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GeneDx claims 11 Myriad patents are invalid

US21-08-2014Legal developments

The molecular diagnostic testing company GeneDx has petitioned the US Patent and Trademark Office to invalidate 11 patents asserted by Myriad in a lawsuit filed against GeneDx in October 2013.

Hospira challenges FDA’s “unlawful” approval of Precedex generics

US20-08-2014Legal developments

Illinois-based drug company Hospira has sued the FDA, challenging its recent decision to approve generic versions of Precedex (dexmedetomidine hydrochloride).

Kilpatrick Townsend appoints new partner to its life sciences team


Andrew Serafini, a specialist in IP in the life sciences sector, has joined Kilpatrick Townsend & Stockton LLP.

Forest sues Lupin to protect $1.5bn Namenda

US19-08-2014Legal developments

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.

Federal Circuit strikes down Apotex patent for inequitable conduct

US18-08-2014Legal developments

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 reacts to FDA’s biosimilars guidance


PhRMA has voiced concerns about the FDA’s draft guidance on biosimilars, which it suggests if enacted, could have an impact on the safety of biosimilar products.

Federal Circuit refuses to review Dolly the sheep ruling


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.

Merck fined $1.8m for “anticompetitive” generic drug scheme


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.

Biotech industry reacts to USPTO’s Myriad/Mayo guidelines

Australia, EU, Japan, UK, US13-08-2014

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.

Celltrion files for FDA approval for Remicade biosimilar


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).

Showing 3081 to 3090 of 3438 results