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  • FDA Approval of Biologic Drugs under 505(b)(2) Expected to Increase

    By James DeGiulio —

    FDAChoosing the appropriate regulatory pathway for biologics drug approval by the U.S. Food and Drug Administration has historically not been a strategic decision to be made by drugmakers.  In most cases, only one pathway is applicable to the particular drug product.  The traditional NDA 505(b)(1) path is for new drugs, the abbreviated new drug application (ANDA) path is for generics, and the 505(b)(2) path covers the middle ground, including reformulations and combinations of existing drugs.  Most new biologic drugs today are approved via a Biological License Application (BLA) rather than an NDA, and are subject to the provisions of the Biologics Price Competition and Innovation Act (BPCIA).  Historically, however, approval of biological products as "drugs" required a NDA filing under 505(b)(1), even if the drug was "generic" and based on a reference biological drug product.  A recent run of FDA approvals for "generic" biologic drugs

    under 505(b)(2), including Sandoz' recombinant human growth hormone Omnitrope, is drawing attention from biotech drugmakers and may influence their choice of approval pathway, according to an October 10 article published in BioWorld.

    BioworldThe 505(b)(2) pathway, often referred to as a "paper NDA," is an attractive alternative for companies seeking to enter a drug market, for it allows a drugmaker to incorporate preexisting data, including data from expensive clinical studies, into its NDA by reference.  This results in a substantial savings in approval costs; the average 505(b)(2) approval costs $3-7 million dollars, which is far less than the estimated $1.3 billion to bring a new drug to market under 505(b)(1).  However, the 505(b)(2) pathway also comprises uncertainty, as approval requirements are determined on a case-by-case basis and can sometimes require extensive trials despite the availability of preexisting data.

    XenoportDespite this uncertainty, producers of "generic" or "follow-on" biologic drugs and prodrug compounds are currently pursuing the 505(b)(2) pathway as a viable strategy for products in their pipeline, according to XenoPort Inc. CEO Ronald Barrett.  XenoPort's prodrug Horizant, used to treat restless leg syndrome, was recently approved by the FDA only after the drugmaker refilled its NDA under 505(b)(2) after receiving a complete response letter from its first 505(b)(1) filing.  However, others are skeptical that pursuing a 505(b)(2) path from the beginning would have saved XenoPort time or money.  Since the reference drug gabapentin was never approved for restless leg  syndrome, it is possible that more extensive clinical trials than is appropriate for a 505(b)(2) NDA would have been required.  Nonetheless, last month XenoPort filed for approval of Horizant under 505(b)(2) in postherpetic neuralgia, conducting just one Phase Ill trial to support its bid for approval, and also has a 505(b)(2) filing planned for a multiple sclerosis drug.

    Of course, if it is available, the 505(b)(2) path is not always the best choice for all prodrugs and follow-on biologic drugs, for there are tradeoffs in the time and money saved with the 505(b)(2) pathway.  Most of the drugs approved via the 505(b)(2) pathway are reformulations such as liposomal encapsulations, and are not blockbusters.  In addition, these reformulations often get just three years of exclusivity.

    Today, specialty pharma and drug delivery companies are most active in 505(b)(2) filings, but this is expected to change soon.  As biologics continue to account for an increasing number of new therapeutics approved, utilization of the BPCIA biosimilar pathway will increase, and fewer standard ANDA opportunities will become available to generic drugmakers.  In addition to biosimilars, generic companies are moving into follow-on biologic drugs, and will further look to drug delivery and other ways to reformulate existing drugs.  To compete, brand biotech and pharma companies will be forced to follow the generics in ramping their own reformulation and drug delivery efforts, perhaps calling upon 505(b)(2) for approval.

