Posts Tagged: "patents"

Hirshfeld Says He May Move Forward on Important Items If Biden Appointee Takes Too Long

IPWatchdog and LexisNexis held a “Conversation with the Commissioner of the USPTO” today, in which Drew Hirshfeld, the U.S. Patent and Trademark Office (USPTO) Commissioner for Patents, Performing the functions and duties of the Under Secretary of Commerce for Intellectual Property and Director, explained that, while he would prefer to wait until a political appointee is heading the Office to move ahead on substantive reforms, he will consider moving forward on important initiatives if necessary. “I’m trying to run the agency as if I was in this permanently, knowing I’m not and I won’t be, because I think that’s the right thing to do for the system,” Hirshfeld said. “If we’re going long enough without a nominee then maybe I need to move forward on things.”

International Academics Push for TRIPS COVID IP Waiver Hold-Outs to Drop Opposition

One-hundred-twenty-four professors and academics from around the world have penned an open letter supporting India and South Africa’s proposed waiver of certain provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), which they claim will help to combat the COVID-19 pandemic. According to a press release about the letter, the United Kingdom, Ireland, Australia, Brazil, Japan, Norway, Switzerland and the EU continue to oppose the waiver proposal. The United States expressed its support for waiver in May. Over the last several weeks, Europe has doubled down on its opposition to the proposal in ongoing talks.

Green Light for Unitary Patent and Unified Patent Court

The long-awaited EU Unitary Patent and Unified Patent Court (UPC) looks likely to be launched in 2022, after Germany’s top court rejected two challenges to ratification on Friday, July 9. In its decision, the Federal Constitutional Court rejected both the applications for preliminary injunction directed against the Act of Approval to ratify the Agreement of February 19, 2013 on a Unified Patent Court (UPCA). (BVerfG, Beschluss des Zweiten Senats vom 23. Juni 2021- 2 BvR 2216/20 -, Rn. 1-81.)

The New Biden Executive Order: Undermining Bayh-Dole is Like Shooting Ourselves in the Foot—Let’s Not Go There

Late Friday, the Biden Administration unveiled what must be one of the longest Executive Orders in history, titled “Promoting Competition in the American Economy.” In 31 pages, it covers everything from agriculture, shipping and railroads to the internet. The aim is to promote a “fair, open and competitive marketplace” against the threats of “excessive market concentration.” Among the intended beneficiaries are entrepreneurs, who will receive “space to experiment, innovate, and pursue the new ideas that have for centuries powered the American economy and improved the quality of life.” Unfortunately, tucked away on page 28 is a directive to the Secretary of Commerce that could threaten to undermine the Bayh-Dole Act, which allows entrepreneurs to commercialize federally-funded inventions. The law has spurred the impressive formation of academic spin-out companies and resulted in approximately 70% of these discoveries being licensed to small companies. It’s also critically important to our economic growth and continued well-being.

New Dance Moves? Purple Book Amendments Require Public Disclosure of ‘Patent Dance’ Patent Lists

Innovator (or “reference”) biologic drug makers and small-molecule drug makers face differing legal obligations with respect to public patent disclosures. Under the Hatch-Waxman Act, reference small-molecule drug makers are required to provide to the U.S. Food and Drug Administration (FDA) a list of the patents covering the active ingredients, compositions, formulations, and methods of treatment for their approved reference drug products, which the FDA in turn is required to publish in its “Orange Book.”  21 U.S.C. § 355(b)(1), (c)(2). The publication of such patents in the FDA Orange Book thus gives all generic drug applicants advance notice of the patents to be asserted by a reference drug maker in future Hatch-Waxman litigation.