•     By Donald Zuhn

    Managing Intellectual Property has released its sixth annual list of the most influential people in intellectual property (see "Politics, power and passion — this year’s MIP 50").  The MIP 50 appears in the magazine’s July/August issue, and can also be found on the magazine’s website (access to the online article requires a subscription or trial membership).  The list of intellectual property movers and shakers was decided by Managing IP reporters based on recommendations and research.  The top ten "individuals" on Managing IP’s list include:

    1.  "The avatar," Second Life

    2.  Margot Fröhlinger, Director, European Commission DG Internal Market

    Knowles_sherry
    3.  Sherry Knowles, Worldwide head of IP, GlaxoSmithKline – spearheaded the lawsuit against the USPTO regarding the Office’s new continuation and claims rules.  The victory in Tafas/GSK v. Dudas could have an impact on other USPTO rules packages, such as the alternative claiming rules, which Knowles noted "change[s] the way chemical and pharmaceutical and biotech patent practice has taken place over the last 100 years and will make it impossible to prosecute a genus of chemical compounds."

    Dudas_jon
    4.  Jon Dudas, Director, USPTO – labeling the Director as a "controversial reformer," Managing IP noted that "he has been the target of criticism from those in the patent community who feel his lack of IP background has resulted in policies that may be harmful to US innovation."  In addition to the Office’s new continuation and claims rules, currently on appeal before the Federal Circuit, the Director has also actively promoted the administration’s applicant quality submissions (AQS) provision to the Senate patent reform bill.

    5.  Li Qunying, Director of IPR division, General Administration of Customs, China

    6.  Francis Gurry, Deputy Director-General, WIPO

    7.  Kapil Sibal, Union Minister in the Ministry of Science and Technology, India

    8.  Rhonda Steele, INTA president and Asia-Pacific marketing properties manager, Mars

    Judge_michel
    9.  Chief Judge Paul Michel, U.S. Court of Appeals for the Federal Circuit – while the percentage and complexity of patent cases heard by the CAFC increases, the Chief Judge "rejects the notion that the [Supreme] Court has increased its focus on patent cases in recent years," noting that the Court actually heard more patent cases in 2001 and 2002 than in recent years.  The Chief Judge, however, concedes that recent Supreme Court cases have involved "fundamental issues."

    10.  Ron Layton, Chief Executive, Light Years IP

    Managing IP’s list also includes a number of other individuals who will be familiar to Patent Docs readers — and others who may not be familiar, but should be — including:

    Ungpakorn_jon
    11.  Jon Ungphakorn, campaigner and AIDS activist – a former member of Thailand’s senate, Ungphakorn began working on AIDS issues in Thailand in 1989, and is now executive secretary of the AIDS Access Foundation and a member of the board of the government’s Universal Health Insurance Programme.  He remains committed to compulsory licensing as the only means of access to drugs.

    Ravicher
    24.  Dan Ravicher, Legal Director, Public Patent Foundation – has been leading a challenge of three Wisconsin Alumni Research Foundation (WARF) stem cell patents.  Ravicher’s group argued that "the three WARF patents were impeding scientific progress and driving vital stem cell research overseas."  According to Managing IP, the PUBPAT Legal Director has also been "outspoken about his support for the USPTO’s enjoined rules package on claims and continuations, which have been the subject of considerable controversy among the patent community."  Speaking on the Tafas/GSK case, Ravicher told Managing IP that "[w]hile patent holders and patent attorneys may couch their arguments in terms of the public interest, in reality their interest is in their own profits and livelihoods, not in designing a patent system that fosters the overall rate of innovation."

    Schwab_susan
    25.  Susan Schwab, U.S. Trade Representative – manages the USTR’s Office of Intellectual Property and Innovation, which produces the Special 301 report, a comprehensive annual review of the global state of IP rights protection and enforcement.  The 2008 report designated China and Russia as the main areas of concern, and included Venezuela, Argentina, Chile, India, Israel, Thailand, and Pakistan on the priority watch list.

    Leahy_patrick
    29.  Patrick Leahy, Chairman, U.S. Senate Judiciary Committee – the Vermont Senator spent the past year seeking a compromise between the IT and telecommunications industries and the pharmaceuticals and biotechnology industries with respect to the Senate patent reform bill (S. 1145), which he introduced.  Senator Leahy characterized the removal of S. 1145 from the Senate calendar in April as "a missed opportunity."

