Here’s the latest.

Amgen Defeats Novartis Appeal Over Arthritis Drug Enbrel’s Patents

Reported by Jonathan Stempel on

In Immunex Corp. v. Sandoz Inc., Amgen successfully defended its patents on the arthritis drug, Enbrel. Prior to the initial suit, Sandoz attempted to market a generic version of Enebrel whose active ingredient is patent protected through 2029. The Federal Circuit upheld Amgen’s multi-billion dollar patents and rejected the effort to invalidate them. Furthermore, Stempel reports the following:

In a 2-1 decision, the U.S. Federal Circuit Court of Appeals in Washington, D.C. rejected the argument by Novartis’ Sandoz generic drugs unit that the patents should be invalidated because they described concepts contained in previous patents and were therefore ‘obvious.’

For more information on this case, see our coverage.

Federal Circuit Affirms PTAB Ax of Aircraft Space-Saving IP

Reported by Britain Eakin on

On the other hand, the Federal Circuit upheld the invalidation of two aircraft patents on space-saving modifications in B/E Aerospace Inc. v. C&D Zodiac Inc. In this case, the Federal Circuit agreed with the USPTO conclusion “‘that a skilled artisan would have used common sense’ to combine elements of existing technology to arrive at B/E’s claimed inventions.” Moreover:

The Federal Circuit, however, said it didn’t need to decide if the board flouted the law because its obviousness determinations — that skilled artisans would’ve been motivated to combine the prior art because they ‘were interested in maximizing space in airplane cabins’ — were sound.
‘The board fully articulated its conclusion of obviousness, and we conclude that substantial evidence supports the board’s determination of obviousness independent of the design drawings.’

For more information on this case, see our coverage.

IN BRIEF: No rehearing for Biogen in Tecfidera patent appeal – Fed. Circuit

Reported by Barbara Grzincic on

Finally, on June 24th, the Federal Circuit refused to rehear Biogen International GmbH v. Banner Life Sciences LLC en banc, upholding their April decision which determined that Banner Life Sciences did not infringe on Biogen’s MS treatment, Tecfidera. The court’s decision paves the way for FDA approval of Banner Life Sciences similar treatment, Bafiertam. Grzincic elaborates further:

Biogen’s patent would have expired in 2018, but was extended to June 20, 2020, to account for the FDA’s review period. In April, the Federal Circuit affirmed that the extension covers only the FDA-approved DMF formulation and its salts and esters, not MMF. On June 18, Biogen lost a separate lawsuit against Mylan Pharmaceuticals, which is also developing a biosimilar version. A federal judge in West Virginia invalidated a later patent that ostensibly protected Tecfidera until 2028. Biogen is expected to appeal.

For more information on this case, see our coverage.