patent Practitioners, National Congress of Inventor Organizations, National Small Business Association, Professional Inventors Alliance USA, and U.S. Business and Industry Council.  In their letter, the groups contend that "[t]he proposed Act has several features that will increase our costs sharply and reduce our access to the patent system, increase the Patent Office's delay and backlog, and decrease our ability to enforce our patents" (emphasis in original).  Among the bill's problematic features is the first-inventor-to-file provision, which the letter argues will lead to a "weakening of the grace period," which in turn "raises risk of loss of patent rights by our members, as it impedes the important process of incubating and vetting inventions."

    The letter suggests that the America Invents Act "limits the grace period to that which is commercially similar to a failed system that the U.S. abandoned in 1839, when the U.S. recognized that inventors need a commercially-reliable opportunity to work and market their inventions before the deadline for patenting."  The letter also notes that the "constitutionality of the 'first to file' provision has been questioned among legal scholars," adding that "this complex constitutional legal question and its uncertainty will disrupt investment until it is decided."  The groups also expressed "serious concerns" about the post-grant review provision of the House bill, stating that "[i]ncreased filings driven by the Act's 'use it or lose it' grace period rules and by post-grant review will further burden the U.S. Patent & Trademark Office (PTO) at a time when its backlogs are unacceptable."  As with their objections to the Senate bill, the groups contend that "[c]hanging U.S. patent law to be like the less-successful patent systems of the rest of the world cannot be regarded as positive 'reform.'"  The letter concludes by "urg[ing] Congress to shift its attention away from the broad and technically difficult America Invents Act, and instead pass a streamlined, targeted bill that focuses only on long-term PTO funding."

    Manzullo, Donald On Wednesday, two members of the House issued statements in opposition to H.R. 1249.  Rep. Don Manzullo (R-IL) (at right) stated that he was "deeply concerned" that the House bill "will stall American innovation and send more of our jobs overseas."  He suggested that "[t]his legislation reflects an approach to patent reform that stalled previously, in 2007, in the face of massive opposition from American innovators."  Rep. Manzullo called the first-inventor-to-file section "an unfortunate provision that would shift America's current patent system — where the first person to conceive of an invention is granted a patent — to a 'first to file' system that would turn our system into a foot race to the Patent Office," and noted that "[t]he Constitution . . . mandates that inventors have exclusive right to their discoveries."  As for those who promote harmonization, Rep. Manzullo stated that "[w]ith all due respect to our friends and allies abroad, I would not trade America's record of innovation for that of any of those first-to-file countries."  He also suggested that the bill would "devastate small inventors by effectively eliminating the one-year 'grace period' that U.S. inventors currently have," which he said was "critical to small inventors, who can use that year to develop their invention, seek investors and raise funds to begin the expensive patent application process."  Rep. Manzullo concluded by noting that "[m]any of America's inventors and innovators are alarmed over these fundamental changes to our patent system," and recommended that "we must hear them out and address their concerns."

    Michaud, Michael Rep. Mike Michaud (D-ME) (at left) also issued a statement in opposition to the House bill, stating that he was "disappointed and concerned with the 'America Invents Act,'" and suggesting that "[p]atent reform should focus on addressing the Patent and Trademark Office's backlog, first, and do no harm, second."  He contended that "[a]s introduced, this bill would be bad for American inventors, bad for American manufacturers, and bad for our economy."  Rep. Michaud called two of the provisions in the bill "particularly troubling" saying that the post-grant review process and changes to inter partes reexamination would "allow infringers to challenge patents more easily," particularly because "the bill does not include all necessary safeguards to prevent strategic attacks of patents that are often used to the disadvantage of American inventors."  He also found fault with the first-inventor-to-file and prior user rights provisions, which would be "particularly problematic for universities, tech startups, and small inventors."  Rep. Michaud urged the House Judiciary Committee "to take testimony and input from a broad range of stakeholders so that we can find a better way forward on this important issue."

    Innovation Alliance The Innovation Alliance also issued a press release opposing the House bill.  On Wednesday, the group, which represents innovators, patent owners, and stakeholders from a diverse range of industries, said it was "disappointed" that the House bill "does not include some important safeguards against the potential for abuse of the post-grant review procedures at the U.S. Patent and Trademark Office (USPTO)."  The group contended that the bill "includes a weak threshold for 'second window' inter partes review proceedings, one that will allow virtually all challenges to proceed to a trial-like hearing before an administrative patent judge," and argued for "a higher threshold . . . to enable the USPTO to manage the increased workload of the new administrative review system fairly and efficiently by screening out meritless or unsubstantiated petitions."  The Innovation Alliance also said it was "deeply concerned" that the House bill:

    [I]ntroduces new standards that may preclude the enforceability of patents in court and at the International Trade Commission (ITC) pending completion of a post-grant administrative review at the USPTO, lengthens the time period defendants in infringement actions have to decide whether to pursue a post-grant administrative review, expands prior user rights to the detriment of early stage innovation and job growth, and unduly prejudices rights in an overly broad category of so-called 'business method patents' regardless of whether they survive a validity challenge.

