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
Specific application of an abstract idea may be patent eligible
| June 26, 2013
Ultramercial, Inc. v. Hulu, LLC.
June 21, 2013
Panel: Rader, Lourie and O’Malley. Opinion by Rader. Concurrence by Lourie
Summary
Ultramercial, Inc. sued Hulu, LLC for infringement of U.S. Patent 7,346,545 (the ‘545 patent) directed to a method of monetizing and distributing copyrighted products over the Internet. The district court dismissed the patent suit by holding that the patent claims an abstract idea; therefore, it is not a process under 35 U.S.C. §101. In an earlier decision, the Federal Circuit reversed the district court’s holding and remanded. The Supreme Court of the United States vacated the earlier decision by the Federal Circuit. The Federal Circuit again holds that the patent does not claim an abstract idea because the claims are not drawn to a mathematical algorithm or a series of purely mental steps because the claims require, among other things, a particular method for collecting revenue from the distribution of media products over the Internet by way of controlled interaction with a consumer over an Internet website. Therefore, the Federal Circuit again reversed the district court’s holding and remanded for further proceeding.
Tags: §101 > abstract idea > mathematical formula > mental process > patent eligibility > patent eligible subject matter > process
How to claim triangle relationships among three elements to win broader claim construction
| June 19, 2013
Douglas Dynamics LLC v. Buyers Products Co.
May 21, 2013
Panel: Rader, Newman, and Mayer. Opinion by Rader. Dissent by Mayer.
Summary
Connection between two elements is relatively clear and does not cast heavy doubt. Adding another element allows possible variations in connections among three elements and requires deeper thoughts of a claim drafter. In this case, the CAFC reversed the district court’s narrower claim interpretation of “connected to” in light of its ordinary meaning and the usage in the specification. Judge Mayer dissented from the majority’s claim construction. Contexts of a claim are source for supporting specific claim interpretation. A functional limitation supported a favorable interpretation for patentee and saved a problematic structural limitation from a pitfall.
特許クレームは、3つの部品(フレーム)相互の接続関係を“connected to”という用語で定義した。クレームは、最初のフレームが3番目のフレームに直接接続されている態様だけに限定されるべきか、それとも2番目のフレームを介して間接的に接続されている態様も権利範囲に含まれるのかが争点となった。クレーム解釈の技法として、クレーム用語の通常の意味、明細書の実施形態の参酌に加えて、地裁およびCAFCともクレームの文脈に基づいて自身のクレーム解釈を正当化した。しかしながら、両者が認定した文脈には違いが存在する。地裁は構造的な限定に注目して解釈をし、CAFCは機能的な限定に鑑みて理由付けを行った。
Tags: claim construction > claim context > context > superfluous
Limitations describing how an apparatus is made can structurally limit the apparatus
| June 12, 2013
Regents of University of Minnesota v. AGA Medical Corp.
June 3, 2013
Panel: Rader, Wallach, Dyk. Opinion by Dyk.
Summary
Regents of University of Minnesota (“University”) sued AGA Medical for infringement of U.S. Patents 6,077,281 and 6,077,291 directed to medical devices called septal occluders. A claim at issue recites two disks having central membranes, the two disks being “affixed” to each other at the central membranes “to define a conjoint disk.” The accused product was a molded one-piece device. In the district court, the claim was construed as to require that the disks, before being affixed, exist separately as individual disks that are then attached to each other. Since the accused device was a single molded device and was not constructed from two separate disks, the district court entered summary judgment of non-infringement. The CAFC affirmed this construction and the summary judgment of non-infringement.
Another claim at issue was found to be anticipated. The University attempted to use prosecution disclaimer to narrow the claim and avoid anticipation. However, the court rejected the prosecution disclaimer because the prosecution disclaimer was from a parent application and applied to “materially” different claim language.
