Claire Fundakowski - Winston & Strawn LLP

For businesses operating in the highly competitive and innovation-driven sectors of pharmaceuticals and medical devices, protecting intellectual property is paramount. In a city like Washington, DC, which sits at the nexus of regulatory bodies, federal courts, and global commerce, securing top-tier legal representation for patent litigation is not just a strategic advantage—it's a fundamental necessity. This is where Claire Fundakowski, a distinguished patent litigator at Winston & Strawn LLP, offers unparalleled expertise to clients in the District of Columbia and beyond.

Claire Fundakowski is a highly acclaimed attorney whose practice focuses on complex patent litigation, with a particular emphasis on the pharmaceutical and medical device sectors. What truly sets her apart is her unique background as a registered pharmacist, which provides her with an invaluable scientific understanding that directly benefits her legal strategies. This dual expertise allows her to delve into intricate scientific issues, making her an exceptionally effective advocate in cases involving the Hatch-Waxman Act, Biologics Price Competition and Innovation Act (BPCIA), and proceedings before the Patent Trial and Appeal Board (PTAB).

This article is designed to provide residents and businesses in the District of Columbia with a comprehensive understanding of Claire Fundakowski's legal services at Winston & Strawn LLP. We will explore her prominent location, the specialized legal services she provides, the unique features that highlight her professional excellence and numerous accolades, and how to contact her office for assistance with your patent and intellectual property legal needs. Her deep involvement in high-stakes pharmaceutical and medical device patent cases, combined with her presence in DC, positions her as a critical resource for navigating complex IP challenges in the region.

Claire's approach to patent litigation is characterized by meticulous preparation, sharp analytical skills, and a strategic mindset honed through extensive trial experience. She is adept at every stage of district court litigation, from conducting and defending depositions to constructing robust invalidity and non-infringement defenses, authoring critical briefs, and examining witnesses at trial. Her particular experience in the District of Delaware, a common venue for patent litigation, further solidifies her capabilities in high-stakes cases.

Beyond her litigation prowess, Claire routinely advises clients on competitive product development strategies, considering competitor patents and FDA regulations. This proactive counsel helps clients avoid potential infringement issues and strategically navigate the complex regulatory landscape, ensuring that their innovations are well-protected and commercially viable. Her commitment to securing victories for her clients, as evidenced by multiple recognitions as "Litigator of the Week" runner-up by Am Law Litigation Daily, underscores her dedication and effectiveness.

Claire Fundakowski practices at the Washington, DC office of Winston & Strawn LLP, located at 1901 L St NW, Washington, DC 20036, USA. This address places her in a prime location within the central business district of the nation's capital, just a short distance from the bustling K Street corridor. This area is a key hub for legal, governmental, and corporate entities, making it an exceptionally convenient and accessible location for clients throughout the District of Columbia.

The firm’s L Street location offers excellent accessibility through various public transportation options. It is within easy walking distance of several WMATA Metro stations, including Farragut North (Red Line) and Farragut West (Orange, Blue, and Silver Lines), providing comprehensive connectivity to all parts of DC, as well as seamless connections to the surrounding Maryland and Virginia suburbs. Numerous Metrobus routes also operate in the vicinity, offering additional transit flexibility for clients.

For those who prefer to drive, while street parking in downtown DC can be limited, there are multiple commercial parking garages available in the immediate area around 1901 L Street NW. Clients should anticipate potential parking fees and typical urban traffic conditions when planning their visit. The vibrant professional environment of this central location also means that the office is surrounded by various amenities, including dining options and other business services, which can be convenient for clients before or after their appointments. This strategic and easily reachable office location highlights Winston & Strawn LLP’s commitment to serving their diverse clientele in the District of Columbia with convenience and ease.

Claire Fundakowski's legal practice at Winston & Strawn LLP is highly specialized, focusing primarily on intellectual property litigation, particularly within the life sciences sector. Her key service offerings include:

• Patent Litigation:

  Representing clients in complex patent disputes across various industries, with a strong emphasis on pharmaceutical and medical device companies. This includes cases involving small molecule drugs, biologics, injectable, oral, and topical compositions, and patents related to lipid compositions, polymorphs, stereoisomers, formulations, and manufacturing processes.

• Hatch-Waxman and BPCIA Litigation:

  Expertise in navigating the intricacies of the Hatch-Waxman Act (Abbreviated New Drug Applications - ANDA litigation) and the Biologics Price Competition and Innovation Act (BPCIA), representing both brand-name and generic pharmaceutical companies in these highly specialized disputes.

• Appellate & Critical Motions:

  Extensive experience litigating cases before the U.S. Court of Appeals for the Federal Circuit, where she regularly authors briefs and advises clients on appellate strategy. She also has a strong track record in arguing substantive motions at the district court level, including claim construction and Daubert motions.

• Patent Trial and Appeal Board (PTAB) Proceedings:

  Representing clients in patent challenges before the PTAB, including inter partes reviews (IPRs), to invalidate or defend patent claims.

