In re Cipro Cases I & II

348 P.3d 845, 61 Cal. 4th 116, 187 Cal. Rptr. 3d 632, 2015 Cal. LEXIS 2486
CourtCalifornia Supreme Court
DecidedMay 7, 2015
DocketS198616
StatusPublished
Cited by30 cases

This text of 348 P.3d 845 (In re Cipro Cases I & II) is published on Counsel Stack Legal Research, covering California Supreme Court primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
In re Cipro Cases I & II, 348 P.3d 845, 61 Cal. 4th 116, 187 Cal. Rptr. 3d 632, 2015 Cal. LEXIS 2486 (Cal. 2015).

Opinion

Opinion

WERDEGAR, J.

To protect competition in the marketplace, antitrust law prohibits agreements that create or perpetuate monopolies. Patent law, in *130 contrast, grants temporary monopolies to inventors to encourage the development of useful innovations. We consider here a crucial question at the intersection of these two bodies of law: What limits, if any, does antitrust law place on the ability of a patent holder to make agreements restricting competition during the life of its patent? In particular, when another entity tries to invalidate a patent and enter the marketplace, can the patentee pay the would-be competitor to withdraw its challenge and refrain from competing until at or near the natural expiration of the potentially invalid patent’s life?

The answer to this is of special moment to the pharmaceutical industry, which has seen a raft of suits in which generic drug manufacturers (generics), seeking to introduce lower priced alternatives to patented brand-name drugs, raise patent invalidity as a defense to claims of infringement. With increasing frequency these cases have settled, with the plaintiff brand-name drug manufacturer (brand) making a “reverse payment” to the defendant generic in exchange for the generic dropping its patent challenge and consenting to stay out of the market. This case involves just such a settlement agreement.

Under federal antitrust law, these settlements are not immune from scrutiny, even if they limit competition no more than a valid patent would have. (FTC v. Actavis, Inc. (2013) 570 U.S. _, _ [186 L.Ed.2d 343, 356, 133 S.Ct. 2223, 2230] (Actavis).) We conclude the same is true under state antitrust law. Some patents are valid; some are not. Sometimes competition would infringe; sometimes it would not. Parties illegally restrain trade when they privately agree to substitute consensual monopoly in place of potential competition that would have followed a finding of invalidity or noninfringement. The Court of Appeal ruled to the contrary; we reverse.

Factual and Procedural Background

Bayer AG and Bayer Corporation (collectively Bayer) market Cipro, an antibiotic that has been among the most prescribed and best-selling drugs in the world. (Arkansas Carpenters Health & Welfare Fund v. Bayer AG (2d Cir. 2010) 604 F.3d 98, 100; In re Ciprofloxacin Hydrochloride Antitrust Litigation (E.D.N.Y. 2003) 261 F.Supp.2d 188, 194; In re Ciprofloxacin Hydrochloride Antitrust Litigation (E.D.N.Y. 2001) 166 F.Supp.2d 740, 743.) In 1987, Bayer was issued a United States patent on the active ingredient in Cipro, ciprofloxacin hydrochloride, a patent that expired in December 2003. (U.S. Patent No. 4,670,444, col. 22, 11. 32-34, claim 12 (the ’444 patent); see In re Ciprofloxacin Hydrochloride Antitrust Litigation (Fed. Cir. 2008) 544 F.3d 1323, 1327-1328.) A subsidiary and licensee of Bayer obtained Food and Drug Administration (FDA) approval to market Cipro in the United States. (In re Ciprofloxacin Hydrochloride Antitrust Litigation, supra, 544 F.3d at p. 1328; In re Ciprofloxacin Hydrochloride Antitrust Litigation, supra, *131 166 F.Supp.2d at p. 743.) Between 1987 and 2003, Bayer was the sole producer of Cipro in the United States and, between 1997 and 2003 alone, Cipro generated more than $6 billion in gross sales.

At one time, pioneer drugs like Cipro and the generic drugs that followed them were governed by the same FDA approval process. 1 Subjecting generic drugs to the same “cumbersome drug approval process [as pioneer drugs] delayed the entry of relatively inexpensive generic drugs into the market place,” at substantial cost to consumers and the government. (Mylan Pharmaceuticals, Inc. v. Shalala (D.D.C. 2000) 81 F.Supp.2d 30, 32; see H.R.Rep. No. 98-857, 2d Sess., pt. 1, p. 17 (1984), reprinted in 1984 U.S. Code Cong. & Admin. News, p. 2650.) To expedite the availability of low-cost generic drugs, Congress authorized an abbreviated approval process for drugs whose active ingredients had already been proven safe and effective in earlier clinical trials. (Drug Price Competition and Patent Term Restoration Act of 1984, Pub.L. No. 98-417, tit. I, §§ 101-106 (Sept. 24, 1984) 98 Stat. 1585, 1585-1597, codified as amended at 21 U.S.C. § 355 (the HatchWaxman Act); see H.R.Rep. No. 98-857, 2d Sess., pt. 1, pp. 14, 16-17 (1984), reprinted in 1984 U.S. Code Cong. & Admin. News, pp. 2647, 2649-2650.)

Under the Hatch-Waxman Act, a prospective generic drug manufacturer may file a streamlined application asserting the generic drug’s bioequivalence with an existing pioneer drug, thus piggybacking on the safety and efficacy data already submitted to the FDA in connection with its approval of the original drug. (21 U.S.C. § 355(j)(2)(A)(ii), (iv); see Actavis, supra, 570 U.S. at p._[186 L.Ed.2d at p. 354, 133 S.Ct. at p. 2228].) With respect to the patent implications of the application, the generic drug manufacturer must make one of four certifications: There is no patent for the underlying drug, the patent is expired, the patent will expire, or (relevant here) the patent is invalid or will not be infringed by the proposed manufacture and sale of the generic drug. (21 U.S.C. § 355(j)(2)(A)(vii); Actavis, at pp. - [186 L.Ed.2d at pp. 353-354, 133 S.Ct. at p. 2228].) An applicant that certifies the affected patent is invalid or will not be infringed (a “paragraph IV” certification) must give notice to all affected patent owners. (21 U.S.C. § 355(j)(2)(B).) Submission of an application to manufacture a generic version of a drug covered by a patent is a technical act of infringement (35 U.S.C. § 271(e)(2)(A); Actavis, at pp. - [186 L.Ed.2d at p. 354, 133 S.Ct. at p. 2228]); to stay approval of the generic version, a patent owner must file an infringement lawsuit against the generic drug manufacturer *132 within 45 days (21 U.S.C. § 355(j)(5)(B)(iii)). To provide an incentive to assume the risks of exposure to such litigation, the first generic manufacturer to file an application and prevail is granted a potentially lucrative 180-day exclusivity window in which to market its drug without competition from any other generic manufacturer. (21 U.S.C. § 355(j)(5)(B)(iv); Actavis, at pp. - [186 L.Ed.2d at p. 354, 133 S.Ct. at pp. 2228-2229].)

In 1991, twelve years before the scheduled expiration of the ’444 patent, defendant Barr Laboratories, Inc., filed an application to market a generic version of Cipro.

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348 P.3d 845, 61 Cal. 4th 116, 187 Cal. Rptr. 3d 632, 2015 Cal. LEXIS 2486, Counsel Stack Legal Research, https://law.counselstack.com/opinion/in-re-cipro-cases-i-ii-cal-2015.