    Malackowski_jim_2
    33.  Jim Malackowski, President and CEO, Ocean Tomo – launched Ocean Tomo, which has become known for its public auctions of intellectual property, in 2003.  Sales at the spring 2008 auction totaled $19,629,500.

    Chan_margaret_who_3
    36.  Margaret Chan, Director-General, World Health Organization – has sought a resolution to the controversy over Thailand’s decision to issue compulsory licenses for a range of anti-AIDS and anti-cancer drugs.

    Griswold_gary
    42.  Gary Griswold, President and CEO, 3M Innovative Properties – played a crucial role on U.S. patent reform discussions as chairman of the Coalition for 21st Century Patent Reform.

    More detailed descriptions of the above individuals, as well as descriptions of the other members of the MIP 50, can be found in the Managing IP article. 

  •     By Sherri Oslick

    Gavel_9
    About
    Court Report:  Each week we will report briefly on recently filed
    biotech and pharma cases, and a few interesting cases will be selected
    for periodic monitoring.


    Shire LLC v. Actavis South Atlantic, LLC et al.

    2:08-cv-00287; filed July 24, 2008 in the Eastern District of Texas

    Infringement of U.S. Patent Nos. 5,326,570 ("Advanced Drug Delivery System and Method of Treating Psychiatric, Neurological and Other Disorders with Carbamazepine," issued July 5, 1994) and 5,912,013 (same title, issued June 15, 1999) following a Paragraph IV certification as part of Actavis’ filing of an ANDA to manufacture a generic version of Shire’s Carbatrol® (carbamazepine, used to treat epilepsy and trigeminal neuralgia).  View the complaint here.


    AstraZeneca LP et al. v. Mylan Pharmaceuticals Inc.

    1:08-cv-00453; filed July 22, 2008 in the District Court of Delaware

    Infringement of U.S. Patent Nos. 6,423,340 ("Method for the Treatment of Inflammatory Bowel Diseases," issued July 23, 2002) and 5,643,602 ("Oral Composition for the Treatment of Inflammatory Bowel Diseases," issued July 1, 1997) following a Paragraph IV certification as part of Mylan’s filing of an ANDA to manufacture a generic version of AstraZeneca’s Entocort® EC (budesonide, used to treat mild to moderate Crohn’s disease).  View the complaint here.


    Cephalon Inc. et al. v. Barr Pharmaceuticals Inc. et al.

    1:08-cv-00455; filed July 22, 2008 in the District Court of Delaware

    Infringement of U.S. Patent Nos. 6,200,604 ("Sublingual Buccal Effervescent," issued March 13, 2001) and 6,974,590 (same title, issued December 13, 2005) following a Paragraph IV certification as part of Barr’s filing of an ANDA to manufacture a generic version of Cephalon’s Fentora® (fentanyl citrate buccal tablets, used to treat breakthrough pain in adult patients with cancer).  View the complaint here.


    Astellas Pharma Inc. et al. v. Impax Laboratories, Inc.

    5:08-cv-03466; filed July 18, 2008 in the Northern District of California

    Infringement of U.S. Patent No. 4,703,063 ("Sulfamoyl Substituted Phenethylamine Derivatives and Process of Producing Them," issued October 27, 1987) following a Paragraph IV certification as part of Impax’s filing of an ANDA to manufacture a generic version of Astellas’ Flomax® (tamsulosin hydrochloride, used to treat benign prostatic hyperplasia, sold in the U.S. by Boehringer Ingelheim Corporation.  View the complaint here.


    Hoffmann-La Roche Inc. v. Dr. Reddy’s Laboratories, Ltd. et al.

    2:08-cv-03607; filed July 18, 2008 in the District Court of New Jersey

    Infringement of U.S. Patent No. 7,192,938 ("Method of Treatment Using Bisphosphonic Acid," issued March 20, 2007) following a Paragraph IV certification as part of an amendment to Dr. Reddy’s ANDA to manufacture a generic version of Roche’s Boniva® (150 mg once-monthly tablets) (ibandronate sodium, used to treat post-menopausal osteoporosis).  View the complaint here.


