On July 18, 2018, the FDA released a Biosimilar Action Plan[1] that is aimed at promoting competition and affordability across the market for biologics and biosimilar products. The Plan uses four key strategies to accomplish these goals:[2]
https://www.regulations.gov/document?D=USTR-2018-0025-0002 The Office of the United States Trade Representative (USTR) released a report on an investigation of China’s acts, policies, and practices related to technology transfer, intellectual property (“IP”), and innovation. The report noted several stakeholders’ concerns, such as trade secret theft, bad faith trademarking, patent infringement by Chinese government-owned entities, inadequate IP enforcement mechanisms, substantial obstacles to civil enforcement, inconsistent criminal and administrative enforcement, and widespread counterfeiting, and the distribution of counterfeit products over the internet. Specifically, the report noted that counterfeiting occurs in a wide range of product categories, including clothing, footwear, and formalwear.
En Banc (excl. Chen), Opinion for the court filed by Stoll, joined by Newman, Lourie, Moore, O’Malley, Wallach, and Taranto. Appeal from the United States District Court for the Eastern District of Virginia.
Summary: 35 U.S.C. § 145 does not require Applicants to pay the attorneys’ fees of the United States Patent and Trademark Office (“USPTO”) when challenging an adverse decision of the USPTO in district court.
Before Prost, Moore, and Reyna. Appeal from the United States District Court for the District of Massachusetts
Summary: A patent claim having multiple permutations is only enabled if each and every permutation is enabled.
Before Frost, Newman, and Lawrie. Appeal from the U.S. District Court for the Eastern District of Texas.
Summary: A weak showing of secondary considerations is insufficient to create a genuine dispute of fact sufficient to overcome a strong showing of obviousness.
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.
