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.  Based on the work done by the employee at the former employer, however, the former employer may believe that it has ownership rights in the new patent.

What rights might the former employer have?  A recent Federal Circuit decision, Bio-Rad v ITC – CAFC, sheds some light on how courts may resolve this kind of dispute—and how thorny the issues may be.  Key takeaways are summarized below.

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 A generic cannot be approved if, in the FDA’s view, the product was withdrawn for “safety and effectiveness” reasons.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.

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). Although the PTAB has recently conformed certain practices more closely to litigation—notably, its claim construction and indefiniteness standards—it remains a valuable venue for patent challengers seeking a relatively speedy, predictable, and cost-effective process.

The Orphan Drug Act provides two mechanisms by which a drug can receive an orphan drug designation for a “rare” disease: (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).  H.R. 4712 (the “Fairness in Orphan Drug Exclusivity Act”), which passed the House on November 17, seeks to amend the latter “cost recovery” pathway in order to address what has been called a “loophole” in the Act.

The regulation of drug prices has received significant recent bipartisan support in Congress. Democrats and Republicans in both houses have proposed approximately eighty bills relating to drug pricing over the past two years. The charts below summarize the key provisions of representative bills.[i]

Although the proposed price-regulating mechanisms differ from bill to bill, the bills do not indicate a clear difference in the parties’ goals when viewed at a high level. Many of the proposed bills focus on price transparency as well as reporting to the Department of Health and Human Services (HHS). Certain bills would require pharmaceutical manufacturers to provide data on, and justifications for, the pricing of certain drugs that would exceed specified price increase limits. These bills usually include penalties for reporting failures; however, they usually do not provide a procedure to lower a price that triggers the reporting provisions. Instead, they often establish or enhance public databases for the reported information, and some go as far as requiring pharmacists to communicate this information to the patient at the point of sale.

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. One kind of product in clinical trials is CRISPR-modified cells, such as CTX001 (CRISPR-Cas9-modified autologous hematopoietic stem cells), currently under study for the treatment of b-thalassemia and severe sickle cell anemia. Another CRISPR-based product, AGN-151587, is injected into the eye with the goal of eliminating a genetic mutation in patients with Leber congenital amaurosis 10, a leading cause of childhood blindness. In parallel, others are working to harness the CRISPR/Cas system to develop drugs for rare diseases, including bespoke therapies tailored to an individual patient’s needs.

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”). Although limited to a particular rule, the Merck decision foreshadows the likely future success of similar forced-disclosure rules.

“Orphan” drug exclusivity, which is intended to reward drug companies’ investment in the development of certain drugs, might soon be harder to get—and keep.

Over the past several months, Congress introduced two similar bills to amend a “loophole” in the Orphan Drug Act (ODA).  On October 17, 2019, a bipartisan group of House members introduced H.R. 4712 (“Fairness in Orphan Drug Exclusivity Act”) (“the House bill”).  On February 11, 2020, bipartisan Senators sponsored a companion bill bearing the same title (S. 3271) (“the Senate bill”).  Consistent with recent political interest in curbing high drug prices, the proposed legislation is intended to limit the availability of orphan drug exclusivity for certain drugs, with the goal of thereby promoting competition.