FCA upholds OSIP decision on timing of patent listing and retroactive eligibility
Bayer submitted a patent list in relation to its 315 Patent and drug submissions for its aflibercept product, EYLEA, on August 22,...Read More
Time warp on the Patent Register: Amendments to Bayer’s aflibercept judicial review
In two judicial reviews considering when a first person’s patent is determined to be eligible for the Patent Register, and when a...Read More
Two-for-One Deal – A Successor Second Person Can Adopt the Original NOA
The Federal Court dismissed a judicial review by Bayer Inc. and Regeneron Pharmaceuticals, Inc. of the Minister of Health’s decision allowing Biosimilar...Read More
For the Defendants’ Eyes Only: Court Permits Filing of Confidential Statement of Claim
In Bayer vs. BGP, Justice Pentney of the Federal Court permitted the filing of a confidential Statement of Claim. Bayer markets aflibercept...Read More
Would a biologic by any other (nonproprietary) name smell as sweet?
One of the many contentious issues in the evolving U.S. biosimilar regulatory landscape regards whether 351(k) biosimilar products will have the same...Read More
Regeneron’s VEGF-TRAP-EYE infringes Genentech’s UK Patent
On March 22, 2012, Justice Floyd of the Chancery Division of the High Court of Justice held that Regneron’s VEGF-TRAP-EYE infringes European...Read More