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