  • USPTO Extends Patent Prosecution Highway Pilot Programs

    By Donald Zuhn —

    PPH LogoSince implementing its first Patent Prosecution Highway (PPH) program with the Japan Patent Office (JPO) on July 3, 2006, the U.S. Patent and Trademark Office has established a total of nineteen PPH programs with other patent offices.  Currently the USPTO has PPH programs (full or pilot) in place with the Japan Patent Office (JPO), the Korean Intellectual Property Office (KIPO), the United Kingdom Intellectual Property Office (UK IPO), the Canadian Intellectual Property Office (CIPO), IP Australia (IP AU), the European Patent Office (EPO), the Danish Patent and Trademark Office (DKPTO), the Intellectual Property Office of Singapore (IPOS), the German Patent and Trade Mark Office (DPMA), the National Board of Patents and Registration of Finland (NBPR), the Hungarian Patent Office (HPO), the Russian Federal Service for Intellectual Property, Patents and Trademarks (ROSPATENT), the Spanish Patent and Trademark Office (SPTO), the Austrian Patent Office (APO), the Mexican Institute of Industrial Property (IMPI), the Swedish Patent and Registration Office (PRV), Nordic Patent Institute (NPI), and the Israel Patent Office (ILPO), and the Taiwan Intellectual Property Office (TIPO).

    Last week, the USPTO announced the continuation of current PPH pilot programs based on Patent Cooperation Treaty (PCT) work products (PCT-PPH) with the Spanish Patent and Trademark Office (SPTO) (see notice), the Russian Federal Service for Intellectual Property, Patents and Trademarks (ROSPATENT) (see notice), and the Austrian Patent Office (APO) (see notice).  Under the PCT-PPH framework, an applicant receiving a positive written opinion or a positive international preliminary report in a PCT application where the SPTO, ROSPATENT, or APO was the International Searching Authority or the International Preliminary Examination Authority may request that the USPTO fast track the examination of corresponding claims in the corresponding U.S. application.  All three pilot programs were extended in order to collect more information before any formal decision on any of the programs is made; the program with the SPTO was extended until to September 30, 2013 and the other two programs were extended for an unspecified period.

    The USPTO also announced last week that it was extending the PPH pilot program with the APO.  The PPH pilot program permits an applicant having an application whose claims have been allowed in the APO to fast track the examination of an application in the USPTO, or vice versa, such that the latter application is examined out of turn.  In particular, an applicant receiving a ruling from the USPTO (or the APO) that at least one claim in an application is patentable may request that the APO (or USPTO) fast track the examination of corresponding claims in the corresponding application in that office.  According to a notice regarding the extension of the USPTO-APO PPH, both offices have agreed to continue the pilot program (for an unspecified period of time) in its current state in order to collect more information before any formal decision on the program is made.

  • AIA Overview: First-Inventor-to-File Provisions

    By Kevin E. Noonan —

    President Signs HR1249_cropThe provisions of the Leahy-Smith America Invents Act (AIA) relating to "First-Inventor-to-File" are set forth in Section 3.  Section 3(a) amends definitions relating to inventorship in 35 U.S.C. § 100.  The "inventor" is defined in new § 100(f) as "the individual, or if a joint invention, the individuals collectively who invented or discovered the subject matter of the invention."  A "joint inventor" is defined as "any 1 of the individuals who invented or discovered the subject matter of the joint invention" (§ 100(g)).  This section also defines a "joint research agreement" along current lines (§ 100(h)).  Importantly for the "first-inventor-to-file" regime, Section 2(a) defines the "effective filing date" either as the actual filing date of the invention (§ 100(i)(1)(A)) or "the filing date of the earliest application for which the patent or application is entitled" under §§ 119, 365(a), 365(b), 120, 121 or 365(c) (§ 100(i)(1)(B)).  Finally, this section defines "the claimed invention" as "the subject matter defined by a claim in a patent or application" (§ 100(j)).

    Section 3(b) effects the changes in 35 U.S.C. § 102 that changes U.S. patent law from "first-to-invent" to "first-inventor-to-file."  Instead of subsections § 102(a) through § 102(g), new § 102 provides that:

    A person shall be entitled to a patent unless:

    (1)  the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention; or

    (2)  the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.

    These provisions eliminate the distinction for public use, on sale or "otherwise available to the public" between acts occurring in the U.S. ("in this country") and acts occurring abroad ("in this or a foreign country") that have long been a feature of defining prior art under § 102; this effect is made explicit under Section 3(d), which repeals 35 U.S.C. § 104.  New § 102(a)(2) expressly defines the "first-inventor-to-file" aspects of the change, by defining as prior art an earlier-filed patent or application that "names another inventor"; it is likely that this provision will include (or be interpreted to include) a definition of "another inventor" as another "inventive entity," i.e., any difference in named joint inventors.  This section of the new statute also expands the scope of foreign-filed applications as prior art:  instead of being limited as prior art to their filing date (or, in the case of a PCT application, the International Filing Date) the new law gives foreign patents and applications the benefit of their earliest effective filing date, which would be the foreign filing date for such applications.