    The group did find some "positive aspects" in the bill, including "language that would end the diversion of USPTO fees," and create "some critical safeguards against abuse of the new post-grant administrative review system, including 'could have raised' estoppel and a presumption of validity for patents."  Notwithstanding the few positives, the Innovation Alliance concluded that it would oppose the America Invents Act absent "significant improvement" in the areas of concern the group raised in its statement.

  • By Kevin E. Noonan  —

    Smith, Lamar Today, the Chairman of the Judiciary Committee in the House of Representatives, Lamar Smith (R-TX) (at right), introduced a version of the America Invents Act (passed by the Senate as S. 23).  While identical in most respects, the bill has come provisions that differ from the Senate bill.  (Update: the House bill has been assigned bill number H.R. 1249).

    The House bill as set forth on Representative Smith's website has the following sections (sections that are unique to the House bill are indicated in italics; where the numbering of sections differs, the Senate section number is indicated in brackets):

    Sec. 1.  Short title; table of contents
    Sec. 2.  First inventor to file
    Sec. 3.  Inventor's oath or declaration
    Sec. 4.  Defense to Infringement Based on Earlier Inventor

    Sec. 5.  Post-grant review proceedings
    Sec. 6.  Patent Trial and Appeal Board
    Sec. 7.  Preissuance submissions by third parties
    Sec. 8.  Venue
    Sec. 9.  Fee setting authority
    Sec. 10.  Fees for patent services

    Sec. 11.  Supplemental examination [Sec. 10, S. 23]
    Sec. 12.  Funding agreements [Sec. 13, S. 23]
    Sec. 13.  Tax strategies deemed within the prior art [Sec. 14, S. 23]
    Sec. 14.  Best mode requirement [Sec. 15, S. 23]
    Sec. 15.  Marking [Sec. 4, S. 23]
    Sec. 16.  Advice of counsel [Sec. 4, S. 23]

    Sec. 17.  Ownership; assignment
    Sec. 18.  Transitional program for covered business method patents
    Sec. 19.  Clarification of jurisdiction [Sec. 17, S. 23]
    Sec. 20.  Technical amendments [Sec. 16, S. 23]
    Sec. 21.  Travel expenses and payment of administrative judges [Sec. 19, S. 23]
    Sec. 22.  Patent and Trademark Office funding [Sec. 20, S. 23]
    Sec. 23.  Satellite offices [Sec. 21, S. 23]
    Sec. 24.  Patent Ombudsman Program for small business concerns [Sec. 22, S. 23]
    Sec. 25.  Priority examination for technologies important to American competitiveness [Sec. 23, S. 23]
    Sec. 26.  Designation of Detroit satellite Office [Sec. 24, S. 23]
    Sec. 27.  Effective date [Sec. 25, S. 23]
    Sec. 28.  Budgetary effects [Sec. 26, S. 23]

    Sec. 11 (Residency of Federal Circuit Judges) and Sec. 12 (Microentity defined) from S. 23 are not included in the House version of the bill.

    Section 4 of the House bill, contains a more extensive revision to 35 U.S.C. § 273 than S. 23, as follows (with differences indicated by strikethrough or underlining):

    35 U.S.C. 273 Defense to infringement based on earlier inventor.

    (a) DEFINITIONS.- For purposes of this section-

    (1) the terms "commercially used" and "commercial use" mean use of a method in use of the subject matter of a patent inside or outside the United States, so long as such use is in connection with an internal commercial use or an actual arm's-length sale or other arm's-length commercial transfer of a useful end result, whether or not the subject matter at issue is accessible to or otherwise known to the public, except that the subject matter for which commercial marketing or use is subject to a premarketing regulatory review period during which the safety or efficacy of the subject matter is established, including any period specified in section 156(g), shall be deemed "commercially used" and in "commercial use" during such regulatory review period;

    (2) in the case of activities performed by a nonprofit research laboratory, or nonprofit entity such as a university, research center, or hospital, a use for which the public is the intended beneficiary shall be considered to be a use described in paragraph (1), except that the use-

    (A) may be asserted as a defense under this section only for continued use by and in the laboratory or nonprofit entity; and

    (B) may not be asserted as a defense with respect to any subsequent commercialization or use outside such laboratory or nonprofit entity;

    (3) the term "method" means a method of doing or conducting business; and

    (4) (3) the "effective filing date" of a patent is the earlier of the actual filing date of the application for the patent or the filing date of any earlier United States, foreign, or international application to which the subject matter at issue is entitled under section 119, 120, or 365 of this title.

    (b) DEFENSE TO INFRINGEMENT.-

    (1) IN GENERAL.- It shall be a defense to an action for infringement under section 271 of this title with respect to any subject matter that would otherwise infringe one or more claims for a method in the patent being asserted against a person, if such person had, acting in good faith, actually reduced the subject matter to practice at least 1 year before the effective filing date of such patent, and commercially used the subject matter before the effective filing date of such patent.

    (2) EXHAUSTION OF RIGHT.- The sale or other disposition of a useful end product produced by a patented process method, by a person entitled to assert a defense under this section with respect to that useful end result shall exhaust the patent owner's rights under the patent to the extent such rights would have been exhausted had such sale or other disposition been made by the patent owner.

