Sanofi Loses Bid to Revive Lantus Solostar Insulin-Pen Patents
Sanofi had been counting on the patents to help it block rival versions of the insulin treatment.
(Bloomberg) -- Sanofi lost its appeals court bid to revive patents on its blockbuster Lantus SoloStar insulin injection pen in a victory for drugmaker Viatris Inc.
A review board was correct to invalidate five patents for a pen-type injection device that allows a user to set and administer a dose of medication, the U.S. Court of Appeals for the Federal Circuit said in a series of three rulings Wednesday.
Sanofi had been counting on the patents to help it block rival versions of the insulin treatment. Lantus generated global sales of 1.9 billion euros ($2.2 billion) in the first nine months of the year, though U.S. sales of diabetes treatments dropped 13%, it said in October. Viatris last year began selling Semglee, which has an identical amino acid sequence to Sanofi’s Lantus and is approved for the same indications, in a vial and pre-filled syringes.
Paris-based Sanofi is facing an antitrust lawsuit accusing it of obtaining some 20 patents on the device in an effort to delay competition after its main patent on the drug expired in 2015. Viatris has been knocking out the patents in both district court and before the review board.
The Patent Trial and Appeal Board “had substantial evidence to support its determination” that earlier devices had substantially similar components and even suggested modifications, the Federal Circuit ruled in the opinion addressing three of the patents.
The rulings involved patents 9,604,008; 8,679,069; 8,603,044; 8,992,486; and 9,526,844. The Federal Circuit said the board was correct to reject Sanofi efforts to substitute new claims in two of the patents.
“These affirmances reinforce the company’s continuing efforts to break down barriers to patient access for important medicines, Viatris said in a statement.”
Sanofi representatives didn’t immediately return messages seeking comment.
The cases are Sanofi-Aventis Deutschland GmBh v Mylan Pharmaceuticals Inc., 20-1871; 20-2071; and 20-2066, all U.S. Court of Appeals for the Federal Circuit
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