    Apotex Inc. v. Shire LLC

    2:08-cv-03598; filed July 17, 2008 in the District Court of New Jersey

    Declaratory judgment of non-infringement and invalidity of U.S. Patent Nos. 5,326,570 ("Advanced Drug Delivery System and Method of Treating Psychiatric, Neurological and Other Disorders with Carbamazepine," issued July 5, 1994) and 5,912,013 (same title, issued June 15, 1999) in conjunction with Apotex’s filing of an ANDA to manufacture a generic version of Shire’s Carbatrol® (carbamazepine, used to treat epilepsy and trigeminal neuralgia).  View the complaint here.

  • Calendar_8
    August 11-12, 2008 – Advanced Patent Prosecution Workshop 2008: Claim Drafting & Amendment Writing (Practising Law Institute) – San Francisco, CA

    August 10-15, 2008 – Advanced Courses (Patent Resources Group) – Washington, DC

    September 11, 2008 – Developments in Pharmaceutical and Biotech Patent Law (Practising Law Institute) – New York, NY

    September 11-12, 2008 – Current Issues in Complex IP Licensing (Law Seminars International) – Philadelphia, PA

    September 15-16, 2008 – Biotech Patents*** (American Conference Institute)

    September 21-23, 2008 – 2008 Annual Meeting (Intellectual Property Owners Association) – San Diego, CA

    September 22-23, 2008 – USPTO Boot Camp: Patent Edition*** (American Conference Institute) – Alexandria, VA

    September 22-23, 2008 – FDA Boot Camp*** (American Conference Institute)

    September 22-23, 2008 – Patent Litigation 2008 (Practising Law Institute) – San Francisco, CA

    September 23-24, 2008 – Biotech Patenting (C5) – London, England

    October 6-7, 2008 – Patent Litigation 2008 (Practising Law Institute) – McLean, VA

    October 7-8, 2008 – Global Patent Litigation*** (American Conference Institute) – New York, NY

    October 15, 2008 – Developments in Pharmaceutical and Biotech Patent Law (Practising Law Institute) – San Francisco, CA

    October 15-17, 2008 – Maximizing Pharmaceutical Patent Lifecycles*** (American Conference Institute) – New York, NY

    October 23-24, 2008 – Patent Litigation 2008 (Practising Law Institute) – Chicago, IL

    October 28-29, 2008 – Pharma/Biotech IP Due Diligence*** (C5) – Amsterdam, Netherlands

    November 10-11, 2008 – Patent Litigation 2008 (Practising Law Institute) – Atlanta, GA

    November 17-18, 2008 – Patent Litigation 2008 (Practising Law Institute) – New York, NY

    November 19-20, 2008 – Paragraph IV on Trial*** (American Conference Institute) – New York, NY

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

  •     By Christopher P. Singer

    EFS-Web Survey

    Efsweb
    The U.S. Patent and Trademark Office is conducting a customer satisfaction survey relating to the experiences that registered users have had with EFS-Web.  The deadline for filling out the survey is 11:30 p.m. (EDT) on Sunday, July 27, 2008.  The USPTO estimates that the survey takes approximately 10 minutes to complete.  The survey can be accessed here or upon logging onto Private PAIR or as a registered EFS-Web user.

    The survey includes multiple choice questions relating to organizational and individual practices and motivations for using EFS-Web, e-filing policies and practice, volume of filings, most beneficial and most difficult aspects of EFS-Web, general satisfaction with EFS-Web and EBC assistance, use habits, and other desired features.  After taking the survey, I realized (again) that because of EFS-Web, electronic filing has become a very reliable and convenient filing option for practitioners.  There is little doubt that it represents one of the most successful programs instituted by the USPTO in recent years.

    For those unable to complete the survey by July 27, the USPTO always accepts feedback by e-mail to:  EFSFeedback@uspto.gov.  Further, the EBC Customer Service Center is always available to field any specific questions about EFS-Web, PAIR, PKI, or any other component of their e-Commerce initiatives at 866-217-9197 (toll-free) or 571-272-4100 or by e-mail at:  ebc@uspto.gov.

