In
Background
Issue(s)
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Whether the claim limitation "treating pulmonary hypertension" of the '793 patent includes safety and efficacy.
- Whether the '793 patent claims are enabled.
- Whether the '793 patent claims are supported by written description.
- Whether the District Court clearly erred in finding induced infringement of claims 1, 4, and 6-8 of the '793 patent.
- Whether the District Court clearly erred in finding infringement of claims 1-3 of the '066 patent.
- Whether the District Court clearly erred in finding no infringement of claims 6 and 8 of the '066 patent.
- Whether the District Court clearly erred in finding claims 1-3, 6, and 9 of the '066 patent invalid based on anticipation under §102 in view of prior art reference Moriarty.
- Claim limitation of "treating pulmonary hypertension" does not include the non-recited limitations of safety and efficacy.
- Claims of the '793 patent are adequately enabled.
- Claims of the '793 patent are supported by written description.
The District Court did not clearly err in finding induced infringement because the '793 IPR decision does not affect finding of induced infringement.- Issue of infringement of claims 1-3 of the '066 patent is rendered moot by invalidated claims.
The District Court did not clearly err in finding claims 1-3, 6, and 9 anticipated by Moriarty.The District Court did not clearly err in finding claims 1-3, 6, and 9 of the '066 patent invalid.- An IPR decision does not have collateral estoppel effect until that decision is affirmed or the parties waive their appeal rights; and
- The PTAB's final written decision does not cancel claims; the claims are cancelled when the Director issues a certificate confirming unpatentability.
Holding(s)
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The District Court's claim construction was correct that "treating pulmonary hypertension" as recited in the '793 patent includes treating all five groups of pulmonary hypertension patients.
Reasoning
As to the claim construction of pulmonary hypertension, the Federal Circuit found that the '793 specification does not limit scope of pulmonary hypertension to any specific group.
The Federal Circuit found that read in context, the claim language of "'treating pulmonary hypertension' does not import any additional efficacy limitations or any safety limitations," and that it is wrong to partition a disease or condition to require a separate disclosure in the specification for each individual variant of the condition, unless the variants are specified in the claims.
The '793 specification describes the claimed "treating pulmonary hypertension comprising administering . . . a therapeutically effective single event dose of a formulation containing treprostinil."
The Federal Circuit noted that safety and efficacy are responsibilities of the
The Federal Circuit found that the district court properly relied on expert testimony and record evidence to conclude that a skilled artisan would understand that the claimed single dose administration of treprostinil would improve hemodynamics regardless of the type (i.e., group) of pulmonary hypertension patient.
As to the enablement issue, the Federal Circuit agreed with the district court's finding of enablement in the details in the '793 patent specification on administration, concentrations, dosages, and description of an open label study; and expert testimony.
The Federal Circuit reasoned that these disclosures in the record satisfy all that the claims require under the district court's construction of a "therapeutically effective single dose."
As to the issue of providing written description, the Federal Circuit agreed with the district court that noted the specification describes "treating pulmonary hypertension comprising administering . . . a therapeutically effective single event dose of a formulation containing Treprostinil."
The Federal Circuit noted that the same reasons for rejecting
As to whether the FWD invalidating claims in the IPR negated the finding of induced infringement, the Federal Circuit noted that "[a] pending, non-final litigation does not negate an intent to infringe that is otherwise supported by evidence."
The Federal Circuit reasoned that:
As to the issue of invalidation by anticipation by Moriarty, the Federal Circuit stated that "a product-by-process claim is a product claim."
Prior art Moriarty discloses treprostinil of 99.7% purity which falls in the scope of the '066 specification of 99.7-99.9% purity, although it may not disclose purification through salt formation and the same level of alkylation or hydrolysis impurities as described in the specification which are not claimed.
No evidence was provided "identifying any structural or functional differences between the Moriarty treprostinil and the claimed treprostinil" of the '066 patent, and the Federal Court found the district court's reasoning well supported.
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