Appeals Court Overturns Ruling Invalidating Gene Patents

On July 29, a federal appeals court ruled that individual genes may be patented, overturning a lower court decision that had reached the opposite conclusion. The case centered on the question of whether genes were inherently products of nature.  In its ruling, the court found that genes were isolated DNA, having “been manipulated chemically so as to produce a molecule that is markedly different from that which exists in the body,” thus making them unique from “naturally-occurring” DNA.

The case revolved around patents held by Myriad Inc. for the BRCA1 and BRCA2 genes that are often mutated in breast cancer. The plaintiffs in the case, which included several researchers and the American Civil Liberties Union, challenged the right of the company to hold exclusive rights to what they felt were products of nature.  While upholding the right of companies to patent individual genes, the appeals court actually invalidated Myriad’s BRCA patents, stating that the patents… “are directed to the abstract mental processes of comparing two nucleotide sequences” and therefore unpatentable.

The ruling reaffirms the judicial standard regarding gene patenting that had, until last year, held since 1980, when the first gene patents were approved by the Supreme Court.  The U.S. Department of Justice upset this standard by filing a brief last fall in support of the plaintiffs in the case, thus awkwardly pitting the administration against the U.S. Patent and Trademark Office. The current ruling restored the previous standard, stating that “an entire industry [had] developed in the decades since the Patent Office first granted patents to isolated DNA,” and warning that “disturbing the biotechnology industry’s settled expectations now risks impeding, not promoting, innovation.”

An appeal to the Supreme Court is likely. ASBMB will continue to monitor the case.

Federal Judge Overturns Ruling Banning NIH Funding of Human Embryonic Stem Cell Research

Today, District of Columbia District Court Judge Royce Lamberth overturned his own ruling in the case of Sherley v. Sebelius that had banned use of funds from the National Institutes of Health for human embryonic stem cell research.  The ruling is the latest, though by no means final, turn in this saga that has seen scientific arguments devolve into interpretations of dictionary definitions.

In 2009, the case against the NIH was first brought by researchers James Sherley and Theresa Deisher, who claimed that funding of human embryonic stem cell research was illegal based on the Dickey-Wicker amendment, which bans federal funding of “research in which a human embryo or embryos are destroyed.” Judge Lambert initially declared that the plaintiffs, both of whom work on adult stem cells, lacked standing to sue, being unable to demonstrate that the “injury” they would suffer due to funds being granted to projects involving human embryonic stem cells “is actual or imminent and traceable to the challenged action of the defendant, and…that a favorable decision would redress the plaintiff’s injury.”

However, this opinion was overturned on appeal, with the D.C. Circuit Court finding that “the undisputed increased competition that Plaintiffs face…is sufficient in and of itself to confer…standing.”  This ruling lead Judge Lambert to grant a preliminary injunction last August halting federal funding for all research projects involved with human embryonic stem cells, based on the merits of the case itself.

The injunction was stayed while the defendants appealed to the Circuit Court, claiming the so-called “Chevron deference,” in which the court “defer[s] to the agency’s interpretation of the statute if it is reasonable and consistent with the statute’s purpose,” applied to NIH’s interpretation of the Dickey-Wicker amendment. The Circuit Court ultimately agreed with the defendants, overturning the preliminary injunction and sending the case back to the District Court.

Forced to abide by the Circuit Court ruling, the latest ruling found that the NIH “reasonably interpreted the Dickey-Wicker Amendment to permit funding for human embryonic stem cell research because such research is not ‘research in which a human embryo or embryos are destroyed,’”  thereby dismissing the plaintiff’s argument that the Dickey-Wicker amendment unambiguously banned such work.

Judge Lambert approved the defendants’ motion for summary judgment, conversely denying the plaintiffs’ own motion, thereby removing the possibility of a jury trial.  However, the possibility of an appeal from the plaintiffs seems likely. Stay tuned to the Blotter for the latest on the case!

Stem Cell Legislation Re-Introduced in Congress

Late last week, Rep. Diana DeGette, D-Colo., and Rep. Charlie Dent, R.-Penn., introduced the Stem Cell Research Advancement Act, the latest congressional attempt to update federal policy governing human embryonic stem cell research. The bill would, according to a press release from Rep. DeGette, “codify the NIH’s guidelines for carrying out all human stem cell research, embryonic and adult,” a position repeatedly advocated for by ASBMB. A key stipulation in the current bill was that “research would have to use leftover embryos that would never be implanted in a woman and would otherwise be discarded,” which Dent praised for “establish[ing] ethical criteria for stem cell research.”

DeGette, with former Representative Michael Castle, R-Del., had previously sponsored similar bills aimed at updating existing stem cell legislation that passed Congress, but were ultimately vetoed by President Bush.  With Castle no longer in Congress, there is hope amongst members of the scientific community that Rep. Dent will now serve as a Republican champion for stem cell research.

The bill was introduced amongst the backdrop of the ever-continuing legal proceedings in the case of Sherley v. Sebelius.  In April, the U.S Appeals court overturned a district court ruling that had halted the use of federal funds for human embryonic stem cell research.  The same day that the Stem Cell Research Advancement Act was being introduced, both the plaintiffs and defendants in the court case filed briefs in the district court, responding to the appeals court ruling.  Though essentially repeating the same arguments that have been made in previous filings, the new briefs at least push the process forward.  Expectations are that the district court may make its decision within the next month.