    New Online System for Registered Practitioner Contact Information

    Uspto_seal_no_background_2
    The USPTO announced on July 25 that it plans to introduce a system that will allow registered practitioners to update their official address of record with the Office of Enrollment and Discipline (OED) through an online interface.  This system should eliminate delays and processing errors in updating information, reduce losses caused by mailings made to obsolete addresses, and ensure prompt receipt of critical communications from OED.  Further, as registered patent practitioners are required to update the OED regarding address changes, the on-line customer interface should make compliance with that requirement much easier.

    To implement this program, the OED will send a letter containing the practitioner’s user identification number to the official address currently listed on the official roster of registered patent attorneys and agents.  The user identification number, along with a separately-retrieved password, will allow the practitioner access to the practitioner’s records through the OED customer interface.  The letter will be sent only to practitioners listed on the official roster of registered patent attorneys and agents, and only to the address in the roster.  So, if your current address information on the official roster (check here) is incorrect, you should complete the address change form (available here), and mail it to Mailstop OED, U.S. Patent and Trademark Office, P.O. Box 1450, Alexandria, Virginia 22313-1450.

  • American Conference Institute (ACI) will be holding its Paragraph IV on Trial conference on November 19-20, 2008 in New York.  At this conference, patent litigators experienced in representing both generic and brand name drug manufacturers will work through a mock trial based on a real world ANDA filing.  The mock trial, Yankee Branded Pharmaceuticals v. Metro Generic Pharmaceuticals, will allow attendees to hone advocacy and litigation skills in:

    • Communicating with the judge in a clear and concise manner while presenting complex technical and scientific information to the court;
    • Developing a cohesive and scientifically-supported theory to address issues raised by infringement, validity, and inequitable conduct claims during trial;
    • Addressing prior art and discrepancies in the patented product’s prosecution history in a manner that supports the theory of your case; and
    • Handling expert and fact witnesses on the stand during direct and cross examination when testifying about sensitive product and company details.

    Paragraph_iv_on_trial
    The conference is structured as an actual trial based on an ANDA filing involving a compound and a formulation patent, during which ACI’s faculty will conduct live demonstrations of direct and cross examinations.  ACI’s faculty will also delve into the key issues at stake during trial, including:

    • Infringement — how to lay the proper foundation through your expert in order to build your case;
    • Obviousness and anticipation — tactics for handling prior art testimony and addressing arguments of validity and invalidity;
    • Secondary considerations — strategies for effectively presenting technical experts and communicating complex, scientific and technical information to the court; and
    • Inequitable conduct — dealing with testifying patent law experts and complicated prosecution records during trial.

    In addition, two panels, one comprised of six jurists experienced in patent litigation, and the other composed of six in-house IP counsel representing both brand name and generic manufacturers, will share their commentary and insights into what factors they consider when deciding and engaging in Paragraph IV litigation.

    An additional master class entitled:  "Litigator’s master class on Paragraph IV pre-trial preparation:  Filing strategies, witness selection, motions and claim construction" will be offered on November 18, 2008.  During the master class, experienced patent litigators representing both brand name and generic manufacturers will discuss proven strategies for preparing for a Paragraph IV case.

    The agenda and mock trial fact pattern for the Paragraph IV on Trial conference can be found here.  A complete brochure for this conference, including an agenda, list of speakers, mock trial fact pattern, and registration form can be downloaded here.

    Aci_american_conference_institute_2
    The registration fee ranges from $2,195 (conference alone) to $2,795 (conference and master class).  Those registering on or before September 12, 2008 will receive a $300 discount off the registration fee and those registering on or before October 24, 2008 will receive a $200 discount off the registration fee.  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 sponsor of ACI’s Paragraph IV on Trial conference.

  • C5 (UK) will be holding its Biotech Patenting conference on September 23-24, 2008 in London, England.  The conference will allow attendees to:

    • Analyze the practical impact of recent changes at the UK-IPO, EPO, and USPTO;
    • Increase knowledge of developments in follow-on biologics and antibody technologies in the patent area;
    • Manage the challenges posed by the conflicting legal approaches to gene patenting;
    • Establish a successful global patent strategy and successfully protect biotech patents in China and India;
    • Get the latest information on second medical use claims; and
    • Tackle inventorship and patent entitlement disputes.

