Claim Construction and Expert Testimony in Pharmaceutical Patent Litigation
| January 31, 2013
Allergan, Inc. v. Barr Laboratories, Inc., Teva Pharmaceutical USA, Inc., and Teva Pharmaceutical Industries Ltd. and Sandoz Inc.
January 28, 2013
Panel: Rader, Bryson and Wallach. Opinion by Bryson.
Summary
Barr Lab. and Sandoz Inc. etc. (collectively Defendants) filed a Abbreviated New Drug Application (ANDA), listing the patented product in Allergan’s ‘819 patent. Allergan filed an infringement suit against the Defendants. The district court ruled for Allergan, and the Defendants brought it to appeal.
One major point of dispute was about one moiety in the claimed compounds described in claim 5 of patent ‘819 as representable by –N(R4)2. The Defendants asserted that the two R4 moieties must be construed as identical. The district court and the CAFC both found for Allergan in holding that the R4 units did not need to be identical.
Another point of dispute was about the requirement for courts’ independent inquiry into “obviousness” type of patent invalidity case. The CAFC affirmed the district court’s decision that the expert testimony may be a required part of patent invalidity cases based on obviousness, and that independent review of a case involving complex technology, in absence of expert witness, is not required.
Barr Labs和Sandoz公司（以下统称被告）向联邦食品药品管理局提出简化新药申请（ANDA）中将Allergan公司的819专利所保护的专利药品列为仿制药。 Allergan公司对被告提起侵权诉讼。联邦地区法院裁定Allergan胜诉，被告遂到联邦巡回法庭提出上诉。
争议要点之一是，在专利819的权利要求5，对要求受保护药物的描述包括该化合物含有基团 “–N（R 4）2”。被告声称，这两个R4基团应该理解为相同基团。区法院和联邦巡回上诉法院都认同Allergan的理解，认定对R4基团定义应基于该专利文件中的具体描述，所以两个R4基团不一定相同。
另一个争议点是专利无效请求的案件中法院是否有义务进行独立调查。联邦巡回上诉法院肯定了地区法院的判决，即专家证词可能是专利无效案件的证据的必要组成部分，而当专利无效案件涉及复杂的技术时，在专利无效请求人未提供专家证人的情况下，法庭不需要独立调查案件即可直接判定专利无效请求人应证据不足败诉。
Tags: ANDA > claim construction > expert witness > markush group
Applicant’s failure to request claim construction under §112, 6th paragraph may invoke waiver of such claim construction
| January 23, 2013
In re Avid Identification Systems, Inc.
January 8, 2013
Panel: Lourie, Clevenger and Bryson. Opinion by Lourie. Dissent by Clevenger.
Summary:
The Examiner rejected claims of a patent at issue, and the PTO board maintained the rejection finding that a means-plus function limitation was found in prior art where its broadest reasonable meaning was given. CAFC affirmed the PTO decision, and denied the Applicants’ request for a claim construction under § 112, 6th paragraph, instead of the broadest reasonable interpretation. CAFC reasoned that the Applicants waived that claim construction by failing to raise the issue during the procedure in the PTO. The dissenting opinion pointed out that the claim construction according to § 112, 6th paragraph is mandatory as the statutory requirement where the claim term clearly invokes the application of § 112, 6th paragraph.
出願人はクレームが自明であるとして拒絶した特許庁審判部の判断を不服として、ＣＡＦＣに控訴した。問題のクレームには、ミーンズプラスファンクション（”means for”の用語を用いた限定 ）を記載がある。そのような記載があると通常、特許法112条第6パラグラフの適用があり、その機能限定は明細書に開示されている構造もしくはそれと均等な構造を記載していると限定解釈される。しかしながら、本件では、特許庁審査官および審判部は、そのミーンズプラスファンクションの限定を、一般的な構造限定のときのように合理的な範囲で最も広い意味（broadest reasonable meaning）の基準を用いて解釈した。この広い解釈に基づいてその機能限定は先行技術に記載されていると特許庁は判断した。この経緯に関してＣＡＦＣは、出願人は特許庁の手続きにおいて112条第6パラグラフの適用を自ら主張しなかったためその機会を放棄したと判断し、出願人の主張を退けた。ＣＡＦＣ裁判官の１人は、112条第6パラグラフの適用は制定法上の要求であり、出願人や審査官が同法に基づく限定解釈を要求しなくても先ずその解釈を採用すべきであるとの反対意見を述べた。
Tags: means > means-plus-function > procedural issues > waiver
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).
Elimination of false marking actions does not violate the Due Process Clause of the U.S. Constitution
| January 3, 2013
Brooks v. Dunlop Manufacturing
December 3, 2012
Panel: Newman, Prost, Moore. Opinion by Prost.
Procedural Summary
Lawyer Brooks sued Dunlop under 35 U.S.C. § 292 for falsely marking a guitar string winder with the number of a patent that had both expired and been found invalid. During the pendency of the law suit, Congress passed the America Invents Act (AIA) that, inter alia, eliminated false marking actions, except under very limited circumstances.
The trial judge therefore dismissed Brooks’ case, despite Brooks’ argument that the AIA’s elimination of false marking cases violated the Due Process Clause of the U.S. Constitution. On appeal, the CAFC agreed with the trial judge and therefore affirmed his dismissal of the case.
Tags: §292 > AIA > America Invents Act > Due process > False marking > qui tam actions > retroactive laws
Vitiation exclusion: a judicial determination ensuring that doctrine of equivalents does not overtake statutory function of claims in defining scope of exclusive rights
| January 2, 2013
Deere & Co. v. Bush Hog
December 4, 2012
Panel: Rader, Newman and Plager. Opinion by Rader.
Summary
The United States District Court for the Southern District of Iowa, among other things, construed the claimed term “into engagement with” of ‘980 Patent to require direct contact and construed “being secured to” of ‘980 Patent as “fastened or attached.” Based on this construction, the district court granted Bush Hog & Co. LLC’s and Great Plains Inc.’s motions for summary judgment of noninfringement by holding that Deere did not raise a genuine issue of material fact as to literal infringement because the upper deck walls do not come into contact with the lower deck walls in any of the accused products. In addition, the district court held that Deere could not assert infringement under the doctrine of equivalents because doing so would vitiate the “into engagement with” limitation. Because in the context of the ‘980 Patent “into engagement with” encompasses indirect contact, the Federal Circuit vacated the district court’s construction of this term, reversed the grant of summary judgment, and remanded for further proceedings. Also, the Federal Circuit found that the district court invoked vitiation exclusion in error by refusing to apply the doctrine of equivalents because “a reasonable jury could find that a small spacer connecting the upper and lower deck walls represents an insubstantial difference from direct contact.” Therefore, the Federal Circuit also vacated the grant of summary judgment of no infringement under the doctrine of equivalents.
Tags: all elements rule > doctrine of equivalents > infringement > literal infringement > vitiation