• Competitive Product Development Strategies:

  Advising clients on strategies for developing new products in view of competitor patents and relevant FDA regulations, helping to mitigate infringement risks and ensure regulatory compliance.

• Workplace Investigations and Litigation (Amicus Briefs):

  While her core practice is patent litigation, she has also contributed to amicus briefs in appellate courts supporting civil rights organizations, demonstrating a broader commitment to legal principles and social justice, including advocating for prisoners' rights. However, this is primarily pro bono work and not a commercial service offering.

Claire Fundakowski's professional profile is marked by several distinguishing features and highlights:

• Pharmacist Background & Scientific Acumen:

  Her previous experience as a registered pharmacist provides her with a unique and invaluable understanding of the scientific and technical complexities inherent in pharmaceutical and medical device patent cases. This background allows her to bridge the gap between scientific detail and legal strategy effectively.

• Recognized Patent Litigation Leader:

  She has been repeatedly named a "Litigator of the Week" runner-up by Am Law Litigation Daily, a "Top Lawyer" by Washingtonian magazine, and recognized by publications like IAM Patent 1000, Benchmark Litigation US ("40 and Under List"), Best Lawyers: Ones to Watch in America, and Lawdragon's "500 X – The Next Generation" for her patent litigation and intellectual property work. These accolades underscore her high standing and success in the field.

• Extensive Trial and Appellate Experience:

  Claire possesses comprehensive experience throughout every stage of district court litigation, including taking and defending depositions, constructing invalidity and non-infringement defenses, authoring critical briefs, arguing substantive motions, and examining witnesses at trial. Her experience extends to the Federal Circuit, where she advises on appellate strategy.

• Focus on High-Stakes Cases:

  She has been a core member of trial teams that secured significant victories, including the invalidation of six patents for a drug with annual sales of approximately US$1 billion and a judgment of non-infringement for a drug compound's polymorphic form, showcasing her ability to handle high-value and complex matters.

• Clerkship with Federal Circuit Chief Judge:

  Prior to joining Winston & Strawn, Claire served as a law clerk to Chief Judge Kimberly A. Moore at the U.S. Court of Appeals for the Federal Circuit, providing her with invaluable insight into the workings of the court that handles all patent appeals.

• Proactive Client Counseling:

  Beyond litigation, she routinely advises clients on competitive product development strategies, anticipating and mitigating patent and regulatory challenges.

As a highly specialized and accomplished attorney at a prominent international law firm like Winston & Strawn LLP, Claire Fundakowski's practice is focused on delivering sophisticated, high-value legal and strategic counsel for complex patent litigation. Therefore, her services are not typically associated with general public promotions or discounts. The value she offers is derived from her extensive experience, deep scientific and legal expertise, and proven track record in high-stakes intellectual property cases within the pharmaceutical and medical device sectors.

While specific ongoing promotions are not publicly advertised, it is standard practice for attorneys in this field to engage in initial consultations with prospective clients. This allows businesses in the District of Columbia and beyond to discuss their specific patent litigation or intellectual property strategy needs, receive a preliminary assessment of their situation, and understand how Claire Fundakowski's specialized expertise can be applied to their unique challenges. For detailed information regarding her services and fee arrangements, interested parties are encouraged to contact her office directly.

To connect with Claire Fundakowski at Winston & Strawn LLP for your patent litigation and intellectual property needs, please use the following contact details:

• Address:

  1901 L St NW, Washington, DC 20036, USA

• Phone:

  (202) 282-5347

• Mobile Phone:

  +1 202-282-5347

Her office is centrally located in Washington, DC, making it easily accessible. Given the specialized and often complex nature of patent litigation, it is advisable to contact her office by phone to schedule a consultation and discuss your specific legal requirements in detail.

For pharmaceutical and medical device companies, as well as other innovators in the District of Columbia grappling with intricate patent disputes and intellectual property strategy, Claire Fundakowski at Winston & Strawn LLP offers an exceptionally suitable and high-caliber legal solution. Her office at 1901 L St NW places her in a prime, accessible location within DC’s central business district, convenient for local clients via public transportation and readily available to service the demanding needs of the region's life sciences and technology sectors.

What truly makes Claire Fundakowski an invaluable resource for locals is her highly specialized expertise, particularly her unique background as a registered pharmacist. This allows her to understand and strategically navigate the complex scientific and regulatory nuances of patent litigation in the pharmaceutical and medical device industries, which are vital for businesses operating in or interacting with the federal regulatory environment of Washington, DC. Her deep knowledge of the Hatch-Waxman Act, BPCIA, and FDA regulations is critical for companies seeking to protect their innovations or challenge competitor patents.

Furthermore, her impressive track record of securing significant victories in high-stakes trials and appeals, coupled with consistent recognition as a top patent litigator, provides undeniable assurance of her capabilities. For businesses in the District of Columbia that demand sophisticated, results-driven legal counsel for their most critical intellectual property assets, Claire Fundakowski offers a unique blend of scientific insight, litigation prowess, and strategic acumen. Her presence in DC provides local innovators with direct access to one of the leading minds in patent law.