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AIPLA is Concerned About Impact of Supreme Court Decision in Myriad


In response to today's decision in Assoc. for Molecular Pathology v. Myriad Genetics, Inc., AIPLA has been quite busy.  We've been taking press calls all day. Tonight, Q. Todd Dickinson, AIPLA's Executive Director, is scheduled to be on the PBS News Hour at approximately 6:20 pm EDT for a brief interview with Judy Woodruff (and one other guest) to talk about the broader implications of the decision. The last time Todd was on PBS, they posted a link to the interview on their web site shortly afterwards. Look for an AIPLA Direct with more analysis of the decision shortly.

Here is the official AIPLA Press Statement on today's decision:

The Supreme Court on June 13, 2013, continued to cut back on the scope of technologies eligible for patent protection, by holding that cDNA molecules are eligible for patent protection but a sequence of DNA molecules isolated from their natural state by known techniques is not.

The American Intellectual Property Law Association (AIPLA) took the position in an amicus brief that isolated DNA is patent eligible because, but for the intervention of science, it cannot be found in nature. The human genes as they exist in the body are not eligible for patent protection, but the DNA molecules claimed here are compositions of matter that are both structurally and functionally different from human genes, and those differences are man-made, according to the brief.

"AIPLA is concerned that, while the Supreme Court has recognized the importance of patent protection to the health industry, today's opinion may throw into question patent protection for important technology that is critical to improving health for the public, and that has become the cornerstone of the biotech industry," said Jeffrey I. D. Lewis, AIPLA President.  Lewis elaborated:

"More generally, the opinion in the case is remarkably short given the complex legal and scientific questions that were raised; it fails to clarify in any meaningful way the difference needed to change natural material into man-made material that is eligible for patent protection. On the other hand, Justice Thomas said the decision was limited, noting that it does not involve (1) method claims, (2) patents on new applications of knowledge about the BRCA1 and BRCA2 genes, or (3) the patentability of DNA in which the order of the naturally occurring nucleotides has been altered.  He said: 'Scientific alteration of the genetic code presents a different inquiry, and we express no opinion about the application of §101 to such endeavors.'

"It remains to be seen how innovation will be affected by this new development, and whether it will affect the kind of investments necessary to produce these kinds of personalized medical advancements," continued Lewis. "It may even backfire on its proponents, leading to increased secrecy in research and reduced collaboration, so critical in today's research environment."