Pharmaceuticals & Biotechnology

Pharmaceuticals_Biotechnology

 

William Fry acts for many of the world’s largest pharmaceutical and biotechnology companies, giving us cutting-edge knowledge of the global and national challenges facing companies operating in this highly innovative sector.

 

We are recognised as Ireland’s leading practice in large scale, multi-jurisdictional litigation in the Pharmaceuticals and Biotechnology sectors. Our team's success lies in its drive to achieve the right commercial outcome for our clients, its strategic expertise and exceptional industry and legal knowledge gained from acting in the majority of patent and SPC cases that have come before the Irish Courts over many years.  

We advise on all aspects of the development of pharmaceutical and biotech pharmaceutical products including antibodies, proteins, blood/plasma derived products and recombinant DNA products. 

Our Life Sciences team prides itself on working with

  • start-ups;
  • the world’s largest pharmaceutical and biotechnology companies such as GSK, Boehringer Ingelheim, Eli Lilly, MSD, Genentech and ViiV Healthcare;
  • finance providers / venture capital investors; and
  • academic institutions.

Our range of services span the entire development cycle of pharmaceutical and biotechnology companies and their products. We advise on mergers and acquisitions, commercial transactions (including licensing and collaborations), IP (contentious and non-contentious), capital markets and finance, taxation and dispute resolution and every phase of a product's life cycle from product development, clinical trials, regulatory approval to commercialisation, infringement disputes and product safety/recall/liability. 

 

Examples of matters on which we have acted include, advising:

  • Genentech in its Commercial Court SPC patent infringement proceedings against Amgen in respect of an anti-VEGF antibody used in the treatment of cancer. 
  • Eli Lilly in complex Commercial Court patent revocation proceedings in respect of a patent owned by Eisai Pharmaceuticals relating to the treatment of Alzheimer's Disease.
  • GlaxoSmithKline (GSK) in Commercial Court patent infringement proceedings against Pfizer and in defence of Pfizer's counterclaim for invalidity. This case related to GSK's MenB vaccine, BEXERO.  
  • Boehringer Ingelheim in its defence of two sets of Commercial Court proceedings brought by Teva Pharmaceuticals seeking the revocation of a Boehringer Ingelheim patent and an SPC relating to Boehringer Ingelheim’s bestselling respiratory pharmaceutical product, SPIRIVA.
  • MSD Corp., in the defence of Irish Commercial Court patent infringement proceedings brought by Bristol-Myers Squibb/Ono Pharmaceuticals / Tasuko Honjo relating to anti-PD-1 antibodies in the treatment of cancer and MSD's product, KEYTRUDA.
  • GSK in its trade mark and passing off action against Rowex Limited and related companies involving the Seretide Inhaler, one of the all-time best-selling prescription drugs.
  • Clonmel Healthcare (part of the STADA group) in the defence of Commercial Court SPC infringement proceedings issued by MSD relating to a combination product of ezetimibe and simvastatin for the treatment of cholesterol and in the prosecution of Clonmel's counterclaim for invalidity.
  • ViiV Healthcare in Commercial Court patent infringement proceedings against Gilead in respect of an anti-retroviral HIV treatment and in the defence of Gilead's counterclaim for invalidity.
  • AbbVie / Allergan Acquisition on applicable provisions of the Irish Takeover Rules, and other relevant corporate and takeover law, to a significant shareholder of Allergan plc, in the context of AbbVie's c.$60bn takeover of Allergan by scheme of arrangement under Ireland's Companies Act 2014.
  • Vivo Capital as exclusive Irish legal advisor in leading an equity investment round in ALX Oncology Limited, a clinical stage immuno-oncology company developing innovative immuno-oncology therapies for cancer.
  • Sublimity Therapeutics on ongoing fundraising and general corporate and regulatory matters in relation to creating new therapies in gastrointestinal and immunological diseases. 
 

Launch of our Medical Device Publication

William Fry are delighted to launch our MDR/IVDR publication. To assist medical device companies navigate the new MDR & IVDR regulatory regime we have published under one roof the Regulations with easy access to the annexes and a table of equivalence comparing key articles from the MDD/AIMD & IVDD with the MDR & IVDR.


Regulatory Flexibility - Key Measures to Support Availability of Medicines and Medical Devices During COVID-19

The COVID-19 pandemic has propelled the healthcare and life sciences industries into uncharted territory. We explore the flexibility of regulators at a national and European level enabling accelerated approval of pharmaceuticals and medical devices so that demand emanating from this global health crisis can be met.


