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Articles by Sarah Cork Ph.D
Ownership of Inventions By Former Employers: Lessons after Bio-Rad v. ITC | JD Supra
The situation is familiar: an employee leaves one company to go work for another, or perhaps to found her own start-up. She may be working on the same problems that she faced at her former workplace, and in the same technological space. The employee’s work at her new company results in the issuance of a patent, and the new company takes the lead in the marketplace.
Generic Competition for Withdrawn Drug Products | JD Supra
When a pharmaceutical company withdraws a product from the market, the basis for the withdrawal can affect whether a competitor can commercialize a generic version of that product. A generic cannot be approved if, in the FDA’s view, the product was withdrawn for “safety and effectiveness” reasons. But how does the FDA reach that conclusion? A newly filed case may shed some light on the Agency’s decision-making process.
I’ve Been Sued for Patent Infringement… Is an IPR Worthwhile? | JD Supra
Recent Precedential Decisions Applying Fintiv When a company is sued for patent infringement, often one early strategic consideration is whether to counterattack the patent’s validity at the Patent Trial and Appeal Board (PTAB) in a parallel post-grant proceeding such as inter partes review (IPR) or post-grant review (PGR).
H.R. 4712: A “Narrowly Tailored” Obligation Under the Orphan Drug Act? | JD Supra
The Orphan Drug Act provides two mechanisms by which a drug can receive an orphan drug designation: (1) if it affects less than 200,000 persons in the United States, or (2) if it “affects more than 200,000 in the United States and for which there is no reasonable expectation that the cost . . . will be recovered from sales in the United States of such drug.” See 21 U.S.C. § 360bb(a)(2).
Pre-Election Drug Pricing Regulation Efforts: Where Does Congress Stand? | JD Supra
S. 3384 Lowering Prescription Drug Prices for America’s Seniors and Families Act of 2020 03/03/2020 Sen. Martha McSally (R-AZ) 03/03/2020 Referred to Committee on Finance Allows HHS to negotiate prices for certain Medicare Part D drugs. Allows individuals to import drugs from Canada. S. 3166 Prescription Drug Affordability and Access Act 01/08/2020 Sen.
Orphan Drug Exclusivity for CRISPR/Cas-Based Therapeutics | JD Supra
The prospect of genetic engineering using CRISPR (clustered regularly interspaced short palindromic repeats) and CRISPR-associated nucleases (Cas) has long been hailed as a “revolutionary” development in medicine. This technology is rapidly advancing, and several CRISPR/Cas-based drugs have entered clinical trials over the past several years.
HHS Can’t Force Disclosure Of Drug Prices In Ads with “Blunderbuss” Rule | JD Supra
Among its various attempts to regulate drug prices, the Trump administration recently sought to force pharmaceutical advertisements to disclose the wholesale acquisition cost (WAC) of certain drugs. This effort was dealt a setback in June, when the D.C. Circuit found that the Department of Health and Human Services (HHS) overstepped its regulatory authority by compelling disclosure of these costs. Merck & Co., Inc. v. U.S. Dep’t Health & Human Servs. (“Merck”).
Bipartisan Congress Intensifies Efforts to Restrict Orphan Drug Exclusivity | JD Supra
Updated: May 25, 2018: JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.
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