Patent Strategies for Generic Medicines and Generic Medicine Companies In-house Training

Marie Walsh is a European Patent Attorney and Chartered (UK) Patent Attorney with over 25 years of experience in advising clients including start-ups and SME’s to large corporations. She has worked across a number of technology areas and specialises in industrial chemistry, materials science, polymer chemistry, and pharmaceutical chemistry. Marie also has in-depth experience in obtaining Supplementary Protection Certificates (SPCs).

Marie has a strong focus on providing commercially relevant, pragmatic advice based on individual clients’ goals. She has an MBA from the Open University which supports her commercially focused approach to advising on IP strategy.

Marie is based in Dublin, Ireland and has worked with clients across the globe, including firms in Ireland and the UK, as well as US and Chinese clients and her objective is on clear communication with the clients’ commercial aims as the central focus. Marie has previously worked with another leading firm of patent attorneys in Ireland where she had the role of Director of Operations for China and Chief Representative of the local China office.

She also has extensive experience of providing opinions and advising in relation to freedom to operate (FTO). In addition, she has represented clients at Oppositions and Appeals at the EPO and achieved successful outcomes for clients.

After a long career at the UK Intellectual Property Office (IPO), Dr Lawrence Cullen recently established his own consultancy to provide advice and develop his interests in IP, especially in the role and relevance of SPCs.

From 2007 to 2024, Dr Cullen was the Deputy Director at the Intellectual Property Office (IPO) in the UK responsible for the patent examination teams in the fields of pharmaceuticals, organic chemistry and biotechnology. He also led the team responsible for the examination and grant, or refusal, of supplementary protection certificates (SPCs) at the IPO. This included the development of UK practice in relation to SPCs and keeping the IPO Manual of Patent Practice chapter on SPCs up to date.

Dr Cullen has a wide experience dealing with questions of validity in the patent and SPC fields. As a hearing officer at the IPO, he was directly involved in over 50 patent cases across all areas of technology including computer implemented inventions as well as biotechnology and pharmaceuticals. In addition, he decided over 25 SPC cases before the IPO gaining a wide experience of UK and EU law in this area. He also has extensive experience of dealing with appeals before the UK courts and, prior to 31 December 2021, referrals to the Court of Justice of the European Union (CJEU).

Dr Cullen gained his BSc in Industrial Chemistry in Ireland and his PhD in organic chemistry in UK. He worked as a research scientist at various universities in Europe, USA and UK before joining the UK-IPO to embark on his career in IP. 

Erin M Dunston is a Partner at Panitch Schwarze. Over the course of her over twenty-year career, her practice has been a purposeful mix of patent prosecution and litigation. Having handled many patent litigations, Erin recognises how every word in prosecution may ultimately be analysed by the fact-finder and thus strives for efficient, law- and science-driven prosecution. Her extensive prosecution experience, in turn, is invaluable when analyzing prosecution documents and issues as part of a litigation. With a background in biochemistry, she concentrates her practice primarily in the fields of biotechnology, pharmaceuticals, medical devices, and associated computer technology.

In terms of patent prosecution, counseling, and strategy, Erin learns her clients’ businesses and how a given project will advance the client’s business objectives, from both offensive and defensive standpoints. Erin also works closely with clients to satisfy budget constraints and assist in leveraging and monetizing patent assets.

To date, Erin has handled more than 20 district court litigations and more than 25 inter partes reviews (IPRs) and more than 40 interferences before the Patent Trial and Appeal Board (P.T.A.B). Assisting both patent owners and putative infringers/petitioners, this experience ranges from pre-filing analyses all the way through appeals to the U.S. Court of Appeals for the Federal Circuit.

Her deep experience in patent law has been recognized by several leading IP organizations and awards programs. Erin has been selected for inclusion among The Best Lawyers in America each year since 2018. She also has been recognized in IAM’s Patent 1000 list – a best-in-class listing of patent prosecution, licensing, and litigation practitioners. For several years, including for 2021, she has been named an IP Star by Managing Intellectual Property and a Leading Intellectual Property Lawyer by Chambers USA. Erin also received Lawyer Monthly’s Women in Law 2016 Award for her contributions to the practice of biotechnology law.