We are pleased to share the latest from our friends at PatentDocs.org, the Biotech and Pharma Patent Law and News Blog. The authors, Donald Zuhn and Kevin Noonan, are partners at McDonnell Boehnen Hulbert & Berghoff, LLP, and contribute to Patent Docs on a daily basis. Today’s post comes from Patent Docs’ fifth annual list of the top biotech/pharma patent stories covered by Patent Docs in 2011. These stories were selected based on their potential to have the greatest impact on biotech/pharma patent practitioners and applicants.

Below is the post that covers the stories ranked numbers 12- 10. For access to the entire list of the top biotech/pharma stories of the past year, click here.

Reflecting upon the events of the past twelve months, Patent Docs presents its fifth annual list of top biotech/pharma patent stories.  For 2011, we identified a dozen stories that were covered on Patent Docs last year that we believe had (or are likely to have) the greatest impact on biotech/pharma patent practitioners and applicants.  Today, we count down stories #12 to #10, and then throughout the week, we will work our way towards the top three stories of 2011.  As with our other lists (2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look.  As always, we love to hear from Patent Docsreaders, so if you think we left something off the list or disagree with anything we included, please let us know.

12.  Europe Seeks Unified Patent System

In February, the European Parliament approved a request to use “enhanced cooperation” to launch a reform of the European patent system.  At the time, it seemed to be the last major hurdle to reaching agreement on a unified patent system and court in Europe.  By April, this view appeared to have been too optimistic, as the European Court of Justice ruled that a separate European patent court would violate EU law by taking powers away from courts in EU countries.  Despite the adverse ruling on a unified patent court, the European Commission moved ahead with its plans to create a unified EU patent.

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

• “European Patent Reform Suffers Another Setback,” April 27, 2011
• “European Parliament Approves Enhanced Cooperation Procedure to Create Unified EP Patent System,” March 1, 2011

11.  FDA Drug Approvals at Decade High (Almost)

Trying to counter some of its critics, the U.S. Food and Drug Administration announced in November that the agency approved 35 new drugs in FY 2011, which, with the exception of 2009 when 37 new drugs were approved, constituted the most approvals in the past decade.  Criticism of the FDA has centered around the agency’s tougher safety standards, which some argue have slowed down the pace of drug approvals and have hurt the drug industry.  Despite the increase in drug approvals, a Health Affairs paper (published in November 2010, but discussed here in January 2011) contends that extending “data exclusivity” for conventional “small molecule” drugs from the present 5 years under the Hatch-Waxman Act to 12 years (the term given biologic drugs under the Affordable Care Act of 2010) would provide a net benefit in new drugs and increased longevity.

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

• “FDA Approves 35 New Drugs in FY 2011,” November 20, 2011
• “FDA Drug Approvals for 2011 on Pace to Surpass 2010 Despite New Safety Standards,” July 13, 2011
• “Authorized Generics Again under Fire in Senate Bill,” February 23, 2011
• “Academic Study Supports Longer Data Exclusivity Term for Conventional Drugs,” January 17, 2011

10.  Deficit Debate Delays USPTO Plans

During the first few months of the year, the U.S. Patent and Trademark Office announced a number of new initiatives aimed at decreasing application pendency and increasing examination quality.  However, by April the USPTO announced that the programs, including both Track I examination and the Detroit satellite office, were being put on hold due to budgetary constraints following enactment of the budget for FY 2011 on April 15.  The good news is that several of the initiatives that were delayed last spring were part of the Leahy-Smith America Invents Act (a story for another day).  Of course, securing appropriate funding to implement the new programs will be an entirely different matter (despite Congress’ promises to the contrary).  Despite the ups and downs of 2011, the USPTO was able to close the year on a good note when it announced that the number of unexamined patent applications had been reduced to 669,625, which constituted a five-year low.

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

• “U.S. Application Backlog Falls to Five-Year Low,” October 24, 2011
• “USPTO Publishes Notice Regarding Prioritized (Track I) Examination Delay,” May 1, 2011
• “USPTO News Briefs,” April 27, 2011
• “USPTO Satellite Offices on Hold,” April 25, 2011
• “USPTO News Briefs,” April 21, 2011
• “USPTO to Launch Prioritized Examination on May 4th,” April 10, 2011
• “USPTO Provides More Details Regarding “Three Track” Examination Proposal,” February 7, 2011

Tags: biotech, FDA, Patent Docs, patent law, pharma, unified patent system, USPTO

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