Life Science Companies Struggling with Natural Product, Diagnostic Method Patent Approvals


Patents for diagnostic methods and natural products have become difficult to obtain of late, in part because the U.S. law in this area is still evolving.

This was a theme at the BIO IP & Diagnostics Symposium in Alexandria, Va., that I covered last week for Bloomberg BNA. You can read one of the articles I wrote on the symposium here.

Two Supreme Court decisions—one that held that claims for isolated DNA were patent ineligible as products of nature, and the other that a drug administration method was patent ineligible as a law of nature—have created some uncertainty in the life sciences community. Products/laws of nature, abstract ideas and natural phenomena are called judicial exceptions to patent eligibility.

Rulings in the lower courts that came immediately after the two Supreme Court decisions strictly adhered to them, even if the facts in the cases were substantially different from those in the decisions. However, the panelists at the symposium did point out that there are signs of a change.

They noted a recent ruling by the U.S. Court of Appeals for the Federal Circuit that found a claim for a method of freezing cells for storage for research to be patent eligible because it applied a natural phenomenon in a new and purposeful way. Some district courts have made similar rulings citing the federal circuit decision.

But the way ahead for these claims is likely to remain difficult. I had an interesting exchange with a Patent and Trademark Office official at the symposium that raised a topic I had discussed previously in one of my blogs on this site.

An attorney had written in his own blog about the PTO’s pilot program, Patents 4 Patients, which is an offshoot of the White House’s Cancer Moonshot program that’s designated to accelerate PTO review of claims for cancer immunotherapies. The attorney suggested that, because of the two Supreme Court rulings, some of those claims might be facing PTO rejection under Section 101 of the patent law as judicial exceptions to patent eligibility.

During the Q&A period, I asked one of the panelists, Robert W. Bahr, the PTO’s deputy commissioner for patent examination policy, about the attorney’s blog.

Bahr responded, jokingly, “There was a rumor going around the agency that a memo would establish a policy that all pilot program applicants should receive a special summary of Section 101. I didn’t get that memo."

"Seriously,” he said, “we follow the court’s decisions, but we have interpreted them concerning life sciences situations in memoranda and life sciences examples on our website. The PTO wants to work with applicants to help get their claims through.”

So maybe there is hope that the journey for diagnostic method and natural product patents may soon be smoother.

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