Mary Bourke is the head of Womble Bond Dickinson’s Life Sciences and Pharmaceuticals sector, which is a multi-disciplinary team focusing on pharmaceuticals, animal health, biotechnology, medical devices, biodefense, and other life sciences industry companies. Mary has been involved with the life sciences industry for more than 30 years, and has served as a trusted advisor and legal advocate for numerous clients, including representing her clients in litigation before various district courts and the Federal Circuit.
Mary and her team’s successes led the IAM Patent 1000 to recognize the team’s success in patent litigations, noting that Mary’s “résumé is replete with ANDA and biologics wins.” She has been described as a “biotechnology beacon in the Delaware litigation landscape and a “go-to” attorney for ANDA litigation. For example, Mary has been lead or co-lead litigation counsel for various pharmaceutical companies and has litigated patents that cover new chemical entities, polymorphs, formulations, methods of treatment, dosing regimes, medical devices, and other pharmaceutical and life sciences patents. She has been lead counsel on multiple ANDA and biologics cases and understands the importance of coordinating ANDA litigation with parallel actions, including actions involving the FDA, post-grant proceedings, and world-wide patent prosecution and litigation actions.
In addition to her work in the biotechnology, pharmaceuticals, and life sciences industries, Mary has also represented clients in other areas (e.g., chemical and chemical manufacturing) in both state and federal court and in front of the USPTO. Mary has a deep knowledge of Delaware practice and was one of sixteen (16) attorneys who was asked to serve on the most recent District of Delaware’s Advisory Committee. In addition, Mary has served as Delaware counsel in various cases, including in non-practicing entity and trade secrets litigation.
Representative Experience
Any result the lawyer or law firm may have achieved on behalf of clients in other matters does not necessarily indicate similar results can be obtained for other clients.
- Lead counsel for an international pharmaceutical client in litigation in the Southern District of New York involving claims for correction of inventorship. At trial in July 2019, successfully proved that the opposing party’s alleged inventor did not invent any of the subject matter claimed in two of our client’s patents.
- Lead counsel representing an international pharmaceutical client in litigation involving declaratory judgment claims of non-infringement and invalidity. Successfully argued that the patents at issue were invalid under §§ 112 and 102(f). The case was one of the first virtual trials in the nation and the first virtual trial in the SDNY.
- Lead counsel for a pharmaceutical company in an ANDA litigation involving the company’s peptide drug for treating prostate cancer.
- Lead counsel for a pharmaceutical in ANDA litigation involving low-volume colonoscopy preparation drug product.
- Lead counsel for a German pharmaceutical company defending against a qui tam action in the Northern District of California.
- Lead counsel for an international pharmaceutical company in multiple ANDA litigations regarding a colonoscopy preparation drug product. In June 2017, the Court issued an opinion that the first filer’s proposed ANDA product infringed all asserted claims of the patents in suit. The subsequent cases were settled on favorable terms.
- Lead trial counsel for a large brand pharmaceutical company in multiple ANDA litigations regarding composition and method of use patents covering a drug used to treat ulcerative colitis.
- Lead counsel in an inter partes review of a method of use patent owned by a large brand-name pharmaceutical company for one of the company’s ulcerative colitis drugs.
- Lead counsel for Duke Energy Carolinas, LLC in a lawsuit brought by Smart Meter Technologies, Inc. and accusing Duke of infringing a patent covering smart power meters. Also serving as oversight counsel for the inter partes review filed on the patent in suit.
- Lead counsel defending a large Delaware chemical manufacturing company from various state law claims, including misappropriation of trade secrets. The lawsuit involved one of the company’s flagship products and Mary was able to successfully litigate the case to the point that the client reached a favorable settlement of all claims.
Professional & Civic Engagement
- Federal Bar Association
- District of Delaware’s Advisory Committee (2015 – 2016)
Thought Leadership
- “Do I Really Own That?” Consero IP Forum for Life Sciences, December 2022
- “Remote Litigation: Lessons Learned from a ‘Zoom’ Trial,” Womble Bond Dickinson's Everything from Everywhere Virtual Summit, January 2021
- “Lessons Learned from The First ZOOM Trial in the SDNY – A Case Study," Consero IP Virtual Forum for Life Sciences, December 2020
Honors & Awards
- Chambers USA Ranked Lawyer, Intellectual Property, Delaware, 2013 – Present
- Named to IAM Patent 1000, Litigation, Intellectual Asset Management Magazine, 2016, 2019, 2020