Myriad Decision May Invalidate Many Patents

The Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc. will have a widespread impact on the biotechnology industry. The technology at issue concerns diagnostic methods for detecting genetic changes that predict an increased risk for developing breast and/or ovarian cancer. Public awareness of this testing was greatly increased when actress Angelina Jolie disclosed her test results and subsequent surgery.

The Court determined that Myriad’s patent claims on isolated, naturally-occurring DNAs were invalid because the genes are naturally occurring phenomena. The Court also ruled that claims to artificially-created combinations and synthetic copies of DNA are patent eligible. The decision did not precisely determine whether proteins and antibodies are patent eligible, but according to the authors it would be prudent to expect that claims covering any biomolecule as it appears in nature, regardless of whether it was isolated, are likely invalid.

Based on a quick search of patents issued by the USPTO, the authors find there are more than 5,000 patents that claim “isolated DNA.” Accordingly, the Myriad decision potentially invalided over 5,000 patents owned by large and small businesses in the biotechnology industry.

From now on the options for claiming biotechnological products will be limited. The authors discuss how to best take advantage of the opportunities presented by the ruling that synthetic combinations are patent eligible. They summarize best practices for drafting specifications and claims, and for amending claims in issued patents and pending patent applications.