American Bioscience v. Thompson, No. 01-5125

CourtUnited States Courts of Appeals. United States Court of Appeals (District of Columbia)
Writing for the CourtSilberman
Citation269 F.3d 1077
Parties(D.C. Cir. 2001) American Bioscience, Inc., Appellant v. Tommy G. Thompson, Secretary of Health and Human Services, et al., Appellees
Docket NumberNo. 01-5125
Decision Date06 November 2001

Page 1077

269 F.3d 1077 (D.C. Cir. 2001)
American Bioscience, Inc., Appellant
v.
Tommy G. Thompson, Secretary of Health and Human Services, et al., Appellees
No. 01-5125
United States Court of Appeals FOR THE DISTRICT OF COLUMBIA CIRCUIT
Argued September 17, 2001
Decided November 6, 2001

Page 1078

Appeal from the United States District Court for the District of Columbia (00cv02247)

Jacqueline H. Eagle argued the cause for appellant. With her on the briefs were Joseph F. Coyne, Jr., Carlton A. Varner, Arthur Y. Tsien, David F. Weeda, and Robert F. Green.

Howard S. Scher, Attorney, United States Department of Justice, argued the cause for appellee. With him on the brief were Kenneth L. Wainstein, United States Attorney, Douglas N. Letter, Litigation Counsel, Michael M. Landa, Acting Chief Counsel, Food & Drug Administration, and AnnaMarie Kempic, Associate Chief Counsel.

Richard M. Cooper argued the cause for appellees Baker Norton Pharmaceuticals, Inc. and IVAX Pharmaceuticals, Inc. With him on the brief was Philip A. Sechler.

Before: Tatel, Circuit Judge; Silberman and Williams,* Senior Circuit Judges.

Opinion for the Court filed by Senior Circuit Judge Silberman.

Silberman, Senior Circuit Judge:

American Bioscience, Inc., appeals from the district court's denial of its request for preliminary injunctive relief. Appellant argues that the Food and Drug Administration's decision to approve intervenordefendant Baker Norton Pharmaceutical's Abbreviated New Drug Application (ANDA) for a generic version of the cancer treatment Taxol was arbitrary and capricious. We agree and vacate that approval.

I.

This case is here for the second time. See American Bioscience, Inc. v. Thompson, 243 F.3d 579 (D.C. Cir. 2001). American Bioscience is a pharmaceutical research firm that has developed a patented process for delivering safer and more effective dosage forms of Taxol. Bristol-Myers Squibb Company holds the patent on and FDA approval of Taxol itself, a drug that has generated billions of dollars in sales. Bristol-Myers intervened in the district court proceeding for the limited purpose of providing information. Appellees Baker Norton Pharmaceuticals, Inc. (BNP) and Zenith Goldline Pharmaceuticals, Inc., who are corporate affiliates and

Page 1079

hold ANDAs for generic versions of Taxol, intervened as defendants.

This dispute arises out of the complex relationship between the FDA's approval process for generic drugs and patent law. A company wishing to market a new (or "pioneer") drug must seek FDA approval, usually by completing a New Drug Application. The NDA is expensive and time-consuming, requiring data from tests showing the drug's safety and effectiveness. Prior to 1984, a firm that wished to make a generic version of an approved drug was required to file a new NDA, complete with new safety and effectiveness studies. In 1984, Congress enacted the Hatch-Waxman Amendments,1 which introduced the Abbreviated NDA and allowed a generic drug ANDA to rely on the pioneer NDA's safety and effectiveness studies. These amendments also provide that a competitor may use and manufacture an approved and patented drug, for the purpose of developing a generic version, without infringing that patent.

The Hatch-Waxman Amendments also sought to afford an NDA holder some patent protection, to lower the risk to innovation posed by the simplified ANDA process. NDAs are required to contain a list of any patents which claim the drug or which claim a method of using such a drug and with respect to which a claim of patent infringement could reasonably be asserted--but that includes patents held by those other than the NDA holder. The FDA publishes all patent listings in the Approved Drug Products With Therapeutic Equivalence (the "Orange Book"). For "each patent which claims" the pioneer drug, an ANDA must certify: (1) that no patent has been filed with the FDA; (2) that the patent has expired; (3) that the patent has not expired, but will expire on a particular date; or (4) that the patent is either invalid or the generic drug will not infringe it (a "Paragraph IV certification"). When an ANDA applicant files a Paragraph IV certification, it must also certify to the FDA that it will give notice to the patent holder. That notice must include a detailed statement of the factual and legal basis of the applicant's opinion that the patent is not valid or will not be infringed and must be given at the same time the certification is submitted to the FDA. Filing a Paragraph IV certification can constitute patent infringement. Upon receipt of notice of a Paragraph IV certification, the patent holder has 45 days in which to file an infringement suit. If the patent holder does not file within that time period, the FDA may immediately approve an otherwise conforming ANDA. If, on the other hand, the patent holder does sue within 45 days, the FDA may not approve the ANDA for 30 months, or until the patent dispute has been resolved, whichever is sooner. The first ANDA filed and approved gets a 180-day period of market exclusivity.

