Charleen O’Keeffe

Partner

Charleen is a Partner in William Fry’s Litigation & Investigations Department specialising in intellectual property litigation and regulatory law.

 

Charleen O’Keeffe

Charleen is a skilled and experienced litigator, with extensive experience in complex, multi-jurisdictional patent and trade mark disputes. Her patent litigation experience ranges from medical devices to pharmaceuticals and biologics. In addition, Charleen has a particular interest in medical device product liability claims.

Charleen advises clients in the life sciences sector on every phase of a product’s life cycle from product development, clinical trials, data exclusivity, regulatory approval to commercialisation and product safety/recall/liability.

Recent significant cases include representing

  • Advising Eli Lilly in multi-jurisdictional patent/spc actions, including
    – an action seeking revocation of a Novartis’ patent and in the defence of infringement proceedings (including a competition law counterclaim) with respect to Lilly’s Taltz®/ixekizumab product, and
    – revocation proceedings against Eisai R&D Management Co regarding patents relating to the treatment of Alzheimer’s disease.
  • Advising a leading proprietor of innovative in-vitro diagnostic technology, on both contentious and non-contentious aspects of their patent licensing arrangements globally.
  • AstraZeneca in its appeal to the Commercial Court relating to the Controller of Intellectual Property’s decision regarding the grant of a supplementary protection certificate.
  • Genentech Inc in Commercial Court proceedings against Amgen relating to Amgen’s product Mvasi®, a biosimilar of Genentech’s leading cancer drug Avastin®.
  • GSK in its trade mark and passing off action against Rowex Limited involving the Seretide Inhaler.
  • Various global life sciences companies on regulatory matters including on data exclusivity issues, the medical devices regulatory regime, SPCs, marketing authorisations, the regulation of clinical trials, compassionate use programmes and parallel imports.

Charleen is ranked as a “Next Generation Partner” by the Legal 500 EMEA 2024 for Intellectual Property and Life Sciences, as “Up and Coming” by Chambers Europe 2024, as an IAM Patent 1000 Silver Individual and as a “Patent Star 2024” by Managing Intellectual Property IP Stars.

Ranking & Recommendations

Knowledge

Article and Insights
21
Dec 2023
With new laws affecting medical devices on the horizon, we discuss changes to the ...
Partner
Charleen O’Keeffe
Article and Insights
15
Dec 2023
The Supreme Court has refused leave to Teva to appeal a preliminary injunction gra...
Partner
Charleen O’Keeffe
Article and Insights
31
Jul 2023
On 22 June, William Fry and the Irish Pharmaceutical Healthcare Association co-hos...
Article and Insights
5
Jul 2023
The Court of Appeal has upheld the grant of a preliminary injunction in favour of ...
Partner
Charleen O’Keeffe
Article and Insights
22
Jun 2023
Our Intellectual Property team were proud to be awarded 'Irish Trademark Disputes ...
Partner
Charleen O’Keeffe
Article and Insights
21
Jun 2023
The Attorney General has delivered a set of 15 principles, emphasising that the St...
Partner
Charleen O’Keeffe
Article and Insights
8
Jun 2023
As the UPC opens its doors, we bring you the latest news as to when a referendum r...
Partner
Charleen O’Keeffe
Article and Insights
28
Apr 2023
The Court of Appeal has ruled in favour of Biogen, overturning the High Court's de...
Partner
Laura Scott
Article and Insights
3
Mar 2023
European Parliament votes to extend MDR transition periods to avoid supply shortag...
Partner
Mary Cooney
Article and Insights
3
Jan 2023
New CJEU guidance on rebranding parallel imported medicines.
Partner
Laura Scott

Charleen is a Partner in William Fry’s Litigation & Investigations Department and a member of its Life Sciences Group, specialising in intellectual property and regulatory law.

Charleen is a skilled commercial litigator, with extensive experience in complex, multi-jurisdictional intellectual property disputes. Her patent litigation experience ranges from pharmaceutical and biologics to a wide range of technologies including hi-tech and medical devices.

She advises in the areas of pharmaceuticals, biotechnology and medical devices, covering every phase of a product’s life cycle from product development, clinical trials, data exclusivity, regulatory approval to commercialisation and product safety/recall/liability.

Recent significant cases include representing:

  • Genentech Inc in Commercial Court proceedings against Amgen relating to Amgen’s product Mvasi®, a biosimilar of Genentech’s leading cancer drug Avastin®.
  • Eli Lilly in complex multi-jurisdictional patent revocation proceedings against Eisai R&D Management Co (relating to the treatment of Alzheimer’s disease).
  • Boehringer Ingelheim in the defence of patent and SPC revocation proceedings brought by Teva Pharmaceuticals.
  • GlaxoSmithKline (“GSK”) in Commercial Court patent infringement proceedings against Pfizer (relating to GSK’s MenB vaccine, BEXERO).
  • GSK in its trade mark and passing off action against Rowex Limited involving the Seretide Inhaler, one of the all-time best-selling prescription drugs.
  • BSA

Charleen is ranked by WTR 1000 2022: The World’s Leading Trademark Professionals by WTR 1000 2022 and is also ranked as a “Notable practitioner” and ‘Rising Star’ (Managing Intellectual Property IP Stars 2022 and 2020).