    (3) LIMITATIONS AND QUALIFICATIONS OF DEFENSE.- The defense to infringement under this section is subject to the following:

    (A) PATENT.- A person may not assert the defense under this section unless the invention for which the defense is asserted is for a method.

    (B) (A) DERIVATION.- A person may not assert the defense under this section if the subject matter on which the defense is based was derived from the patentee or persons in privity with the patentee.

    (C) NOT A GENERAL LICENSE.- The defense asserted by a person under this section is not a general license under all claims of the patent at issue, but extends only to the specific subject matter claimed in the patent with respect to which the person can assert a defense under this chapter, except that the defense shall also extend to variations in the quantity or volume of use of the claimed subject matter, and to improvements in the claimed subject matter that do not infringe additional specifically claimed subject matter of the patent.

    (D) FUNDING. –

    (i) DEFENSE NOT AVAILANLE IN CERTAIN CASES. -  A person may not assert the defense under this section if the subject matter of the patent in which the defense is based was developer pursuant to a funding agreement under chapter 18 of this title of be a nonprofit institution of higher education, or a technology transfer organization affiliated with such an institution, that did not receive funding from a private business enterprise in support of that development.

    (ii) DEFINITIONS. – In this subparagraph –

    (I)  the term "institution of higher education" has the meaning given that term in section 101(a) of the Higher Education Act of 1965 (20 U.S.C. 1001(a); and

    (II)  the term "technology transfer organization" means an organization the primary purpose of which is to facilitate the commercialization of technologies developed by one or more institutions of higher education.

    (4) BURDEN OF PROOF.- A person asserting the defense under this section shall have the burden of establishing the defense by clear and convincing evidence.

    (5) ABANDONMENT OF USE.- A person who has abandoned commercial use of subject matter may not rely on activities performed before the date of such abandonment in establishing a defense under this section with respect to actions taken after the date of such abandonment.

    (6) PERSONAL DEFENSE.-

    (A) IN GENERAL: The defense under this section may be asserted only by the person who performed or caused the performance of the acts necessary to establish the defense, as well as any other entity that controls, is controlled by, or is under common control with such person, and, except for any transfer to the patent owner, the right to assert the defense shall not be licensed or assigned or transferred to another person except as an ancillary and subordinate part of a good faith assignment or transfer for other reasons of the entire enterprise or line of business to which the defense relates.

    (B) EXCEPTION. – Notwithstanding subparagraph (A), any person may, ion the person's own behalf, assert a defense based on the exhaustion of rights provided under paragraph (2), including any necessary elements thereof.

    (7) LIMITATION ON SITES.- A defense under this section, when acquired as part of a good faith assignment or transfer of an entire enterprise or line of business to which the defense relates, may only be asserted for uses at sites where the subject matter that would otherwise infringe one or more of the claims is in use before the later of the effective filing date of the patent or the date of the assignment or transfer of such enterprise or line of business.

    (8) UNSUCCESSFUL ASSERTION OF DEFENSE.- If the defense under this section is pleaded by a person who is found to infringe the patent and who subsequently fails to demonstrate a reasonable basis for asserting the defense, the court shall find the case exceptional for the purpose of awarding attorney fees under section 285 of this title.

    (9) INVALIDITY.- A patent shall not be deemed to be invalid under section 102 or 103 of this title solely because a defense is raised or established under this section.

    In addition, Section 2 lacks the provisions of S. 23 relating to amending the False Marking statute (35 U.S.C. § 291) to restrict actions under subsection (a) to the U.S., and to restrict private plaintiffs to those that can allege a competitive injury under subsection (b).

    Regarding Section 5, the post-grant review provisions, the House amendments to the inter partes reexamination provisions differ from the Senate version by maintaining the current standard for granting inter partes reexamination, i.e., raising a substantial new question of patentability (rather than showing a "reasonable likelihood that the petition would prevail with respect to at least one of the claims challenged in the petition" in S. 23).  The House version also gives the Director less time to initiate an inter partes reexamination where the patentee does not respond to the petition (§ 314(b)).  The House version also contains provisions in § 315 requiring an automatic stay of "civil proceedings" if an inter partes reexamination request is filed (and exempt counterclaims of invalidity from these provisions (§ 315(a)(2) and (a)(3)).  The House bill also includes a new section not in the Senate version, § 320, providing that, when a party seeks a stay in a "civil action" (including patent infringement litigation as well as actions before the International Trade Commission), the court "shall decide" whether to grant the stay based on "whether the stay, or denial thereof, will simplify the issues . . . and streamline the trial" (§ 320(1)); "whether discovery is complete and whether a trial date has been set" (§ 320(2)); "whether a stay, or the denial thereof, would unduly prejudice the nonmoving party or present a clear tactical advantage for the moving party" (§ 320(3)); or "whether a stay, or the denial thereof, will reduce the burden of litigation on the parties and on the court" (§ 320(4)).  (These provisions are in both the Senate and House versions of the section relating to expedited Patent Office review of business method patents; Sec. 18(c).)  Moreover, the House bill does not contain the exception in S. 23, that the provisions as amended do not apply to an inter partes reexamination request filed prior to the date of enactment.

