Superko, Colleen

Colleen Superko

Mrs. 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.

Learn more about Mrs. Superko's practice and how she can support your startup on WilmerHaleLaunch.com.

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.

Community Involvement

Mrs. Superko served on the Board of Directors, including a two-year term as President of the Wellesley Youth Hockey Association. In connection with her service, the Boston Globe  profiled her as one of five local residents making a difference in the community, in an article entitled "Colleen Superko: Youth hockey's keeper of the heart." Mrs. Superko was specifically recognized for her campaign to improve the safety of the sport. She raised awareness about the threat of cardiac arrest in youth sports and spearheaded the donation of twelve automated external defibrillators (AEDs) to local area rinks. All three of her sons were student-athletes in college. 

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.

Professional Activities

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.

Experience

    • 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 Braintree Laboratories, Inc. in its ANDA case against Novel Laboratories, after it proposed a plan to make a generic version of SUPREP ®. Following a six-day bench trial, WilmerHale obtained a favorable judgment in the District of New Jersey for Braintree. The judge found that defendant had not proven by clear and convincing evidence that the asserted claims of the patent at issue were invalid for obviousness, anticipation, or indefiniteness. In his opinion, the judge evaluated more than 20 pieces of prior art asserted by Novel and concluded that Braintree's expert was more credible than Novel's in arguing that the asserted claims were neither anticipated nor obvious. On appeal by Novel, the Federal Circuit upheld the validity of the patent and two of the claim constructions, reversed two claim constructions, vacated the infringement finding, and remanded the case to the district court for further factual findings on the issue of infringement. On remand, the judge found that Novel's proposed generic version of SUPREP and its use would infringe the asserted claims.
    • 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.
    • Conducted IP due diligence on Intrexon's synthetic biology patent portfolio in connection with Ziopharm Oncology's global exclusive channel partnership in oncology, which leverages Intrexon's advanced transgene engineering platform for the controlled and precise cellular production of anti-cancer effectors
    • Conducted IP due diligence for a diversified technology leader seeking to enhance its medical technologies platform by acquiring a target company with a portfolio of integrated tissue diagnostic systems and reagents for cancer and infectious disease
    • 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 leading European specialty pharmaceutical company in performing IP due diligence for a potential in-licensing of a drug product for treating a women's health disorder that causes symptoms in up to 25% of reproductive age women, including a freedom-to-operate analysis, a patentability analysis and a market exclusivity analysis
    • Represented a publicly traded biotech company's $24.5M sale of IP assets related to the fields of prenatal and reproductive health
    • Represented several large pharmaceutical companies on their patent prosecution, reexamination, and counseling matters related to discovery and development of lead biologics and small molecule compounds, as well as a range of life cycle management issues regarding many different commercial products
    • Represented a specialty pharmaceutical company in its strategic patent portfolio management of and diligence activities for its FDA-approved pain product, co-developed with its partner, and the protection and clearance of other drug delivery technologies, pain products and formulations
    • 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
    • Represented a biotech company in due diligence activities and an inter partes reexamination

Recognition

Insights & News

Credentials

  • Education

    • JD, Catholic University of America, Columbus School of Law, 1992

      Law Review
    • MS, Biochemistry, University of Vermont School of Medicine, 1987

    • BS, Biology, Dickinson College, 1984

  • Admissions

    • Massachusetts

    • Maryland

    • United States Patent and Trademark Office

Credentials