By Donald Zuhn --
On New Year's Day, we counted down the first four of the top thirteen stories covered on Patent Docs in 2008 (see "Top Stories of 2008: #13 to #10"). Today, we count down stories #9 to #6, and tomorrow, we will count down last year's top five stories. In case you missed the articles the first time around or wish to go back and review them, we have provided links to our coverage of these stories (as well as a few links to articles on related topics). As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with our rankings, please let us know.
#9 -- The USPTO Tightens Its Grip on Practitioners
We kicked off 2008 by reporting on the comments made by Harry Moatz (at right), USPTO Director of the Office of Enrollment and Discipline (OED), at an Intellectual Property Owners (IPO) meeting in New York. At that meeting, Mr. Moatz made it clear that the Office planned to discipline registered practitioners who did not comply with the new claims and continuations rules (despite the fact that the rules had been preliminarily enjoined less than three months before his address). Then Robert Clarke, USPTO Director of the Office of Legal Administration, announced at a panel discussion on patent reform that the OED also planned to "investigate" attorneys who file a "large number" of references that "could be used" to reject "a substantial number" of the claims presented in an application. By appealing the Tafas decision and abandoning (at least for now) the new IDS, Markush, and appeals rules, the USPTO has put some of the OED's plans on hold. The OED has kept busy, however, by announcing the creation of online registration system for registered practitioners, initiating an online Continuing Education for Practitioners (CEP) pilot program (expected to eventually be expanded to all registered practitioners), and relying on a December 12, 2003 Federal Register Notice to institute a $118 annual fee for all registered practitioners.
For information regarding this topic, please see:
• "Patent Office Reminds Patent Practitioners to Update Contact Information," December 12, 2008
• "Annual Fee Announced for Registered Practitioners," November 19, 2008
• "Patent Office Seeking Volunteers to Test Continuing Education System," September 1, 2008
• "EFS-Web Customer Satisfaction Survey & New Online Contact Information System for Practitioners," July 25, 2008
• "New Rules, New Threats: More on the Office of Enrollment and Discipline," January 14, 2008
#8 -- Impact of Presidential Election on U.S. Patent Practice
On November 4th, Senator Barack Obama was elected the 44th president of the United States. The impact of Senator Obama's election on U.S. patent policy will have to await the President-elect's commerce secretary and USPTO director appointments (interestingly, New Mexico Governor Bill Richardson, President-elect Obama's selection for commerce secretary, withdrew his name from consideration earlier today; see New York Times report). In October, we provided a hint of what patent practitioners and applicants could expect from an Obama Administration in our coverage of a panel discussion between representatives of Senator Obama and Senator McCain. Representing Senator Obama's campaign were Professor Arti Rai, from the Duke University School of Law, and Associate Professor Christopher Sprigman, from the University of Virginia School of Law. While the panel discussed the Obama campaign's gold-plated patent plan, we noted that all mention of the concept had been removed from the campaign's official website. We subsequently noted that Prof. Rai co-signed one of only two amicus briefs in support of the USPTO in the Tafas v. Dudas appeal. On a more positive note, Harold Wegner, a partner at Foley & Lardner LLP and professor at George Washington University Law School, noted this fall that the Obama Administration was also listening patent practitioners such as Chicago-based Foley partner Sharon Barner. The direction that the new Administration takes the USPTO will likely be a top story in 2009.
For information regarding this topic, please see:
• "New Administration Will Act Quickly to Jump-Start Stem Cell Research," November 11, 2008
• "Reaction to Historic Presidential Election," November 5, 2008
• "A Second Look at President-elect Obama's Technology Platform," November 4, 2008
• "Presidential 'Debate' on U.S. Patent Policy," October 14, 2008
#7 -- Follow-on Biologics Debate Continues
While innovator and generic companies have reached a consensus regarding the need for a follow-on biologics regulatory pathway, they have been unable to reach consensus on the primary sticking point holding up passage of a follow-on biologics bill: an appropriate exclusivity period. Over the past twelve months, both sides issued reports and press releases supporting their particular stances. For example, a Teva-funded study released in November suggested that a data exclusivity period of seven years would be "sufficient for maintaining strong incentives to innovate while fostering a competitive marketplace." Another Teva-funded study released in September questioned the need for exclusivity provisions that would tack on an extra 7-12 years of protection. Meanwhile, innovator companies have supported bills providing 12-14 years of exclusivity. Five follow-on biologics bills were introduced during the 110th Congress: H.R. 1956 (which provides twelve years of data exclusivity and two years of market exclusivity), S. 1695 and H.R. 5629 (which provide four years of data exclusivity and eight years of market exclusivity), and S. 623 and H.R. 1038 (which do not address data/market exclusivity). Whether the 111th Congress will be able to devote much attention to a follow-on biologics bill in view of the current economic crisis, and if it does, what type of bill makes it to the White House, will also be a top story in 2009.