    The grace period that remains under the AIA is contained in new § 102(b), which provides exceptions that include:

    102(b) EXCEPTIONS

    (1)  DISCLOSURES MADE 1 YEAR OR LESS BEFORE THE EFFECTIVE FILING DATE OF THE CLAIMED INVENTION- A disclosure made 1 year or less before the effective filing date of a claimed invention shall not be prior art to the claimed invention under subsection (a)(1) if–

    (A)  the disclosure was made by the inventor or joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor; or

    (B)  the subject matter disclosed had, before such disclosure, been publicly disclosed by the inventor or a joint inventor or another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor.

    (2)  DISCLOSURES APPEARING IN APPLICATIONS AND PATENTS- A disclosure shall not be prior art to a claimed invention under subsection (a)(2) if–

    (A)  the subject matter disclosed was obtained directly or indirectly from the inventor or a joint inventor;

    (B)  the subject matter disclosed had, before such subject matter was effectively filed under subsection (a)(2), been publicly disclosed by the inventor or a joint inventor or another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor; or

    (C)  the subject matter disclosed and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person.

    New § 102(b)(1)(A) establishes the one-year grace period for the inventor's own disclosure or disclosure by another who derived the invention ("obtained directly or indirectly") from the "true" inventor.  New § 102(b)(1)(B), on the other hand, relates to a "second" disclosure of the subject matter that had previously been disclosed ("before such disclosure [had] been publicly disclosed") by the inventor or "another" who derived ("directly or indirectly") the invention from the inventor, also presumably less than one year prior to the effective filing date.  Thus, this new provision provides that the "true" inventor's public disclosure "immunizes" the inventor from disclosure by another, presumably provided that the "true" inventor files a patent application within one year of his or her initial disclosure (i.e., within the grace period).

    New § 102(b)(2) disqualifies as prior art disclosure in a patent or patent application by another who "obtained [the subject matter] directly or indirectly from the inventor" (§ 102(b)(2)(A)) or wherein the subject matter had been publicly disclosed by the inventor or another who derived the invention from the inventor prior to the effective filing date of the earlier patent or application (§ 102(b)(2)(B)) or there was joint ownership ("not later than the effective filing date of the claimed invention") of the earlier disclosed subject matter and the claimed invention.  These provisions provide an incentive for early disclosure of inventions within the one-year grace period, because the effect of earlier disclosure is to eliminate as prior art any disclosure or patent or patent application that occurs after the first public disclosure by the inventor, provided the inventor files a patent application on the subject matter within the one-year grace period.  However, experience with the current law has established that such a disclosure must be an enabling disclosure, and that prior disclosure could create the possibility (if not the likelihood) that variations (obvious or otherwise) could be created and filed by "another," resulting in a diminution of the "true" inventor's patent rights.

    New § 102 also defines common ownership under a joint research agreement (new § 102(c))(which seems to broaden the protections thereof from obviousness currently under § 103 to novelty under the new provisions), and the intent for "continuity" of the treatment of joint research agreements under the new law and the CREATE Act (new § 102(d)).

    Section 3(c) amends current 35 U.S.C. § 103, which sub silentio repeals §§ 103(b) and (c):

    A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains.  Patentability shall not be negated by the manner in which the invention was made.

    Section 3(e) repeals statutory invention registrations, and §§ 3(f) and 3(g) are "conforming" amendments (§ 3(f) amends Section 120 to change "which is filed by an inventor or inventors named" to "which names an inventor or joint inventor").

    Section 3(h) provides an amended § 291 defining "derived patents":

    (a)  IN GENERAL- The owner of a patent may have relief by civil action against the owner of another patent that claims the same invention and has an earlier effective filing date if the invention claimed in such other patent was derived from the inventor of the invention claimed in the patent owned by the person seeking relief under this section.

    (b)  FILING LIMITATION- An action under this section may only be filed within 1 year after the issuance of the first patent containing a claim to the allegedly derived invention and naming an individual alleged to have derived such invention as the inventor or joint inventor.