    In particular, C5 faculty will offer presentations on the following topics:

    Biotech_patenting
    • Critical update on legislative and policy developments at the UK-IPO and EPO;
    • EPO insight:  An examiner’s perspective on biotech patent applications;
    • Review of recent EPO and EU National Court biotech decisions;
    • Impact of the EPC 2000 on medical use claims;
    • Analysis of the latest decisions of the U.S. courts and their implications;
    • Implications and status of the patent reform act;
    • Obviousness determinations after KSR v. Teleflex;
    • How to successfully obtain and enforce your biotech patents in China and India;
    • Keynote presentation:  Judicial address from Federal Circuit Judge Randall Rader;
    • Developing your patent strategy to develop competitive advantage, obtain maximum revenue and extend patent lifecycles;
    • Unravelling the legal conflict in gene patenting in Europe;
    • Comparison of the U.S. and European legal issues surrounding biosimilars:  Legislation, case law, and approvals to date;
    • Case study on bringing and defending inventorship and patent entitlement actions; and
    • Managing your biotech patent litigation:  In-house and outside counsel perspectives.

    Two additional pre-conference workshops will be offered on September 22, 2008.  The first pre-conference workshop, entitled "Advanced Practical Workshop on Successfully Evaluating Freedom to Operate" and "Successfully Evaluating Freedom to Operate," will held from 8:30 am to 12:00 pm, and will cover the preparation and conduct of FTO searches, including how to analyze FTO search results and communicate them for the purposes of patent procurement and company reporting.  This workshop will use a real-life FTO case study to highlight key strategic points, including the design of the FTO search and drafting of the FTO report.  The second pre-conference workshop, entitled "How to Conduct Effective IP Due Diligence," will be held from 1:00 pm to 4:30 pm, and will provide step-by-step guidance on how to conduct thorough due diligence and ensure that costly mistakes that erode IP value are avoided.  In addition to providing information on key legal and business issues impacting IP due diligence, this workshop will provide insights on the essential components of a due diligence review, spotting IP red flags and managing the reporting process.

    The agenda for the Biotech Patenting conference can be found here.  A complete brochure for this conference, including an agenda, list of speakers, and registration form can be downloaded here.

    C5
    The registration fee for the conference is £1878.83 ($3,739.78), for the conference plus one workshop £2582.65 ($5,140.73), and for the conference plus both workshops £3286.48 ($6,541.69); attendees can also register for just one workshop for £703.83 ($1,400.96).  For those registering on or before August 26, 2008, the registration fee for the conference is £1643.83 ($3,272.02), for the conference plus one workshop £2347.65 ($4,672.96), for the conference plus both workshops £3051.48 ($6,073.93), and for just one workshop £703.83 ($1,400.96).  Those interested in registering for the conference can do so here, by calling +44 (0) 20 7878 6888, by faxing a registration form to +44 (0) 20 7878 6896, or by e-mailing marketing@C5-Online.com.

  •     By Kevin E. Noonan

    One of the promises of the genomics revolution of the late 20th Century is the advent of personalized medicine.  The belief was (and is) that the unfolding understanding of genetic variation stemming from sequence analysis of genes known or discovered to be involved in an individual’s response to a drug would permit physicians to identify which patients should (and more importantly) should not receive a particular drug.  In addition to these benefits for individuals, the prospect of understanding how genetic variation affected drug responses was also believed to provide a way to screen populations of drug trial participants, to avoid clinical trial failures for pharmaceutical lead compounds because the trial population contained individuals whose genetic makeup was inappropriate for the drug.

    Like a great deal of the biotechnology revolution, these prospects have not generally come to fruition.  There have been some applications of the personalized medicine paradigm (excessive toxicity of Camptosar® (irinotecan) for colon carcinoma is associated with the *28 variant of UGT1A1 enzyme, for example), but by and large most patients and their physicians do not test their genotype before taking (or prescribing) a drug.  This makes those instances where the genetic component is taken into account more noteworthy; the latest example involves GlaxoSmithKline’s drug abacavir (structure at right), a reverse transcriptase inhibitor drug used widely for infection with the human immunodeficiency virus and its sequellae, acquired immune deficiency syndrome.  It is sold as Ziagen®, and is also a component in two other AIDS medications, Trizivir® (abacavir sulfate/lamivudine/zidovudine) and Epzicom® (abacavir sulfate/lamivudine).

