SACGHS Gene Patent Recommendations Still Controversial
The Secretary’s Advisory Committee on Genetics, Health and Society (SACGHS) for the Department of Health and Human Services (HHS) convened again on Friday for a snow-shortened session. One of several items on the Committee’s agenda was a report that the GLR has covered several times (see here and here): Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests. With the threat of a blizzard looming, the meeting was unexpectedly short, with only a pair of public comments followed by the Committee’s vote to approve the report.
The report itself will not be available for several weeks, but the six recommendations on gene patenting and licensing approved by the Committee this past October continue to provoke a heated response. The Biotechnology Industry Organization (BIO), along with former Senator Birch Bayh (of Bayh-Dole Act fame) and others, held a Friday press conference to denounce – again – the report’s recommendations.
The SACGHS Recommendations. Most of the recommendations are uncontroversial, urging the Secretary of HHS to convene stakeholders to “explore” and “encourage” strategies to improve access to genetic testing, enhance patent licensing and ensure that the USPTO is “kept current with the latest scientific and technological developments related to genetic testing and technology.”
So what prompted Bayh’s charge that the recommendations represent “an attempt to send us back to a time when it appeared that American innovation was on its last legs and our economy was in deep distress”?
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Follow-on Biologics: How Much Incentive Do We Need?
After almost a full year of debate, a pathway for approving “follow-on biologics” or “biosimilars” continues to be a hot topic in Congress. We are all familiar with generic versions of brand-name drugs, and the federal regulatory scheme sets out well-defined shortcut procedures for approval of generics. Congress is now grappling with designing procedures for approval of generic versions of biological drugs. Although follow-on biologics are in some ways similar to generic drugs, the differences are crucial, and in fact the regulatory scheme for generic drugs does not work at all for biologics. Congress has its work cut out for it.
Biologics 101. In short, here is the problem: typical pharmaceutical drugs (“small molecule drugs”) are chemically synthesized, and once the brand-name manufacturer’s exclusive patent rights expire, generic manufacturers are free to obtain approvals under abbreviated procedures, Generic manufacturers are generally not required to submit preclinical (animal) and clinical (human) data along with these Abbreviated New Drug Applications (ANDAs), thereby avoiding the huge expenses associated with developing new pharmaceuticals. But this route is only open to the generic manufacturer if it can prove that the generic version of the drug contains an identical replica of the drug’s active ingredient. Under the Hatch-Waxman Act of 1984, the Food and Drug Administration (FDA) may approve a generic version of a drug if the generic contains the same active ingredient as the original, shows bioequivalence to the original, and is demonstrated to be manufactured according to appropriate practices. Once these are shown, the generic is allowed to piggyback on the designation of the original drug as safe and effective.
Bilski and Biotechnology: The Supremes Speak Up
The Supreme Court heard oral argument in the Bilski case yesterday (pdf of full transcript). The Justices’ questions evinced unmitigated hostility to Bilski’s claim on a method of hedging commodities risks, and to business method patents generally. Detailed analysis of the oral argument is available from ScotusBlog, Patent Docs and Blawg IT. The decision in Bilski will have far-reaching consequences for patents on methods of analysis, data interpretation, and performing certain tasks, and at the GLR we have several times noted the potential significance of the case for biotechnology patent law.
The Justices may not be reading the GLR (or are they?), but they are well aware of Bilksi’s potential implications. In argument, Justice Sotomayor commented that if the Court upheld the Federal Circuit’s Bilski decision she would “have no idea what the limits of that ruling will impose in the computer world, in the biomedical,” but expressed concern that upholding Bilski’s machine or transformation test could “destroy industries” by “shoe-horning technologies that might be different.” And Justice Ginsburg, while remarking that Bilski “could be decided without making any bold steps,” conceded that “we know that things that we haven’t yet contemplated may be around the corner, and when they happen, we will deal with them.”
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A Court Ruling in the ACLU v. Myriad Gene Patent Litigation, But We’re Still A Long Way From A Gene Patent Resolution
For nearly six months the Genomics Law Report has been covering the developments in the ACLU-instigated lawsuit against Myriad Genetics, the University of Utah and the U.S. Patent and Trademark Office (USPTO). In late July, Myriad and its co-defendants filed motions to dismiss the lawsuit. Yesterday, Judge Robert W. Sweet of the Southern District of New York finally denied those motions.
Judge Sweet ruled against the defendants in each of several separate motions to dismiss, including lack of subject matter jurisdiction, lack of personal jurisdiction and failure to state a claim. The always-comprehensive Patent Docs blog has a complete summary of yesterday’s ruling—as well as the court’s full opinion (pdf)—but there’s at least one part of the ruling that’s worth highlighting here.
