Date: 10 December, 2021

Wisdom successfully defended Synmosa Biopharma Corporation against a patent infringement suit filed by Bayer HealthCare LLC. In Bayer HealthCare LLC v Synmosa Biopharma Corporation (2021 Minzhuansuzi No. 8 Judgment, 30 November, 2021), The Taiwan Intellectual Property Court (IP Court) found in favour of Synmosa on all claims and defenses. Our client became the first entity ever to successfully challenge a new drug patent under Paragraph IV declaration since the patent linkage system took effect in 2019. Our client was also the first generic drug manufacturer to be granted a 12-month marketing exclusivity for the generic drug of “Nexavar film-coated tablets” for treating advanced liver cancer. Wisdom Director George J. H. Huang (Attorney at Law, Patent Attorney) led the team representing Synmosa.

Synmosa made a Paragraph IV declaration when applying for a generic drug permit (similar to Abbreviated New Drug Application (ANDA) at the USFDA) with the Taiwan Food and Drug Administration (TFDA). Bayer then filed a patent infringement suit against Synmosa in 2020, accusing Synmosa’s generic drug falls into the scope of protection of two corresponding patent rights of Bayer’s anti-cancer drug Nexavar®.

On 30 November 2021, The IP Court deemed that all 26 claims of Bayer’s two patents are invalid and determined that Synmosa was not entitled to any damages. Besides, this is the first Taiwan court decision on the determination of obviousness on the crystal form of a compound.

We played a significant role in obtaining a complete win for the client. With the help of our extensive search, comparison of prior arts and detailed analysis, we illuminated the reasons why the patents failed to meet non-obviousness requirements and all 26 claims shall be deemed invalid.

About Wisdom

Wisdom International Patent & Law Office is one of the leading intellectual property law firms in Taiwan. We advise and facilitate local and international clients on all aspects of intellectual property protection and enforcement, including patent, trademark, design and copyright across diverse commercial sectors and technological fields. With the extensive experiences of our Patent Attorneys and skilled experts, we are capable to give you the most secure protection on your patents and intellectual property rights. Contact us if you wish to find out more about IP protection.