Confusion dogging best mode requirement in its waning days: Is intentional concealment required?
| June 5, 2013
Ateliers de la Haute-Garonne, and F2C2 Systems SAS v. Broetje Automation USA Inc. and Broetje Automation GMBH
May 21, 2013
Panel: Newman, Prost, and Reyna. Opinion by Newman. Dissent by Prost.
Summary:
An embodiment with three grooves is disclosed in the specification of the patents-in-suit as a preferred embodiment of an apparatus for dispensing rivets. In his deposition one of the two inventors stated that an odd number of grooves was required to prevent a rivet from rotating on itself in the device as a result of the rivet stem going inside one of the grooves. The district court found that the specification did not “state that an odd number of grooves is better than an even number”, and concluded that the patents “effectively conceal the best mode.” Summary judgment is granted. On appeal the CAFC finds no violation of the best mode requirement. Questions: Is the three-groove embodiment the best mode, or is the belief that an odd number of grooves is required the best mode? Has the best mode been concealed, and does the concealment have to be intentional for the patent to be invalidated?
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Public use bar inappropriate when participants in clinical trials do not discern specifics of new product
| May 22, 2013
Dey, L.P. v. Sunovion Pharmaceuticals, Inc.
May 20, 2013
Panel: Bryson, O’Malley, and Newman. Opinion by Bryson. Dissent by Newman.
Summary:
The Federal Circuit reversed and remanded the holding of the District Court that some of Dey’s patents were invalid because a Sunovion’s clinical trial, where Sunovion tested its own product, constituted an invalidating public use. The Federal Circuit determined that although some of test samples were lost and clinical trial was not perfectly confidential, Sunovion’s clinical trial is not an invalidating public use as long as participants do not recognize the specifics of a new drug.
연방지방법원 뉴욕 남부지원(U.S. District Court for the Southern District of New York)은 Sunovion의 임상실험 (clinical trial)이 공용 (public use)에 해당된다고 판단하여, Dey의 특허가 무효 (invalid)라도 판결하였다.
이에 불복하여, 원고는 연방항소법원 (U.S. Court of Appeals for the Federal Circuit)에 상고 (appeal)하였다. 연방항소법원은 임상실험 도중 test sample이 분실되었거나 임상실험이 완벽히 비공개로 진행되지 않았더라도 실험참가자가 신약에 대한 자세한 정보를 모른다면Sunovion의 임상실험은 공용에 해당되지 않는다고 판결하였다.
Tags: anticipation > clinical trial > public use bar > summary judgment > third party use
The Alice in Wonderland En Banc Decision by the Federal Circuit in CLS Bank v. Alice
| May 13, 2013
CLS Bank v. Alice Corporation (en banc)May 10, 2013
After the Federal Circuit issued its en banc decision on May 10, 2013 in CLS Bank v. Alice Corp, the patent owner Alice Corp must be feeling like Alice in Alice in Wonderland, bewildered and frightened by the fantastical situation in which they find themselves:
(1) “bewildered” because an equally divided Federal Circuit affirmed the district court’s holding that Alice’s claimed system to tangible machine components including a first party device, a data storage unit, a second party device, a computer, and a communications controller, programmed with specialized functions consistent with detailed algorithms disclosed in the patent, constitutes a patent ineligible “abstract idea;”
(2) “frightened” because, as Judge Moore puts it, “this case is the death of hundreds of thousands of patents, including all business method, financial system, and software patents as well as many computer implemented and telecommunications patents” (Moore Op. at 2); and
(3) “fantastical” because, as Judge Newman puts it, the en banc court was tasked to provide objective standards for 35 USC §101 patent-eligibility, but instead has “propounded at least three incompatible standards, devoid of consensus, serving to add to the unreliability and cost of the [patent] system…[such that] the only assurance is that any successful innovation is likely to be challenged in opportunistic litigation, whose result will depend on the random selection of the panel” (Newman Op. at 1-2).
