By Donald Zuhn --
Reflecting upon the events of the past twelve months, Patent Docs presents its fourth annual list of top biotech/pharma patent stories. For 2010, 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 #9. Later this week, we will present stories #8 to #5, and then conclude the series by presenting our top four stories of 2010. As with our other lists (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.
#12 -- Patent Reform Movement Stalls (Again)
For a brief moment, it looked like Senate Judiciary Committee Chairman Patrick Leahy (D-VT) was finally going to move a patent reform bill to the Senate floor for a vote. In February, Chairman Leahy announced during an Executive Business Meeting that the Committee had reached a "tentative agreement in principle" regarding patent reform legislation. He also mentioned that he had been meeting with members of the House majority and minority leadership to discuss the Senate bill in an effort to prevent the legislation from becoming a "partisan issue." Only days later, however, House leaders on both sides of the aisle issued a short statement (on the Republicans' separate House Committee on the Judiciary website) saying that Chairman Leahy's patent reform efforts "have thus far proceeded without adequate input from House members." While Congressional watchers may not have known it at the time, the House leadership's statement essentially signaled an end to the passage of comprehensive patent reform legislation in 2010.
Instead of passing a comprehensive patent reform package, several members of the House turned to stand-alone bills designed to address individual problems with the patent system. For example, Rep. Darrell Issa (R-CA) introduced a bill in the House (H.R. 4954) in late March that would put an end to qui tam (or whistleblower) suits for false patent marking. An alternative false patent marking bill (H.R. 6352) was introduced by Rep. Robert Latta (R-OH) in September. In May, the House nearly brought a bill to the floor for a vote that would provide the U.S. Patent and Trademark Office with fee-setting authority. Finally, the House sent H.R. 628, which would establish a pilot program in certain U.S. district courts to encourage enhancement of expertise in patent cases among district judges, to the President for his signature in late December.
For information regarding this and other related topics, please see:
• "Legislation to Enhance Patent Case Expertise Among District Judges Awaits President's Signature," December 29, 2010
• "New False Marking Bill Introduced in the House," October 14, 2010
• "IPO Announces Support for Patent Reform Act of 2010," September 20, 2010
• "Senators Seek Vote on Patent Reform Bill," September 15, 2010
• "Journal Examines Effects of Patent Reform on Medical Innovation," July 14, 2010
• "The Phoenix That Is S. 515," July 13, 2010
• "New USPTO Fee-Setting Bill Introduced in House," May 18, 2010
• "House to Vote on Bill That Would Give USPTO Fee-Setting Authority," May 17, 2010
• "Patent Reform News Briefs," May 11, 2010
• "USPTO Administrator Arti Rai Responds to Patent Docs Post on PTO White Paper," April 26, 2010
• "USPTO White Paper Supports Patent Reform Proposals," April 22, 2010
• "False Patent Marking Bill Introduced in the House," March 29, 2010
• "PUBPAT Expresses 'Deep Concern' over Senate False Marking Provision," March 25, 2010
• "Senator Landrieu Introduces Legislation Requiring Study on Effects of First-to-File Provision," March 11, 2010
• "Senate Leadership Unveils Details of Patent Reform Agreement," March 8, 2010
• "Qui Tam Actions in Senate Sights," March 4, 2010
• "House Leadership Says It Lacked 'Adequate Input' on Senate Patent Reform Bill," March 2, 2010
• "Chairman Leahy Announces 'Tentative Agreement in Principle' on Patent Reform Bill," February 25, 2010
• "AIPR Reiterates Opposition to Patent Reform Legislation," January 14, 2010
#11 -- Pay-for-Delay/Reverse Payment Opponents Try to Prohibit Practice
The year began with seven consumer groups sending a letter to Speaker of the House Nancy Pelosi (D-CA) and Senate Majority Leader Harry Reid (D-NV), urging the House and Senate to include provisions in their health care reform bills that would prohibit exclusion payments (i.e., pay-for-delay settlements or reverse payments) in pharmaceutical patent settlements. One month later, in February, the Federal Trade Commission (FTC) released a report about "pay-for-delay" arrangements, in which the FTC's position on the issue was made clear in the title of its report: "Pay-for-Delay: How Drug Company Pay-Offs Cost Consumers Billions." However, in a four-part series on "Reverse Payments in Generic Drug Settlements," Patent Docs looked at the decisions by several Courts of Appeals (the Federal Circuit, 11th Circuit, and Second Circuit), which suggest that the FTC may be wrong in pushing for the elimination of pay-for-delay settlements as per se violations of Section 1 of the Sherman Antitrust Act.
On Capitol Hill, the Senate Appropriations Committee passed an appropriations bill (S. 3677) in August that contained a pay-for delay provision that would allow the FTC to "initiate a proceeding . . . against the parties to any agreement resolving or settling, on a final or interim basis, a patent infringement claim, in connection with the sale of a drug product," wherein the agreement has "anticompetitive effects." Only one week earlier, the Senate had voted for a supplemental appropriations bill after stripping the bill of just such a provision. In July, the House had also squeezed a pay-for-delay provision into its own appropriations legislation (H.R. 4899). However, the Senate bill did not pass and the House bill passed and was signed into law but without the pay-for-delay provision.