    This section thus conforms the new regime to what were heretofore "interfering patents," under circumstances where one of the patents was derived from the "true inventor." 

    Section 3(i) provides for "derivation proceedings" in the Office by amendment of 35 U.S.C. § 135:

    (a)  INSTITUTION OF PROCEEDING- An applicant for patent may file a petition to institute a derivation proceeding in the Office.  The petition shall set forth with particularity the basis for finding that an inventor named in an earlier application derived the claimed invention from an inventor named in the petitioner's application and, without authorization, the earlier application claiming such invention was filed.  Any such petition may only be filed within 1 year after the first publication of a claim to an invention that is the same or substantially the same as the earlier application's claim to the invention, shall be made under oath, and shall be supported by substantial evidence.  Whenever the Director determines that a petition filed under this subsection demonstrates that the standards for instituting a derivation proceeding are met, the Director may institute a derivation proceeding.  The determination by the Director whether to institute a derivation proceeding shall be final and nonappealable.

    (b)  DETERMINATION BY PATENT TRIAL AND APPEAL BOARD- In a derivation proceeding instituted under subsection (a), the Patent Trial and Appeal Board shall determine whether an inventor named in the earlier application derived the claimed invention from an inventor named in the petitioner's application and, without authorization, the earlier application claiming such invention was filed.  The Director shall prescribe regulations setting forth standards for the conduct of derivation proceedings.

    (c)  DEFERRAL OF DECISION- The Patent Trial and Appeal Board may defer action on a petition for a derivation proceeding until 3 months after the date on which the Director issues a patent that includes the claimed invention that is the subject of the petition.  The Patent Trial and Appeal Board also may defer action on a petition for a derivation proceeding, or stay the proceeding after it has been instituted, until the termination of a proceeding under chapter 30, 31, or 32 involving the patent of the earlier applicant.

    (d)  EFFECT OF FINAL DECISION- The final decision of the Patent Trial and Appeal Board, if adverse to claims in an application for patent, shall constitute the final refusal by the Office on those claims.  The final decision of the Patent Trial and Appeal Board, if adverse to claims in a patent, shall, if no appeal or other review of the decision has been or can be taken or had, constitute cancellation of those claims, and notice of such cancellation shall be endorsed on copies of the patent distributed after such cancellation.

    (e)  SETTLEMENT- Parties to a proceeding instituted under subsection (a) may terminate the proceeding by filing a written statement reflecting the agreement of the parties as to the correct inventors of the claimed invention in dispute.  Unless the Patent Trial and Appeal Board finds the agreement to be inconsistent with the evidence of record, if any, it shall take action consistent with the agreement.  Any written settlement or understanding of the parties shall be filed with the Director.  At the request of a party to the proceeding, the agreement or understanding shall be treated as business confidential information, shall be kept separate from the file of the involved patents or applications, and shall be made available only to Government agencies on written request, or to any person on a showing of good cause.

    (f)  ARBITRATION- Parties to a proceeding instituted under subsection (a) may, within such time as may be specified by the Director by regulation, determine such contest or any aspect thereof by arbitration.  Such arbitration shall be governed by the provisions of title 9, to the extent such title is not inconsistent with this section.  The parties shall give notice of any arbitration award to the Director, and such award shall, as between the parties to the arbitration, be dispositive of the issues to which it relates.  The arbitration award shall be unenforceable until such notice is given.  Nothing in this subsection shall preclude the Director from determining the patentability of the claimed inventions involved in the proceeding.

    The right is limited to an "applicant for patent" within one year after first publication of the derived application, thus imposing an obligation to monitor publication databases for any possibly derived patent applications.  Whether these proceedings will include patents (as current interference practice does) is unclear; an argument can be made that Section 291 is restricted to derived patents and new Section 135 for derived applications.  This interpretation is supported by the limitation that derivation proceedings in the Office must be initiated within one year of publication (an event that should precede patenting in most cases). In addition, the petition must be supported by "substantial evidence," but without any of the provisions for discovery (or obligations to provide evidence) currently available under interference provisions of current law.  In addition, the Board is given broad discretion to delay action on any petition until after the putatively derived patent has granted, without capacity to appeal such a decision (other than, perhaps, a "civil action").  And, while other portions of the bill establish the Patent Trial and Appeal Board that will be related to the current Board of Patent Appeals and Interferences, the Office will need to create the infrastructure for this "new" adjudicative body.  Section 3(j) of the bill strips current law of all references to interferences wherever they appear in the statute.

