Biogen, Inc. v. SCHERING AG

954 F. Supp. 391, 1996 WL 774902
CourtDistrict Court, D. Massachusetts
DecidedDecember 4, 1996
DocketC.A. 96-10916-MLW
StatusPublished
Cited by9 cases

This text of 954 F. Supp. 391 (Biogen, Inc. v. SCHERING AG) is published on Counsel Stack Legal Research, covering District Court, D. Massachusetts primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Biogen, Inc. v. SCHERING AG, 954 F. Supp. 391, 1996 WL 774902 (D. Mass. 1996).

Opinion

MEMORANDUM AND ORDER

WOLF, District Judge.

I. INTRODUCTION

On May 3, 1996, Plaintiff Biogen, Inc. (“Biogen”) filed this action seeking a declaration that its Avonex product does not infringe defendants’ McCormick ’567 patent (the “’567 Patent”) and that the ’567 Patent is invalid. Biogen did not, however, attempt to serve its complaint immediately on the defendants. On July 3, 1996, defendant Berlex Laboratories, Inc. (“Berlex”) filed its own suit in the District of New Jersey, seeking monetary and injunctive relief against Biogen for alleged infringement of the ’567 Patent. As a result, Biogen served its complaint two days later.

Berlex has moved for dismissal of Biogen’s declaratory judgment action for lack of subject matter jurisdiction, claiming that no case or controversy existed at the time Biogen filed its suit. Alternatively, Berlex urges the court to exercise its discretion to dismiss the declaratory judgment action on the basis of Biogen’s alleged improper forum shopping. Berlex’s parent company and co-defendant Schering Aktiengesellschaft (“Schering AG”) has filed a separate motion alleging that it is not a proper party to this action because it *393 holds no legally cognizable interest in the ’567 Patent. As indicated at the hearing on October 9,1996, since the parties have not fully briefed the issue of whether Sehering AG is a proper party, the court will not address that issue at this time.

As explained below, the court finds that a case and controversy existed on May 3,1996 because Biogen had a reasonable apprehension that it would face an infringement suit by Berlex, and Biogen had made a substantial investment in developing Avonex and producing it for sale promptly after the anticipated approval of the United States Food and Drug Administration (the “FDA”), which occurred on May 17, 1996. In addition, the court finds that neither equitable factors nor the convenience of the defendant suffice to overcome the presumption that this litigation should be conducted in the forum of first filing. Accordingly, Berlex’s motion to dismiss is being denied.

II. FACTUAL AND PROCEDURAL BACKGROUND

The following facts are either undisputed or established by a preponderance of the evidence. Berlex is a pharmaceutical corporation with headquarters in Wayne, New Jersey. It is a wholly-owned subsidiary of Sehering AG, a German pharmaceutical company. Biogen is a corporation based in Cambridge, Massachusetts that specializes in biotechnology.

For a number of years both Sehering AG/Berlex and Biogen have been doing research and developing products relating to the production of human beta interferon using recombinant DNA technology. Among these products are drugs intended for the treatment of multiple sclerosis. These include Biogen’s Avonex, a beta interferon-based drug extracted from Chinese hamster ovary (“CHO”) cells, and Berlex/Schering AG’s Betaseron, another beta interferon drug produced using a different process not covered by the ’567 Patent. Avonex and the ’567 Patent are at issue in this case.

In the fall of 1993, Dr. Ulrich Kostlin of Sehering AG approached Biogen about licensing Biogen’s portfolio of patents related to beta interferon. Also discussed at that time was a mutual “unblocking” agreement which would permit each party to market its respective beta interferon products without fear of infringement suit by the other. These negotiations terminated in late 1993 without agreement.

On December 27, 1994, the ’567 ^Patent issued to Berlex and the Board of Trustees of Leland Stanford, Jr. University (“Stanford”). By prior agreement, Berlex’s rights in the patent vested at that time in Sehering AG.

On January 12, 1995, the New York Times published an article headlined “Biogen’s Share Price Drops in a Running Patent Battle.” Plaintiffs Appendix of Deposition Transcripts and Exhibits (“Plaintiffs App.”), Ex. 14. The article began by stating:

Firing a volley in a war over biotechnology patents, Sehering AG, the German drug maker, said yesterday that it had been awarded exclusive rights in a process being used by Biogen, Inc. The announcement sent shares of Biogen tumbling..

Id. The article then quoted a Sehering AG spokesman as stating that “the [’567 Patent] could block Biogen ... from making its version of beta interferon for the treatment of multiple sclerosis.” Id.

Similarly, on January 26, 1995, the Wail Street Journal reported on what it characterized as the “patent dispute [between Schering AG and Biogen] over novel drugs for multiple sclerosis with a potential value of $1 billion in annual revenue.” Plaintiffs App., Ex. 23. The article stated that:

The dispute heated up with Schering’s surprise announcement that it holds rights to the U.S. and European patents covering technology Biogen uses to make beta interferon, its MS drug under development.

Id. In the article, Biogen denied it infringed the ’567 Patent, and raised questions concerning its validity. Id. A Sehering AG spokesman was quoted as saying that the company did not “plan to ‘use [its] patents to block’ Biogen from marketing beta interferon but foresees patent ‘negotiations’ between the companies.” Id.

*394 On May 22, 1995 Biogen announced that it had submitted a Product License Application for its Avonex product to the FDA. Berlex promptly raised numerous objections to the approval of Avonex in letter briefs submitted to the FDA.

Also0in the Spring of 1995, Biogen filed applications with foreign regulatory authorities for approval to market Avonex abroad. In connection with its foreign approval applications, Biogen sent samples of Avonex made in the United States to the pertinent foreign regulatory authorities.

In July 1995, Kostlin and Kenneth Bate of Biogen met to discuss issues related to Avonex and the ’567 Patent. As foreshadowed by the January 1995 Wall Street Journal article, Kostlin suggested cross-licensing of the parties’ respective beta interferon products and shared access to clinical data. In support of this suggestion Kostlin stated that export of Avonex produced in the United States would infringe Sehering AG’s ’567 Patent and, therefore, could if necessary be prevented. At the July 1995 meeting, Bates told Kostlin that Sehering AG’s cross-licensing proposal was “unacceptable.”

In the fall of 1995, and again in March 1996, Kostlin contacted Bate in an effort to resume the discussions which failed in July 1995. Biogen, however, was not receptive to these requests.

In the second half of 1995, Berlex and Sehering AG began preparing a possible transfer of Sehering AG’s interest in the ’567 Patent to Berlex in anticipation of possible litigation with Biogen. Such a transfer had the potential to simplify any litigation related to the ’567 Patent by enabling Berlex to sue in its own name and reducing the risk that Sehering AG would be deemed a necessary party.

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