Roche scores—again—in hemophilia drug patent case against Takeda

In a patent case centered on two rival hemophilia medicines, Roche's Genentech unit has scored its second straight win.

After a U.S. district court last year ruled in favor of Roche and invalidated a patent held by Takeda's Baxalta unit, the U.S. Court of Appeals for the Federal Circuit reaffirmed the ruling.

In the decision, U.S. Circuit Judge Timothy B. Dyk wrote that in order to be valid, patents must describe inventions “in such full, clear, concise and exact terms” so that any skilled person can make and use the same product “without undue experimentation."

In this case, Baxalta's patent describes an antibody that binds to a protein that’s key to enable blood clotting. In its appeal, Baxalta argued that skilled practitioners can use a screening process that doesn't amount to undue experimentation.

But the circuit court shot down this argument, supporting the decision that the patent should be invalidated.

In laying out its rationale, the Circuit Court referenced the high-profile Supreme Court decision in Amgen v. Sanofi, which upheld a prior ruling to invalidate two of Amgen’s Repatha patents after finding a similar lack of enablement. 

The "enablement" requirement states that patents are only valid if they contain enough disclosure to allow a person of ordinary expertise in a relevant trade to make the invention without undue experiments.

Takeda picked up Baxalta through a series of merger deals. Shire added Baxalta to its fold in 2016, then Takeda bought Shire in 2019.