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Bayer Healthcare, LLC v. United States Food and Drug Administration

United States District Court, District of Columbia

April 17, 2013

BAYER HEALTHCARE, LLC, Plaintiff,
v.
UNITED STATES FOOD AND DRUG ADMINISTRATION, et al., [1] Defendants

Page 18

For BAYER HEALTHCARE, LLC, Plaintiff: Bruce Roger Genderson, Stanley Edward Fisher, LEAD ATTORNEYS, David Isaac Berl, WILLIAMS & CONNOLLY, LLP, Washington, DC; Aaron Philip Maurer, WILLIAMS & CONNOLLY, Washington, DC.

For UNITED STATES FOOD AND DRUG ADMINISTRATION, MARGARET A. HAMBURG, in her official capacity as Commissioner, CENTER FOR VETERINARY MEDICINE, BERNADETTE DUNHAM, in her official capacity as Director, UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES, KATHLEEN SEBELIUS, in her official capacity as Secretary, Defendants: Gerald Cooper Kell, LEAD ATTORNEY, U.S. DEPARTMENT OF JUSTICE, Office of Consumer Litigation, Washington, DC; Andrew E. Clark, U.S. DEPARTMENT OF JUSTICE, Consumer Protection Branch, Washington, DC.

For NORBROOK LABORATORIES, LTD., Intervenor Defendant: Catherine E. Stetson, Judith E. Coleman, LEAD ATTORNEYS, HOGAN LOVELLS, U.S. LLP, Washington, DC.

OPINION

Page 19

MEMORANDUM OPINION

ROSEMARY M. COLLYER, United States District Judge.

Bayer HealthCare, LLC patented a highly-successful drug and method for treating bovine respiratory disease named Baytril® 100. While Baytril can be administered over three days, its real advantage is that it can also be administered in a single injection to cure the animal. In 2006, Bayer submitted a Citizen Petition to

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the Food and Drug Administration, expressing its concern that generic versions of Baytril could be labeled only for multi-day use but inevitably would be used in a single dose, contrary to its labeling. Bayer supported its Petition with affidavits and market research. Without addressing the Petition, FDA recently approved a generic version of Baytril® 100, called Enroflox 100, which is labeled only for multi-day administration. Bayer immediately filed suit, claiming that FDA's approval of Enroflox 100 violated the statutory command that FDA not approve an animal drug when it finds " the conditions of use prescribed, recommended, or suggested in the proposed labeling are not reasonably certain to be followed in practice." 21 U.S.C. § 360b(c)(2)(A)(ii). FDA acknowledges that it erred by failing to respond to Bayer's Citizen Petition but nonetheless asks the Court to afford its decision to approve Enroflox 100 deference in light of the agency's expertise in veterinary medicine. The matter proceeded to a hearing on Bayer's motion for a temporary restraining order on April 12, 2013.

For reasons stated at the hearing and specified below, the Court issued a temporary restraining order. FDA offers no evidence that it considered any of the concerns, facts, or arguments raised in Bayer's Citizen Petition when it approved Enroflox 100--concerns which strongly suggest that approval of a generic for Baytril only for multi-day use might well violate 21 U.S.C. § 360b(c)(2)(A)(ii). It says only that it trusts veterinarians and ranchers to follow the Enroflox 100 labeling for multi-day use and an applicable regulation, despite the ready ease (and benefits) with which Enroflox 100 could be administered in a single dose contrary to its label. The Court concluded that Bayer is likely to succeed on the merits, would suffer irreparable harm, and is favored by the balance of equities. Also, the public interest supports a TRO. The Court ordered FDA to suspend its approval of Enroflox 100, as well as its approval of the label, for treating cattle (but not swine). The Court also ordered FDA to notify all interested parties of the Order. See Order [Dkt. 11]. This Memorandum Opinion explains its rationale. A hearing on Bayer's motion for a preliminary injunction is scheduled for April 25, 2013.

I. FACTS

A. Baytril® 100

Bayer HealthCare, LLC patented a drug and method for treating bovine respiratory disease (BRD) called Baytril® 100 (Baytril). Prior to Baytril, the " conventional wisdom was that BRD had to be treated by administering multiple, low doses of antibiotic -- a time consuming, expensive, and cumbersome process." Compl. ¶ 19 [Dkt. 4]. Bayer " revolutionized the industry" by developing a single, high-dose treatment with a fluoroquinolone antibiotic. Id. ¶ 20.

Bayer secured two patents for Baytril-- U.S. Patent No. 4,670,444 (the " 444 patent" ) and U.S. Patent No. 5,756,506 (the " 506 patent" ). Mot. for Leave to File under Seal [Dkt. 1], Ex. 3 [Dkt. 1-5] (" Citizen Petition" ) at 3. Both patents protect the " Dosing Administration regimens" for Baytril. The 444 patent claims the compound itself, " fluoroquinolone compounds and their use as antimicrobial agents," and the multiple-dosing therapy. Citizen Petition at 4. The 506 patent claims the single, high-dose therapy using fluoroquinolone. Id.; see also Mot. for Leave to File Under Seal, Ex. 1 [Dkt. 1-3] (" 506 patent" ). The single, high-dose therapy " allows veterinarians to vastly reduce the time and expense associated with the treatment of infected animals." Citizen Petition at 4.

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Bayer commercialized Baytril for single, high-dose therapy in 1998. Id. at 5. The 444 patent expired on December 9, 2006. The 506 patent expires on June 27, 2015. Id. at 4.

Baytril comes as a " ready-to-use injectable antimicrobial solution." Mot. for Leave to File Under Seal, Ex. 2 [Dkt. 1-4] (Product Label for Baytril). The labeling for Baytril provides detailed instructions for administration:

Dosage and Administration:
Baytril® 100 provides flexible dosages and durations of therapy.
Baytril® 100 may be administered as a single dose for one day (cattle and swine [2] ) or for multiple days (cattle) of therapy. Selection of the appropriate dose and duration of therapy should be based on an assessment of the severity of disease pathogen susceptibility and clinical response.

Cattle:

Single-Dose Therapy: Administer once, a subcutaneous dose of 7.5-12.5 mg/kg of body weight (3.4-5.7 mL/100 lb).

Multiple-Day Therapy: Administer daily, a subcutaneous dose of 2.5-5.0 mg/kg of body weight (1.1-2.3 mL/100 lb). Treatment should be repeated at 24-hour intervals for three days. Additional treatments may be given on Days 4 and 5 to animals ...

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