Appeals court could uphold gene patents, legal experts say

A U.S. Supreme Court ruling invalidating a set of diagnostic test patents might not affect a similar case centering on whether isolated genes are patentable, legal observers said.

A federal appeals court reheard arguments July 20 in Assn. for Molecular Pathology v. U.S. Patent and Trademark Office et al. The case was sent back to the court for reconsideration in light of a high court decision that restricted medical-testing patents. However, during the oral arguments, appeals court judges suggested that they may split from the high court ruling and reaffirm their upholding of the gene patents.

“I would say that all three judges are going to come out exactly where they were before,” said Paul H. Berghoff, a patent law attorney who co-wrote a friend-of-the-court brief in support of such patents for the Intellectual Property Owners Assn., a trade association for patent holders. During arguments, the judges “more or less reiterated arguments that favor coming out the same way.”

The proceedings were the latest in a three-year court battle between the Assn. for Molecular Pathology and Myriad Genetics. The association sued Myriad in 2009, challenging the validity of Myriad’s patents on two genes — BRCA1 and BRCA2 — linked to breast and ovarian cancer.

The suit claimed that Myriad’s sole rights to the genes and diagnostic analysis of them leaves women unable to confirm their test results elsewhere. In addition, many patients cannot afford Myriad’s $3,000 screening, the suit said.

Myriad argued that its patent claims cover patent-eligible compositions of matter and that transformative steps taken by scientists make the invention man-made.

A district court overturned the patents, ruling that they were barred by laws preventing the patentability of natural phenomena. Myriad appealed to the U.S. Court of Appeals for the Federal Circuit. In a 2-1 decision, a panel of the appeals court upheld the patents in 2011, and the defendants appealed to the Supreme Court.

The Litigation Center of the American Medical Association and the State Medical Societies issued a friend-of-the-court brief to the high court requesting that the patents be ruled invalid. The Supreme Court accepted the case but delayed its review until after deciding the separate case of Mayo Collaborative Services v. Prometheus Laboratories Inc.

In that case, Prometheus sued Mayo in 2004, claiming that Mayo infringed on its patents on a metabolite test for patients receiving certain drugs when Mayo developed a similar test. In March, the high court ruled that the patents were invalid because the correlations between metabolite levels and drug efficacy are derived from a natural body process, which cannot be patented. The high court then vacated the appeals court decision in the Myriad case and asked appellate judges to take another look at it.

Appeals judges did not appear swayed by the ruling. Judge Alan Lourie repeatedly asked questions suggesting that the Myriad case should be viewed differently from Prometheus.

“Mayo dealt with administering and determining. & Here we have something more,” he said. “The Supreme Court said what you need is something more. Isn’t this significantly more?”

Judge Kimberly Moore, who concurred with Lourie in the prior decision, also appeared critical of the plaintiffs’ position. She noted that denying the patents could negatively impact the biotech industry.

“The Patent and Trademark Office clearly announced these things to be patentable for decades, and thousands of patents exist on this, and the industry has been built up on this,” Moore said. “There’s a lot of money at stake here. If it was so obvious these things are unpatentable, how come nobody brought this up in 30-plus years that this has been going on?”

Similarities among cases are key

Judges’ questions can have different meanings, and there is no way to tell how they will rule, said Chris Hansen, an American Civil Liberties Union attorney who argued for the Assn. for Molecular Pathology.

“It is always very tricky to try and read a conclusion into their questions,” he said. “Sometimes, judges ask questions because they’re generally puzzled. Sometimes, because they’re being hostile to you. And sometimes, because they want to do you a favor and help you out.”

At this article’s deadline, Myriad and an attorney for the company had not returned messages seeking comment.

Other legal experts said the appeals judges appeared to show their hand during re-arguments.

“I would be very surprised if the federal circuit rules substantially different from the first decision,” said David Forman, a patent attorney who co-wrote a brief in support of such patents for the American Intellectual Property Law Assn., a national bar association for patent, trademark and copyright lawyers. Forman attended the arguments.

In general, courts often side with the Supreme Court when asked to reconsider cases, Hansen said. However, an opposite decision can happen, he said. Sending a case back for reconsideration is not an order requiring the lower court to change its mind, but a suggestion that it entertain the possibility.

A primary question appeals judges face in this case is: How similar are the cases involving Myriad and Prometheus?

Because one case deals with product claims and the other covers a process, the subject matter of the challenges is too different to be connected, said Christopher M. Holman, an associate law professor for the University of Missouri-Kansas City School of Law. Holman issued a friend-of-the-court brief in support of the Myriad patents.

“Prometheus shouldn’t have anything to do with the isolated DNA claims of Myriad,” he said.

But the Assn. for Molecular Pathology argues that the Prometheus decision changes the way courts should examine patent cases. For example, the high court said judges should review whether changes to a product of nature are significant or minor. Under the new Supreme Court clarification, Myriad’s patent claims should not succeed, Hansen said.

Ultimately, the Myriad case most likely will go before high court justices again.

“It is probable that it’ll go back to the Supreme Court because it’s so controversial,” Forman said. “Because of Prometheus, there is more uncertainty as to what the Supreme Court might do with this.”