law of nature : CAFC Alert

Patent eligible Laboratory methods

Yoshiya Nakamura | July 13, 2016

Rapid Litigation Management Ltd. v. CellzDirect, Inc.

July 5, 2016

Before Prost, Moore and Stoll.  Opinion by Prost.


Patented claims at issue were directed to a method of producing a desired preparation of hepatocytes (liver cells) useful for laboratory tests such as drug safety tests.  The claimed process was invented based on the discovery that liver cells are capable of surviving multiple freeze-thaw cycles, which provides desired pool samples of hepatocytes from multiple donners.  The district court held that the claims were invalid under 35 U.S.C. §101.  CAFC vacated the decision, holding that the claimed process is not directed to a patent-ineligible concept.


近年最高裁判決の下、自然法則または自然現象を優位に超える特徴をクレームに記載しなければ特許対象にはならない。地裁は肝細胞が冷凍保存可能であることはその細胞の自然能力の発揮にすぎず、本特許の方法は自然法則の利用を優位に超える特徴を記載していないとして同特許を無効にした。高裁はその地裁判決を破棄し、従来の知見反して肝細胞の冷凍を2回以上繰り返す工程を記載した本特許の方法は従来の方法にはない利点があるから特許可能対象であると判示した。複数回の冷凍保存を行うことができるという科学的発見に基づくシンプルな発明コンセプトであるが、新規で有用な結果をもたらす方法は特許対象になりえることが示された。このケースは発見を利用する発明を新規な「方法」として記載することで特許対象になり得ることを示しているが、その肝細胞を「プロダクト」としてクレームした場合は自然物の寄せ集めであり特許対象になりえないことも示唆された(Funk Bros判決参照)。一方で、101条の特許対象要件の判断において従来技術との対比が重要な意味を持ち得ることを示した判決でもある。

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Fractured CAFC panel again affirms patent eligibility of isolated DNA, and applies Mayo

Ryan Chirnomas | August 21, 2012

Association for Molecular Pathology et al. v. U.S.P.T.O. et al.

August 16, 2012

Panel:  Lourie, Bryson and Moore.  Majority opinion by Lourie, concurrence by Moore, dissent by Bryson.

Less than a month after hearing oral arguments, the CAFC panel of Judges Lourie, Bryson and Moore last week issued an updated decision in the controversial AMP v. USPTO (Myriad genetics) case. The CAFC reached the same conclusion as they did last year: (1) the Plaintiffs do have standing, (2) the isolated DNA and cDNA claims are patent eligible, (3) the “analyzing” and “comparing” method claims are not patent eligible and (4) the screening method claim is patent eligible.

As with the decision last year, the panel reached a unanimous conclusion with respect to the issues of standing, subject matter eligibility of the cDNA claims, and subject matter eligibility of the method claims.  However, the panel reached different conclusions with respect to the composition claims which recite isolated DNA.  Since the opinions of the Court are very similar to the opinions issued in 2011, this article will focus on the Judges’ views with respect to the impact of Mayo v. Prometheus (English summary; Japanese summary) on the claims in question, and particularly with respect to the isolated DNA claims.

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Summary of Oral Arguments in AMP v. USPTO remand

Ryan Chirnomas | July 20, 2012

July 20, 2012

In the immortal words of baseball great Yogi Berra, “It’s déjà vu all over again”.  A little more than a year after they previously heard AMP v. USPTO, the CAFC panel of Judges Lourie, Bryson and Moore have once again taken up the question of whether isolated DNA and related methods are patent eligible subject matter under 35 U.S.C. §101.

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USPTO issues Interim Procedure for §101 examination after Prometheus v. Mayo

WHDA Blogging Team | July 3, 2012

Since the Supreme Court issued their decision in Mayo v. Prometheus (English discussion here; Japanese discussion here), rejections of claims based on failure to comply patent-eligible subject matter requirements of §101 seem to be on the rise.  Until now, Examiners had been given only very little guidance (see here), resulting in Mayo being cited inconsistently.  However, today, the USPTO has provided Examiners with additional guidance about how to handle this issue.  Please click below for more information:

2012 Interim Procedure for Subject Matter Eligibility Analysis of Process Claims Involving Laws of Nature

Memo Cover Letter

These guidelines should improve consistency of the manner in which Mayo and related cases are relied upon by the Examining Corps, as well as provide practitioners with a basic framework for responding to such rejections.

Keep in mind that as the CAFC (and perhaps the Supreme Court, eventually) continues to address this issue in other pending cases such as Myriad and Ultramercial, these guidelines may be revised by the USPTO.


Yoshiya Nakamura | March 23, 2012

No. 10–1150. Argued December 7, 2011—Decided March 20, 2012

For an English discussion of Mayo v. Prometheus, please click here.


Prometheus Laboratories(以下、Prometheus)は、自己免疫疾患を治療するためのチオプリン(thiopurine)ドラッグに関する2つの特許(U.S. Patent No. 6,355,623、No.6,680,302)の独占的使用権を有する。特許クレームは、チオプリンが投与された患者の血中の代謝物量を測定し、それに合わて投与量を調整する方法に関するものである。

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Supreme Court strikes down diagnostic method claims as non-patent-eligible subject matter

Ryan Chirnomas | March 20, 2012

Mayo Collaborative Services v. Prometheus Laboratories

March 20, 2012

Supreme Court, 9-0, opinion by Justice Breyer


Although we typically cover the CAFC in this blog, today we will be visiting the Supreme Court.  The Supreme Court unanimously ruled that the diagnostic method claims in this highly-anticipated case were invalid as failing to comply with 35 U.S.C. §101.  In short, the Court ruled that a claim reciting a diagnostic method (which is inherently based upon a law of nature) that applies only conventional, known steps is invalid.

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