A U.S. Supreme Court ruling last week that patents should be presumed valid could make it easier for medical devicemakers to sue for patent infringement, a patent law attorney said.

The 6-2 ruling, with one abstention, in Commil USA v. Cisco Systems means plaintiffs will no longer need to prove their patents are good to bring a claim, says Jonathan Losk, a partner with Knobbe Martens. Previously, defendants could not be held liable for infringement if they had a good faith belief the patent was invalid.

The case involved allegations by Commil that Cisco infringed upon a patent for a method of implementing short-range wireless networks. The case went to trial, and Cisco was held liable for direct and induced infringement, despite the defendant’s claim that it had a “good-faith belief” that the patent was invalid. The U.S. District Court for the Eastern District of Texas deemed Cisco’s supporting evidence inadmissible, and the Federal Circuit affirmed the decision.

In upholding the appeals court and lower court rulings, the Supreme Court said “a defendant’s belief regarding patent validity is not a defense to an induced infringement claim.”

While this is good news for devicemakers, there are steps they can take better protect intellectual property, says Losk. For starters, companies should file separate patents on the device, the device system, the method for treating patients with the device and the manufacturing process. The patent applications should “give breadth and length to your intellectual property protections,” Losk says. He spoke at an FDAnews webinar last week.

Protect Critical Assets

Companies should take extra care to protect critical assets — those that, if usurped by competitors, could disrupt the business, Losk says. This normally involves identifying an asset owner, implementing primary and secondary safeguards and restricting access based on the need to know. In addition, firms should forensically capture and review every computing asset when it is replaced or when an employee leaves.

Losk also recommends correlating patents with business value models by developing a list of key clinical value features and mapping patent claims against these features. He further advises adding restrictive labeling to devices, such as one-time use restrictions, or restricting implied licenses for use.

Once patents are attained, companies should monitor the landscape for possible infringement, which can be done by searching the USPTO database, watching key foreign markets and watching for FDA clearances, CE marks, or other regulatory authorizations for products similar to your own, Losk says.

Losk also recommends establishing a firm internal policy that any unsolicited product concepts be channeled to a single individual or office, normally patent counsel or business development. He cites the example of a physician sharing an invention with a devicemaker’s sales rep, who then takes the product to the corporate office where in-house R&D staff have been working on the same concept. Without any internal policy, the physician might expect a lucrative business agreement, and failure to get one could lead to loss of a customer or a lawsuit, the attorney says.

Companies can further protect themselves if they accept only copies of filed patent applications, which will require inventors to protect their concepts before disclosing them. When accepting a concept, the firm should issue a nondisclosure agreement limiting access to the product idea to a few company representatives.

View the decision in Commil USA v. Cisco Systems at www.fdanews.com/06-01-15-CommilvCisco.pdf. — Elizabeth Orr