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
Damage calculations based on entire market value rule is improper absent evidence that patented feature drives demand for entire multi-component product
| September 19, 2012
LaserDynamics, Inc., v. Quanta Computer, Inc.,
August 30, 2012
Panel: Dyk, Clevenger and Reyna. Opinion by Reyna.
Summary
LaserDynamics, owner of a patent regarding optical disc drives, sued Quanta Computer Inc. and Quanta Storage Inc., etc. for patent infringement. In calculating damages, the entire market value rule is a narrow exception to the general rule under 35 U.S.C. § 284 adequate to compensate for the infringement. Only if showing that the patented feature drives the demand for an entire multi-component product, a patentee may be awarded damages as a percentage of revenues or profits of the entire product. The date of the hypothetical negotiation for the purpose of determining the reasonable royalty is the date that the infringement began, which is sometimes or often earlier than the date of the first notice of the infringer’s infringement. To prove or tend to prove a reasonable royalty, the evidence of the granted licenses and the royalties received by the patentee for the patent in suit are probative.
原告は光ディスクドライブに関する特許の所有者であり、光ディスクドライブメーカーと、そのドライブを組み込んだラップトップPC組立メーカーとを特許侵害で訴えた。争点の一つは、損害賠償の計算方法であるが、特許技術の部品を含む完成品の市場価格に基づく計算方法（entire market value rule）は、合理的なロイヤルティ（reasonable royalty）について定めた特許法284条の例外であるため、特許の特徴が複数部品からなる完成品全体に対する需要を引き起こしたということを証明しなければ、そのような計算方法を使用することはできない。換言すると、そのような立証ができた場合にのみ、特許権者はその完成品の売上もしくは利益に乗じた損害賠償を受けることができる。また、合理的なロイヤリティを決定するための判断基準となる日は、いわゆる仮想的交渉日(hypothetical negotiation date)に基づいて判断されるのであるが、それは、被告による侵害開始の日であって、被告が侵害を最初に知った日（たとえば警告日や訴状提出日）ではない。さらに、合理的なロイヤルティを証明するためには、問題特許に関して、特許権者が受け取ったロイヤルティなどが、証拠の一つとなる。
Tags: damages > entire market value > entire market value rule > license > licensee > reasonable royalty > royalty
Infringement Argument Contradicting Prosecution History and Based On Unreliable Expert Testimony Can Make The Case “Exceptional” Incurring Opponent’s Attorneys Fees
| January 11, 2012
MarcTec, LLC v. Johnson & Johnson and Cordis Corp.
January 3, 2012
Panel: Newman, Prost and O’Malley. Opinion by O’Malley.
Summary
The CAFC affirmed the district court’s award of attorney fees and expert fees under 35 U.S.C. § 285. During prosecution of the application, Applicant amended the claims to make clear that his invention required the application of heat to a heat-bondable material. Applicant also distinguished the surgical device from stents in order to obtain allowance. Patentee alleged infringement by accused stents having a coating sprayed at room temperature. Patentee further argued that accused product’s coating is, in fact, bonded by heat. In support of this position, Patentee offered expert testimony that spraying the coating at nearly the speed of sound would cause an increase in temperature such that heat is involved in bonding the coating to the stent. The expert testimony also alleged that heat is used in some of the manufacturing steps before the coating is sprayed onto the accused product. The court held that Patentee’s argument was baseless and frivolous and that Patentee acted in bad faith in bringing and pressing this suit.
CAFCは、米国特許法285条の例外的なケースとして相手方の弁護士費用と専門化証人の費用の支払いを命じた地裁の決定を維持した。問題の特許の審査過程において、出願人は、クレームを補正して、発明が熱を適用して結合する点で先行技術と異なることを主張し、また、本発明は、先行技術の血管を拡張するステントとは異なると主張した。この事件で特許権者は、常温でスプレーコーティングした被疑侵害者のステントを特許侵害で提訴した。そして、被疑侵害者のステントのコーティングにおいて熱が適用されていると主張した。特許権者の専門家証人は、音速に近いスプレーは温度上昇を伴うと主張し、また、スプレーコーティングの前に熱を使う工程があることもその根拠とした。裁判所は、特許権者の主張は根拠のない軽薄なものであり、不誠実なものであると判示した。
