The Food and Drug Administration (FDA) has announced a medical device innovation challenge to help address opioid abuse and misuse. With the FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder, the FDA intends to encourage development of medical devices that will help to combat the ongoing opioid crisis.
On July 20, 2018, the Federal Circuit held that tribal sovereign immunity is not available as a defense in IPR.
On July 19th, 2018, the United States Department of Veterans Affairs (VA) and IBM Watson Health announced an extension of their ongoing partnership to interpret cancer data in patients.
Senator Orrin Hatch (R-UT) recently introduced a bill titled the “Hatch-Waxman Integrity Act of 2018” (HWIA). Sen. Hatch suggests that the HWIA will (i) “restore the careful balance the Hatch-Waxman Act struck to incentivize generic drug development,” (ii) “prevent alternative procedures for challenging drug patents from tilting the playing field contrary to Hatch-Waxman’s design,” and (iii) “ensure that brand-name and generic manufacturers alike have the proper incentives to develop life-saving medications.” Press Release dated June 14, 2018. Specifically, the proposed legislation would amend certain sections of the Food, Drug, and Cosmetic Act that provide the current framework for generic pharmaceutical and biosimilar product approvals.
Before Dyk, Moore, and Reyna. Appeal from the Patent Trial and Appeal Board.
Summary: Tribal sovereign immunity does not shield Indian Tribe owned patents from IPR.
Before Taranto, Plager, and Chen. Appeal from the U.S. District Court for the Western District of Washington.
Summary: A patent claim is directed to an abstract idea where it broadly recites a result without defining how the result is achieved other than through implementation of generic computer functions.
Envision Healthcare Corporation (“Envision”) recently announced an agreement to be acquired by KKR & Co. L.P. (“KKR”) for about $5.5 billion in cash. The transaction is valued at $9.9 billion, including the assumption or repayment of debt. The transaction remains subject to regulatory and shareholder approvals, but is expected to close in the fourth quarter of 2018.
Stryker recently announced an agreement to acquire SafeAir AG, a Swiss surgical smoke evacuation company. The acquisition will likely close by the end of 2018.
President Donald Trump’s 25 percent tariffs on Chinese imports went into effect on July 6, a move that, according to industry experts, could have wide-ranging effects on American medical device manufacturers. In early April, RBC Capital Markets estimated the proposed tariffs could cost the entire medical device industry up to $1.5 billion each year.
Before Prost, Moore and Reyna. Appeal from the District Court of Delaware.
Summary: A limitation in the specification should not be imported into a claim when there is no evidence that the limitation is important, essential or critical.
