By Kevin E. Noonan --
Last Friday, the Biotechnology Industry Organization (BIO) presented its members-only 2009 Spring IP Policy Briefing to member companies, particularly directed to member law firms. The presentation was moderated by Lila Feisee, BIO's Managing Director, Intellectual Property. The briefing included discussions on Membership Benefits, U.S. court cases, biosimilars and patent reform legislation, and the Department of Health and Human Service's draft report from the Committee on Genetics, Health and Society.
The Membership Benefits overview, presented by Jason Rupp, BIO's Membership Director, reminded participants of BIO's demographics: the organization has a staff of 160 and a membership of about 1,200 biotechnology and related companies. Two-thirds of these are R&D-focused organizations, with another 16% consisting of academic or other non-profit groups. The remainder are made up of service providers and state or international affiliates. Mr. Rupp mentioned several opportunities for participation on a number of committees, as well as other member benefits directed to practical business solutions (found at www.biobusinessolutions.com).
One of these committees, the amicus committee, files between 4 and 6 briefs a year; recent cases where BIO filed an amicus brief included eBay Inc. v. MercExchange, L.L.C.; KSR Int'l Co. v. Teleflex Inc.; Ferring B.V. v. Barr Labs., Inc.; In re Seagate Technology, LLC; Quanta Computer, Inc. v. LG Electronics, Inc.; Tafas v. Dudas; In re Bilski; In re Kubin; Amgen v. Hoffman-LaRoche; Aventis Pharma S.A. v. Amphastar Pharmaceuticals; and Prometheus v. Mayo (see BIO's Amicus Briefs page for links to the organization's filed briefs). The amicus committee considers cases that impact BIO members generally and does not typically take a position relating to specific commercial disputes or in cases between BIO members. Recent cases where BIO did not file an amicus brief include Laboratory Corp. v. Metabolite Labs., Inc.; Medimmune, Inc. v. Genentech, Inc.; Microsoft Corp. v. AT&T Corp.; Pharmastem Therapeutics, Inc. v. Viacell, Inc.; and In re Bilski's petition for certiorari. The committee is currently interested in petitions for rehearing en banc in the Kubin and Tafas cases, and in the patent term adjustment dispute in Wyeth v. Doll.
Sandra J.P. Dennis, BIO's Deputy General Counsel for Healthcare, then discussed the current state of biosimilars legislation. She reminded listeners that the last (110th) Congress saw five bills introduced, by Mr. Waxman (D-CA), Mr. Inslee (D-WA), and Ms. Eschoo(D-CA)/Mr. Barton (R-TX) in the House, and Senator Gregg (R-NH) and Senators Kennedy (D-MA), Clinton (D-NY), Hatch (R-UT), and Enzi (R-WY) in the Senate; the latter bill represented a compromise on the all-important data exclusivity period at 12 years. In this Congress, Mr. Waxman has introduced a bipartisan bill (H.R. 1427), joined by Mssrs. Deal (R-GA), and Pallone (D-NJ) and Ms. Emerson (R-MO) that provides only 5 years of data exclusivity and only if the "major substance" had not been previously approved (3 years otherwise) (see "Waxman Introduces Follow-on Biologics Bill"). There is a competing bill, H.R. 1548, introduced by Ms. Eschoo, Mr. Inslee, and Mr. Barton (that has more than 65 co-sponsors) that specifies 12 years of data exclusivity with provisions for an additional 2 years for a "medically-significant new indication" and 6 months for pediatric studies (see "Second Follow-on Biologics Bill Is Introduced in House"). In the Senate, a companion to the Waxman bills has been introduced (see "Third Follow-on Biologics Bill Introduced in 111th Congress"), and Senator Kennedy is expected to introduce a bill with a 12-year data exclusivity period.
Hans Sauer, BIO's Associate General Counsel for Intellectual Property, addressed patent reform legislation. Mr. Sauer characterized the Senate bill, S. 515, as a bill BIO could support, in contrast to the bills introduced (S. 1453) and passed (H.R. 1983) in the last Congress. Turning to specific provisions, Mr. Sauer said that BIO does not support the "trigger" provisions in the House bill on changing U.S. patent law to "first inventor to file" from "first inventor to invent." These provisions, not contained in the Senate bill, would forestall the legislated change until the President certified that the European Patent Office and the Japan Patent Office had instituted a "grace period," like ours, for an inventor's own prior disclosure. He said that BIO supports the Senate compromise on damages and post-grant review, and opposes provisions in the House bill that include public use or on-sale activity as prior art. BIO also opposes provisions in the House bill that specify a reasonable royalty determination would be based on "specific contribution[s] over prior art." BIO is also concerned, he said, about the absence of inequitable conduct reform in the pending bills, and noted that while some stakeholders have attempted to use reforming of inequitable conduct as a bargaining chip for damages apportionment, this was not acceptable to BIO -- inequitable conduct reform is not "tradable" for "harmful damages language." While BIO seeks repeal/elimination of the best mode requirement, the Senate compromise that retains the provision but strips it of any meaningful penalty for failing to disclose the best mode is acceptable to BIO. He also mentioned provisions on willfulness, interlocutory appeals, venue, mandatory publication, and ending fee diversion.
The last presentation, by Ms. Feisee, concerned the draft report from the HHS Secretary's Advisory Committee on Genetics, Health and Society. This draft report, dealing with recommendations on gene patenting and licensing practices, actually contains good news -- the purported anticompetitive effects of the mythical "tragedy of the anti-commons" do not exist, and the report concludes (somewhat begrudgingly) that patents are not "a cause of concern in relation to price and access." Rather than provide recommendations consistent with these empirical findings, however, the report presents "a range of potential policy options" for consideration, including policies that "promote 'broad licensing'" of genetic inventions, pursuing an Executive Order "clarifying authority under the Bayh-Dole Act" that would "impose a requirement for non-exclusive licensing" of materials produced using Federal funds, and "clarifying" Patent Office policies relating to genetic materials. Despite its express findings, somewhat incredibly the report also proposes statutory changes (to be promoted, no doubt, as "reform") to restrict patents on nucleic acid-based inventions. Comments on the report are due by May 15th; BIO will be providing comments.
BIO intends to have another policy briefing later this summer.