For information regarding this and other related topics, please see:
• "FTC Continues Attempts to Block Reverse Payments," November 23, 2010
• "Second Circuit Denies En Banc Reconsideration in Cipro® Case," September 8, 2010
• "Pay-For-Delay Provision Added to Senate Appropriations Bill," August 5, 2010
• "Senate Removes Pay-For-Delay Provision from Appropriations Bill," July 29, 2010
• "House Slips Pay-For-Delay Provision into Appropriations Bill," July 7, 2010
• "House Passes Health Care Reform Bill -- Biosimilar Regulatory Pathway Makes Cut, Pay-for-Delay Ban Does Not," March 22, 2010
• "Reverse Payments in Generic Drug Settlements - Part IV," March 2, 2010
• "Reverse Payments in Generic Drug Settlements - Part III," February 25, 2010
• "President's Health Care Plan Includes Pay-for-Delay Ban and Biosimilar Regulatory Pathway," February 24, 2010
• "Reverse Payments in Generic Drug Settlements - Part II," February 23, 2010
• "Reverse Payments in Generic Drug Settlements," February 22, 2010
• "FTC Disapproves of 'Pay-for-Delay' Drug Deals,'" February 15, 2010
• "Consumer Groups Ask Congress to Add Pay-for-Delay Provision to Health Care Bill," January 13, 2010
#10 -- USPTO Supplements Obviousness Examination Guidelines
In September, the U.S. Patent and Trademark Office issued an update to its obviousness guidelines, publishing a Federal Register notice that highlights case law developments on obviousness since the Supreme Court's 2007 decision in KSR Int'l Co. v. Teleflex Inc. The update supplements the Office's 2007 guidelines, in which the Office identified seven rationales gleaned from the KSR decision. The Office's focus on decisional law in the update is reminiscent of the implementation of the 2007 obviousness examination guidelines by Technology Center 1600 almost three years ago. Bruce Kisliuk -- at the time a TC 1600 Director -- noted that examiners in the Group were being given "high-level" obviousness training in which they were taught to analyze the issue of obviousness using eleven key cases as tools (see "USPTO's Bruce Kisliuk Addresses ACI Conference"). The Office's recent notice lists two-dozen Federal Circuit cases that "have been selected for their instructional value on the issue of obviousness." Whether it amounts to a point of pride or a source of frustration (or both), half of the two-dozen cases discussed in the update are biotech/pharma cases.
For information regarding this topic, please see:
• "USPTO Updates Obviousness Examination Guidelines," September 8, 2010
#9 -- Biotech/Pharma Industry Recovers (Slowly) from Great Recession
In 2009, the country suffered through its worst recession since the Great Depression, and in 2010, the biotech/pharma industry (like many other industries) suffered through a very slow recovery from the effects of the recession. During this slow recovery, the economic news has been mixed. With regard to venture funding, an improvement in the final quarter of 2009 was followed by a drop in the first quarter of 2010 and then another drop in the third quarter. While an Ernst & Young report indicated that the biotech industry had finally become profitable, a BIO report showed that the number of publicly traded biotech companies dropped from 394 in the fourth quarter of 2007 to only 294 by the second quarter of 2010 -- a loss of 25% of the sector's publicly traded companies. Ultimately, the suggestion by Deloitte Touche Tohmatsu (DTT) that the global recession had permanently reshaped the life sciences industry may provide the most accurate picture. DTT's assessment was backed by a survey in which respondents noted that companies making it past the five-year mark post-recession, would do so by focusing on innovation. (Unfortunately, 43% of respondents to the DTT survey indicated that their companies had reduced R&D spending and were focusing instead on products providing immediate returns, and almost a third of the respondents (32%) believed that R&D spending would continue to drop in the future.) If the recession and its slow recovery can be eliminated from next year's Top Stories list altogether, 2011 will be a very good year.
For information regarding this and other related topics, please see:
• "NVCA Reports 31% Drop in Venture Funding for Third Quarter," October 17, 2010
• "One Quarter of Public Biotech Companies Shut Doors Since 4Q 2007," October 11, 2010
• "University Start-ups and Licensing Activity Held Steady During Recession," October 7, 2010
• "WIPO Report Shows Signs of Recovery Following Economic Crisis," September 28, 2010
• "NVCA Reports 34% Increase in Venture Funding for Second Quarter," July 22, 2010
• "Marks & Clerk Survey Predicts Rise in Consolidation as Biotech/Pharma Industry Nears Patent Cliff," May 25, 2010
• "Docs at BIO: Steve Burrill's State of the Biotechnology Industry Report 2010," May 12, 2010
• "Deloitte White Paper Points to Recession as Turning Point for Life Sciences Industry; Indicates That Survival Will Depend on Innovation," May 5, 2010
• "Ernst & Young Report: Biotech Industry Reaches Profitability for the First Time," April 29, 2010
• "NVCA Report Shows First Quarter Drop in Venture Funding," April 20, 2010
• "VentureDeal Report Shows 65% Increase in Fourth Quarter Biotech Venture Funding," March 16, 2010
• "AUTM Survey Shows Drop in Issued Patents," March 9, 2010
• "NVCA Report Shows Slight Drop in 4Q Venture Funding and Sharp Decline for 2009," January 24, 2010
• "Partnerships Between Startup Firms and Big Pharma Fueled 85% Increase in Biotech Funding in 2009," January 13, 2010
Re:#12: Even more encouraging recent IP news: the formation of a congressional IP subcommittee. Though it's questionable as to whether this will lead to much-needed patent reform, nevertheless the Obama administration's continued efforts on behalf of intellectual property are very much welcomed.
http://www.washingtontimes.com/news/2010/may/25/patent-reform-misses-the-mark/
Posted by: patent litigation | January 04, 2011 at 02:49 PM