The recent ruling in Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al., No. 09-Civ-4515 (S.D.N.Y.) (“Myriad Genetics“) has created more than a few ripples in the biotech industry. It is only the first round in the fight, but careful action by a biotech patent applicant now can help prevent a patent portfolio from being swamped in the future.
The rock was tossed into the biotech pond on March 29, 2010, when Judge Robert W. Sweet issued a 156-page opinion holding that the purification of a natural product (in this case, human BRCA1 and BRCA2 genes), without more, could not transform it into patentable subject matter. He relied on U.S. Supreme Court precedent, including the often cited case of Diamond v. Chakrabarty, to determine that the appropriate test was whether the invention had “markedly different characteristics” from the natural product (i.e., had a new or distinctive form, quality or property). The court then examined the isolated DNA for the BRCA1 and BRCA2 genes as claimed in the patents, and held that it was unpatentable as it was not markedly different from native DNA as it exists in the human body.
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