    House of Representatives Seal With regard to the new post-grant review provisions relating to review after a patent grants, there are some important differences between the House and Senate bills (in addition to formatting changes in some of the provisions).  These differences include expanding the time for filing a petition from 9 months to 12 months from grant (Sec. 321(c)), permitting as the basis of review an assertion of "a novel legal question that is important to other patents or patent applications" (Sec. 324(b)), and outlining the considerations courts should make regarding whether to grant a stay in a civil action (§ 330).

    There are also some minor differences in where certain provisions can be found in the two bills.  For example, the definition of "micro-entity" is set forth in a separate section in S. 23 (Sec. 12) and is contained in Section 9 on Fee Setting Authority in the House bill; the only substantive difference in the definition is that the House bill requires an applicant claiming the benefits of micro-entity status not to have been named on 4 or more previously filed application, while in the Senate bill the requirement is 5 or fewer.  The Fees for Patent Services provisions in Section 9 of S. 23 are set forth in a separate section (Sec. 10) in the House bill, which contains a specified amount for Patent Office services (which will be presumably subject to adjustment by the Director under the provisions of Section 9).  The virtual marking and changes to the False Marking provisions found in S. 23 in Sec. 4 and Sec. 4 are together in Sec. 15 of the House bill, and the advice of counsel provisions in Sec. 4 of S. 23 are separately set forth in Sec. 16 of the House version of the bill.

    The provisions regarding tax strategy patents being considered to be within the prior art is slightly more precisely worded in the House bill, exempting not only computer programs for tax filing but also any "method, apparatus, technology, computer program product or system used solely for financial management, to the extent that it is severable from any tax strategy or does not limit the use of any tax strategy by any taxpayer of tax advisor" (Sec. 13(e)(2)).

    Section 17 of the House bill uniquely amends 35 U.S.C. § 261 by adding the following provision:

    35 U.S.C. 261 Ownership; assignment.

    Subject to the provisions of this title, patents shall have the attributes of personal property.

    Applications for patent, patents, or any interest therein, shall be assignable in law by an instrument in writing. The applicant, patentee, or his assigns or legal representatives may in like manner grant and convey an exclusive right under his application for patent, or patents, to the whole or any specified part of the United States.

    A certificate of acknowledgment under the hand and official seal of a person authorized to administer oaths within the United States, or, in a foreign country, of a diplomatic or consular officer of the United States or an officer authorized to administer oaths whose authority is proved by a certificate of a diplomatic or consular officer of the United States, or apostille of an official designated by a foreign country which, by treaty or convention, accords like effect to apostilles of designated officials in the United States, shall be prima facie evidence of the execution of an assignment, grant, or conveyance of a patent or application for patent.

    An assignment, grant, or conveyance shall be void as against any subsequent purchaser or mortgagee for a valuable consideration, without notice, unless it is recorded in the Patent and Trademark Office within three months from its date or prior to the date of such subsequent purchase or mortgage and identifies all real parties in interest and those entities that control, directly or indirectly, such real parties in interest.

    The provisions for institution of a transitional program for covered business-method patents (Sec. 18 in both bills) differ only in that the House bill has an extensive section on venue, limiting venue for business method patent infringement to be brought "only in a judicial district . . . (1) where the defendant has its principal place of business or is incorporated" [or] "(2) has committed acts of infringement and has a regular and established place of business" [or] "(3) where the defendant has agreed or consented to be sued" [or] "(4) for foreign defendants [that do not meet the requirements of (1) or (2)] in accordance with [28 U.S.C. § 1391(d)." (Sec. 18(d)).  The House bill also contains provisions of recovery of attorney's fees for the prevailing party (Sec. 18(e)) and exempts automated teller machines from the definition of a "physical facility" for venue purposes (Sec. 18(f)).

    The House bill does not contain provisions relating to the residency requirements for Federal Circuit judges (Sec. 11 of S. 23).

    The House held a hearing before the Subcommittee on Intellectual Property, Competition and the Internet on its version of the America Invents Act today; there has been no announcement by Rep. Smith regarding any additional hearings or timing of bringing the bill to a vote by the full Judiciary Committee.

  • By Donald Zuhn

    House of Representatives Seal On Wednesday afternoon, the House Subcommittee on Intellectual Property, Competition and the Internet will hold a hearing on the House version of Senate bill S. 23, otherwise known as the "America Invents Act."  The hearing on the as yet unnumbered House bill, which begins at 1:30 pm (ET), will consist of two panels of witnesses, with U.S. Patent and Trademark Director David Kappos on the first panel, and Steve Bartlett, President and Chief Executive Officer of the Financial Services Roundtable; Steven W. Miller, Vice President and General Counsel for Intellectual Property for the Procter & Gamble Co.; Mark Chandler, Senior Vice President, General Counsel and Secretary for Cisco Systems, Inc.; and John Vaughn, Executive Vice President of the Association of American Universities on the second panel.