    Section 3(k) introduces a 10-year "statute of limitations" into 35 U.S.C. § 32 regarding disciplinary proceedings before the Office and a biennial description of incidents that were barred from being brought under this section by the statute of limitations.  Section 3(l) relates to a small business study to determine the effects of the change to "first-inventor-to-file," with a Report to be provided to Congress not later than one year after the Act is enacted.  Similarly, Section 3(m) provides for a Report to Congress on prior user rights in the U.S. and abroad in Europe, Japan, Canada, and Australia and their effects "if any[] on small businesses, universities and individual inventors."

    Section 3(n) provides that the effective date of this bill, if enacted, is 18 months from the date of enactment, and continuing present interference practice for all patents and applications having an effective filing date prior to the date of enactment of the provisions set forth in Section 3 of the Act.  Finally, Sections 3(o) and 3(p) express the "Sense of the Congress" that the changes effected by these provisions of the Act "will promote the progress of science and the useful arts" and will "promote harmonization of the U.S. patent system with patent systems" in the rest of the world and "promote greater national uniformity and certainty" in patenting.

  • USPTO Seeking Comment on AIA Mandated Studies

    By Donald Zuhn —

    USPTO Seal On Friday, the U.S. Patent and Trademark Office announced that it was seeking comments with regard to two studies it must conduct under the Leahy-Smith America Invents Act (AIA).  The studies, on the operation of prior user rights in selected countries in the industrialized world and international patent protection for small businesses, are mandated by §§ 3(m) and 31 of the AIA.

    The Office's request for comments with regard to the prior user rights study came via a notice in the Federal Register (76 Fed. Reg. 62388).  The Office notes that it is seeking information regarding the following:

    (1)  comparison(s) between the patent laws of the U.S. and the laws of other industrialized countries;
    (2)  the effect of prior user rights on innovation rates;
    (3)  the correlation, if any, between prior user rights and start-up enterprises as well as the ability to attract venture capital to start new companies;
    (4)  the effect of prior user rights, if any, on small businesses, universities, and individual inventors;
    (5)  legal and constitutional issues with placing trade secret law in patent law; and
    (6)  whether or not the change to a first-to-file patent system creates any particular need for prior user rights.

    Written comments can be sent by e-mail to IP.Policy@uspto.gov or by regular mail addressed to:  Mail Stop OPEA, P.O. Box 1450, Alexandria, VA 22313–1450, ATTN: Elizabeth Shaw, and must be submitted by November 8, 2011.

    The Office also notes that it will be holding a public hearing on the prior user rights study from 8:30 to 11:30 am (EDT) on October 25, 2011 in the Madison Auditorium at the USPTO.  Those wishing to present oral testimony at the hearing must send a request to do so by e-mail to IP.Policy@uspto.gov by October 18, 2011.  Requests must be accompanied by the name of the person testifying, the person's contact information (telephone number and e-mail address), the organizations the person represents, if any, and a preliminary written copy of the person's testimony.  The USPTO plans to webcast the hearing.

    The notice concludes with a list of seven topics/questions for which the Office seeks comment and testimony.  Additional information regarding the submission of comments and the hearing can be found in the notice.

    The Office set forth its request for comments concerning international patent protection for small businesses in a second Federal Register notice (76 Fed. Reg. 62389).  Written comments regarding the study can be sent by e-mail to SMEpatenting@uspto.gov or by regular mail addressed to:  Saurabh Vishnubhakat, Attorney Advisor, Office of Chief Economist, United States Patent and Trademark Office, Mail Stop External Affairs, P.O. Box 1450, Alexandria, VA 22313–1450, and must be submitted by November 8, 2011.

    The notice also indicates that the Office will be holding two hearings regarding the study:  the first from 1 to 4 pm (EDT) on October 27, 2011, and the second from 9 am to 12 pm (EDT) on November 1, 2011.  The first hearing will be held in the Madison Auditorium at the USPTO and the second hearing will be held in the Gould School of Law at the University of Southern California.  Those wishing to present oral testimony at either hearing must send a request to do so by e-mail to SMEpatenting@uspto.gov by October 20, 2011 for the first meeting and by October 25, 2011 for the second meeting.  Requests must be accompanied by the name of the person testifying, the person's contact information (telephone number and e-mail address), the organizations the person represents, if any, and a preliminary written copy of the person's testimony.  The USPTO plans to webcast both hearings.