General Scheme Of Assisted Human Reproduction Bill Approved By Government

The General Scheme of the Assisted Human Reproduction Bill 2017 was approved by the Government on 3 October 2017. This long-awaited piece of legislation addresses legal issues over establishing parentage and introduces measures that will protect the best interests of all parties involved in AHR.


Ireland and the European Medicines Agency Prepare for Brexit

Ireland has set its sights on ensuring uninterrupted supply of medicines and assuming a greater role in EU regulatory activities post-Brexit.


EU Court of Justice holds that vaccines can be considered to be cause of illness even if absence of scientific link

The Court of Justice of the European Union has recently ruled that courts may consider vaccines to be the cause of an illness, even in the absence of scientific evidence confirming a link


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"William Fry was instrumental in guiding us through all aspects of the complex transaction and due diligence. The expertise include Irish law, government contracting, tax, property, bank restructurings, real estate/leasing as well as general advice on the Irish business culture….Overall, the service provided by William Fry was excellent. At all times they approached matters with professionalism and with UPMC’s best interest……Our business objective was successfully completed. It would have been impossible without the counsel of William Fry. It was well worth the investment spend…..Excellent advisor to contracting matters with the Irish government.”

David Farner, Senior Vice President and Chief of Staff, UPMC

Department

  • Sources laud the team's "strategic thinking" in complex cross-border disputes, going on to say: "The firm is very efficient and has a lot of depth of talent." Another client adds that "the lawyers find practical solutions to complex and sensitive legal problems." Chambers Europe 2020
  • One client describes the lawyers as "incredibly responsive" and "very easy to deal with" adding that they provide "succinct and well-delivered advice". Chambers Europe 2019
  • One client admires the "width and depth of expertise within the firm" and lauds the department as a "strong practice that understands the minutiae of the life sciences sector." Sources appreciate the "first-rate access and availability" of the team and describe its advice as "considered, pragmatic and clear." Chambers Europe, 2017

Team

Laura Scott

  • Laura has been described as an "expert in all areas of IP." One client reports they have worked with Laura "on a number of cases in the last 12 months ranging from SPC validity proceedings to copyright. We are awaiting judgment in one case where I expected we would lose at the proofs stage but now believe that we will likely win because of the work put in by the team. On the IP side I would rate Fry as the leading firm in Ireland." Another client adds that Laura "stands out for her technical know-how and is an excellent drafter." Legal 500 2020
  • Laura has been ranked in IP Stars 2019 as one of the Top 250 Women in IPglobally.  
  • Laura Scott  is a highly respected IP practitioner with significant expertise in patent litigation. Sources praise her client-oriented approach, highlighting her "commitment and attention to detail" and adding that "she's a pleasure to deal with." Chambers Europe 2019
  • "Outstanding and a real pleasure to work with...Laura is a highly experienced litigator with intimate knowledge of all areas of intellectual property."  WTR1000 2019
  • “She is calm under pressure and has a depth of knowledge and experience which inspires confidence in her clients,” observes one source. Chambers Europe 2018
  • Laura is "on top of the technical detail...strategic and practical" and is praised for her "attention to detail and drafting skills". Legal 500 EMEA 2018 
  • Laura Scott receives plaudits for her trade mark and patent litigation practice, with particular knowledge of the pharmaceutical and life sciences sectors. Clients say: "She is very hard-working, responsive and dedicated to leaving no stone unturned in considering and communicating all available options. She is also extremely pleasant to work with." Chambers Europe 2017
  • Laura Scott has the ‘Midas touch with clients’. Legal 500 EMEA 2017

Fiona Barry

  • According to Chambers Europe 2020, clients appreciate that Fiona Barry is "very careful and thorough," while market commentators highlight her ability to "efficiently find her way to the core of the case." Another clients add that Fiona is "very timely and clear in her advice."
  • Sources say Fiona Barry is "knowledgeable, practical, clear, concise and not afraid to express an opinion." She is widely esteemed for her contentious experience, including acting on defamation suits. One source says: "She is excellent: confident, careful and easy to get on with."  Chambers Europe 2019
  • Fiona is particularly noted for her work on matters related to medical negligence and for acting for insurance companies on personal injury claims and is well regarded by market commentators for her media expertise. Chambers Europe 2018 
  • Fiona Barry is "straightforward and clear". Legal 500 EMEA 2018
  • According to Chambers Global 2017, Fiona holds a commanding position in the medical negligence and healthcare litigation sphere, including regulatory and insurance matters where clients praise her as being "responsive, knowledgeable and pleasant." 
  • Fiona Barry is ‘responsive, calm and considered’. Legal 500 EMEA 2016

Key Contacts

Laura Scott Partner

Colette Brady Partner