    Last week, the Intellectual Property Owners Association (IPO) reported that the House bill was likely to be introduced on Tuesday in advance of tomorrow's hearing.  However, it does not appear that the House version of S. 23 was introduced during today's legislative session.  The IPO also reported that while many observers expect the House bill to be similar to S. 23, the inter partes review procedure may differ.  One area where the bills are not expected to differ is with respect to the first-inventor-to-file provision.

    Tomorrow's hearing will be the Subcommittee's third patent-related hearing in the past month and a half.  On February 11, the Subcommittee held a hearing on "Crossing the Finish Line on Patent Reform — What Can and Should be Done," where it heard testimony from David Simon, Associate General Counsel, Intellectual Property Policy for Intel Corp.; Carl Horton, Chief Intellectual Property Counsel for General Electric, who spoke on behalf of the Coalition for 21st Century Patent Reform; and the Honorable Paul Michel  former Chief Judge for the U.S. Court of Appeals for Federal Circuit.  On March 10, the Subcommittee held a hearing on "Review of Recent Judicial Decisions on Patent Law," where it heard testimony from Dan L. Burk, Chancellor's Professor of Law at the University of California, Irvine; Andrew J. Pincus, Partner at Mayer Brown; and Dennis D. Crouch, Associate Professor of Law at the University of Missouri School of Law (and founder of the patent weblog Patently-O).

    American Innovators for Patent Reform While the House has picked up the patent reform discussion from the Senate, the debate in the patent community over the Senate bill, which was passed on March 8 (see "Senate Passes S. 23"), continues.  The latest group to voice its opposition to S. 23 is American Innovators for Patent Reform (AIPR), a trade association dedicated to promoting innovation by strengthening the U.S. patent system, which issued a press release last week stating that the Senate bill "does not address the needs of the innovation community: inventors, small businesses and universities."  AIPR founder and president Dr. Alexander Poltorak said that notwithstanding the bill's new name "the America Invents Act is still anti-inventor and anti-small-business legislation."

    The AIPR contends that that there are two "problematic" elements in the legislation that "will hinder American innovation and weaken the U.S. patent system":  the first-inventor-to-file provision, which the AIPR believes "will result in a flood of patent applications as applicants rush to the patent office with half-baked inventions afraid of losing their priority date," which in turn "will further clog a Patent Office that already has a 700,000 patent application backlog," and post-grant review, a third patent challenge that the AIPR calls "a dream-come-true for infringers."  Although the AIPR found fault with the above provisions of S. 23, it found favor with the bill's reduction in the fee small entities would pay for accelerated examination and end to fee diversion (the AIPR believed the bill could have gone even farther, however, by calling for a return of the nearly one billion dollars diverted from the USPTO since 1992).

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

    • "The Disappearance of Deceptive Intent in S. 23," March 23, 2011
    • "'Reform' at the U.S. Patent and Trademark Office," March 22, 2011
    • "Few 'Reform' Provisions Remain in S. 23 Relating to the Judiciary," Marech 21, 2011
    • "Additional Opportunities for Pre- and Post-grant Review, and Brand New Patent Trial and Appeal Board in S. 23," March 17, 2011
    • "Post-grant Review Provisions of S. 23," March 16, 2011
    • "Inventor's Interests, If Not Rights, Limited by S. 23," March 15, 2011
    • "What Are the Provisions of the Proposed "First-Inventor-to-File" System in S. 23?" March 14, 2011
    • "Obama Administration Supports S. 23," March 9, 2011
    • "Reaction to Senate Passage of S. 23," March 8, 2011
    • "Senate Passes S. 23," March 8, 2011

  • LSI - Law Seminars International - blue Law Seminars International (LSI) will be offering a one-hour telebriefing on the Federal Circuit's recent decision in Centocor Ortho Biotech, Inc. v. Abbott Laboratories on March 31, 2011 from 3:00-4:00 PM (ET).  Patent Docs author Dr. Donald Zuhn of McDonnell Boehnen Hulbert & Berghoff LLP will moderate panel including Courtenay Brinckerhoff of Foley & Lardner LLP and Dr. Chris Holman, Associate Professor of Law at the University of Missouri-Kansas City School of Law.  The panel will provide an overview of the Federal Circuit's decision and discuss its implications.  Among the topics to be covered are:

    • Whether the test applied in Centocor is appropriate and workable for antibody claims,
    • How Centocor fits with earlier Federal Circuit written description precedent,
    • Whether it is possible to reconcile Centocor with Noelle and the USPTO Written Description Guidelines,
    • Whether Centocor validates Chief Judge Rader's assertion that Lilly written description is nothing more than a "wildcard" for invalidating "unworthy" patent claims.

    The registration fee is $125 per caller and $50 each additional person on the same line who desires continuing education credit.  Those interested in registering for the telebrief, can do so here.  Additional information regarding the telebriefing can be found here.

