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Wednesday, May 12, 2010
Biotech industry focuses on how gene patent case turns out
By Julie M. Donnelly
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The local biotechnology industry is on tenterhooks, waiting to see if a court ruling that invalidates patents on genes will be overturned. The federal court case, decided March 29, received an inordinate amount of attention from both the media and the legal community, prompting nine amicus briefs on the side of the defendant and several more on the side of the plaintiffs.
Attorneys who filed amicus briefs say that upholding the decision would have a wide-ranging negative impact on biotechnology, diagnostics and vaccines companies in Massachusetts.
New York U.S. District Judge Robert Sweet issued an injunction against Utah-based Myriad Genetics Inc., invalidating two patents related to breast cancer that are used in conjunction with its diagnostic test for a certain type of the cancer. The plaintiffs in the case, researchers and breast cancer patients led by the American Civil Liberties Union, successfully argued that the patents were illegal under patent law and under the U.S. Constitution. The judge ruled that the patents that were the subject of the case cover parts of the natural world and are therefore not patentable. There were two other named defendants in the case; the University of Utah, and the U.S. Patent and Trademark Office.
“There is a misconception that this is about patenting genes. These are patents for diagnostics, and in the past those have been validated,” said Erik Belt, a patent attorney at McCarter & English LLP who was part of a team that drafted one of the amicus briefs in support of the biotechnology industry on behalf of the Boston Patent Law Association.
Belt said it is important that the case is not about a specific person’s DNA; it’s an isolated sequence that has a different chemical structure to DNA inside the body. In this case, however, Belt said the judge determined that the isolated DNA conveyed the same information as in vitro genes, and therefore were not patentable.
Belt said the firm has received a number of inquiries from biotech clients on this issue and that the IP team has developed a strategy to help companies navigate the decision.
“We’ve implemented a claim drafting strategy to include an extra transformational step in the process when they write their patents,” Maria Laccotripe Zacharakis, a member of the life sciences IP team at McCarter English, said. It is clear that when the chemical structure is modified by a piece of equipment, a transformation has occurred, she said, but it is often more complicated to show that transformation with a diagnostic, which requires interpretation by a clinician but is not necessarily modified by an apparatus.
Some have argued that interpreting a diagnostic is just a “thought process” and is not patentable.
But many lawyers feel the decision won’t stand.
“This case is a set up for the Supreme Court. It is very likely to get reversed by the Federal Court of Appeals,” said Bruce Sunstein of Sunstein Kann Murphy & LLP. Sunstein said the district court judge relied on “Neanderthal patent law,” including a case from 1948, which found that plants could not be patented.
Court of appeals decisions have run more along the lines of the so-called Prometheus case, which said that diagnostic methods are patentable. But Sunstein said that if the case does make it to the U.S. Supreme Court, the idea that things close to nature can’t be patented may find some sympathy. Supreme Court Justices including Associate Justice Stephen Breyer have historically been wary of monopolies created by patents.
“The point of patents is to incent innovation. But if patents are too powerful, they can retard innovation,” said Jerry Cohen, a patent attorney at Burns and Levinson LLP, and a board member of the Massachusetts chapter of the ACLU. Cohen said that in this case the use of the patent-protected diagnostic technology prevented outside researchers from using the information, without paying Myriad for the privilege of doing so.
Cohen said the researchers and cancer patients in the case argued that these restrictions were not for the public good. Patients said they were unable to obtain second opinions of their diagnoses because outside researchers could not get access to the technology or because their insurance wouldn’t cover the expensive tests.
“But the alternative is, maybe the companies don’t make the tests or the drugs if they don’t have patent exclusivity,” Sunstein said. It’s not a hypothetical argument. One example of this phenomenon is the vaccine industry, Cohen acknowledges.
“Broadly across the industry, vaccines are not patentable, so big pharma is not motivated,” he said. Cohen agreed that this has been one factor that has fueled shortages of vaccines, such as flu vaccine, in recent years. But Cohen said that the government has other tools at its disposal to promote such monopolies if they are for the public good, aside from the patent landscape.
“If you look at the cable television industry for instance, they dig up streets, don’t have competition, but they don’t need patents to do it,” Cohen said.
Myriad has said it will appeal the decision.
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