    Ziagen
    The reason for genotype testing is simple:  the Food and Drug Administration has determined that administering the drug to people having the ‘wrong’ genotype can be life-threatening.  The problem is a severe allergic reaction in people with a particular variant gene in the human immunohistocompatibility complex.  This variant, HLA-B*5701, is associated with more than a 15-fold increase in the incidence of a hypersensitivity reaction (from 4% to 61%) when these patients are administered the drug, and prescreening for the variant reduces the incidence of hypersensitivity reactions from 7.8% to 3.4%.  Symptoms of the reaction range from the merely annoying (rash, nausea) to the severe (fever, breathing difficulties).

    Fda
    The FDA posted the following notice on its website earlier today:

    FDA informed healthcare professionals that serious and sometimes fatal hypersensitivity reactions (HSR) caused by abacavir therapy are significantly more common in patients with a particular human leukocyte antigen (HLA) allele, HLA-B*5701.  FDA reviewed data from two studies that support a recommendation for pre-therapy screening for the presence of the HLA-B*5701 allele and the selection of alternative therapy in positive subjects.  Genetic tests for HLA-B*5701 are available and all patients should be screened for the HLA-B*5701 allele before starting or restarting treatment with abacavir or abacavir-containing medications.  Development of clinically suspected abacavir HSR requires immediate and permanent discontinuation of abacavir therapy in all patients, including patients negative for HLA-B*5701.

    The association of this genetic variant with the hypersensitivity reaction was first reported in February by a multinational group including GSK researchers, in an article in the New England Journal of Medicine (see "HLA-B*5701 Screening for Hypersensitivity to Abacavir").

    The drug currently bears this warning:

                                         WARNINGS

    Hypersensitivity Reactions: Serious and sometimes fatal hypersensitivity reactions have been associated with ZIAGEN (abacavir sulfate).  Hypersensitivity to abacavir is a multi-organ clinical syndrome usually characterized by a sign or symptom in 2 or more of the following groups: (1) fever, (2) rash, (3) gastrointestinal (including nausea, vomiting, diarrhea, or abdominal pain), (4) constitutional (including generalized malaise, fatigue, or achiness), and (5) respiratory (including dyspnea, cough, or pharyngitis).  Discontinue ZIAGEN as soon as a hypersensitivity reaction is suspected.  Permanently discontinue ZIAGEN if hypersensitivity cannot be ruled out, even when other diagnoses are possible.  Following a hypersensitivity reaction to abacavir, NEVER restart ZIAGEN or any other abacavir-containing product because more severe symptoms can occur within hours and may include life-threatening hypotension and death.

    Reintroduction of ZIAGEN or any other abacavir-containing product, even in patients who have no identified history or unrecognized symptoms of hypersensitivity to abacavir therapy, can result in serious or fatal hypersensitivity reactions.  Such reactions can occur within hours (see WARNINGS and PRECAUTIONS: INFORMATION FOR PATIENTS).

    Lactic Acidosis and Severe Hepatomegaly: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including ZIAGEN and other antiretrovirals (see WARNINGS).

    Glaxosmithkline_gsk
    The good news for GSK is that the percentage of the population bearing this variant is small — about 5%.  The company also benefits from having a way of preventing this small percentage of patients from being harmed by the drug.  This may offset the negative consequences stemming from the FDA’s intention to include the genotype advisory in a "black box" label for the drug, which alerts physicians to potentially significant side-effects but also can inhibit physicians from prescribing the drug in the first place.  Having a way to determine whether a particular patient falls outside the proscribed patient population should be sufficiently reassuring to physicians that prescriptions should not plummet as a consequence of the new labeling.

