By Donald Zuhn --
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. Yesterday, we counted down stories #12 to #10, and today we cover stories #9 to #7. 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 Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know.
9. Legislators and FTC Continue Efforts to Prohibit Pay-for-Delay Deals
The year began with Sen. Herb Kohl (D-WI) introducing a bill that would prohibit brand name drug companies from compensating generic drug companies for delaying the entry of generic drugs into the market, which the Senator has characterized as "backroom" deals constituting "one of the most egregious tactics used to keep generic competitors off the market." Senator Kohl's bill was voted out of committee in July, but has yet to come to the floor of the Senate for a vote. In November, Sen. Jeff Bingaman (D-NM) introduced an alternative bill that would eliminate the 180-day exclusivity period for a generic applicant that enters into a "disqualifying agreement" (i.e., a reverse or pay-for-delay agreement). These legislators found a supporter in President Obama, who proposed a 2012 budget in February that included a proposal providing the Federal Trade Commission with the authority to stop drug companies from entering into anticompetitive agreements intended to block consumer access to safe and effective generics. In September, the President released his plan for economic growth and deficit reduction that similarly proposed to prohibit pay-for-delay deals. Meanwhile, the Federal Trade Commission continued its attack on pay-for-delay deals, issuing a report in May that highlights what the agency viewed as an increase of settlements in which a generic company is compensated for staying off the market for longer than would be the case if it won ANDA litigation against the innovator.
For information regarding this and other related topics, please see:
• "Senate Bill Creates New Incentive Structure to End Pay-for-Delay Deals," November 21, 2011
• "The FTC's Thinking Does Not Make It So Regarding Reverse Payment Agreements," October 25, 2011
• "Generic Pharmaceutical Association Releases Report on Value of Pay-for-Delay Agreements," October 2, 2011
• "President's Deficit Reduction Plan Seeks to Reduce Exclusivity Period for Biologics and Prohibit Pay-for-Delay Deals," September 21, 2011
• "Bill Prohibiting Reverse Payments Voted out of Committee," July 25, 2011
• "Federal Trade Commission Issues Report on Reverse Settlement Agreements in FY2010," May 9, 2011
• "Supreme Court Refuses to Review Reverse Payments," March 7, 2011
• "President's Budget Proposal Increases Funding for Basic Research But Seeks to "Trim" Data Exclusivity Period and Pay-for-Delay Agreements," February 21, 2011
• "Sen. Kohl Introduces Bill to Prohibit Reverse Payments," February 2, 2011
8. Legislators Explain & President Seeks to Reduce Data Exclusivity Period
On the biosimilar front, 2011 kicked off with legislators debating the meaning of the term "exclusivity" in the biosimilars regulatory pathway provisions of the Patient Protection and Affordable Care Act (PPACA). While legislators debated the meaning of this term, President Obama continued his efforts to shorten the exclusivity period from 12 years as provided under the PPACA to 7 years. Before signing the PPACA in March 2010, the President pushed hard for a reduction of the 12-year period, and when the President unveiled his 2012 budget in February, it specified that the exclusivity period be reduced to 7 years. The President's plan for economic growth and deficit reduction, released in September, proposed "modifying the length of exclusivity on brand name biologics" established under the PPACA by "award[ing] brand biologic manufacturers seven years of exclusivity rather than 12 years under current law." As the year drew to a close, the FDA fell short of its goal to release regulatory guidelines for biosimilars by the end of 2011.
For information regarding this and other related topics, please see:
• "If Patents Become Irrelevant in a Biosimilars Future, What About University Patents and Startups?" December 21, 2011
• "Will Patents Become Irrelevant in a Biosimilars Future?" December 19, 2011
• "Representatives Oppose President's Attempt to Reduce Data Exclusivity Period," October 17, 2011
• "FDA Biosimilar Guidelines Complete, Awaiting Publication," September 29, 2011
• "President's Deficit Reduction Plan Seeks to Reduce Exclusivity Period for Biologics and Prohibit Pay-for-Delay Deals," September 21, 2011
• "Senators Support Inclusion of 12-Year Exclusivity Period in Free Trade Agreement," September 12, 2011
• "Legislators Urge President to Include 12-Year Data Exclusivity Period in Free Trade Agreement," August 15, 2011
• "House Legislators Lobby to Exclude 12-Year Data Exclusivity Period from Free Trade Agreement," August 11, 2011
• "FDA Looks to Multiple Sources, Including EMA Guidelines, in Developing Biosimilar Approval Standards," August 9, 2011
• "FDA Officials Hint at Provisions of Biosimilar Guidances," May 24, 2011
• "FDA Seeks Comment on Biosimilar User Fee Proposal," May 10, 2011
• "President's Budget Proposal Increases Funding for Basic Research But Seeks to "Trim" Data Exclusivity Period and Pay-for-Delay Agreements," February 21, 2011
• "Data or Market Exclusivity? (Perhaps) Only Congress Knows for Sure," January 26, 2011
• "More on Data Exclusivity," January 25, 2011
• "Senators Let FDA Know Their Intent Regarding Data Exclusivity Provisions of PPACA," January 11, 2011
• "Representatives Send Letter to FDA to Explain Data Exclusivity Provisions of Biosimilars Legislation," January 9, 2011
7. Life Sciences Industry Continues to Feel Impact of Economic Crisis
In 2009, the country suffered through its worst recession since the Great Depression, and in 2010, the life sciences industry (like many other industries) suffered through a very slow recovery from the effects of the recession. In 2011, the (glacially) slow recovery continued. While venture funding was up in both the first and second quarters, it declined again in the third quarter. Patent application filings, which dropped at the height of the recession, were on the rise again. Hopefully, 2012 will see some recovery in venture funding (despite the less than rosy forecasts) and continued increases in application filings.
For information regarding this and other related topics, please see:
• "USPTO Releases Performance and Accountability Report for FY 2011," November 30, 2011
• "Life Sciences Venture Funding Drops in Third Quarter," October 27, 2011
• "AUTM Survey Shows Significant Increases in University Patent Filings and Issuances in FY2010," October 5, 2011
• "WIPO Releases Report on IP Activity," October 4, 2011
• "Biotech/Pharma Patent Issuances Increased 39% in 2010," September 13, 2011
• "Life Sciences Venture Funding up 37% in Second Quarter," August 1, 2011
• "Docs at BIO: Steve Burrill's State of the Biotechnology Industry Report 2011," July 5, 2011
• "VentureSource Reports 35% Increase in 1Q Venture Funding," April 26, 2011
• "Number of Patent Filings in Europe Growing," April 20, 2011
• "NVCA Reports Modest Gains in First Quarter Venture Funding," April 19, 2011
• "Inovia Releases Report on Global Patent Trends," March 16, 2011
• "PCT and EP Filings on the Rise Again," February 17, 2011
• "The Nexus between Biotechnology and Economic Recovery," January 24, 2011
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