Amgen c. Sanofi: la corte suprema sulla sufficiente descrizione di brevetto farmaceutico

Corte Suprema 18 maggio 2023, n°  21-757, Amgen c. Sanofi, su questione brevettual-farmaceutica di un certo interesse, relativa alla descrizione (<<(a) In General.— The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention>>, 35 US Code § 112; da noi art. 51 c.p.i.)

DAl Syllabus:

<<amino acid sequences of 26 antibodies that perform these two functions. Amgen then described two methods—one Amgen called “the roadmap”and a second it called “conservative substitution”—that scientists could use to make other antibodies that perform the binding-and-blocking functions described in the claims>>

E poi andando al giudizio:

<<(b) Turning to the patent claims at issue in this case, Amgen’s claims sweep much broader than the 26 exemplary antibodies it identifies bytheir amino acid sequences. Amgen has failed to enable all that it has claimed, even allowing for a reasonable degree of experimentation.Amgen’s claims bear more than a passing resemblance to the broadest claims in Morse, Incandescent Lamp, and Holland Furniture. While Amgen seeks to monopolize an entire class of things defined by their function—every antibody that both binds to particular areas of the sweet spot of PCSK9 and blocks PCSK9 from binding to LDL receptors—the record reflects that this class of antibodies does not include just the 26 that Amgen has described by their amino acid sequences, but a vast number of additional antibodies that it has not.
Amgen insists that its claims are nevertheless enabled because scientists can make and use every functional antibody if they simply follow the “roadmap” or “conservative substitution.” These two approaches, however, amount to little more than two research assignments. The “roadmap” merely describes step-by-step Amgen’s own trial-and-error method for finding functional antibodies. Not
much different, “conservative substitution” requires scientists to make substitutions to the amino acid sequences of antibodies known to work and then test the resulting antibodies to see if they do too.
Amgen’s alternative arguments lack merit. Amgen first suggests that the Federal Circuit erred by conflating the question whether an invention is enabled with the question how long may it take a person skilled in the art to make every embodiment within a broad claim. But the Federal Circuit made clear that it was not treating as dispositive the cumulative time and effort required to make the entire class of antibodies. Amgen next argues that the Patent Act supplies a single, universal enablement standard, while the Federal Circuit applied a higher standard to Amgen’s claims that encompass an entire genus of embodiments defined by their function. The Court agrees in principlethat there is one statutory enablement standard, but the Federal Circuit’s treatment in this case is entirely consistent with Congress’s directive and this Court’s precedents. Finally, while Amgen warns thata ruling against it risks destroying the incentives that lead to breakthrough inventions, since 1790 Congress has included an enablement mandate as one feature among many designed to achieve the balanceit wishes to strike between incentivizing inventors and ensuring thepublic receives the full benefit of their innovations. In this case, the Court’s duty is to enforce the statutory enablement requirement according to its terms. Pp. 15–19>>.

Si noti che la lite verteva sul requisito dell’ enablement (modalità attuative) che per legge integra la descrizione in senso stretto (da non espressamente richiesto).

V. commento di Rose Hughes su IpKat.