obvious to try : CAFC Alert

Somewhat unexpected results yield to strong evidence of obviousness to try

John M. Wang | August 8, 2014

Roche and Genentech v. Apotex Inc; Roche and Genentech v. Dr. Reddy’s laboratories; Roche and Genentech v. Watson etc.; Roche and Genentech v. Orchid chemicals & pharmaceuticals etc; and Genentech v. Mylan etc.

April 11, 2014

Before  Newman, Lourie, and Bryson.  Opinion by Bryson. Dissent by Newman

Summary

Plaintiff Roche appeals from the decision of the U.S. District Court for the District of New Jersey granting the defendant generic drug companies summary judgment of invalidity of Roche’s two patents related to Boniva®, a commercial drug for the treatment of osteoporosis. CAFC affirms.


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Unexpected result for combination therapy using two known drugs

Yoshiya Nakamura | July 24, 2013

Novo Nordisk A/S v. Caraco Phamaceutical Laboratories, Ltd.

June 18, 2013

Panel:  Newman, Dyk and Prost.  Opinion by Prost.  Dissent by Newman.

Summary:

A patent claims a combination therapy using two drugs.  The patent was issued by overcoming prior art as an examiner recognized an unexpected result proved by an inventor’s declaration.  In the district court, defendant presented new evidence challenging the validity of the patent.   The evidence showed that one of the claimed drugs was well known to be used in the therapy, and another drug having similar mechanism as the other was also well known to be used in such combination therapy.  Relying on the evidence, the district court hold that the patent was obvious because the evidence created a strong prima facie case of obviousness, and it was so strong that the patentee’s evidence showing certain superior effects did not overcome the prima facie obviousness. The majority agreed with the district court holding.  Judge Newman dissented.

地裁は、2つの公知の薬物(repaglinideとmetformin)の併用による糖尿病治療方法の特許に関して予期せぬ効果は立証されなかったため無効であると判断した。連邦巡回区控訴裁判所(CAFC)はその特許無効判決を支持した。Metforminは同治療用として周知であり、repaglinideはmetforminとは異なる経路に作用するものとして糖尿病治療に利用されていた。先ず特許庁では、その併用は加算的な効果しかないとして審査官に拒絶されたが、出願人が追加実験データを提出することにより相乗効果が認められ特許になった。その後、侵害被疑者は地裁で新たな証拠を出した。それによるとrepaglinideと同じクラス(sulfonylureas)に属する同様の機能を有する化合物をmetforminと併用する療法が知られていた。他方、特許権者は、repaglinideはその文献に記載のsulfonylurea化合物とは異なること、特にmetforminとrepaglinideの併用はmetforminの単独使用と比較して空腹時血漿グルコースレベルを8倍も改善するという証拠を出した。しかしながら,地裁は侵害被疑者の証拠を採用し、特許無効の判決を出した。CAFCは、repaglinideとsulfonylurea類の併用が周知であり、ある種の相乗効果も報告されている点を強調し、地裁に同意し、特許権者の主張を退けた。特許権者の証拠によるとrepaglinide単独の特性から見て予想外な併用効果があることも示唆されるがCAFCは類似の併用療法が周知であるという全体的な方向性を見て、特許権者の具体的な反論を認めなかった。本件は、公知の薬物の併用はそれと類似の併用例が知られていると強い自明性の仮定が働き、特許権者はそれを克服するために相当に高いレベルの反証が要求されることを示す判決である。本件では、クレーム治療方法の商業的成功の証拠は不十分であるとして認められなかった。

なお、判事の一人(Newman)は、反対意見を述べている。化学的実験というものはある程度の予測、希望を持ってなされるものであり、そのような状況があるということで直ちに「自明な試み」として特許しないのはいかにも不合理であるといった趣旨である。特にrepaglinide自体は先行技術の化合物とは異なるにもかかわらず、repaglinideによる併用効果の発見は特許権者が公知の併用療法をさらに追求した結果にすぎないと示唆したことは、後知恵による判断であると非難した。


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CAFC defines “common sense” and warns against impermissible hindsight

Ryan Chirnomas | June 6, 2012

Mintz and Jif-Pak Manufacturing v. Dietz & Watson and Package Concepts and Materials

May 30, 2012

Rader, Newman, Dyk.  Opinion by Rader.

Summary

This case highlights the important point that obviousness cannot be established by vague and unsubstantiated reliance on “common sense.”  Rather, Judge Rader defines the term “common sense” as “knowledge so basic that it certainly lies within the skill set of an ordinary artisan.”  The CAFC also warns against hindsight due to defining the problem to be solved based on the solution found by the inventors.   Furthermore, the CAFC reminds us that when references from a secondary technical field are used in a rejection, the person of ordinary skill in the art is not a person familiar merely with this secondary technical field, but rather a person familiar with at least the primary technical field.


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KSR Reigned In For A Preliminary Injunction

John Kong | January 18, 2012

Celsis in Vitro, Inc. v Cellzdirect, Inc. and Invitrogen Corp.

January 9, 2012

Panel:  Rader, Gajarsa, and Prost.  Opinion by Rader; Dissent by Gajarsa.

Summary:

While Rader’s majority opinion affirmed the district court’s grant of a preliminary injunction despite defendant’s obviousness challenge, Gajarsa’s dissenting opinion asserts that the majority’s decision disregards the Supreme Court’s KSR flexible guidelines regarding the finding of obviousness in the mere repetition of well-known techniques to achieve a desired result, and in the application of “obvious to try.”  Gajarsa’s dissent also notes that this is a preliminary injunction, and the standard is not whether defendant has shown obviousness by clear and convincing evidence, but rather, whether defendant has shown a “substantial question of invalidity” to defeat a preliminary injunction.  Perhaps, the strongest position for the majority opinion is its consideration of the showing of a “teaching away” in the record, as well as deference given to the district court’s determinations of credibility of the parties’ expert witnesses.


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