Simon has in-depth experience and knowledge in Hatch-Waxman related litigations involving small molecules as well as other pharma-related patent matters including those involving large molecule pharmaceuticals. With a proven track record in high-stakes litigation matters, Simon represents clients before the federal courts as well as the United States Patent and Trademark Office (USPTO) in contested proceedings including IPRs and PGRs.

Notably, Simon orchestrated the first successful supplemental examination request to be filed with the USPTO that included disclosures unrelated to prior art leading to the significant strengthening of a patent portfolio protecting one of the world’s most successful branded pharmaceutical products. He also has the rare distinction of being permitted to present oral argument before the Patent Reexamination Board (PRB) of China’s Intellectual Property Office (SIPO) in Beijing, resulting in the PRB upholding the patentability of the patent covering an active ingredient in the world’s best-selling HIV medications. All of Simon’s litigations to date have resulted in successful outcomes for his clients, despite many involving secondary patents that involved both disputed validity and infringement contentions.

Click here to read Simon’s full biography in Japanese.

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• Participated in the lead IP team for a major Japan-based pharmaceutical company in its multi-billion dollar acquisition of an Israeli pharmaceutical company (the largest ever acquisition of an Israeli company)*
• Successfully represented a global pharmaceutical company in the prevention of institution of IPR petition filed by generic drug company seeking to invalidate US compound patent covering its crown jewel product*
• Successfully obtained summary judgement of validity and infringement of patents covering Astellas’s and Boeringer Ingelheim’s Flomax® product preventing generic entries prior to patent expiry*
• Led the litigation team that successfully represented Gilead against several generic drug companies that had challenged patents covering Viread®, Truvada®, and a number of other leading HIV treatments*
• Successfully represented Gilead in an interference with Idenix at the US Patent and Trademark Office concerning patents covering Hepatitis C treatments*
• Successfully represented Astra Zeneca in multiple district court cases involving many generics relating to patents covering Prilosec®*
• Successfully represented Novartis in multiple cases, including one jury trial, involving several generics relating to four patents covering the Famvir® and Penvir® products*
• Successfully defended SmithKline Beecham against patent infringement allegations made by Glaxo Welcome attempting to prevent the Famvir® product from competing against Glaxo’s acyclovir products in the US*
• Led the litigation team in the successful representation of Astellas against several generic drug companies seeking to invalidate the compound and formulation patents covering Mycamine®*
• Successfully led the litigation team for Astellas against several generics arguing non-infringement and invalidity of Astellas’s patents directed to polymorphs that cover Celgene’s Istodax® product*
• Successfully represented Astellas in patent infringement suits relating to patents covering Astellas’s VesiCare® product (best-selling anti-muscarinic brand treatment of overactive bladder)*
• Successfully represented BMS and Kyorin Pharmaceuticals in patent litigations in which several generic companies sought to invalidate Kyorin’s patents covering BMS’s Tequin® product*
• Successfully represented Eli Lilly against several generic drug companies seeking to invalidate Eli Lilly’s patents covering the Prilosec® product*

*Matter handled prior to joining McDermott.

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