Tags: §101 > 101 > abstract ideas > Alice > CLS Bank > computer patents > patent eligibility > patentable subject matter > preemption > software patents
CAFC Reverses Trial Court’s Indefiniteness Ruling
| May 9, 2013
Biosig Instruments v. Nautilus
April 26, 2013
Panel: Wallach, Schall and Newman. Opinion by Wallach. Concurrence by Schall.
Summary
The Court of Appeals for the Federal Circuit rarely finds patent claims to be so indefinite that the they are invalid under 35 U.S.C. § 112, ¶ 2. This historical proclivity was on display last in the CAFC’s decision in Biosig Instruments V. Nautilus. There, the Court reversed a summary judgment of invalidity for indefiniteness, concluding that the claim was “amenable to construction” and not ‘insolubly ambiguous.”
Tags: claim construction > indefiniteness
If Alleged Infringer Doesn’t Cross-Appeal Validity of Narrowly Interpreted Claim, He May Not Challenge Validity of Later Broadly Construed Claim
| May 8, 2013
Lazare Kaplan Int’l, Inc. v. Photoscribe Techs., Inc.,
April 19, 2013
Panel: Lourie, Dyk and Reyna. Opinion by Lourie. Dissent by Dyk.
Summary
Based on narrow claim construction, the district court issued a prior judgment that patent claims were valid but not infringed either literally or under the doctrine of equivalents. Lazare Kaplan (Patentee) appealed the judgment of non-infringement. But Photoscribe (Alleged Infringer) did not cross-appeal the judgment of validity. On appeal, CAFC broadly interpreted the claims and vacated the judgments of no infringement. The issue of infringement was remanded to the district court.
On remand, Photoscribe moved for summary judgment of invalidity based on the CAFC’s broad claim construction, and moved for relief from the district court’s prior judgment of validity under Rule 60(b). The district court granted both of Photoscribe’s motions. Lazare Kaplan appealed. CAFC reversed both district court decisions holding that the district court abused its discretion by granting relief under Rule 60(b).
地裁は、先の判決で、クレームを狭く解釈し、特許クレームは有効だが、侵害はないと判決した。特許権者Lazare Kaplan社は非侵害判決を不服として控訴したが、被疑侵害者Photoscribe社は、特許有効の判決に関して控訴しなかった。控訴審でCAFCはクレームを広く解釈し、非侵害判決を破棄し、地裁に差戻した。
差戻審で、Photoscribe社は、CAFCの解釈に基づいて特許クレームの無効を主張し、一方、特許有効の確定判決に関し、それに拘束されない連邦民事訴訟規則60(b)に基づく救済を求めた。地裁はPhotoscribe社の両方の申立てを認めた。CAFCは地裁が規則60(b)に基づく救済を認めたことは裁量権を逸脱するとし、また、特許クレーム無効判決を破棄した。
Tags: appeal > cross-appeal > rule 60(b)
Clear and Unmistakeable Evidence of a Disclaimer Found in Response to Enablement Rejection
| April 24, 2013
Biogen Idec, Inc., et al. v. GlaxoSmithKline LLC, et al.
April 16, 2013
Panel: Dyk, Plager, Reyna. Opinion by Reyna. Dissent by Plager.
Summary
During prosecution of the patent, applicants responded to the examiner’s enablement rejection, wherein they failed to challenge the examiner’s understanding of the crucial terms, and limited their invention to what the examiner believed their specification enabled. The CAFC affirmed the district court’s narrow claim interpretation of the term “anti-CD20 antibody” based on prosecution history disclaimer.
実施可能要件を満たしていないとして発せられた拒絶通知に対して、出願人は、審査官の理解に対して反論することなく、明細書により実施可能であると審査官が判断したものに発明を限定するような主張を行った。よって、「anti-CD20 antibody」という用語について、狭いクレーム解釈を容認した地裁の判断は誤りでなかったとCAFCは判示した。
Tags: claim construction > disclaimer > estoppel > prosecution disclaimer > prosecution history disclaimer > prosecution history estoppel