For information regarding this and other related topics, please see:
• "BIO Says CBO Estimate of Follow-on Biologics Savings Is Based on 'Troubling Assumption'," December 29, 2008
• "Medco Predicts Follow-on Biologics Regulatory Pathway by 2011," November 25, 2008
• "Former House Ways and Means Economist Claims 7-Year Data Exclusivity Period Is Sufficient," November 20, 2008
• "Follow-on Biologics in the News," September 23, 2008
• "BU Economics Professor Releases Report on the Impact of Marketing Exclusivity on Biologics Innovation," September 18, 2008
• "BIO Discusses Legislative Accomplishments," September 3, 2008
• "Congressional Fact-finding on Follow-on Biologics," August 13, 2008
• "Insmed's Follow-on Biologics Campaign Continues," August 13, 2008
• "JEC Holds Hearing on Drug Pricing; GPhA Lobbies for Follow-on Biologics Pathway," July 31, 2008
• "Insmed Announces Bioequivalent G-CSF Biologic," July 10, 2008
• "CBO Releases Report on Senate Follow-on Biologics Bill; BIO Calls for Congress to Pass Biologics Bill in 2008," July 1, 2008
• "Follow-on Biologic Drugs and Patent Law: A Potential Disconnect?" March 25, 2008
• "New Follow-on Biologics Bill Introduced in the House," March 18, 2008
• "Dr. Robert Shapiro Discusses Follow-on Biologics Report," February 19, 2008
• "BIO CEO Provides Update on Patent Reform and Follow-on Biologics Legislation - Part II," February 14, 2008
• "Insmed Announces National Awareness Campaign Regarding Follow-on Biologics," February 13, 2008
#6 -- The USPTO Comes under Attack
In February, we reported on a USPTO oversight hearing held by the House Subcommittee on Courts, the Internet, and Intellectual Property. In addition to hearing from USPTO Director Jon Dudas, the Subcommittee also heard from Robin Nazzaro, the Director of National Resources and Environment for the U.S. General Accountability Office; Robert Budens, the President of the Patent Office Professional Association (POPA); and Alan Kasper, the First Vice President of the American Intellectual Property Law Association (AIPLA) and a partner with Sughrue, Mion, PLLC. Some of the most interesting testimony was provided by the POPA president, who indicted the Office's antiquated production system, which has remained essentially unchanged since it was put in place in 1976, for much of the Office's pendency problems. In May, we reported that the Subcommittee's Chairman, Congressman Howard Berman (D-CA) (at right), sent a letter to Director Dudas requesting "additional information" regarding the Director's earlier testimony, and in June, we analyzed the Director's response to Congressman Berman's letter. The Subcommittee's inquiry may have helped stall the Patent Office's efforts to enact some of the most sweeping changes to U.S. patent practice that have been proposed or promulgated in recent memory. More on that tomorrow.
For information regarding this and other related topics, please see:
• "Pinkos Appointment Provokes Allegations - Updated," November 24, 2008
• "Deputy Director Peterlin Announces Resignation," July 29, 2008
• "Docs at BIO: Panel Discusses Impact of USPTO Rules Changes and Patent Reform Legislation on Biotech Patenting," June 23, 2008
• "What the Director's Letter Didn't Say," June 15, 2008
• "Director Answers House Subcommittee's Questions," June 12, 2008
• "Maybe It's Finally Time They Went Home," May 28, 2008
• "Maybe It Isn't Going to Get Much Better," May 21, 2008
• "Congressman Berman Is on the Case," May 14, 2008
• "IPO Disagrees with Director Dudas," May 11, 2008
• "GAO Testimony Supports POPA's Position on Examiner Attrition," March 13, 2008
• "POPA President Critical of USPTO During House Subcommittee Oversight Hearing," March 4, 2008
• "More on House Subcommittee USPTO Oversight Hearing," February 28, 2008
• "House Subcommittee Holds USPTO Oversight Hearing," February 27, 2008
Comments