Minding Your Business

Proskauer’s perspective on developments and trends in commercial litigation.

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Sarah Cork

Dr. Sarah M. Cork is a member of the Litigation Department and the Life Sciences Group in Proskauer’s Los Angeles office.

Her practice focuses on patent litigation in the life sciences sector, with an emphasis on pharmaceutical, medical device, Hatch-Waxman, and BPCIA matters, and she has represented both patentees and patent challengers in district courts and at the Federal Circuit. Leveraging her extensive scientific training, Sarah understands her clients’ technology at a deep level, and she is skilled at translating complex technical concepts for a lay audience. Select notable representations have concerned the drug products Avastin®, Rituxan®, Kadcyla®, Cialis®, Latuda®, and Lantus®.

Sarah has significant experience with all phases of litigation from pre-suit diligence through trial and appeal, including day-to-day case management, motion practice, fact and expert discovery, witness preparation, taking and defending depositions, and arguing discovery matters in court. Before joining Proskauer, she was an associate at Fish & Richardson P.C.

Prior to her legal career, Sarah conducted research on neurological development and disorders. Her graduate thesis work characterized novel biologic therapeutics for aggressive brain tumors.

Sarah maintains an active pro bono practice relating to children with health concerns, including in Michigan Law’s Pediatric Advocacy Clinic. She also interned in the chambers of the Hon. Anthony Porcelli (M.D. Fla.).

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Generic Competition for Withdrawn Drug Products

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 A generic cannot be approved if, in the FDA’s view, the product was withdrawn for “safety and effectiveness” reasons.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

I’ve Been Sued for Patent Infringement… Is an IPR Worthwhile?

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 … Continue Reading

Pre-Election Drug Pricing Regulation Efforts: Where Does Congress Stand?

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 … Continue Reading

Orphan Drug Exclusivity for CRISPR/Cas-Based Therapeutics

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, … Continue Reading

HHS Can’t Force Disclosure of Drug Prices in Ads with “Blunderbuss” Rule

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 … Continue Reading

Bipartisan Congress Intensifies Efforts to Restrict Orphan Drug Exclusivity

“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 … Continue Reading
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