    The notice concludes with a list of ten topics/questions for which the Office seeks comment and testimony.  Additional information regarding the submission of comments and the hearings can be found in the notice.

  • Court Report

    By Sherri Oslick —

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

    Pfizer Inc. et al. v. Watson Pharmaceuticals Inc. et al.
    1:11-cv-00914; filed October 6, 2011 in the District Court of Delaware

    • Plaintiffs:  Pfizer Inc.; Alpharma Pharmaceuticals LLC; King Pharmaceuticals Inc.
    • Defendants:  Watson Pharmaceuticals Inc.; Watson Laboratories Inc.; Watson Pharma Inc.; Watson Laboratories Inc. – Florida

    Infringement of U.S. Patent Nos. 7,682,633 ("Pharmaceutical Composition," issued March 23, 2010), 7,682,634 ("Pharmaceutical Compositions," issued March 23, 2010), and 7,815,934 ("Sequestering Subunit and Related Compositions and Methods," issued October 19, 2010) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of Pfizer subsidiary King Pharmaceutical's EMBEDA® (morphine sulfate and naltrexone hydrochloride extended release capsules, used in the management of moderate to severe pain).  View the complaint here.


    Eisai Inc. v. Banner Pharmacaps Inc.
    1:11-cv-00901; filed October 4, 2011 in the District Court of Delaware

    Infringement of U.S. Patent Nos. 5,780,676 ("Compounds Having Selective Activity for Retinoid X Receptors, and Means for Modulation of Processes Mediated by Retinoid X Receptors," issued July 14, 1998) and 5,962,731 (same title, issued October 5, 1999) following a Paragraph IV certification as part of Banner's filing of an ANDA to manufacture a generic version of Eisai's Targretin® (bexarotene, used to treat cutaneous T-cell lymphoma).  View the complaint here.


    Cellectis S.A. v. Precision Biosciences Inc.
    1:11-cv-00890; filed September 30, 2011 in the District Court of Delaware

    Declaratory judgment of invalidity and non-infringement of U.S. Patent No. 8,021,867 ("Rationally Designed Meganucleases with Altered Sequence Specificity and DNA-Binding Affinity," issued September 20, 2011) based on Cellectis' manufacture and sale of its engineered I-Crel meganucleases.  View the complaint here.

  • Conference & CLE Calendar

    Calendar

    October 11, 2011 – America Invents Act: Patent Reform 2011 (Intellectual Property Law Association of Chicago) – 11:30 AM to 1:45 PM (CT)

    October 13, 2011 – Patent Reform: Prior Art under the AIA (Intellectual Property Owners Association) – 12:00 – 1:00 PM (ET)

    October 14, 2011 – Patent Reform: Impact and Strategy for University Research and Tech Transfer (Technology Transfer Tactics) – 1:00 – 5:00 PM (Eastern)

    October 19, 2011 – Biotechnology European Patent Case Law (D Young & Co.) – 7:00 – 7:45 AM (EDT) and 12:00 – 12:45 PM (EDT)

    October 19, 2011 – Impact of the New Patent Law: An Overview of the America Invents Act (McDonnell Boehnen Hulbert & Berghoff LLP) – 8:00 – 9:15 AM (CT)

    October 24-26, 2011 – Developing IP Strategies for Crystalline Forms*** (International Quality & Productivity Center) – London, UK

    October 25, 2011 – Innovation and Commerce — Global Legal Considerations (U.S. Patent and Trademark Office and Federal Circuit Bar Association) – Tokyo, Japan

    October 25-26, 2011 – FDA Boot Camp Devices Edition*** (American Conference Institute) – Chicago, IL

    October 26, 2011 – A Discussion with Robert Stoll of the USPTO (Association of Intellectual Property Firms) – 1:00 – 2:00 PM (EDT)

    October 26-27, 2011 – Joint Judicial Conference (U.S. Court of Appeals for the Federal Circuit and Tokyo Intellectual Property High Court) – Tokyo, Japan

    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 – Biotechnology from the Ground Up (Management Forum and JNB Marketing & Events) – San Diego, CA

