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Joel Wallace Image

Joel Wallace

is a partner at Schiff Hardin focusing his practice in intellectual property litigation, with significant experience in patent and trademark litigation and non-litigation analyses across a range of industries, including pharmaceuticals, medical devices and consumer goods and services. As part of his practice, he regularly prepares Hatch-Waxman Paragraph IV letters, advises clients on patent and regulatory issues, and advocates for clients in litigation, including fact discovery, expert discovery, trial, and appeal. Joel also has experience in post-grant review practice before the PTO, including preparation of petitions for inter partes review.

Recent Articles by Joel Wallace

Sanofi Decision Presents Opportunities to Clear the Patent Thicket for Generic Pharmaceuticals

The U.S. Court of Appeals for the First Circuit has made brand companies think twice about creating patent thickets in the Orange Book by resuscitating an antitrust suit against Sanofi by direct purchasers of insulin glargine. In re Lantus Direct Purchaser Antitrust Litigation (Feb. 2020). The Sanofi decision provides a possible opportunity to seek antitrust liability against brand companies for abusing Food and Drug Administration (FDA) regulations. The decisions should make branded companies reconsider over-listing patents in the Orange Book, and potentially slowing down generic competition. While this decision sets the stage for further fights over what patents should not be listed as covering approved “drugs,” it also sets a clear test for courts to consider when evaluating other tactics that brands have used to create regulatory delays to stall approval of potential rival products.

Mad Dash to Coronavirus Vaccine May Face Legal Hurdles

Almost a third of the recently signed $8.3 billion bill to fund the United States response to the coronavirus outbreak is devoted directly to vaccine research and development. And while the realities of drug development and FDA approval mean it is unlikely any vaccine will be available before next year, the government has numerous tools at its disposal in seeking to reduce the strain on the nation’s health care system. As many as nine different pharmaceutical companies worldwide are rushing to develop a safe and effective vaccine. Some are using traditional vaccine methods, including testing previously developed vaccines for other viruses. Others are using new technology to address the outbreak. The rush to find and deploy a coronavirus vaccine raises several interesting legal and regulatory issues, including balancing speed with efficacy, understanding ownership, and vaccine costs.