Holding: The phrase “clinically proven effective” cannot be the sole basis for patentability for a claim, as this is a functionally unrelated limitation to a claimed method or composition.
Bayer owns US Patent No. 10,828,310, which is directed to the results of a phase III clinical trial that evaluated the efficiency and safety of administering rivaroxaban with and without aspirin for the prevention of major cardiac events. Bayer appealed the PTAB’s final written decision that the claims 1-2 of the ‘310 Patent are anticipated and that claims 1-8 of the ‘310 Patent are obvious in view of the prior art.
Claim 1 of the ‘310 Patent is directed to a method of reducing the risk of cardiac events by administering rivaroxaban and aspirin in amounts that are “clinically proven effective” to reduce the risk of myocardial infarction, stroke or cardiovascular death. Claim 1 also recites that “rivaroxaban is administered in an amount of 2.5 mg twice daily and aspirin is administered in an amount of 75-100 mg daily.
Claim 5 also recites a method of reducing the risk of myocardial infarction, stroke or cardiovascular death by administering rivaroxaban and aspirin in amounts that are “clinically proven effective.” However, the method claimed in claim 5 recites “once daily administration of a first product comprising rivaroxaban and aspirin and a second product comprising rivaroxaban” where “the first product comprises 2.5 mg rivaroxaban and 75-100 mg aspirin and the second product comprises 2.5 mg rivaroxaban.”
Bayer argued that the PTAB erred by construing the phrase “clinically proven effective” in independent claims 1 and 5 to be non-limiting. However, the Federal Circuit upheld the PTAB’s construction. The phrase “clinically proven effective” has no functional relationship to the claimed method. A method that is already in the public domain cannot later be patented merely by adding a limitation that requires that the method to be shown to perform well in a clinical trial. Further, the “clinically proven effective” portion of the claims does not meaningfully transform the claimed method of taking the drugs or the claimed composition to be administered. The claimed method remains the same whether that method has been clinically proven or not, so the phrase “clinically proven effective” cannot make otherwise anticipated claims patentable.
The fact that the phrase “clinically proven effective” should not be given patentable weight does not prohibit clauses disclosing minimum safety and efficacy requirements in other patents from being limiting. If those safety requirement clauses modify the overall composition as functional limitations that limit the open-ended universe of the claimed potential compositions, those clauses may be limiting. The phrase “clinically proven effective” does not serve that same function for the ‘310 Patent, as this phrase does not further define the dosages that are to be administered as claimed.
Bayer also argued that the PTAB erred by construing that the first product comprising rivaroxaban and aspirin in claim 5 was not limited to a single dosage form, but could also apply to a rivaroxaban and aspirin administered separately but sequentially. The Federal Circuit agreed with Bayer, holding that the first product recited in claim 5 must be a single dosage form that includes both rivaroxaban and aspirin. The plain language of the claim that recites “the first product comprises 2.5 mg rivaroxaban and 75-100 mg aspirin” (emphasis added), requires that the dose include both rivaroxaban and aspirin. The PTAB’s construction including separate dosage forms would render the term “first product” meaningless. Further, the specification supports construing this phrase to require a single dosage form.
Mylan argued that this claim construction for claim 5 is moot because Bayer did not make any arguments as to why this claim construction would overcome Mylan’s obviousness arguments. However, the patent challengers bear the burden of proving that challenged claims are unpatentable under the correct construction.
Bayer further claimed that the PTAB erred by failing to consider its secondary considerations evidence that the clinical proof of efficacy showed that the claims provided an unexpected result. However, this secondary evidence is based solely on the phrase “clinically proven effective” in the claims, which is limitation that holds no patentable weight. To be relevant, evidence of secondary considerations must have a nexus to the claimed invention. There is no nexus if the evidence is the result of something that is different from what is novel in the claimed invention. Since the “clinically proven effective” language holds not patentable weight, this cannot be the novel portion of the claim. Therefore, proof of clinical effectiveness has no connection to the merits of the claimed invention and does not have the requisite nexus to the claims to be used as evidence of nonobviousness.
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