Swartz, John L.

Colleen Superko is co-vice chair of the Intellectual Property Department, and a member of the Intellectual Property Litigation Practice Group. She joined the firm in 1996.

Practice

Mrs. Superko serves as counsel to many sectors of the pharmaceutical and biotechnology industries, including both start-up ventures and well-established, multi-national branded companies. For over fifteen 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 inter partes 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. 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. 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.

Representative Client Matters

• 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

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.  

Honors and Awards

• Named a "Massachusetts Super Lawyers' Rising Star" in intellectual property law in the May 2005 issue of Boston Magazine

Publications

• Co-author “Less Obvious? USPTO's New Post-KSR Guidelines Suggest a More Balanced Approach,” WilmerHale Intellectual Property Alert, September 8, 2010.
• Co-author “The U.S. Patent and Trademark Office Clarifies How a Patentee Can Challenge Its Determination That an Ex Parte Reexamination Should Proceed,” WilmerHale Intellectual Property Alert, June 30, 2010.
• Co-author “New Legislative Approval Pathway for Biosimilars,” WilmerHale Intellectual Property Alert, April 1, 2010.
• Co-author “District Court Invalidates Composition and Method Claims Relating to BRCA1/2 Human Cancer Genes as Unpatentable Subject Matter,” WilmerHale Intellectual Property Alert, March 31, 2010.
• Co-author “PTO Issues Guidelines on New Patent Term Adjustment Calculations,” WilmerHale Intellectual Property Alert, January 29, 2010.
• Co-author “Federal Circuit Affirms Decision Granting Patentees Additional Patent Term,” WilmerHale Intellectual Property Alert, January 8, 2010.
• Co-author, "Don't Leave the Money on the Table: Run an IP Audit," Mass High Tech, October 19, 2007.
• Co-author, "Making Every Patent Count--Maximizing the Value of a Patent Portfolio," The Journal of BioLaw & Business 7, No. 4 (2004).

Community Involvement

Mrs. Superko currently serves on the Board of Directors and most recently completed 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. 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. The article, entitled "Colleen Superko: Youth hockey's keeper of the heart," can be found on boston.com.