Weekly Roundup: Science Funding, DTC and Medical Device Caucusing
With so many developments at the intersection of genomics and the law, there are often a variety of interesting stories that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. Here we recap several recent key developments and, at bottom, round up all of the recent tweets from @genomicslawyer.
The Continuing Threat of Decreased Science Funding. At least for the moment, the two houses of Congress appear, finally, to be edging toward a budget compromise that would bridge the $51 billion gap between the House bill (which passed at the beginning of March) and the most recent Senate proposal. That’s a good thing, given that the current continuing resolution is set to expire on April 8.
Nevertheless, it seems increasingly clear that federal science funding is unlikely to increase from its fiscal year 2010 levels, and funding almost certainly will not meet the targets President Obama set in his FY 2012 budget proposal.
Swine Soar Higher in Myriad Thanks to US Government’s Amicus Brief
This past March Judge Robert Sweet handed down an unexpected summary judgment ruling in the Myriad gene patent litigation (see: Pigs Fly: Federal Court Invalidates Myriad’s Patent Claims). Myriad quickly appealed Sweet’s district court decision to the Court of Appeals for the Federal Circuit (CAFC).
After several months of courtroom quiet, the briefs began rolling in to the CAFC last week. Most, including Myriad’s own appellant brief (pdf), presented the argument we would expect. Myriad and its supporters frame Judge Sweet’s ruling as an erroneous application of settled patent law and policy that, if upheld, “would have far-reaching negative consequences” (pdf) for the continued development of biotechnology.
And then there is the United States government. In an amicus brief filed on Friday (pdf) the Department of Justice (DOJ), on behalf of the United States, dropped a minor bombshell. Contradicting the longstanding policy of the United States Patent and Trademark Office (PTO), the government’s brief argues that isolated human genes, without further modification, are a product of nature and do not constitute patent-eligible subject matter under § 101 of the Patent Act.
Bilski and Biotech: Business As Usual, For Now
Earlier today the Supreme Court handed down its opinion in what some patent observers have termed “the most highly anticipated patent decision of all time“: Bilski v. Kappos (pdf). The Bilski case was widely watched not for the significance of the particular patent at issue but for the far-reaching effect on patent law that the case might have.
Would the Court treat Bilski as a referendum on the patentability of so-called “business methods”? Would it speak more broadly still, using Bilski as an opportunity to clarify the patentability of a range of emerging technologies, particularly in the areas of software and biotechnology? These questions took on added significance for biotechnology companies, investors, researchers and observers earlier this spring when a federal court in New York used Bilski’s machine-or-transformation test to invalidate several of Myriad Genetics’ diagnostic method claims.
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”?
Read the rest of this entry »
Myriad Genetics, USPTO File Summary Judgment Motions in Gene Patent Case
Two of the defendants in Association for Molecular Pathology v. U.S. Patent and Trademark Office, the frontal attack on Myriad Genetics’ breast cancer gene patents organized by the American Civil Liberties Union, have now filed their own summary judgment motions. (Click through to read the memorandum in support of Myriad Genetics’ motion (pdf) filed on December 23 and the memorandum in support of the PTO’s motion (pdf) filed on December 24). As we explained in an earlier post, a summary judgment motion seeks to convince the trial judge that the facts are so clear-cut that there is no reason to go ahead with the trial—in legal jargon, that there is “no issue of material fact” that needs to be tried. This is the rare case in which both sides have asked for summary judgment (the plaintiffs filed their motion and supporting memorandum (pdf) back on August 26). The filings by both sides are not a surprise here, however, since the facts surrounding the challenged patents are largely undisputed and the real question is how to apply patent law to those facts.
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.