  • By Donald Zuhn

    Duramed On Friday, in Duramed Pharmaceuticals, Inc. v. Watson Laboratories, Inc., the Federal Circuit reversed a decision by the District Court for the District of Nevada on summary judgment that the asserted claims of U.S. Patent No. 7,320,969 were nonobvious, determining that the District Court erred in its obviousness analysis.  The Federal Circuit also affirmed the District Court's exclusion of expert testimony on prior use, finding that Watson failed to demonstrate that the lower court abused its discretion in excluding the testimony.

    Seasonique Plaintiff-Appellee Duramed Pharmaceuticals owns the '969 patent, which is directed to an extended-cycle combined oral contraceptive ("COC") regimen that Duramed markets as Seasonique®.  In contrast with a traditional 28-day COC, in which estrogen/progestin pills are taken for 21 days and then hormone-free pills are taken for 7 days, under Duramed's extended-cycle COC, estrogen/progestin pills (30 μg ethinyl estradiol and 150 μg of levonorgestrel) are taken for 84 days and then low-dose estrogen (10 μg ethinyl estradiol) are taken for 7 days.  The extended-cycle regimen serves to increase the menstrual cycle's natural length, and the low-dose estrogen helps to postpone estrogen-withdrawal symptoms that may be experienced during the hormone-free period of traditional COC regimens.

    Watson Pharmaceuticals Seeking approval to market a generic version of Seasonique®, Defendant-Appellant Watson Laboratories filed an Abbreviated New Drug Application (ANDA) with the FDA.  In response to Watson's ANDA filing, Duramed brought suit against Watson for infringement of claims 1-9, 15, and 17-19 of the '969 patent.  Watson stipulated to infringement but challenged the validity of the asserted claims, asserting that they were obvious in view of several references, including three articles (one by Kovacs and two by Sulak) and U.S. Patent No. 6,027,749.  The Kovacs article describes an extended-cycle COC regimen in which pills containing 30 μg ethinyl estradiol and 150 μg levonorgestrel are taken for 84 days and then hormone-free pills are taken for 7 days, the '749 patent describes COC regimens in which pills containing 15-20 μg ethinyl estradiol and 50-125 μg levonorgestrel are taken for up to 77 days and then pills containing 10-15 μg ethinyl estradiol are taken for 7 days in order to reduce the incidence of premenstrual headaches, and the Sulak articles describe the use of low-dose estrogen during the hormone-free period as a way to alleviate headaches resulting from estrogen withdrawal.  Watson also introduced testimony from an expert who opined that one of skill in the art would have been motivated to combine the above references to arrive at the extended-cycle COC of the '969 patent, and further testified that he had personally prescribed the extended-cycle COC regimen of the '969 patent prior to the patent's priority date.  The District Court granted Duramed's motion for summary judgment of nonobviousness and its motion to exclude the expert's testimony regarding prior use  for lack of corroboration.

    On appeal, Watson argued that it had raised genuine issues of material fact regarding whether it would have been obvious to combine the Kovacs COC regimen with low-dose estrogen administration during the traditional hormone-free period to treat estrogen-withdrawal headaches in light of the Sulak articles and the '749 patent.  Watson contended that the District Court, by granting summary judgment of nonobviousness, erred by focusing on individual references instead of considering the teaching of the prior art as a whole, improperly required clear and convincing evidence of invalidity on summary judgment, ignored all but three prior art references as cumulative, erroneously required that the prior art teach a virtual guarantee of success, and failed to make a finding of the level of skill in the art.  In reversing the District Court's grant of summary judgment, the Federal Circuit agreed with Watson that the lower court had erred in assessing the content and scope of the prior art, appeared to have applied an incorrect evidentiary standard on summary judgment, and failed to make any finding on the level of skill in the art.

    With respect to the District Court's assessment of the content and scope of the prior art, the Federal Circuit first addressed the lower court's findings with respect to the Sulak references, stating:

    Regarding Sulak, the court rejected all consideration of the articles' teaching of the use of unopposed estrogen because that use was mentioned only as a "theoretical," rather than a tested solution to estrogen-withdrawal headaches.  A reference, however, is prior art for all that it discloses, and there is no requirement that a teaching in the prior art be scientifically tested, or even guarantee success, before providing a reason to combine.  Rather, it is sufficient that one of ordinary skill in the art would perceive from the prior art a reasonable likelihood of success.

    (citations omitted).  As for the '749 patent, the panel noted that:

    The district court . . . found that the '749 patent discloses a variety of COC regimens and thus concluded that the patent "does not teach any one specific combination that would establish consistent knowledge in the community."  However, the question is not whether there existed a consistent COC regimen in the art, but rather whether one of ordinary skill in the art would have been motivated to combine the Kovacs regimen with 7 days of low-dose, unopposed estrogen with the reasonable expectation that the addition of low-dose estrogen would successfully reduce the incidence of estrogen-withdrawal headaches during the hormone-free period.

    (citation omitted).  The Federal Circuit concluded that:

    Based on its errors in assessing the content of these prior art references, the district court improperly analyzed and rejected the teaching of each in isolation, concluding that each alone failed to establish by clear and convincing evidence a motivation to combine.  . . .  Accordingly, the district court failed to properly consider the collective teaching of the prior art in light of the common sense and creativity of the person of ordinary skill in the art.

