Mrs. Colleen Superko serves as counsel to many sectors of the pharmaceutical and biotechnology industries, including both startup ventures and well-established, multi-national branded companies. For more than 25 years, she has gained experience in all areas of drug discovery through drug development, including product launch.
Mrs. Superko understands the integral role that IP plays during the different stages of pharmaceutical development. Her diverse patent practice includes strategic development, analysis and management of domestic and foreign patent portfolios, client counseling, intellectual property due diligence for licensing, transactions and financings, opinion work and patent litigation.
She advises life science clients across a spectrum of innovative technologies, including small molecule discovery and development, biologics, stem cell research, protein and antibody expression and purification, screening assays, formulations and combination products. She is also heavily invested in growing the firm’s clean technology practice, particularly, alternative fuel sources.
Her practice centers around her ability to listen to and comprehend her client’s issues and deliver critical IP advice that is tailored to leverage the entity’s business objectives. With respect to domestic patent procurement, Mrs. Superko provides patent prosecution services, conducts appeals, files ex parte and reexamination proceedings and calculates patent term adjustment before the USPTO.
Her opinion work focuses on patent infringement, validity, scope and enforceability issues. She has provided frequent due diligence advice to potential investors needing to understand the risks associated with funding a technology and its related intellectual property, and to companies seeking to acquire product portfolios, launch an IPO or series financing, or in-license molecules or platform technology from a third party.
In 2017, she worked on three IPO transactions and five other corporate financings in life science companies, including Series C, D and E rounds, shelf offerings, and private-equity financings for major investment banks, asset management companies and healthcare fund management companies.
Mrs. Superko spends a significant amount of time conducting pre-litigation investigations for patent infringement and ANDA actions, as well as playing an active role in the proceedings if they mature beyond the investigatory stage.
The pitfalls she contends with in litigation help to inform her drafting and prosecuting of patents that cover commercial products and their improvements. She particularly enjoys working with scientific fact and expert witnesses.
Recently, she worked closely with a biostatistician to develop a successful infringement theory for a specialty pharmaceutical client to prove the claimed physiological effect of a drug on a patient population through clinical trial data.
With regard to the interplay between the FDA regulatory practice and patents, Mrs. Superko regularly advises clients on Orange Book listing strategies, patent term extension, and other life cycle management opportunities for New Drug Applications.
Mrs. Superko was actively involved in the creation of the firm’s BIO 2009 panel in Atlanta on Shaping Follow-on Biologics Policy: The Interplay of Date Exclusivity, Patient Safety and Patents.
She successfully represented several homeless clients seeking to obtain Social Security Administration Disability benefits, both in the hearing stage and on appeal, through the firm’s affiliation with Lawyer’s Clearinghouse.
Mrs. Superko recently became a Fellow with the Culinary Institute of America, which supports the quality, camaraderie, creativity, and culture of the college and its students. Mrs. Superko is a member of the American Bar Association and the American Intellectual Property Law Association. She is a former member of the Boston Cabinet of Dickinson College.
- Secured a significant victory at the Federal Circuit for Braintree Laboratories, Inc. when the appeals court reversed a district court’s grant of summary judgment of noninfringement for Breckenridge Pharmaceutical and remanded with instructions to enter judgment in Braintree’s favor. This Hatch-Waxman matter involved a patent owned by Braintree pertaining to its product SUPREP®, a highly successful product designed to cleanse the colon safely before a colonoscopy.
- Represented GlaxoSmithKline in its ANDA suit involving its patent covering the active ingredient in Avodart® and Jalyn™ products. Following a three-day bench trial, the judge ruled that the patent at issue was not invalid for lack of enablement, written description and anticipation.
- Conducted IP due diligence for a Japanese pharmaceutical company seeking to in-license two small molecule compounds for development as potential therapies for treating depression and anxiety.
- Represented a private pharmaceutical company with approved and pipeline products in the CNS and respiratory disorders space to file and prosecute US and non-US patent portfolios.
- Conducted IP due diligence for a public company seeking to acquire another public company’s late-stage antibiotic candidate for the treatment of MRSA, methicillin-resistant Staphylococcus aureus.
- Represent a privately held algae biofuel company in its patent portfolio development and technology licensing in the following strategic areas: algae strains, photobioreactor designs, extraction processes and refining processes.
- Represented a private biotech company for its strategic portfolio development of its kinase switch inhibitor program, including protection of its BRL-ABL kinase inhibitor that recently entered the clinic, as its exclusive intellectual property counsel.
- JD, Catholic University of America, Columbus School of Law, 1992
- MS, Biochemistry, University of Vermont School of Medicine, 1987
- BS, Biology, Dickinson College, 1984
- United States Patent and Trademark Office
Rate : $$$$