Penn joins two patent infringement lawsuits over breast cancer gene testing

While Penn was recently named as a plaintiff in two court actions filed by a genetics company over breast-cancer-related patents, two similar cases in which Penn is involved might influence the result of these new filings.

In its most recent court battles over genetic testing, Myriad Genetics — along with Penn, the University of Utah Research Foundation, Endorecherche, Inc. and the Hospital for Sick Children Research and Development LP — has filed two separate lawsuits against Quest Diagnostics and GeneDx Inc. in mid-October.

The two October suits mark the third and fourth court actions brought by Myriad, a large genetic testing company, against organizations it alleges are violating patents that protect its right to perform certain genetic testing. In July, Myriad and the four other plaintiffs” filed suit against two different genetics companies”: http://www.thedp.com/r/898e51b4 — Ambry Genetics and Gene by Gene, LTD — which they accused of patent infringement.

At issue in the four cases are several patents owned or exclusively licensed to Myriad that deal with BRCA1 and BRCA2 — two genes that are highly determinative of a person’s risk for breast cancer. Penn is a partial owner of two of the BRCA2-related patents in these suits.

It is likely that Myriad is “controlling the direction of this lawsuit,” Jacob Sherkow, a fellow at Stanford Law School’s Center for Law and Biosciences, said.

“Anyone who has any ownership [of a] patent has to be [part of] the lawsuit for the federal court to have power to hear it,” Sherkow said. That’s why, he noted, Penn and several others might be plaintiffs in the lawsuit — not necessarily because they want to be a part of it.

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“It is a matter of law, not a matter of choice,” Senior Vice President of the University of Pennsylvania Health System Susan Phillips told The Daily Pennsylvanian in July with regards to the Ambry and Gene by Gene cases. “We did not seek out this lawsuit.”

She reiterated those same sentiments with regards to the Quest and GeneDx cases. “We were dragged into it by an agreement,” she said.

In each complaint, Myriad alleges that services being offered by the defendant are infringing on claims asserted in the patents it controls.

Myriad said in a statement that it and the other plaintiffs continue to believe that the patent claims in question are “valid and enforceable” and will show that Quest and GeneDx’s testing procedures are infringing on those claims.

One part of Penn’s patents that Myriad alleges is being infringed upon relates to BRCA primers — small pieces of DNA that researchers use to copy different genes. The other is a method by which a person’s susceptibility to cancer can be detected based on their BRCA gene.

Sherkow said that the primer-related issues in the Quest and GeneDx cases might be settled before either party has the chance to argue them.

When the U.S. Supreme Court decided this summer that naturally occurring genes could not be patented, it “left open the issue of whether primers are still patentable,” Sherkow said.

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However, he noted that since this is one of the key issues in the cases against Ambry and Gene by Gene — the two companies that were sued by Myriad this summer — it is possible that the court hearing those cases will decide whether primers can be patented.

Currently, the court is deliberating on whether to issue a preliminary injunction against Ambry and Gene by Gene, which would prevent them from conducting the genetic testing in question throughout the length of the trial.

“Myriad, GeneDx and Quest may want to wait to see how this issue in the Ambry and Gene by Gene cases play out before they make any big decisions,” Sherkow said.

Some of the other plaintiffs likely entered the lawsuit due to their agreement with Myriad. According to Myriad’s agreement with HSC, which co-owns two of the patents with Penn, if Myriad were to file a lawsuit for patent infringement, then HSC is obligated to be a plaintiff in the case.

HSC did not respond to a request for a comment for this story. The University of Utah Research Foundation, another plaintiff, deferred comment to Myriad.

Quest said in a statement that it is “confident that our offering does not violate any valid Myriad claims” and that it will “vigorously defend” and continue to provide BRCA testing to patients.

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