Law.com Subscribers SAVE 30%

Call 855-808-4530 or email [email protected] to receive your discount on a new subscription.

The Intellectual Property StrategistKickerSectionsNewsLJN Newsletters

Application of the Reverse Doctrine of Equivalents to Amgen v. Hoechst Marion, Inc.

By Justin S. Rerko
August 26, 2003

In the previous issue, we discussed the principle of the Reverse Doctrine of Equivalents and provided several illustrations of cases that have addressed the same. In this issue, we apply the principle to the Amgen, Inc. v. Hoechst Marion, Inc. case, wherein the defendants Hoecht Marion and Transkarayotic Therapies (collectively 'TKT') were found liable for infringing several of Amgen's patents. Amgen, Inc. v. Hoechst Marion, Inc., 126 F. Supp. 2d 69 (D. Mass. 2001). Although the Reverse Doctrine of Equivalents defense was not raised, this article discusses how this doctrine might have relieved TKT of liability.

Although Amgen asserted a number of patents against TKT, this article focuses on claim 1 of U.S. Patent No. 5,756,349 (the '349 patent), the text of which is as follows:

1. Vertebrate cells which can be propagated in vitro and which are capable upon growth in culture of producing erythropoietin in the medium of their growth in excess of 100 U of erythropoietin per 106 cells in 48 hours as determined by radioimmunoassay, said cells comprising non-human DNA sequences that control transcription of DNA encoding human erythropoietin.

(Erythropoietin is a protein that stimulates the production of red blood cells.)

Amgen's Technology: By taking advantage of recombinant DNA techniques, Amgen developed a method for producing human erythropoietin (EPO) in quantities previously unattainable by purification from bodily fluids. In short, Amgen removes the gene that encodes EPO from a cell naturally containing the gene and then introduces (transfects) it with non-human control sequences (SV40 viral promoter) into a Chinese Hamster Ovary (CHO) cell. Relative to the CHO cells, the promoter DNA and the human EPO gene are exogenous because the promoter and the EPO gene do not naturally reside in the CHO cells. Amgen, 126 F. Supp. 2d at 55.

This premium content is locked for LJN Newsletters subscribers only

  • Stay current on the latest information, rulings, regulations, and trends
  • Includes practical, must-have information on copyrights, royalties, AI, and more
  • Tap into expert guidance from top entertainment lawyers and experts

For enterprise-wide or corporate acess, please contact Customer Service at [email protected] or 877-256-2473

Read These Next
The DOJ's Corporate Enforcement Policy: One Year Later Image

The DOJ's Criminal Division issued three declinations since the issuance of the revised CEP a year ago. Review of these cases gives insight into DOJ's implementation of the new policy in practice.

Use of Deferred Prosecution Agreements In White Collar Investigations Image

This article discusses the practical and policy reasons for the use of DPAs and NPAs in white-collar criminal investigations, and considers the NDAA's new reporting provision and its relationship with other efforts to enhance transparency in DOJ decision-making.

The DOJ's New Parameters for Evaluating Corporate Compliance Programs Image

The parameters set forth in the DOJ's memorandum have implications not only for the government's evaluation of compliance programs in the context of criminal charging decisions, but also for how defense counsel structure their conference-room advocacy seeking declinations or lesser sanctions in both criminal and civil investigations.

CLE Shouldn't Be the Only Mandatory Training for Attorneys Image

Each stage of an attorney's career offers opportunities for a curriculum that addresses both the individual's and the firm's need to drive success.

A defendant in a patent infringement suit may, during discovery and prior to a <i>Markman</i> hearing, compel the plaintiff to produce claim charts, claim constructions, and element-by-element infringement analyses.