    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 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 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

  • More CLE Events on Leahy-Smith America Invents Act

    A number of additional CLE events addressing the Leahy-Smith America Invents Act have been added to the list of events that we posted last week.  The new events include:

    IPO #2 In its continuing series of webinars on the Leahy-Smith America Invents Act, the Intellectual Property Owners Association (IPO) is offering a pair of one-hour presentations on October 13 and November 1, 2011.  The first webinar, entitled "Patent Reform: Prior Art under the AIA," will begin at 12:00 PM (ET), and the second webinar, entitled "Patent Reform: Advanced Prior Art under the AIA," will begin at 2:00 PM (ET).  The two webinars will look at how the Leahy-Smith America Invents Act alters traditional notions of prior art.  The panel includes Robert Armitage of Eli Lilly and Co.; Thomas Irving of Finnegan, Henderson, Farabow, Garrett & Dunner, LLP; and Joe Matal, Judiciary Committee Counsel to Senator Jon Kyl.

    The registration fee for each webinar is $120 (government and academic rates are available upon request).  Those interested in registering for the webinar can do so here.

    MBHB Logo 1 McDonnell Boehnen Hulbert & Berghoff LLP will be offering a live webinar on the "Impact of the New Patent Law: An Overview of the America Invents Act" on October 19, 2011 from 8:00 am to 9:15 am (CT).  Grantland Drutchas and Patent Docs author Dr. Donald Zuhn will provide an overview of the impact of the new patent law with respect to the following:

    • First-to-file versus first-to-invent;
    • Patent litigation;
    • Patent prosecution;
    • PTO fees, practices and operations;
    • Post-grant review;
    • Inter partes review;
    • False marking claims; and
    • Expansion of prior user rights.

    While there is no fee to participate, attendees must register in advance.  Those wishing to register can do so here.  CLE credit is pending for the states of California, Georgia, Illinois, North Carolina, New Jersey, New York, and Virginia.

    Strafford #1 Strafford will be offering a webinar entitled "Patent Reform: First to File Provisions" on November 15, 2011 from 1:00 – 2:30 PM (EST).  Stephen G. Kunin of Oblon, Spivak, McClelland, Maier & Neustadt LLP and Brad D. Pedersen of Patterson Thuente Christensen Pedersen, P.A. will provide guidance for counsel to IP owners and inventors on the first-to-file system under the new America Invents Law, and review what constitutes prior art and the new derivation practice.  The webinar will review the following questions:

    • What constitutes prior art under the new first-to-file system?
    • How does the derivation practice differ from interference practice?
    • How will the new first-to-file system under section 102 work under the AIA?

    An interactive Q&A session will follow the presentation.

    The registration fee for the webinar is $297 ($362 for registration and CLE processing).  Those registering by October 21, 2011 will receive a $50 discount.  Those interested in registering for the webinar, can do so here.

    IBC Legal IBC Legal Conferences will be holding "The US Patent Reform Congress" on November 18, 2011 in London, UK.  IBC Legal faculty will offer presentations on the following topics:

    • An update & key points of focus: The changing landscape for intellectual property owners — presented by Q. Todd Dickinson, Executive Director for the American Intellectual Property law Association;
    • Identifying & understanding the new "first-to-file" system & grace period;
    • An overview of the post-grant review proceedings;
    • The impact of the post-grant review proceedings;
    • The addition of third party pre-issuance submissions;
    • USPTO practice reforms — to be presented by Teresa Stanek Rea, Deputy Director of the U.S. Patent and Trademark Office;
    • A round-up of smaller but significant changes;
    • The US patent reform from a European perspective — to be presented by Wim van der Eijk, Principal Director Patent Law and Multilateral Affairs of the European Patent Office; and
    • The industry's perspective: Operating in a new statutory environment (panel discussion).

    A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.

    The registration fee for the conference is £999.  Those registering by October 21, 2011 will receive a £100 discount.  Those interested in registering for the conference can do so here, by calling +44 (0)20 7017 5503, or by faxing a registration form to +44 (0)20 7017 4746.

  • Webinar on European Biotech Patent Law

    D Young & Co D Young & Co. will be offering a live webinar on "Biotechnology European Patent Case Law" on October 19, 2011.  The 45-minute webinar will be offered at two times:  7:00 am (EDT) and 12:00 pm (EDT).  Robert Dempster and Simon O'Brien will provide an essential update and live Q&A on European biotechnology case law.

