Drug & Device News

At High Court's Request, Fed Circuit Reconsiders Patent Decision

Last July, the U.S. Court of Appeals for the Federal Circuit handed a favorable ruling to drug manufacturers in Association for Molecular Pathology v. Myriad Genetics, a case concerning the patentability of isolated genes. That case was brought by The American Civil Liberties Union (ACLU) and the Public Patent Foundation against several defendants, including Myriad Genetics Inc., which lost its method patents but won its fight to protect patents on two genes chemically separated from DNA associated with ovarian and breast cancer. On July 20 of this year, however, the parties were back in court, arguing before the Federal Circuit over whether the March 2012 U.S. Supreme Court decision in Mayo Collaborative Services v. Prometheus Laboratories Inc. dictates a different outcome. In Mayo, the Court invalidated patents on a method for determining the optimum drug dosage for individuals with certain diseases. The Supreme Court reasoned that the disputed method involved “laws of nature,” but not in an inventive manner, so no patent could be awarded on it. After issuing its Mayo decision, the Court invalidated the Federal Circuit's 2011 ruling and returned the case to it for reconsideration in light of Mayo. On re-argument, Jones Day partner Gregory Castanias asserted that the Federal Circuit had already concluded in its previous decision that the patents it upheld in Myriad involved “non-naturally-occurring, human-made inventions.” Thus, the Mayo decision should not alter the outcome, he said. The ACLU countered that Mayo applies to Myriad because it dealt with the issue of whether a disputed patent prevents scientists from conducting research involving a law or product of nature. If it does, and the patent is upheld, it could squelch scientific research and hinder the invention of useful products.

Common MS Treatment May Not Slow Progression of Disease

In an article published in the June 18 issues of the Journal of the American Medical Association, researchers reported that they could find no correlation between the use of interferon beta drugs and a reduction in the progress to disability of multiple sclerosis sufferers. Afsaneh, Shirani, “Association Between Use of Interferon Beta and Progression of Disability in Patients with Relapsing-Remitting Multiple Sclerosis, JAMA, 2012;308(3):247-256. Because these drugs are known to reduce the incidence of relapses and brain lesions in those with multiple sclerosis, they are routinely prescribed to patients with MS. This study appears to show, however, that these complications are not driving forces behind the development of disability. The authors stated in the concluding paragraph of their comments on the study that “[t]he ultimate goal of treatment for MS is to prevent or delay long-term disability. Our findings bring into question the routine use of interferon beta drugs to achieve this goal in MS.”

At High Court's Request, Fed Circuit Reconsiders Patent Decision

Last July, the U.S. Court of Appeals for the Federal Circuit handed a favorable ruling to drug manufacturers in Association for Molecular Pathology v. Myriad Genetics, a case concerning the patentability of isolated genes. That case was brought by The American Civil Liberties Union (ACLU) and the Public Patent Foundation against several defendants, including Myriad Genetics Inc., which lost its method patents but won its fight to protect patents on two genes chemically separated from DNA associated with ovarian and breast cancer. On July 20 of this year, however, the parties were back in court, arguing before the Federal Circuit over whether the March 2012 U.S. Supreme Court decision in Mayo Collaborative Services v. Prometheus Laboratories Inc. dictates a different outcome. In Mayo, the Court invalidated patents on a method for determining the optimum drug dosage for individuals with certain diseases. The Supreme Court reasoned that the disputed method involved “laws of nature,” but not in an inventive manner, so no patent could be awarded on it. After issuing its Mayo decision, the Court invalidated the Federal Circuit's 2011 ruling and returned the case to it for reconsideration in light of Mayo. On re-argument, Jones Day partner Gregory Castanias asserted that the Federal Circuit had already concluded in its previous decision that the patents it upheld in Myriad involved “non-naturally-occurring, human-made inventions.” Thus, the Mayo decision should not alter the outcome, he said. The ACLU countered that Mayo applies to Myriad because it dealt with the issue of whether a disputed patent prevents scientists from conducting research involving a law or product of nature. If it does, and the patent is upheld, it could squelch scientific research and hinder the invention of useful products.

Common MS Treatment May Not Slow Progression of Disease

In an article published in the June 18 issues of the Journal of the American Medical Association, researchers reported that they could find no correlation between the use of interferon beta drugs and a reduction in the progress to disability of multiple sclerosis sufferers. Afsaneh, Shirani, “Association Between Use of Interferon Beta and Progression of Disability in Patients with Relapsing-Remitting Multiple Sclerosis, JAMA, 2012;308(3):247-256. Because these drugs are known to reduce the incidence of relapses and brain lesions in those with multiple sclerosis, they are routinely prescribed to patients with MS. This study appears to show, however, that these complications are not driving forces behind the development of disability. The authors stated in the concluding paragraph of their comments on the study that “[t]he ultimate goal of treatment for MS is to prevent or delay long-term disability. Our findings bring into question the routine use of interferon beta drugs to achieve this goal in MS.”