Oblon Named Number One Filer for the IAM/ktMINE US Patent Elite

December 23, 2019

Oblon has been recognized as the law firm that has worked with the most members of the US Patent Elite on patent prosecutions at the USPTO. In addition, Oblon representatives are identified to have filed the highest volume of patent applications for the US Patent Elite, according to analysis conducted using Anaqua’s AcclaimIP Analytics Software.<... Read more

Not-So-Safe Harbor for Hospira's Erythropoietin Biosimilar

December 19, 2019

This week the Federal Circuit affirmed Amgen's win against Hospira with respect to Hospira's erythropoietin ("EPO") biosimilar—a drug used to increase red blood cell number—in a Delaware trial where Amgen's U.S. Patent No. 5,856,298 was found to be infringed and not invalid and Amgen was found to be entitled to $70 million for damages associated with its EPO drug Epogen®. Part of the appeal was also dedicated to examining the so-called Safe Harbor provision of 35 U.S.C. § 271(e)(1), where the Federal Circuit agreed with Amgen that Hospira manufactured at least 14 batches of the drug that were not protected by this provision. The Court's decision provides lessons in how companies should be careful to avoid stretching the bounds of the Safe Harbor provision... Read more

Solicitor General on Patent Eligibility

December 16, 2019

The Solicitor General (SG) was invited by the Supreme Court to provide comments on the certiorari petitions filed by Berkheimer and Hikma to review the Federal Circuit's 101 decisions adverse to them. The two briefs have numerous similarities including identifying the Court's decision in Bilski[1]as starting the patent eligibility confusion by not grounding its decision on interpreting the meaning of the 35 U..S.C. 101 terms "process, machine, manufacture, [and] composition of matter." The SG asserts that in Bilski the Court did not ground its decision on the stature terms but instead found three exceptions to be not required by the statutory text: laws of nature, physical phenomenon, and abstract ideas. While these concepts are found earlier Supreme Court decisions, Bilski represented the first time they were used independent of the statutory language or constitutional concept of the "useful arts." The SG then described Mayo[2] as continuing the Court's Bilski practice of not tying patent eligibility to any of the statutory or Constitutional language. Alice[3] characterized the Mayo decisional approach as a two step process.... Read more

Motions to Amend in Inter Partes Review: Why did Ethicon Cut Against the Grain?

December 9, 2019

Motions to amend (MTAs) are generally disfavored. The prevailing approach calls for patentees to file an MTA in Inter Partes Review (IPR) only in limited circumstances. In particular, most patentees are moving to narrow or clarify claim scope via an MTA only in cases where (i) there is no related application pending at the Office and (ii) the specter of lost past damages due to intervening rights outweighs the risk of an invalidity finding. At first glance, neither (i) nor (ii) appears to be true in the case of Intuitive Surgical, Inc. v. Ethicon, LLC, (IPRs2018-00933, 00934, and 00935), yet Ethicon elected to pursue an MTA in each of the IPRs and was successful in doing so.... Read more

Short-Term Uncertainties after Arthrex

November 20, 2019

The Federal Circuit in a precedential opinion in Arthrex, Inc. v. Smith & Nephew, Inc., vacated and remanded a final written decision of the Patent Trial and Appeal Board (PTAB), finding that the Administrative Patent Judges (APJs) are not constitutionally appointed, violating the Appointments Clause. Arthrex, Inc. v. Smith & Nephew, Inc., No. 2018-2140 (Fed. Cir. Oct. 31, 2019). The opinion in Arthrex also indicates that an Appointments Clause challenge should be timely raised on appeal, and thus, is waived when not presented in an appeal that has passed or been decided.... Read more

Patent Eligibility Under 35 U.S.C. 101 of Articles of Manufacture

November 6, 2019

FYF-JB, LLC sued Pet Factory, Inc. for infringing its U.S. Patent 9,681,643 ("the ‘643 patent") covering a tug toy for animals that emits a sound when it is pulled on both sides. Pet Factory moved to dismiss FYF-JB's complaint, arguing that the asserted claims were directed to patent ineligible subject matter under 35 U.S.C. § 101. The United States District Court for the Northern District of Illinois ("the Court") denied Pet Factory's motion to dismiss.... Read more

Think Before You Sign: Protecting IP Rights with MTAs

October 23, 2019

Material transfer agreements (MTAs) are contracts that allow one party to perform research using the materials of another party. These agreements provide a mechanism to protect the interests of the owners of discoveries and inventions, while promoting data and material sharing in the research community. Although these are admirable goals in principle, MTAs have a bad reputation with some researchers and institutions for being overly complex and, in fact, hindering research. Nonetheless, MTAs are important for defining the rights, responsibilities, and obligations of the parties with respect to research collaborations and need to be carefully considered, particularly with respect to ownership of IP rights implicated by the transferred materials.... Read more

Some Natural Phenomena are Better than Others: How which Natural Phenomenon a Claim is Directed to Influences Alice Step 2

October 16, 2019

In patents for diagnostic methods, which natural phenomena the patent is directed to may be just as important as whether it is directed to a natural phenomenon at all. A January 2019 decision of the Patent Trial and Appeal Board (PTAB) suggests that which natural phenomena a court determines the patent claim is directed to under Alice step one could have significant implications for Alice step 2. The Board’s decision in Ex parte Lee stands in contrast to the Federal Circuit’s decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc. And comparing the two side-by-side reveals that patent applicants have an incentive to not only argue whether their patent is directed to a natural phenomenon, but also to which natural phenomena it is directed.

Ex Parte Lee
 concerned an appeal from the Examiner’s determination that the diagnostic claims were patent ineligible. Claim 1 of the application was representative and describes:<... Read more

The Flip Side of Reasonable Expectation of Success is Unpredictability

October 11, 2019

The Federal Circuit in a precedential opinion in Osai Pharmaceuticals, LLC v Apotex et al (Fed. Cir., October 4, 2019) reversed the USPTO's determination of obviousness in an IPR for patent claims directed to the treatment of non-small cell lung cancer (NSCLC). Just reading the background of the first three or four pages of the decision, it was already apparent that the Court was not going to be affirming the PTAB's decision. Notably:... Read more

USPTO Proposed Revisions to Rules on Patent Term Adjustment

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