BIO's membership represents a complete cross-section of the industry, from small startups to large pharmaceutical and agricultural biotechnology companies. Patents are often the sole assets of many of BIO members. As such, strong and predictable patent protection enables the flow of risk capital that is vital to achieving biotechnology's promise. BIO supports strengthening the U.S. patent system and opposes efforts to undermine or limit protection and enforcement.

Patent Reform Legislation

America needs to protect and fully enforce intellectual property rights, without which the biotechnology industry would be irrevocably harmed. Inventions in biotechnology are entitled to the same patent term as inventions in other technologies. However, due to the added step of Food and Drug Administration (FDA) regulatory review, biotechnology inventions lose eight to ten years of patent life. BIO advocates day-for-day restoration of all patent term lost due to regulatory delays.

• BIO Testimony to the House Judiciary Committee Concerning the Hearing on Patent Reform (April 30, 2009) Read the testimony (94 KB)

• Patent Bill Compromise a Major Step Forward Toward Positive Reform (April 2, 2009) BIO commends the Senate Judiciary Committee for its success in developing a more consensus-oriented approach to patent reform legislation - one that makes encouraging progress toward reforms that will help strengthen and improve our nation’s patent system. Read the press release, Read BIO’s Letter of Support (67 KB PDF)

• BIO Encourages Senate Judiciary Committee to Improve Patent Reform Legislation (March 10, 2009) In submitted testimony, BIO asked the Committee to improve pending patent reform legislation and expressed concerns with the potential impact of some provisions on the U.S. economy. Read the press release, Read the testimony (64 KB PDF)

• BIO Encourages Congress to Improve Patent System (March 3, 2009) BIO continues to welcome improvements to the U.S. patent system, particularly those that increase patent quality, increase public participation, and provide additional resources to the Patent and Trademark Office (PTO). Read the press release

• BIO Says Kyl Legislation Advances Patent Reform Debate (September 25, 2008) The Patent Reform Act of 2008, introduced by Senator Jon Kyl (R, AZ), is a vast improvement over previous bills in the House and Senate with respect to many concerns raised by BIO, patient groups, universities, labor unions and many other stakeholders over the past two years. Read the press release

• BIO Says Patent Reform Legislation Not Ready for a Vote (April 1, 2008)  BIO rejects claims made by a group of high tech and communications lobbyists that patent reform legislation is close to ready for consideration by the full Senate. Read the press release

• New Study Concludes Patent 'Reform' Legislation Would Impose Significant Costs on Patent System (February 14, 2008) Two independent experts concluded certain controversial elements of the patent 'reform' legislation pending before the Congress would sharply increase patent costs and risks, undermining innovation with potentially serious consequences for the U.S. economy. Read the press release, Read the study (324 KB PDF)

• Study Finds Lack of Evidence to Support Draconian Efforts to Weaken Patent Rights (January 31, 2008) A study by researchers at the University of Virginia found that the three key reports often cited as justification for a sweeping overhaul of the U.S. patent system lack any empirical data to support the claims that alleged over-patenting and poor quality patents are hampering innovation and successful commercialization of inventions. Read the press release, Read the study (213 KB PDF)

• The Patent Reform Act of 2007 - Coalition Letter (October 23, 2007) More than 430 organizations representing American innovation in a wide range of industries in all 50 states wrote Senate leaders to express continued concern with S. 1145. Read the letter (40 KB PDF)

• BIO Expresses Disappointment with House Vote on Patent Reform (September 7, 2007) Read the press release

• BIO's “What's at Stake” Patent Reform Ad (September 7, 2007) See the advertisement (2.11 MB PDF)

• BIO's “What's at Stake” Patent Reform Ad (September 7, 2007) See the advertisement (723 KB PDF)

• BIO Expresses Concern with Patent Reform Legislation as Reported Out of  House Judiciary Committee (July 19, 2007) Read the press release

• Patent Reform: The Future of American Innovation (June 6, 2007) Written Testimony of Kathryn L. Biberstein, Senior Vice President General Counsel and Secretary, Chief Compliance Officer, Alkermes, Inc. before the Senate Committee on the Judiciary. Read the testimony, Read the press release

• The Patent Reform Act of 2007 -- Coalition Letter (May 15, 2007) More than 100 companies, associations, venture capital firms and universities signed a letter to key leaders of the U.S. House of Representatives and U.S. Senate. Read the letter (119 KB PDF), Read the press release

• H.R. 1908, the Patent Reform Act of 2007 (April 26, 2007) BIO's statement to the House Judiciary Subcommittee on Courts, the Internet and Intellectual Property. Read the statement (44 KB PDF)

• BIO's written comments regarding USPTO's proposed 5-year Strategic Plan (October 6, 2006) (490 KB PDF)

• BIO Testimony on Patent Reform (September 15, 2005) (51 KB PDF)

• BIO Response to PTO's Green Paper (September 14, 2005) (60 KB PDF)

• BIO letter on Patent Reform (May 12, 2005) (142 KB PDF)

• Letter regarding "Patent Quality Improvement: Post-Grant Opposition" (July 8, 2004) to Committee on the Judiciary, Subcommittee on Courts, the Internet and Intellectual Property The Honorable Lamar Smith, Chairman and The Honarable Howard Berman, Ranking Minority Member Read the Letter (432 KB PDF)

• Response to FTC Patent System Reform Recommendations (April 26, 2004) (225 KB PDF)

