USPTO Proposed Revisions to Rules on Patent Term Adjustment

Attorney: Yuki Onoe
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

Argument with Emphasis on "Particular" Combination of Salts Invoked Prosecution History Estoppel

Attorney: Yuki Onoe
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

Commercial Success of Claimed Product over Non-Infringing Competitive Products as Evidence of Non-Obviousness

Attorneys: Richard D. Kelly and Yuki Onoe
June 17, 2019

During litigation or contested proceeding the patentee can point to commercial success of a product as evidence of non-obviousness of the claimed product. Although some work is necessary to show the nexus between the success in the market and the claimed invention, the evidence showing, for example, the product taking sales from competitive products could help the patentee's case.... Read more

Follow-On IPR Petitions - Institution Is Not Impossible But Difficult

Attorney: Yuki Onoe
April 16, 2019

同一特許に対するIPR申請 ¾審理開始は不可能ではないが難しい<... Read more

No More IPRs From Generic Drug Makers?

Attorney: Yuki Onoe
February 24, 2019

The USPTO argues that a petitioner who has received a favorable final written decision in an IPR is estopped from reusing the same winning argument in a district court. If the Federal Circuit in BTG International Ltd. v. Amneal Pharmaceuticals LLC, agrees with the PTO, an ANDA sponsor would not take the risk of "winning" at the PTAB and would rather present the best argument in a district court.... Read more

Patents 4 Patients Extended Until June 30, 2020

Attorney: Yuki Onoe
January 2, 2019

The USPTO has recently announced extension of Patents 4 Patients, also called as the Cancer Immunotherapy Pilot Program, until June 30, 2020.  This pilot program was started on June 29, 2016, to provide a fast-track examination for an application related to cancer immunotherapy.  The PTO’s goal is to issue a final decision within a year of the entry of the program. <... Read more

Helsinn – The Government Sides with Reality

Attorney: Yuki Onoe
October 1, 2018

On September 24, 2018, the Solicitor General filed a motion to participate in oral argument as amicus curiae in Helsinn Healthcare v. Teva Pharmaceuticals. The U.S. government's interest in this case is obvious, as the decision would have a direct impact on how the USPTO examines and determines patentability of invention.... Read more

Jurisdiction for "Late Listed" Orange Book Patent and Injunction Based on Induced Infringement by Drug Label

Attorney: Yuki Onoe
April 25, 2018

As re ported earlier, the Federal Circuit in Vanda Pharm. Inc. v. West-Ward Pharm. Int'l. Ltd. held that jurisdiction exists under 35 U.S.C. § 271(e)(2) for a "late listed" Orange Book patent. The Court also decided that an injunction is available to prevent inducement of infringement by a label.... Read more