    The Federal Circuit also noted that the District Court appeared to have applied an incorrect evidentiary standard on summary judgment, placing the burden of proof on Watson, the nonmoving party, to show clear and convincing evidence of invalidity.  The panel explained that because Duramed had moved for summary judgment of nonobviousness, "the burden rested with Duramed to show that Watson had failed to come forth with clear and convincing evidence of an essential element of its prima facie case of obviousness."

    With respect to findings regarding the level of skill in the art, the Federal Circuit first noted that "[w]hen a finding of the level of skill affects the court's ultimate conclusion under § 103, the failure to make such a finding constitutes reversible error."  In this case, the panel determined that "the district court appears to have simply rejected all of Watson's expert's testimony by finding that [the expert] was not a person of ordinary skill, but extraordinary skill," which the Court found "was error."

    While noting that "in reviewing the record de novo on summary judgment and crediting Duramed's lower level of skill in the art, the district court on remand may well conclude that the claimed extended-cycle COC regimen would have been obvious as a matter of law," the Federal Circuit stated that:

    [O]n the record before us, there appear to be no genuine issues of material fact that, based on the teaching of Kovacs, the '749 patent, and the Sulak articles, one of ordinary skill would have been motivated to combine the Kovacs regimen and 7 days of 10 μg unopposed ethinyl estradiol with a reasonable expectation that the combination would reduce the incidence of headaches associated with that regimen.

    However, because Duramed did not have an opportunity to challenge Watson's prima facie case of obviousness or introduce any secondary considerations of nonobviousness, the Federal Circuit remanded the case to the District Court.

    Duramed Pharmaceuticals, Inc. v. Watson Laboratories, Inc. (Fed. Cir. 2011)
    Nonprecedential disposition
    Panel: Circuit Judges Lourie, Linn, and Dyk
    Opinion by Circuit Judge Lourie

  • By Sherri Oslick

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

    Purdue Pharma L.P. et al. v. Watson Laboratories, Inc. – Florida
    0:11-cv-60643; filed March 24, 2011 in the Southern District of Florida

    • Plaintiffs:  Purdue Pharma L.P.; The P.F. Laboratories, Inc.; Purdue Pharmaceuticals, L.P.; Rhodes Technologies; Board of Regents of the University of Texas System; Grunenthal GMBH
    • Defendant:  Watson Laboratories, Inc. – Florida

    Infringement of U.S. Patent Nos. 6,488,963 ("Hot-Melt Extrudable Pharmaceutical Formulation," issued December 3, 2002), 7,674,799 ("Oxycodone Hydrochloride Having Less Than 25 PPM 14-Hydroxycodeinone," issued March 9, 2010), 7,674,800 (same title, issued March 9, 2010), 7,683,072 (same title, issued March 23, 2010), and 7,776,314 ("Abuse-Proofed Dosage System," issued August 17, 2010) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of Purdue Pharma's OxyContin® (controlled release oxycodone hydrochloride, used to treat pain).  View the complaint here.


    Par Pharmaceutical, Inc. v. UCB, Inc. et al
    .
    2:11-cv-02010; filed March 23, 2011 in the Eastern District of Pennsylvania

    • Plaintiff:  Par Pharmaceutical, Inc.
    • Defendants:  UCB, Inc.; UCB Pharma S.A.

    Declaratory judgment of invalidity and noninfringement of U.S. Patent Nos. 7,858,122 ("Extended Release Formulation of Levetiracetam," issued December 29, 2010) and 7,863,316 (same title, issued January 4, 2011) based on Par's filing of an ANDA to manufacture a generic version of UCB's Keppra XR® (levetiracetam, used to treat epilepsy).  View the complaint here.


    Takeda Pharmaceutical Co. et al. v. Apotex, Inc. et al
    .
    0:11-cv-60609; filed March 22, 2011 in the Southern District of Florida

    • Plaintiffs:  Takeda Pharmaceutical Co.; Takeda Pharmaceuticals North America, Inc.
    • Defendants:  Apotex, Inc.; Apotex Corp.

    Infringement of U.S. Patent Nos. 5,965,584 ("Pharmaceutical Composition," issued October 12, 1999), 6,329,404 (same title, issued December 11, 2001), 6,166,043 (same title, issued December 26, 2000), 6,172,090 (same title, issued January 9, 2001), 6,211,205 (same title, issued April 3, 2001), 6,271,243 (same title, issued August 7, 2001), and 6,303,640 (same title, issued October 16, 2001) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Takeda's Actos® (pioglitazone hydrochloride, used to treat type II diabetes).  View the complaint here.


    Warner Chilcott Co. et al. v. Mylan Pharmaceuticals Inc.

    1:11-cv-00236; filed March 21, 2011 in the District Court of Delaware

    • Plaintiffs:  Warner Chilcott Co.; Hoffmann-La Roche Inc.
    • Defendant:  Mylan Pharmaceuticals Inc.

    Infringement of U.S. Patent No. 7,718,634 ("Method of Treatment Using Bisphosphonic Acid," issued May 18, 2010), licensed to Warner Chilcott, following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Warner Chilcott's Once-a-Month Actonel® (risedronate sodium, used to treat and prevent postmenopausal osteoporosis).  View the complaint here.


