Patent Docs

TTT Webinar on Changes in Defense Options under AIA

2012-05-27T23:17:13-05:00

Technology Transfer Tactics will be offering a webinar entitled "The Elimination and Creation of Defenses in the Wake of AIA" on June 14, 2012 from 1:00 - 2:00 pm (Eastern). U.S. and European patent attorney Robert Lelkes of Steffin Lelkes Azod, LLP will cover those portions of the Leahy-Smith America Invents Act that impact the elimination and creation of certain defenses and provide practical strategies for protecting patents. The webinar will cover the following topics: • Enhance university income from patents via preservation of the university exception to the prior use defense; • Preserve ownership of inventions via the new...

ACI Freedom to Operate Conference

2012-05-25T23:59:00-05:00

American Conference Institute (ACI) will be holding its 6th National Tactical and Practical Guide to Freedom to Operate on July 30-31, 2012 in Philadelphia, PA. The conference will allow attendees to: • Preserve privilege and confidentiality in freedom to operate opinions; • License your way out of trouble; • Analyze smart freedom to operate game plans post-America Invents Act; • Evaluate the effects of the recent Mayo v. Prometheus decision and determine its impact on protecting diagnostic methods; • Utilize new procedures like post-grant review to challenge troubling patents; • Create a "living" freedom to operate strategy conducted in tandem...

USPTO Revises Agenda for Next BCP Customer Partnership Meeting

2012-05-25T23:55:00-05:00

The U.S. Patent and Trademark Office has announced a revised agenda for the next biotechnology/ chemical/pharmaceutical (BCP) customer partnership meeting to be held on June 6, 2012. New to the agenda is an afternoon session on the Recommendation for the Disclosure of Sequence Listings using XML (Proposed ST.26). The time slots for a number of sessions have also been changed. The revised agenda is as follows: Morning Session • Opening Remarks (9:00 - 9:15 am ET): George Elliott, Wanda Walker, and Dan Sullivan (Acting), Directors, Technology Center 1600 • AIA Update (9:15 - 10:15 am): Janet Gongola, Patent Reform Coordinator...

Obama Administration Releases National Bioeconomy Blueprint

2012-05-24T23:59:00-05:00

By Kevin E. Noonan -- In April, the White House released a policy paper what was styled the "National Bioeconomy Blueprint." Its presumptions are based on the idea that the portion of the economy "fueled by research and innovation in the biological sciences" is a "large and rapidly growing segment of the world economy that provides substantial public benefit." This has caused innovation in the biological sciences to become a priority of the Obama Administration, promising not only economic development but to "live longer, healthier lives, reduce our dependence on oil, address key environmental challenges, transform manufacturing processes, and increase...

USPTO News Briefs

2012-05-23T23:59:00-05:00

By Donald Zuhn -- USPTO Releases Certain AIA Implementation Dates The U.S. Patent and Trademark Office recently updated its Leahy-Smith America Invents Act Implementation micro-site to announce several AIA implementation dates. On the micro-site, USPTO Patent Reform Coordinator Janet Gongola (at right) indicated that the Office will submit its genetic testing study to Congress (pursuant to § 27 of the AIA) on June 15; will issue a Federal Register notice making the Patent Ombudsman Program permanent in June or July; will issue three notices of proposed rulemaking on First-Inventor-to-File, Fee Setting, and Micro-entity provisions and one guidance document on the...

Court Report - Part II

2012-05-23T23:22:06-05:00

By Sherri Oslick -- In an effort to catch up with recently filed biotech and pharma cases, Patent Docs presents this additional installment of Court Report. Janssen Products, L.P. et al. v. Lupin Ltd. et al. 2:12-cv-02840; filed May 10, 2012 in the District Court of New Jersey • Plaintiffs: Janssen Products, L.P.; Janssen R&D Ireland; G.D. Searle, LLC • Defendants: Lupin Ltd.; Lupin Pharmaceuticals Inc. Infringement of U.S. Patent No. RE42,889 ("α- and β-Amino Acid Hydroxyethylamino Sulfonamides Useful as Retroviral Protease Inhibitors," issued November 1, 2011) following a Paragraph IV certification as part of Lupin's filing of an ANDA...

USPTO Posts Comments on Genetic Diagnostic Testing

2012-05-22T23:59:00-05:00

By Donald Zuhn -- As part of its efforts to implement the Leahy-Smith America Invents Act, the U.S. Patent and Trademark Office issued a Federal Register notice (77 Fed. Reg. 3748) earlier this year indicating that the Office had begun to collect information on independent second opinion genetic diagnostic testing where patents and exclusive licenses exist that cover primary genetic diagnostic tests (see "USPTO News Briefs," January 26, 2012). This collection of information was needed in order for the Office to fulfill its obligations under § 27 of the AIA to prepare a report on genetic diagnostic testing for submission...

USPTO to Raise Patent Fees A Bit More

2012-05-21T23:40:49-05:00

By Donald Zuhn -- Last week, the U.S. Patent and Trademark Office published a notice if the Federal Register (77 Fed. Reg. 28331) proposing another increase in patent fees. The newly proposed adjustment in fees, which would go into effect on October 1, 2012, is intended to reflect fluctuations in the Consumer Price Index (CPI). Pursuant to 35 U.S.C. § 41(f), the Office is authorized to adjust patent fees annually based on the CPI in order to recover higher costs of providing services, but only if the CPI is higher than 1%. The notice uses a hypothetical 2.9% increase in...

Court Report

2012-05-21T23:33:40-05:00

By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Orion Corp. v. Mylan Pharmaceuticals Inc. 1:12-cv-00523; filed April 26, 2012 in the District Court of Delaware Infringement of U.S. Patent Nos. 5,446,194 ("Pharmacologically active catechol derivatives," issued August 29, 1995), 6,500,867 ("Pharmaceutical Composition Comprising Entacapone, Levodopa, and Carbidopa," issued December 31, 2002), and 6,797,732 (same title, issued September 28, 2004) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Orion's Stalevo® (marketed by Novartis in the U.S.) (entacapone, levodopa,...

FDA Holds Public Hearing on Biosimilar Draft Guidance

2012-05-20T23:16:57-05:00

By James DeGiulio -- Last week, the U.S. Food and Drug Administration held a public hearing on the Draft Guidance on Biosimilar Development, where researchers, payors, patient and physician groups, and industry advocates provided their thoughts on the FDA's first attempt to clarify the logistics as to the operation of the Biologics Price Competition and Innovation Act of 2009 (BPCIA). The panel was headed by Dr. Rachel Sherman, M.D., Associate Director for Medical Policy at CDER, and comprised other agency members Dr. Leah Christl, Ph.D.; Denise Esposito, J.D.; Dr. Steven Kozlowski, M.D.; Diane Maloney, J.D.; Heidi C. Marchand, PharmD; Maryll...