  •     By Donald Zuhn

    Ipo_2
    The Intellectual Property Owners Association (IPO) reported today on data compiled by Esther Kepplinger, the Director of Patent Operations for Wilson Sonsini Goodrich & Rosati, which the IPO believes "has received little attention and has contributed to misunderstanding of patenting trends."  In particular, Ms. Kepplinger’s analysis shows that Requests for Continued Examination (RCEs) rose from 8.3% in 1998 to 19.6% in 2007, while continuation and divisional filings remained relatively stable over the same period (continuation filings rose from 10.7% to 11%; divisional filings dropped from 5.1% to 4.8%).  Noting that the Patent Office currently counts an original application as one application and a subsequent RCE as a "second" application (with the original application counting as an abandoned application), the IPO argued that "[r]eported increases in U.S. patent filings of 9.2 percent in 2006 and 5.2 percent in 2007 would have been substantially smaller without the increase in RCEs," and further, that "[t]he highly-publicized decline in the USPTO’s ‘allowance rate’ . . . is attributable in part to the rise in RCEs, which results in more unallowed (i.e., abandoned) applications."

    Kepplinger_esther
    Ms. Kepplinger (at left) discussed her analysis on filing trends last month during a panel discussion at the Biotechnology Industry Organization (BIO) International Convention.  For more information regarding Ms. Kepplinger’s presentation, Patent Docs readers are encouraged to refer to our report on the presentation (see "Docs at BIO: Panel Discusses Impact of USPTO Rules Changes and Patent Reform Legislation on Biotech Patenting").

  •     By Christopher P. Singer

    Uspto_seal_no_background_2
    In a July 16, 2008 press release, the U.S. Patent and Trademark Office announced it will extend the duration, increase the maximum number of applications, and expand the scope of applications eligible to participate in its Peer Review Pilot program.  The extension and expansion became effective on July 16, 2008.

    Peer_to_patent
    The Peer Review Pilot program is intended to encourage the public to review published patent applications and submit technical references and comments on what participants believe is the best prior art to consider during the examination of those applications.  Since its inception in June 2007, the pilot has been limited to patent applications in the computer-related arts (Technology Center 2100).  As of July 16th, the scope of the program is expanded to include applications in the automated business data processing technologies class 705 (business methods).  Those having technical expertise in computer and business methods-related arts and who register with peertopatent.org at their website will be eligible to review and submit information for up to 400 published patent applications.  The Peer-to-Patent Project is organized by the New York Law School’s Institute for Information Law and Policy.

    The pilot program is extended for an additional 12 months and will end on June 15, 2009.  According to the USPTO press release, companies that have participated in the Peer Review Pilot include IBM, Microsoft, Hewlett-Packard, Sun Microsystems, Intel, GE, Red Hat, Cisco, and Yahoo!, among others.

    More information about this program, including the Official Gazette notice, can be found here.

  •     By Christopher P. Singer

    Uspto_seal_no_background_2
    In a Notice published in the Federal Register (73 Fed. Reg. 42781) on Wednesday, July 23, 2008, the U.S. Patent and Trademark Office discussed the general scope of the foreign filing licenses that it issues.  While the Notice states that it serves to clarify the existing law and regulations, the USPTO was motivated to publish it in light of the Office "becoming aware that a number of law firms or service provider companies located in foreign countries are sending solicitations to . . . practitioners offering their services in connection with the preparation of patent applications to be filed in the United States."  The Notice reminds practitioners that the export of subject matter abroad pursuant to a USPTO-issue foreign filing license is limited to purposes related to the filing of foreign patent applications (see 37 C.F.R. § 5.15).  The Notice states unequivocally that a foreign filing license from the USPTO does not authorize exporting of subject matter abroad for the preparation of patent applications to be filed in the United States.

    Earth_2
    Accordingly, Applicants who consider exporting subject matter abroad for the preparation of patent applications to be filed in the United States should contact the Bureau of Industry and Security (BIS) at the Commerce Department in order to secure the appropriate clearances, as the USPTO’s foreign filing licenses do not authorize this exportation.  This Bureau promulgates the Export Administration Regulations (EAR) which govern the export of a variety of goods and materials, including technical data.  More information regarding the EAR can be found at the Bureau’s website, or the Bureau’s Outreach and Educational Services Division, which can be contacted at 202-482-4811.

    Those wishing to get further information regarding this Notice can contact Mr. Mike Carone, Supervisory Patent Examiner, Technology Center 3600 by telephone at 571-272-6873.