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

  • Australian Senate Committee Issues Recommendation on Gene Patenting Bill

    By Donald Zuhn —

    Australian Senate Last month, the Legal and Constitutional Affairs Legislation Committee of the Australian Senate issued its recommendation on a bill that would have prevented the patenting of biological materials that are identical or substantially identical to materials as they exist in nature (such as genes and proteins).  The Patent Amendment (Human Genes and Biological Materials) Bill 2010, which was introduced by Senators Helen Coonan, Bill Heffernan, Rachel Siewert, and Nick Xenophon last November, would have amended Section 18 of the Australian Patents Act 1990 to add "biological materials including their components and derivatives, whether isolated or purified or not and however made, which are identical or substantially identical to such materials as they exist in nature" to the list of inventions that are not patentable.

    The Committee's 124-page report included the recommendation that "the Senate should not pass the Bill."  In a more detailed discussion of the Committee's conclusions and recommendations, the report states that:

    [T]he committee does not agree that the Bill represents an effective solution to the problems which may be caused by patents over human genes and biological materials.  In particular, the committee is concerned that proposed amendments in the Bill, which are focused on addressing a specific issue, could have a large number of unintended consequences across the entire patent system with indeterminate impacts on a range of industries and sectors.

    * * *

    Despite the need for further reform to the patent system, the committee agrees that removing an area of patentable subject matter, as proposed by the Bill, is not an appropriate solution to this complex set of issues.

    Australia Coat of Arms In a report in The Australian, one of the bill's co-sponsors, Sen. Bill Heffernan, stated that despite the Committee's recommendation, "[t]he fight has just begun" ("Senate patently at odds over genes").  The debate over the Australian gene patenting bill was complicated by another bill, the Intellectual Property Laws Amendment (Raising the Bar) Bill 2011, which would guarantee free access to "patented inventions for research and regulatory activities."  While the Legislation Committee acknowledged that the amendments in the Raising the Bar Bill would not resolve all of the issues in the patent system, the committee noted that it preferred the solutions offered in that bill over those in the Human Genes and Biological Materials bill.

    For additional information on this topic, please see:

    • "Australian Senate to Release Gene Patenting Findings Next Week," June 8, 2010
    • "Gene Patenting: Australian Potpourri," December 28, 2009

  • AUTM Survey Shows Significant Increases in University Patent Filings and Issuances in FY2010

    By Donald Zuhn —

    AUTM The Association of University Technology Managers (AUTM) recently presented the highlights of the AUTM Licensing Activity Survey Summary for FY2010.  While the full report will be released later this fall, the academic technology transfer organization noted that "[d]espite continuing difficult economic conditions, university and research institute licensing and startup activity remained very strong" in 2010.  In particular, the AUTM survey found that 651 university start-ups were created in 2010, up 9.2% from the 596 university start-ups created in 2009.  The survey also found that licensing revenue rose 3.0% from 2009 to 2010, reversing a sharp decline that saw revenue drop 32.5% between 2008 and 2009.  The number of licenses also increased in 2010, albeit only by 0.6%.

    The AUTM survey also found that research expenditures were up 10.5% to $59.1 billion and income from licenses hit $2.4 billion (up from $2.3 billion in 2009).  With regard to IP management, the survey shows that invention disclosures increased by 1.6% to 20,642; 12,281 new U.S. patent applications were filed by survey respondents (up 46.8% from the 8,364 applications filed in 2009); and 4,469 U.S. patents were issued to survey respondents (a 30.8% increase from the 3,417 patents issued to respondents in 2009).  AUTM noted that the increase in patent issuances was the largest the group had seen in the 17 years that it has been collecting licensing data.

    The survey was generated from 183 responses to a survey sent to 307 U.S. institutions, consisting of 236 universities and colleges, 65 hospitals and research institutions, two national laboratories, and four third-party technology investment firms.  Additional information regarding the AUTM survey can be found here.

    For additional information on other related topics, please see:

    • "University Start-ups and Licensing Activity Held Steady During Recession," October 7, 2010
    • "AUTM Survey Shows Drop in Issued Patents," March 9, 2010