Jessica M. Karmasek Jul. 22, 2014, 9:10am

SAN DIEGO (Legal Newsline) – A study released last month shows that two U.S. Supreme Court rulings have made it more difficult for companies in the life sciences industry to obtain patents.

Bloomberg BNA and law firm Robins Kaplan Miller & Ciresi LLP, in conjunction with the Biotechnology Industry Organization, published the June 25 report, “Stopped at the Threshold: The Practical Implications of the Supreme Court’s Mayo and Myriad Decisions on Life Sciences Patent Practices.”

The report looks at the impact of the high court’s rulings in Mayo Collaborative Sciences v. Prometheus Laboratories and Association for Molecular Pathology v. Myriad Genetics, and the U.S. Patent and Trademark Office’s interpretation of the decisions, on companies that own or license patents across the life sciences industry.

Life sciences are those fields of science that involve the study of living organisms, such as microorganisms, plants, animals and human beings.

“The decisions made by the Supreme Court and the resulting PTO guidance have far-reaching implications for the life sciences industry,” said Randy Kubetin, managing editor of Bloomberg BNA’s Life Sciences Law & Industry Report.

“The industry is still reverberating from the impact of these events.”

In Mayo, the Supreme Court ruled that a company’s processes, which help doctors who use thiopurine drugs to treat patients with autoimmune diseases determine whether a given dosage level is too low or too high, were not patent eligible.

Petitioners Mayo Collaborative Services and Mayo Clinic Rochester had bought and used diagnostic tests based on Prometheus Laboratories Inc.’s patents.

But in 2004 Mayo announced that it intended to sell and market its own, somewhat different, diagnostic test.

Prometheus sued Mayo, contending that Mayo’s test infringed its patents.

A district court found that the test infringed the patents but granted summary judgment to Mayo, saying the processes claimed by the patents effectively claim natural laws or natural phenomena and are, therefore, not patentable.

The U.S. Court of Appeals for the Federal Circuit reversed, finding the processes to be patent eligible under its so-called “machine or transformation test.”

The Supreme Court, in its March 2012 decision, reversed the Federal Circuit’s ruling.

In Myriad, the high court ruled mostly against a Utah-based molecular diagnostic company in its attempt to patent a pair of genes linked to breast and ovarian cancer.

In its unanimous opinion last June, the Supreme Court wrote that defendant Myriad Genetics Inc. “did not create anything.”

“To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention,” Justice Clarence Thomas wrote in the court’s 18-page ruling.

Myriad faced claims that its patents on genes BRCA1 and BRCA2 — the two human genes that indicate a higher risk of breast and ovarian cancer — violate intellectual property law, as well as the First Amendment.

Last month’s report shows the court’s interpretations have “shaken the life sciences industry at its roots.”

According to interviews with industry experts, some of those affected companies believe the current environment could force inventors and investors to abandon what could be life-saving projects, or even move to other countries where the laws facilitate innovation.

The court’s rulings — and the PTO’s guidance on them — have “rewritten the playbook for biotechnology companies… [and] not only limit the scope of what discoveries remain patent eligible, they also transform the way the PTO’s patent examiners will review life sciences applications,” the study states.

“We were surprised to see how many claims the Patent and Trademark Office rejected on the basis of the Supreme Court’s recent decisions,” said Matthew McFarlane, co-author and principal with Robins Kaplan.

Tara Sharp, an associate with Robins Kaplan and co-author of the report, said the inventions impacted by the court rulings and PTO guidelines range from methods for diagnosing disease, biological products, including antibodies and proteins, and even plants and metallic compounds.

As part of the study, the authors interviewed 24 industry legal professionals representing the biotechnology industries, including corporate representatives affected by the changes and patent attorneys who deal regularly with the PTO, and gathered commentary from PTO officials.

The report also analyzed about 350 patent applications recently rejected by the PTO that have been impacted by the decisions.

To view an executive summary of the study, click here.

From Legal Newsline: Reach Jessica Karmasek by email at


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