Source: http://patents.hdp.com/?m=201701
Timestamp: 2019-04-21 16:17:39+00:00

Document:
In Cumberland Pharmaceuticals, Inc.v. Mylan Institutioal LLC, [2016-1155, 2016-1259] (January 26, 2017) the Federal Circuit affirmed the district court holding that U.S. Patent No. 8,399,445, which describes and claims acetylcysteine compositions substantially free of chelating agents, was not derived from the FDA.
Mylan argued that the claimed invention was obvious from the FDA’s action on Cumberland’s petition to market the predecessor composition that contained a chelating agent. The FDA asked Cumberland for data supporting the function of the chelating agent, which Mylan argued was proof that the FDA conceived of the idea of acetylcysteine free of chelating agents.
research that would have inevitably led it to the invention. Noting that derivation is not proved by showing conception and communication of an idea different from the claimed invention even where that idea would make the claimed idea obvious.
In Eli Lilly and Company v. Teva Parenteral Medicines, Inc., [2015-2067] (January 12, 2017), the Federal Circuit affirmed judgment of inducement of infringement of U.S. Patent No. 7,772,209, and that the the asserted claims were not invalid for indefiniteness, obviousness, or obviousness-type double patenting.
pemetrexed, patients self-administer folic acid with guidance from physicians. Specifically, the Physician Prescribing Information and the Patient Information accompanying the product instructed the patient to self-administer folic acid.
actor: (1) conditions participation in an activity or receipt of a benefit upon others’ performance of one or more steps of a patented method, and (2) establishes the manner or timing of that performance. However the Federal Circuit also said that other factual scenarios may arise which warrant attributing others’ performance of method steps to a single actor.
can only condition the performance of a step by imposing a legal obligation to do so, by interposing that step as an unavoidable technological prerequisite to participation, or both. Conditioning is not limited to legal obligations or technological prerequisites.
The Federal Circuit also found sufficient control over the manner and timing of performance, again relying upon the written instructions and the testimony.
infringement.” Takeda argued that Lily did not show what physicians do, just what they may do. The Federal Circuit rejected this argument, finding taht the label simply must encourage, recommend, or promote infringement, and that it is irrelevant that some users may ignore the warnings in the proposed label.
The Federal Circuit rejected arguments that “Vitamin B12” made the claims indefinite, and arguments that the claims were obvious, and that they were invalid for obviousness type double patenting.
In Phigenix, Inc. v. ImmunoGen, Inc., [2016-1544] (January 9, 2017), the Federal Circuit held that Phigenix, the losing petitioner in an IPR, lacked standing to appeal the PTAB’s decision that claims 1–8 of U.S. Patent No. 8,337,856 were nonobvious. The Federal Circuit said that although Article III standing is not necessarily a requirement to appear before an administrative agency, an appellant must nevertheless supply the requisite proof of an injury in fact when it seeks review of an agency’s final action in a federal court. To show this standing, an appellant must have (1) suffered an injury in fact, (2) that is fairly traceable to the challenged conduct of the appellee, (3) that is likely to be redressed by a favorable judicial decision.
The Federal Circuited noted that in some cases, an appellant’s standing to seek review of administrative action is self-evident; no evidence outside the administrative record is necessary for the court to be sure of it. When the appellant’s standing is not self-evident, however, the appellant must supplement the record to the extent necessary to explain and substantiate its entitlement to judicial review. In so doing, an appellant may submit arguments and any affidavits or other evidence to demonstrate its standing. Taken together, an appellant must either identify record evidence sufficient to support its standing to seek review or, if there is none because standing was not an issue before the agency, submit additional evidence to the court of appeals, such as by affidavit or other evidence.
The Federal Circuit noted that Phigenix does not contend that it faces risk of infringing the patent, that it is an actual or prospective licensee of the patent, or that it otherwise plans to take any action that would implicate the patent. Instead, Phigenix asserted that it has suffered an actual economic injury because the existence of the patent increases competition between Phigenix and ImmunoGen, which the Federal Circuit found unsubstantiated. The Federal Circuit also rejected Phigenix contention that it has suffered an injury in fact because 35 U.S.C. §141(c) “provides a statutory basis for appeal.” While §141(c) permitted the filing of an appeal, it does nothing to establish Article III standing. Finally, the Federal Circuit rejected the argument that the estoppel provisions of 35 U.S.C. § 315(e) created standing, but the Federal Circuit found it did not constitute an injury in fact when the appellant is not engaged in any activity that would give rise to a possible infringement suit.
Should this court overrule Achates Reference Publishing, Inc. v. Apple Inc., 803 F.3d 652 (Fed. Cir. 2015) and hold that judicial review is available for a patent owner to challenge the PTO’s determination that the petitioner satisfied the timeliness requirement of 35 U.S.C. §315(b) governing the filing of petitions for inter partes review?
The PTAB’s decisions applying the one year bar under §315(b) have been inconsistent, and Achates effectively insulates the misapplication of the bar from review, leaving patent owners without remedy should the Board institute a proceeding that is in fact barred.

References: v. 
 v. 
 §141
 §141
 § 315
 v. 
 §315
 §315