Major Issues Make These Exciting Times for Biopharma Patent Attorneys


How to convince the patent office and a federal court that claims based on natural products are patentable continues to be a major concern for biopharma patent attorneys.

I say this with some authority. I have for the past eight years been privileged to be the only journalist invited by the Biotechnology Innovation Organization to attend the BIO IP Counsels Committee meetings—several attorney-bloggers attend but not as journalists. I covered the meeting of this intellectual property division of BIO in Newport Beach, Calif., in late March, and important themes emerged, as you can read by clicking on the links in this blog.

In several recent decisions, the Supreme Court has invalidated claims on isolated DNA and diagnostic methods, arguing that they are invalid as products of and laws of nature, respectively.

In one session at Newport Beach, panelists said Congress needs to amend the law on patent eligibility to make clear that the involvement of human activity can make an invention involving natural material patent-eligible. The session discussed proposed legislative language disseminated by the Intellectual Property Owners Association and noted other proposals are in development by the American Bar Association and the American Intellectual Property Law Association. You can read my full article here.

At a related session, a law professor said the Supreme Court has misinterpreted or chosen to ignore legislative history in finding certain life sciences discoveries are patent ineligible. The U.S. Court of Appeals for the Federal Circuit, following Supreme Court precedent, ruled that a life-changing and life-saving discovery by Sequenom Inc. that maternal blood or plasma could be used to test for fetal abnormalities was invalid.

Jeffrey A. Lefstin, associate academic dean and professor of law at the University of California, Hastings College of the Law, said the Supreme Court’s recent decisions shows it “is done with this issue.” He added, “I do think it’s time for legislation that amends the patent law. It’s the only way to go.” You can read my full article here.

Another session looked at legal basics, highlighting issues such as venue (which court may hear a particular lawsuit), standing (who may bring a lawsuit to court), and estoppel (a legal doctrine that governs whether on appeal or in a different lawsuit a litigant may argue the same issues that were raised in prior litigation). Panelists said these are issues that have been the focus of recent court decisions and are topics attorneys wish they had studied harder in law school. You can read my full article here.

There were other BIO IPCC sessions I covered, and the articles on those are still available only to Bloomberg Law subscribers and on the Bloomberg terminal.

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