    Abbott Laboratories et al. v. Teva Pharmaceutical Industries Ltd. et al
    .
    1:11-cv-00239; filed March 21, 2011 in the District Court of Delaware

    • Plaintiffs:  Abbott Laboratories; Abbott Respiratory LLC
    • Defendants:  Teva Pharmaceutical Industries Ltd.; Teva Pharmaceuticals USA Inc.

    Infringement of U.S. Patent Nos. 6,129,930 ("Methods and Sustained Release Nicotinic Acid Compositions for Treating Hyperlipidemia at Night," issued October 10, 2000), 6,406,715 ("Intermediate Release Nicotinic Acid Compositions for Treating Hyperlipidemia Having Unique Urinary Metabolite Profiles," issued June 18, 2002), 6,676,967 ("Methods for Reducing Flushing in Individuals Being Treated with Nicotinic Acid for Hyperlipidemia," issued January 13, 2004), 6,746,691 ("Intermediate Release Nicotinic Acid Compositions for Treating Hyperlipidemia Having Unique Biopharmaceutical Characteristics," issued June 8, 2004), 7,011,848 ("Hydrophobic Component Free Sustained Release Nicotinic Acid Compositions for Treating Hyperlipidemia and Related Methods Therefor," issued March 14, 2006), 6,818,229 ("Intermediate Release Nicotinic Acid Compositions for Treating Hyperlipidemia," issued November 16, 2004), 6,080,428 ("Nicotinic Acid Compositions for Treating Hyperlipidemia and Related Methods Therefor," issued June 27, 2000), and 6,469,035 ("Methods of Pretreating Hyperlipidemic Individuals with a Flush Inhibiting Agent Prior to the Start of Single Daily Dose Nicotinic Acid Therapy to Reduce Flushing Provoked by Nicotinic Acid," issued October 22, 2002) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Abbott's Simcor® (niacin extended release / simvastatin tablets, used to treat hypercholesterolemia).  View the complaint here.


    Lupin Atlantis Holdings SA v. Apotex Inc. et al
    .
    1:11-cv-00234; filed March 18, 2011 in the District Court of Delaware

    • Plaintiff:  Lupin Atlantis Holdings SA
    • Defendants:  Apotex Inc.; Apotex Corp.; Ethypharm SA

    Lupin Atlantis Holdings S.A. v. Mylan Inc. et al.
    2:11-cv-01930; filed March 18, 2011 in the Eastern District of Pennsylvania

    • Plaintiff:  Lupin Atlantis Holdings S.A.
    • Defendants:  Mylan Inc.; Mylan Pharmaceuticals, Inc.; Ethypharm S.A.

    Lupin Atlantis Holdings S.A. v. Apotex Inc. et al.
    2:11-cv-01931; filed March 18, 2011 in the Eastern District of Pennsylvania

    • Plaintiff:  Lupin Atlantis Holdings S.A.
    • Defendants:  Apotex Inc.; Apotex Corp.; Ethypharm S.A.

    Lupin Atlantis Holdings S.A. v. Mylan, Inc. et al.
    2:11-cv-00358; filed March 18, 2011 in the Western District of Pennsylvania

    • Plaintiff:  Lupin Atlantis Holdings S.A.
    • Defendants:  Mylan Inc.; Mylan Pharmaceuticals, Inc.; Ethypharm S.A.

    The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 7,101,574 ("Pharmaceutical Composition Containing Fenofibrate and the Preparation Method," issued September 5, 2006) and 7,863,331 ("Pharmaceutical Composition Containing Fenofibrate and Method for the Preparation Thereof," issued January 4, 2011) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Lupin's Antara® (fenofibrate, used to treat hypercholesterolemia and hypertriglyceridemia).  View the Delaware Lupin complaint here.


    Tibotec Inc. et al. v. Teva Pharmaceuticals USA, Inc. et al
    .
    2:11-cv-01509; filed March 16, 2011 in the District Court of New Jersey

    • Plaintiffs:  Tibotec Inc.; Tibotec Pharmaceuticals; G.D. Searle, LLC
    • Defendants:  Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries, Ltd.

    Infringement of U.S. Patent Nos. 5,843,946 ("α- and β-Amino Acid Hydroxyethylamino Sulfonamides Useful as Retroviral Protease Inhibitors," issued December 1, 1998) and 7,700,645 ("Pseudopolymorphic Forms of a HIV Protease Inhibitor," issued April 20, 2010) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Tibotec's Prezista® (darunavir, used to treat human immunodeficiency virus (HIV-1) infection).  View the complaint here.


    Nycomed US Inc. v. Glycobiosciences Inc.

    2:11-cv-01539; filed March 11, 2011 in the District Court of New Jersey

    Declaratory judgment of noninfringement of U.S. Patent No. 5,897,880 ("Topical Drug Preparations," issued April 27, 1999) based on Nycomed's manufacture and sale of Solaraze® (diclofenac sodium, used to actinic keratosis).  View the complaint here.