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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.).

How is orphan drug exclusivity affected when the FDA-approved use for an orphan drug is arguably narrower than the treatment of the rare disease it was designated for?

By way of background, a sponsor can obtain orphan drug exclusivity when the FDA approves an application for a drug that has first been designated under 21 U.S.C. § 360bb of the Orphan Drug Act (ODA) for a “rare disease or condition.”  Id. § 360cc(a).  Except in any of three statutorily prescribed circumstances (§§ 360cc(b), (c)), the FDA cannot approve another application for the “same drug” for “the same disease or condition” for seven years after the first approval.


Continue Reading In the Orphan Drug Approval Race, Winner Takes All? Ramifications of Catalyst Pharms. v. Becerra

The presidential administration may have changed, but the legislative branch remains focused on issues relating to patient access to drugs. One of these efforts includes P.L. 117-8, the Advancing Education on Biosimilars Act of 2021. Formerly S.164, it was introduced in the Senate in February 2021 and sped through the House to enactment on April 23, less than three months later.

Continue Reading “Advancing Education on Biosimilars”: Game Changer or More of the Same?

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.


Continue Reading Generic Competition for Withdrawn Drug Products

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.


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