Did the CAFC Extrapolate From the Teachings of the References to Reach the Conclusion of Obviousness?
| August 12, 2013
In re Adler
July 18, 2013
Panel: Prost, Reyna and Wallach. Opinion by Wallach
Summary
The Examiner rejected all of the pending claims under 35 U.S.C. §103 as obvious over several prior art references, including International Patent Publication WO 00/22975 (“Meron”) in view of Masaru Hirata et al., Study of New Prognostic Factors of Esophageal Variceal Rupture By Use of Image Processing With a Video Endoscope, 116 Surgery 8–16 (1994) (“Hirata”).
The Board of Patent Appeals and Interferences (“the Board”) affirmed the Examiner’s rejection of all pending claims of U.S. Patent Application No. 10/097,096 (the ‘096 application) under 35 U.S.C. §103 as being obvious over a combination of prior art references. Adler appealed the Board’s decision to the Court of Appeals for the Federal Circuit (CAFC). The CAFC affirms holding that the Board did not err in rejecting the pending claims as obvious and did not rely on new grounds for rejection.
Unexpected result for combination therapy using two known drugs
| 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。
Tags: obvious to try > obviousness > unexpected results
Board Should Consider Appellee’s Grounds For Affirming Rejection Presented To Examiner During Reexamination, Even If Grounds Had Not Been Raised On Appeal
| February 6, 2013
Rexnord Industries v. Kappos
January 23, 2013
Panel: Newman, Lourie, Prost. Opinion by Newman.
Summary:
In 2003 Habasit filed an infringement suit against Rexnord in the United States District Court for the District of Delaware for infringement of its U.S. Patent No. 6,523,680 (the ’680 patent). Rexnord then requested inter partes reexamination of the ’680 patent, and the district court stayed the infringement suit pending completion of reexamination.
On reexamination, the examiner held all of the claims in the ’680 patent unpatentable for anticipation and obviousness. Habasit appealed the examiner’s decision to the United States Patent and Trademark Office (PTO) Board of Patent Appeals and Interferences (Board). On appeal, the Board reversed the examiner’s decision and held the claims patentable.
Rexnord appealed to the CAFC. The CAFC affirmed that the claims are not anticipated, and reversed the Board’s determination that the claimed invention is not obvious in view of certain prior art.
Tags: anticipation > appeal > obviousness > reexamination
The Non-Obviousness of Obviousness Determinations: Even In Simple Technologies, It Can Be Difficult to Draw a Line in Obviousness Determinations
| January 9, 2013
C.W. Zumbiel Company, Inc. v. Kappos and Graphic Packaging International, Inc.
December 27, 2012
Panel: Prost, Moore, and Wallach. Opinion by Wallach. Dissent byProst.
Summary:
This appeal arises out of an Inter Partes Reexamination before the Board of Patent Appeals and Interferences, the decision. Both the patentee and the third-party requester appealed the Board’s decision, which indicated that certain claims were obvious and certain claims were nonobvious. In this case, the Federal Circuit affirmed the Board’s entire decision. The technology at issue involved a carton for a pack of cans (such as, e.g., soda cans) having a perforated flap portion that is torn and folded down to dispensing the cans. This case highlights that even in non-complex technologies, it can be difficult to draw a line in obviousness determinations, and how when there are little possible variations in structure, if such variations lead to predictable results obviousness may be found (such as here in, e.g., claim 1), but that when there are little possible variations in structure, if other factors such as teaching away in the art, lack of incentive for such a modification exist, nonobviousness may be found (such as here in, e.g., claim 2).
Prior art can show what the claims would mean to those skilled in the art
| December 5, 2012
ArcelorMittal v. AK Steel Corp.
November 30, 2012
Panel: Dyk, Clevenger, and Wallach. Opinion by Dyk.
Summary:
The U.S. District Court for the District of Delaware held that defendants AK Steel did not infringe plaintiffs ArcelorMittal’s U.S. Patent No. 6,296,805 (the ‘805 patent), and that the asserted claims were invalid as anticipated and obvious based on a jury verdict.
ArcelorMittal appealed the district court’s decision. On appeal, the CAFC upheld the district court’s claim construction in part and reverse it in part. With regard to anticipation, the CAFC reversed the jury’s verdict of anticipation. With regard to obviousness, the CAFC held that a new trial is required because the district court’s claim construction error prevented the jury from properly considering ArcelorMittal’s evidence of commercial success.
