Illinois-based drug company Hospira has sued the FDA, challenging its recent decision to approve generic versions of Precedex (dexmedetomidine hydrochloride).
Andrew Serafini, a specialist in IP in the life sciences sector, has joined Kilpatrick Townsend & Stockton LLP.
Actavis-owned pharmaceutical company Forest, along with US-based Adamas Pharmaceuticals, has sued Indian generic drug maker Lupin for infringing seven patents directed to its Alzheimer’s drug Namenda XR (memantine hydrochloride), a once daily version of Namenda.
The US Court of Appeals for the Federal Circuit has affirmed a lower court’s ruling that an Apotex patent covering a method of making a drug is unenforceable due to inequitable conduct by the company’s founder and chairman Bernard Sherman.
PhRMA has voiced concerns about the FDA’s draft guidance on biosimilars, which it suggests if enacted, could have an impact on the safety of biosimilar products.
The US Court of Appeals for the Federal Circuit has refused to grant an en banc review of its ruling that cloned animals made by methods that produced Dolly the sheep cannot be patented, according to Law360.
A Brazilian antitrust watchdog is fining German pharmaceutical company Merck $1.8 million for an alleged conspiracy to stop medicine distributors from working with generic drug makers.
A group of 12 international biotechnology associations has written to the US Patent and Trademark Office (USPTO), raising concerns about the office’s guidelines on determining the patent eligibility of natural products in the aftermath of the Myriad and Mayo cases.
South Korean biopharmaceutical company Celltrion has applied for approval from the US Food and Drug Administration (FDA) to market a biosimilar version of Remicade (infliximab), it announced yesterday (August 11).
French pharmaceutical company Sanofi and the US-based MannKind Corporation have entered into an exclusive licensing agreement to develop and commercialise MannKind’s Afrezza (insulin human), an inhalable insulin therapy for adults with types 1 and 2 diabetes.