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October 7, 1996


James Robertson, United States District Judge

The opinion of the court was delivered by: ROBERTSON

Plaintiff Berlex Laboratories, Inc. ("Berlex") manufactures Betaseron, a biological drug classified as an interferon beta product. *fn1" On July 23, 1993, the Food and Drug Administration approved Betaseron for the treatment of multiple sclerosis. Because it was the first interferon beta product approved for the treatment of MS, Betaseron was also given market exclusivity for seven years under the Orphan Drug Act. 21 U.S.C. §§ 360aa-360dd.

 Intervenor-defendant Biogen, Inc. developed an interferon beta product similar to Betaseron. On May 17, 1996, the FDA approved Biogen's product, known as Avonex, for manufacture and sale in the United States for the treatment of MS.

 In this action, Berlex seeks a judgment declaring that FDA's approval of Biogen's Avonex was unlawful and an order rescinding that approval. Berlex's claims are that FDA 1) unlawfully nullified Betaseron's Orphan Drug protection upon an arbitrary and capricious finding that Avonex is "clinically superior" to Betaseron; 2) violated the Public Health Service Act, 42 U.S.C. § 262, and regulations issued thereunder by approving Avonex without requiring the completion of full clinical trials; and 3) failed to conduct required notice-and-comment rulemaking before issuing a "comparability guidance document" that was important to the approval of Avonex.

 Biogen has intervened as a defendant. Cross-motions for summary judgment were argued on September 5, 1996. This memorandum sets forth the reasons for the accompanying order granting the motions of FDA and Biogen and denying the motion of Berlex.


 FDA's approval of Avonex on May 17, 1996, marked the first time FDA had approved a biological product for manufacture and sale without requiring the completion of full clinical trials on that actual product. In approving Avonex, FDA allowed Biogen to rely on the results of a clinical study of another company's interferon beta product, known as BG9015, after concluding that BG9015 was "comparable" to Avonex.

 BG9015 was manufactured in Laupheim, Germany, by a joint venture owned half by Biogen and half by Rentschler Technology. This joint venture commissioned Dr. Lawrence Jacobs to do a clinical study of BG9015 in the United States beginning in 1990. In 1993, while the clinical trial was going on, the joint venture failed and went into receivership. Production of BG9015 ceased, but researchers had enough BG9015 to complete the clinical trials, which ended in 1994. AR 2, 157-58.

 As early as 1991, Biogen had begun separately producing interferon beta products similar to BG9015 at a manufacturing site in Cambridge, Massachusetts. After the Biogen-Rentschler joint venture failed, Biogen sought FDA approval of a new interferon beta, known as BG9216. Rather than conduct new clinical trials of BG9216, Biogen sought to rely on the Jacobs study and sought to demonstrate to FDA that BG9216 and BG9015 were comparable. The FDA concluded that BG9216 and BG9015 were not comparable, however, and declined to consider data from the Jacobs study in connection with the application of BG9216. AR 2.

 Biogen then developed the interferon beta cell line that ultimately became Avonex and submitted it for FDA approval. Although FDA had invariably required full-scale clinical trials for new biological drugs in the past, Biogen again sought to rely on the results of the Jacobs study conducted on BG9015, asserting that Avonex was comparable to BG9015. This time FDA agreed. After extensive biological, biochemical, and biophysical analyses, as well as pharmacokinetic studies in humans, FDA concluded that BG9015 and Avonex were "comparable" -- that they were "biochemically and functionally equivalent" -- and permitted the Jacobs study to be used in place of a separate clinical trial of Avonex itself. AR 2-10, 55-57.

 Before Avonex could be approved for sale in the face of Betaseron's exclusivity under the Orphan Drug Act, FDA also had to make a finding that Avonex was "different" from Betaseron. FDA made that finding, basing its conclusion on the substantially less frequent occurrence of the death of skin tissue in the injection area, or injection site necrosis, associated with Avonex. *fn2" AR 29. FDA also noted that four percent of Avonex patients experience injection site reactions, such as swelling, redness or tenderness, compared to 85 percent of Betaseron patients. On the basis of those comparisons, FDA found Avonex "clinically superior" to Betaseron and therefore "different" for Orphan Drug Act purposes.

 On May 17, 1996, FDA approved Avonex "for the treatment of relapsing forms of multiple sclerosis to slow the accumulation of physical disability and decrease the frequency of clinical exacerbations." AR 1.


 As a preliminary matter, it should be noted that this decision proceeds from an examination not only of the pleadings, but also of the administrative record. Defendants' motions have been treated as motions for summary judgment. Marshall County Health Care Auth. v. Shalala, 300 U.S. App. D.C. 263, 988 F.2d 1221, 1226 n.5 (D.C. Cir. 1993). Affidavits submitted by Berlex have not been considered, nor are they deemed to be part of ...

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