October 9, 2019
特許期間調整に関する米国特許庁ルールの変更が提案されました
米国の出願審査が特許庁の遅延により極端に遅れた場合、その遅れの日数分だけプラスアルファで特許期間を長くするよう調整されます。一方で、出願人が期限延長を行うなど、自ら遅れの原因を作ってしまった場合、プラスアルファで長くなった日数分から出願人の遅延分が差し引かれることになります。このような特許期間調整（Patent Term Adjustment, PTA）により特許期間が１日でも長くなるとビジネス上大きなメリットとなり得るため、PTAを自ら減らすことのないよう拒絶応答を進めることが大事です。
先週10月4日付のFederal Registerにおいて米国特許庁は、PTAの計算方法に関する特許庁ルールの変更を提案しました。これは、今年1月のSupernus Pharm., Inc. v. Iancu, 913 F.3d 1351 (Fed. Cir. 2019)の判決内容に沿ってルールを変更することを目的としています。
Supernus事件では、出願人の遅延（"a failure of the applicant to engage in reasonable efforts to conclude processing or examination of an application"）によりPTAが差し引かれる際の日数の数え方が争点になりました。関係するのは37 CFR 1.704(c)(8)で、現行のルールは下記の通りです。<... Read more
September 19, 2019
Five years after Alice Corp. Pty. v. CLS Bank Int'l, 573 U.S. 208 (2014) and the institution of the Alice test, district courts are still wading through precedent set by the Federal Circuit while it attempts to apply the test. Recently, one New Mexico District Court turned to prior art introduced during the prosecution process that was aimed at the questions of novelty and non-obviousness to determine whether there was an "inventive concept" for the Alice/Mayo test.... Read more
September 17, 2019
The doctrine of equivalents is an equitable exception to the basic concept that the patent claims define the limit of claim protection. It is intended to prevent one from making an insubstantial change to a claimed invention to avoid infringement which is defined by the function-way-result test. The doctrine is limited by the prior art, dedication to the public, and prosecution history estoppel.... Read more
September 13, 2019
On August 27, 2019, in INO Therapeutics LLC v. Praxair Distribution Inc., in a 2-1 decision, the Federal Circuit upheld a district court decision that method-of-treatment claims, comprising excluding certain patients from treatment, were invalid under 35 U.S.C. § 101.... Read more
September 9, 2019
Drs. Stephen Quake and Christina Fan ("Quake") appealed a decision of the U.S. Patent and Trademark Office Patent Trial and Appeal Board ("the Board") finding the four claims of Quake's U.S. Patent 8,008,018 and Claim 25 of their U.S. Application No. 12/393,833 unpatentable for lack of written description.... Read more
August 16, 2019
Nalpropion Pharmaceuticals, Inc. v Actavis Laboratories FL, Inc (Fed. Cir. Aug. 15, 2019) is a precedential opinion written by Judge Lourie with Judge Wallach and a dissent from Judge Prost in a case centered on an ANDA litigation in which Actavis sought approval for their generic version to Nalpropion's patents for the Contrave® product. Footnote 1 in the opinion outlines the rather complex history of the ownership/license interests as they changed over time.... Read more
August 16, 2019
「特定の」塩の組み合わせを強調して反論を行ったために包袋禁反言（審査経過に基づくエストッペル）が適用された事例<... Read more
August 12, 2019
Every innovative pharma company faces the same challenge, how to delay the patent cliff. The existence of the "skinny viii" (21 U.S.C. § 355(j)(2)(A)(viii)) makes developing additional FDA approved indications unattractive from an LCM viewpoint. Such additional indications may allow for market expansion during the life of the patents protecting the original indication but offer no protection once those patents have expired. With a skinny viii the generic seeks approval only for indication with the earliest patent expiration. Formulation patents often provide scant protection because of the possibility of design arounds and being more easily challenged for invalidity since often the original patents are available as prior art... Read more
July 17, 2019
Enzo Life Sciences, Inc. ("Enzo") appealed the decision of the U.S. District Court for the District of Delaware granting summary judgment against Enzo and holding that the asserted claims were invalid for lack of enablement. The Federal Circuit affirmed.... Read more
July 15, 2019
In denying the petition for rehearing en banc the majority of the Federal Circuit abdicated its responsibility to define the limits of the Supreme Court's Mayo decision. Judge Dyk on the 25th birthday of the Federal Circuit noted that: Frequently, the Supreme Court in patent cases articulates a general principle and leaves it to our court to both administer the rule and apply it to the individual case.... Read more