If a qualifying patent issues at a later date--after the NDA is approved--the NDA holder must inform the FDA within 30 days of the patent's issuance. See 21 U.S.C. § 355(c)(2). But if the NDA holder fails to so notify the FDA, an ANDA applicant is excused, according to the FDA's late-listing regulation, from amending its patent certification to reflect the new patent so long as the ANDA had an "appropriate" patent certification on file. As shall be apparent, however, only the NDA holder has the obligation (and the right) to list the new patent--not the patent holder if it is another company. In this case, if Bristol-Myers listed American Bioscience's patent within 30 days of its issuance,

Page 1080

BNP was required to certify to that patent, potentially leading to a patent infringement suit and 30-month stay.2

In the event a person disputes the accuracy or relevance of patent information published by the FDA in the Orange Book, he must first notify the agency, in writing, stating the grounds for disagreement. The FDA will then request that the applicable NDA holder confirm the correctness of the patent information or omission of patent information. Unless the NDA holder withdraws or amends its patent information in response to the FDA's request, the agency will not change the patent information in the list. And if the NDA holder does not change the patent information, an ANDA must, despite any disagreement as to the correctness of the patent information, contain an appropriate certification for each listed patent. The FDA, pursuant to longstanding practice and its own regulations, and based on its acknowledged lack of expertise and resources, has refused to become involved in patent listing disputes, accepting at face value the accuracy of NDA holders' patent declarations and following their listing instructions.

The FDA approved Bristol-Myers' NDA to manufacture and distribute Taxol, an anti-cancer drug with the active ingredient paclitaxel, in 1992. Five years later, BNP submitted an ANDA for a generic version of Taxol. Bristol-Myers instituted patent infringement proceedings against BNP within the 45-day statutory window, triggering the 30-month stay, which expired in June 2000. The record does not reveal, and counsel for the FDA could not explain, why the FDA did not approve BNP's ANDA promptly upon expiration of the stay. But on August 1, 2000, American Bioscience received U.S. Patent Number 6,906,331 for a new process that purported to permit a patient to receive higher doses of Taxol with fewer side effects. Bristol-Myers did not immediately list the new patent.3 Ten days after the patent issued, American Bioscience sued Bristol-Myers in the United States District Court for the Central District of California requesting a TRO compelling Bristol-Myers to submit the '331 patent for listing in the Orange Book, which the court granted, ordering Bristol-Myers to "immediately take all steps under its control to cause the FDA to list in its 'Orange Book' [American Bioscience's] Taxol Patent, subject to the proviso that, unless Plaintiff carries its burden of proof on the [Order to Show Cause], [Bristol-Myers] shall then take all steps

under its control to cause the de-listing of the Taxol Patent from the FDA's Orange Book." That same day, BristolMyers sent a letter to the FDA, stating that it was submitting the '331 patent for listing "pursuant to" the August 11 court order and "in accordance with" the voluntary listing provision. Bristol-Myers also submitted a patent declaration with the listing.

On August 14, 2000, BNP filed a Paragraph IV certification for the '331 patent but contrary to the statute it did not notify either Bristol-Myers or American Bioscience. One week later, the California court held a hearing at which BristolMyers, American Bioscience and BNP (as a proposed intervenor) were present.4 American

Page 1081

Bioscience then learned for the first time of BNP's Paragraph IV certification. On August 28, 2000, the FDA tentatively approved BNP's ANDA, subject to resolution of the '331 patent issues. Meanwhile, after two hearings, the California court determined that it lacked "jurisdiction" over American Bioscience's suit because the Food Drug and Cosmetic Act did not provide American Bioscience a private right of action. On September 7, 2000, the California court dissolved the TRO and ordered Bristol-Myers "[p]ursuant to the condition in the TRO and in order to restore the status quo ... [to] use its best efforts to cause the delisting of [American Bioscience's] '331 Patent from the Orange Book." It recommended to the FDA that it toll the amount of time the TRO was in place and stayed its order until September 13, 2000.