• BIO letter supporting the goals of H.R. 2391, the Cooperative Research and Technology Enhancement (CREATE) Act(January 21, 2004) (87 KB PDF)

• Letter to James E. Rogan on Unity of Invention (December 5, 2003) (16.8 MB PDF)

• BIO Comments to PTO on Unity of Invention (July 21, 2003) (168 KB PDF)

• BIO Statement on Proposed PTO Fee Restructuring (July 18, 2002) (3.4 MB PDF)

• In Depth Legal Analysis of Proposed PTO Fee Restructuring (July 17, 2002) (362 KB PDF)

• Letter to the Senate strongly supporting the Conference Agreement on the Department of Justice Authorization Act (HR 2215) and urging passage by the U.S. Senate (October 2, 2002)

• BIO Statement on Patents: Improving Quality and Curing Defects before the Subcommittee on Courts, the Internet and Intellectual Property of the House Judiciary Committee (May 2001)

• BIO's testimony on patent reform to maximize innovation in the biotechnology industry before the House Subcommittee on Courts and Intellectual Property (March 1999)

Biotechnology Patenting

Because biotech companies depend on private investments, patents are among the first and most important benchmarks of progress in developing a new biotechnology product. Patents offer limited protection against commercial use of a company's invention by a competitor. In biotechnology, patents are critical to raising capital to fund the research and development of products. BIO advocates strong intellectual property protection for biotechnology inventions. For this reason, the organization opposes any legislation, regulatory change by the Patent and Trademark Office (PTO) or judicial effort that would shorten the length of a patent or limit the scope and protections a patent affords.

• Intellectual Property Rights Spur Innovation (October 13, 2008) BIO responds to a recent report entitled "Toward a New Era of Intellectual Property: From Confrontation to Negotiation" which offered no empirical evidence to back up its claim to the contrary. Read BIO’s statement, Read BIO’s full response

• Law and Policy in the Knowledge E-Based Economy (February 26, 2002) Testimony Before the Federal Trade Commission and the Department of Justice

• Primer: Genome and Genetic Research, Patent Protection and 21st Century Medicine

• To Representative John Conyers, Ranking Member of the House Judiciary Committee (259 KB PDF)

• To Representative Howard Coble, Chairman of the House Judiciary Subcommittee on Courts, The Internet, and Intellectual Property (262 KB PDF)

• To Representative Howard Berman, Ranking Member of the House Judiciary Subcommittee on Courts, The Internet, and Intellectual Property (273 KB PDF)

Hatch-Waxman Reform

The Hatch-Waxman Act, or the Drug Price Competition and Patent Term Restoration Act of 1984, was designed to both encourage innovation and facilitate generic competition with the branded products they copy. The Act itself consists of two titles, Title I of which serves to facilitate drug discovery and development by restoring effective patent life to innovators. Under Title I of the Act, a generic company could file for an Abbreviated New Drug Application (ANDA) and refer to the innovator's clinical research. The generic company can also reference an innovator's trade secret as long as at least 5 years have passed since the date FDA approved the innovator application. In addition, generic companies can use a patented drug prior to patent expiry to conduct pre-market testing in support of an ANDA. Title II of the Hatch-Waxman Act provides the opportunity for pioneer companies to obtain partial restoration of time lost during pre-market testing and approval required by the FDA. The total effective patent life may be restored to no more then 14 years. The total time restored between filing an IND and approval at the FDA is limited to no more than 5 years. The Act provides for a half-day cap on clinical development time during the investigational New Drug Application phase with the FDA.

• Hatch-Waxman Amendments in Senate Bill S. 1 Penalize Biotechnology Companies (Sep. 8, 2003)

• Fact sheet on S. 54, the Greater Access to Affordable Pharmaceuticals Act of 2003 (GAAP)

• Letter Opposing H. Res. 517: discharge petition for H.R. 1862/S.812

• Letter from Jim Rogan, USPTO Director Opposing S. 812 (485 KB PDF)

• Letter to Sen. Ted Kennedy expressing strong concerns regarding S. 812 (McCain/Schumer- Edwards/Collins) (July 15, 2002) (11.2 MB PDF)

• Response to Sen. Ted Kennedy (190 KB PDF) (July 22, 2002)

• Fact Sheet on S. 812 McCain/Schumer (July 15, 2002)

• FDA Proposed Rule to Revise Hatch-Waxman Regulations

• BIO letter to Rep. Michael Bilirakis, Chairman, Energy & Commerce Cmte., Subcommittee on Health, regarding the proposed approval of generic biologics (July 26, 2001)

• BIO's statement regarding reform of Hatch-Waxman Law, submitted to the Subcommittee on Courts and Intellectual Property House Judiciary Committee (July 1, 1999)

Cloning and Intellectual Property

BIO supports the PTO's current practice of denying patents on human beings. BIO however, opposes revising patent laws in order to deal with ethical concerns such as cloning. Such changes to patent laws can have serious long term implications for all industry sectors. Modification of patent laws in order to carve out specific subject matter from patentability must be considered carefully. Revision of the patent laws to exclude one subject area from patent eligibility can lead to other types of exclusions. Opening up the Patent Act could open the door and create a pathway to preclude patents on virtually any item or industrial product.

• Cloning Fact Sheet

• Letter to Majority Leader Daschle, on Senator Brownback's patent amendment to S. 2600, the Terrorism Risk Insurance Act of 2002 (June 14, 2002)