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.

TKT's Technology: TKT also developed a method of producing human EPO. However, rather than transfecting a cell with an exogenous EPO gene, TKT manipulates the endogenous human EPO gene where it naturally resides in a human cell. The EPO gene is endogenous relative to the cells used by TKT because the EPO gene naturally resides in those cells. To facilitate the manipulation, TKT inserts a control element (a cytomegalovirus (CMV) promoter) upstream from the EPO gene. Additionally, TKT homologously recombines its CMV promoter into the cells, as opposed to the heterologous recombination used by Amgen, and TKT inserts its CMV promoter at a position farther upstream than the position at which Amgen inserts the SV40 promoter.

This premium content is locked for Entertainment Law & Finance 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
Major Differences In UK, U.S. Copyright Laws Image

This article highlights how copyright law in the United Kingdom differs from U.S. copyright law, and points out differences that may be crucial to entertainment and media businesses familiar with U.S law that are interested in operating in the United Kingdom or under UK law. The article also briefly addresses contrasts in UK and U.S. trademark law.

The Article 8 Opt In Image

The Article 8 opt-in election adds an additional layer of complexity to the already labyrinthine rules governing perfection of security interests under the UCC. A lender that is unaware of the nuances created by the opt in (may find its security interest vulnerable to being primed by another party that has taken steps to perfect in a superior manner under the circumstances.

Strategy vs. Tactics: Two Sides of a Difficult Coin Image

With each successive large-scale cyber attack, it is slowly becoming clear that ransomware attacks are targeting the critical infrastructure of the most powerful country on the planet. Understanding the strategy, and tactics of our opponents, as well as the strategy and the tactics we implement as a response are vital to victory.

Removing Restrictive Covenants In New York Image

In Rockwell v. Despart, the New York Supreme Court, Third Department, recently revisited a recurring question: When may a landowner seek judicial removal of a covenant restricting use of her land?

The Cost of Making Partner Image

Making partner isn't cheap, and the cost is more than just the years of hard work and stress that associates put in as they reach for the brass ring.