Contact your members of Congress and urge them to support the Stem Cell Research Advancement Act!

Find your representatives: http://capwiz.com/faseb/dbq/officials/

Stem Cell Funding Ban Lifted

In a long-awaited decision, the U.S. Court of Appeals has ruled 2-1 in favor of allowing the National Institutes of Health to continue to fund human embryonic stem cell research.  The decision invalidates the preliminary injunction, issued back in August 2010 in the case of Sherley v. Sebelius, which barred the use of federal funds for any “research in which a human embryo or embryos are destroyed.”  After the injunction was enacted, the Department of Justice appealed, and the Appeals court stayed the ruling in September, allowing the NIH to continue funding hES work while the court contemplated the case.

The majority in the case ruled that the plaintiffs were unable to demonstrate that “they are more likely than not to succeed on the merits of their case,” a key determinant for granting a preliminary injunction.  The main point of contention is the notorious “Dickey-Wicker” amendment, the source of the funding ban, and its definition of the term “research.”  The plaintiffs argued that Congress was unambiguous in deriving the language of the amendment and clearly intended to prohibit any and all research done involving material that was obtained through destruction of a human embryo.  However, the court instead deferred to the NIH’s interpretation of Dickey-Wicker, pointing out that “the NIH seems reasonably to have concluded that, although Dickey-Wicker bars funding for the destructive act of deriving an ESC [Embryonic Stem Cell] from an embryo, it does not prohibit funding a research project in which an ESC will be used.”  In her dissent, Judge Karen Henderson argued that the majority had performed “linguistic jujitsu” in attempting to define the context of “research.”

Unfortunately, the matter is far from settled.  The case now returns to the district court, where Judge Royce Lamberth will rule on the case itself.  Regardless of his decision, more appeals are expected.  ASBMB has previously joined with other organizations to urge Congress to explicitly codify the National Institutes of Health Guidelines on Human Stem Cell Research, in order to prevent legal challenges that would delay this critical line of work.

Gene Patents Back in Court

On Monday, the U.S. Federal Appeals Court in Washington D.C. heard testimony in a case that may well set legal precedent on the ability of companies to obtain patents on natural materials. The case centers on two patents held by Myriad Genetics that cover the BRCA1 and BRCA2 genes, mutations in which are highly linked to breast cancer. The company is being sued by a consortium of research and patient advocates who argue that the patents illegally allow Myriad to develop exclusive genetic tests for the mutations, thus limiting diagnosis and treatment options.

The majority of Monday’s hearing centered on whether the act of identifying and isolating a gene is a patentable act of human ingenuity, or whether a gene is a product of nature, regardless of whether it has been isolated or not. The three-judge panel peppered lawyers on both sides with highly technical questions on the science behind genetic manipulation, but offered no hint as to how they intended to rule.

The case has produced the extremely unusual circumstance of having the government argue against itself.  The U.S. Patent Office was named a defendant along with Myriad, as government policy has, actively or not, allowed patenting of genetic material ever since the Supreme Court ruled in Diamond v. Chakrabarty that products of genetic engineering were eligible for protection.  However, the Department of Justice has now taken a stand against that position, first filing an amicus brief in favor of the plaintiffs back in November, and then testifying on their behalf in front of the Appeals Court.

The Appeals Court is expected to deliver their decision over the summer.

Government Opposes Patenting of Individual Genes

Stepping into a case that could have wide-ranging effects on scientific researchers, the U.S. Department of Justice on Friday filed a brief that opposes the patentability of genes.  The filing represents a reversal of position for the government, which for decades has allowed the U.S. Patent and Trademark Office to grant patents on individual genes.

In May 2009, the American Civil Liberties Union organized a lawsuit on behalf of four breast cancer patients, scientific researchers and professional societies that challenged the patents held by Myriad Genetics on the BRCA1 and BRCA2 genes.  Mutations in these two genes are highly correlated with development of breast cancer, and Myriad used its patents to develop exclusive tests that determined cancer risks.

In March, a New York District Court judge ruled in favor the plaintiffs, arguing that, as products of nature, genes are not patentable.  The defendants appealed, and, while a final ruling is being contemplated, the Justice Department decided to file an amicus brief stating its position.  While the brief itself was not filed in support of either party, its contents favor the plaintiffs’ point of view concerning the ability to patent genes.  The government agreed that forms of recombinant DNA, including vectors, cDNA and various other genetically modified materials, were “in every meaningful sense the fruits of human ingenuity,” thus qualifying them as “‘human-made inventions’ eligible for patent protection.”  By contrast, it said that “genomic DNA that has merely been isolated from the human body, without further alteration or manipulation, is not patent-eligible.”

The ability to patent genetic material dates to 1980, when the U.S. Supreme Court, ruling in Diamond v. Chakrabarty, held that products of genetic engineering were patentable, as they represented significant modifications to an existing “product.”  Researchers and companies interpreted the ruling to pertain to all genetic-related material (whether “natural” or modified) and seized upon this decision to gain patent protection for their experimental discoveries, resulting in nearly 20 percent of the 23,000 human genes being covered under patents.  Basic researchers long have argued that such an arrangement restrains scientific discovery, though in 2006 the National Research Council issued a report indicating that such patents “rarely impose significant burdens on biomedical research.”  The report did warn that “there are reasons to be apprehensive about their future impact on scientific advances in this area.”

 

What are your thoughts on the case?  Do you agree with the government?