미국 델라웨어주 연방지방법원 (U.S. District Court for the District of Delaware)은 원고 (ArcelorMittal)가 피고 (AK Steel)를 상대로 낸 특허 침해 소송에서 원고의 특허 (U.S. Patent No. 6,296,805)가 예견가능성 (anticipation) 및 자명성 (obviousness) 기준을 통과하지 못하였다는 배심원의 판단을 바탕으로 피고가 원고의 특허를 침해하지 않았다고 판결하였다.
이에 불복하여 원고는 연방항소법원 (U.S. Court of Appeals for the Federal Circuit)에서 상고 (appeal) 하였으며, 연방항소법원은 지방법원의 청구항 해석 (claim construction)에 대해 일정 부분은 확인하였으나, 나머지 부분은 번복하였다.
예견가능성과 관련하여 연방항소법원은 배심원의 예견가능성 판단과 다른 결정을 내렸다.
자명성과 관련해서는 연방지방법원의 잘못된 청구항 해석으로 인하여 배심원이 원고의 상업적 성공 (commercial success) 증거를 고려하지 않았기때문에 재심 (new trial)이 필요하다고 판결하였다.
Tags: anticipation > claims construction > commercial success > extrinsic evidence > intrinsic evidence > obviousness > prior art > secondary considerations
Presumption of validity attaches to all issued patents, even incorrectly issued patents
| July 5, 2012
Sciele Pharma Inc. v. Lupin Ltd.
July 2, 2012
Panel: Lourie, Prost, Moore. Opinion by Moore
Summary
Shionogi (new name for Sciele Pharma) obtained US Patent No. 6,866,866 (“the ‘866 patent”) which included broader claims that were intended to be cancelled in favor of narrower claims in response to a rejection. Shionogi brought suit against Lupin for infringement of the ‘866 patent including claims that were to be cancelled. Lupin began selling the alleged infringing product and Shionogi moved for a preliminary injunction. The District Court granted Shionogi’s request for preliminary injunction and Lupin appealed. On appeal, the CAFC stated that even though the ‘866 patent issued with the incorrect claims, the ‘866 patent nonetheless had a presumption of validity and that the clear and convincing evidentiary standard applied for invalidating the patent. The CAFC also stated that there is not a heightened standard just because references were considered by the PTO. With the proper clear and convincing evidentiary standard applied to the ‘866 patent, the CAFC stated that Lupin has raised a substantial question of invalidity, and thus, the preliminary injunction is vacated.
Tags: clear and convincing standard > enablement > injunction > obviousness > preliminary injunction > presumption of validity > validity
CAFC defines “common sense” and warns against impermissible hindsight
| 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.
Tags: common sense > obvious to try > obviousness
Another per se rule bites the dust. A reference that discloses a range encompassing a somewhat narrower claimed range may not be sufficient to establish a prima facie case of obviousness
| April 12, 2012
Genetics Institute, LLC v. Novartis Vaccines and Diagnostics, Inc.
August 23, 2011
Panel: Lourie, Plager and Dyk. Opinion by Lourie. Concurrence-in-part and dissent-in part by Dyk.
Summary:
This article concludes a three-part series regarding this important case from last year. For part 1, click here. For part 2, click here. This final article discusses the following questions:
Question 1: Does a broad range necessarily render obvious a narrower range falling within that broader range?
Answer 1: No.
Question 2: Do all minor chemical differences always lead to a conclusion of obviousness?
Answer 2: No.
Unexpected results, not disclosed in the specification, of a compound may overcome a prima facie case of obviousness
| April 2, 2012
Genetics Institute, LLC v. Novartis Vaccines and Diagnostics, Inc.
August 23, 2011
Panel: Lourie, Plager and Dyk. Opinion by Lourie. Concurrence-in-part and dissent-in part by Dyk.
Summary:
Today, we bring you the first in a series of three articles regarding an important case from last year. This article discusses the following question:
Question: Can evidence of unexpected results of a compound be used to overcome a prima facie case of obviousness, where the unexpected result is not disclosed in the specification as originally filed?
Answer: Yes.
Evidence of unexpected results to a property of a compound, where the unexpected result is not disclosed in the specification as originally filed, can be used to overcome a prima facie case of obviousness.
Tags: comparative results > interference > obviousness > secondary considerations > unexpected data
KSR Reigned In For A Preliminary Injunction
| 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.
Tags: common sense > injunction > KSR > obvious to try > obviousness > preliminary injunction > teaching away