Also on September 7, 2000, American Bioscience sued BNP for patent infringement and informed the FDA the next day but the FDA did not grant a stay. On September 11,...

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  • Humane Soc'y of U.S. v. Jewell, Civil Action No. 13–186 BAH
    • United States
    • United States District Courts. United States District Court (Columbia)
    • December 19, 2014
    ...“the district judge sits as an appellate tribunal. The ‘entire case’ on review is a question of law.” Am. Bioscience, Inc. v. Thompson, 269 F.3d 1077, 1083 (D.C.Cir.2001) (collecting cases). Accordingly, this Court need not and ought not engage in lengthy fact finding, since “[g]enerally sp......
  • Greene v. Carson, 14 Civ. 3676 (AT) (GWG).
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    • United States District Courts. 2nd Circuit. United States District Courts. 2nd Circuit. Southern District of New York
    • June 14, 2017
    ...The entire case on review is a question of law." Glara Fashion , 2012 WL 352309, at *1 n.1 (quoting Am. Bioscience, Inc. v. Thompson , 269 F.3d 1077, 1083 (D.C. Cir. 2001) ). "Generally, a court reviewing an agency decision is confined to the administrative record compiled by that agency wh......
  • E. Tex. Med. Center-Athens v. Azar, Civil Action No. 17-543 (RBW)
    • United States
    • United States District Courts. United States District Court (Columbia)
    • October 18, 2018
    ...judge sits as an appellate tribunal," and "[t]he ‘entire case’ on review is a question of law." Am. Bioscience, Inc. v. Thompson, 269 F.3d 1077, 1083 (D.C. Cir. 2001) (footnote and citations omitted). The APA "sets forth the full extent of judicial authority to review executive agency actio......
  • Oceana, Inc. v. Pritzker, Civil Action No.: 11-1896 (RC)
    • United States
    • United States District Courts. United States District Court (Columbia)
    • March 10, 2014
    ...assessing a summary judgment motion in an APA case, "the district judge sits as an appellate tribunal." Am. Bioscience, Inc. v. Thompson, 269 F.3d 1077, 1083 (D.C. Cir. 2001). "The entire case on review is a question of law, and only aPage 13question of law." Marshall Cnty. Health Care Auth......
  • Request a trial to view additional results
517 cases
  • Humane Soc'y of U.S. v. Jewell, Civil Action No. 13–186 BAH
    • United States
    • United States District Courts. United States District Court (Columbia)
    • December 19, 2014
    ...“the district judge sits as an appellate tribunal. The ‘entire case’ on review is a question of law.” Am. Bioscience, Inc. v. Thompson, 269 F.3d 1077, 1083 (D.C.Cir.2001) (collecting cases). Accordingly, this Court need not and ought not engage in lengthy fact finding, since “[g]enerally sp......
  • Greene v. Carson, 14 Civ. 3676 (AT) (GWG).
    • United States
    • United States District Courts. 2nd Circuit. United States District Courts. 2nd Circuit. Southern District of New York
    • June 14, 2017
    ...The entire case on review is a question of law." Glara Fashion , 2012 WL 352309, at *1 n.1 (quoting Am. Bioscience, Inc. v. Thompson , 269 F.3d 1077, 1083 (D.C. Cir. 2001) ). "Generally, a court reviewing an agency decision is confined to the administrative record compiled by that agency wh......
  • E. Tex. Med. Center-Athens v. Azar, Civil Action No. 17-543 (RBW)
    • United States
    • United States District Courts. United States District Court (Columbia)
    • October 18, 2018
    ...judge sits as an appellate tribunal," and "[t]he ‘entire case’ on review is a question of law." Am. Bioscience, Inc. v. Thompson, 269 F.3d 1077, 1083 (D.C. Cir. 2001) (footnote and citations omitted). The APA "sets forth the full extent of judicial authority to review executive agency actio......
  • Oceana, Inc. v. Pritzker, Civil Action No.: 11-1896 (RC)
    • United States
    • United States District Courts. United States District Court (Columbia)
    • March 10, 2014
    ...assessing a summary judgment motion in an APA case, "the district judge sits as an appellate tribunal." Am. Bioscience, Inc. v. Thompson, 269 F.3d 1077, 1083 (D.C. Cir. 2001). "The entire case on review is a question of law, and only aPage 13question of law." Marshall Cnty. Health Care Auth......
  • Request a trial to view additional results

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