Arkansas Carpenters Health & Welfare Fund v. Bayer AG
Arkansas Carpenters Health & Welfare Fund v. Bayer AG
Dissenting Opinion
dissenting:
In 1991, Barr Labs sought to market a generic version of ciprofloxacin hydrochloride (“Cipro”). Bayer, which holds the Cipro patent, sued Barr for infringement, lost its motion for summary judgment, and subsequently settled with Barr on the eve of trial. Under the terms of the settlement agreement, Bayer paid Barr nearly $400 million and in exchange Barr agreed not to market a generic version of Cipro during the life of the patent.
The Bayer-Barr settlement agreement was unusual in a number of respects.
This type of settlement, once unheard of, has become increasingly common. This Court has played a significant role in encouraging this unfortunate practice. In In re Tamoxifen Citrate Antitrust Litig., 466 F.3d 187 (2d Cir. 2006), a panel of this Court, over my dissent, held that exclusion payment settlements are lawful unless the branded firm’s patent is “shown to have been procured by fraud, or a suit for its enforcement is objectively baseless ...” Id. at 213. What followed was a dramatic surge in the practice of pharmaceutical patent holders paying potential competitors to concede the validity of their patents. In, the five years before Tamoxifen was decided, there were no settlements involving exclusion payments,
Of course, all of this would not be this Court’s concern if the Hatch-Waxman Act explicitly permitted exclusion payment settlements. However, the Act is silent on the legality of such settlements, and the
More significantly, the Hatch Waxman Act does nothing to change the general rule that market-sharing agreements violate the antitrust laws. See Palmer v. BRG of Georgia, Inc., 498 U.S. 46, 49, 111 S.Ct. 401, 112 L.Ed.2d 349 (1990) (per curiam); United States v. Sealy, Inc., 388 U.S. 350, 357-58, 87 S.Ct. 1847, 18 L.Ed.2d 1238 (1967). This is just as true when one of the parties to a market-sharing agreement happens to hold a patent. See Palmer v. BRG of Georgia, Inc., 498 U.S. 46, 49, 111 S.Ct. 401, 112 L.Ed.2d 349 (1990); United States v. Sealy, Inc., 388 U.S. 350, 357-58, 87 S.Ct. 1847, 18 L.Ed.2d 1238 (1967). Thus, even though we are required to presume that Bayer’s patent is valid, 35 U.S.C. § 282, as the United States points out in its amicus brief,
[t]he presumption of patent validity is simply a procedural device that assigns burdens in litigation challenging the validity of an issued patent. There is no basis for treating that presumption as virtually conclusive and allowing it to serve as a substantive basis to limit the application of the Sherman Act.
Br. of United States, at 6-7 (internal citations omitted).
It should not be surprising, therefore, that our Tamoxifen decision has inspired vigorous criticism from a variety of sources. The United States has described our Tamoxifen rule as “incorrect,”
In the light of all this, I think that our Tamoxifen decision unambiguously deserves reexamination. The Tamoxifen majority recognized the “troubling dynamic” of permitting exclusion payments that
. Senior Circuit Judges Jon O. Newman and Barrington D. Parker, members of the original panel, are not authorized to participate in the en banc poll, but the panel opinion endorses the views expressed in this opinion.
. See generally C. Scott Hemphill, Paying for Delay: Pharmaceutical Patent Settlement as a Regulatory Design Problem, 81 N.Y.U. L.Rev. 1553 (2006).
. See Jon Leibowitz, Commissioner, Federal Trade Commission, Prepared Statement to the Committee on the Judiciary of the United States Senate: Anticompetitive Patent Settlements in the Pharmaceutical Industry, at 13 (Jan. 17, 2007), available at http://www.ftc. gov/speeche s/leibowitzJ070117anticompetitivepalentsettlements senate.pdf.
. See Hearing No. 107-1081 Before S. Comm. On Commerce, Science, and Transportation, 107th Cong. (Apr. 23, 2002), at 71 (statement of Greg Glover, Pharmaceutical Research and Manufacturers of America).
. See Federal Trade Commission, Pay-for-Delay: How Drug Company Pay-Offs Cost Consumers Billions: An PTC Staff Study, at 4 (Jan. 2010), available at www.ftc.gov/os/2010/ 01/100112payfordelayrpt.pdf.
. Id. at 8; see also Br. of the United States, available at http:/lwww.justice.gov/atr/cases/f 259300/259325.htm, at 4 (relying on FTC Staff Study). Cf. C. Scott Hemphill, An Aggregate Approach to Antitrust: Using New Data and Rulemaking to Preserve Drug Competition, 109 Colum. L.Rev. 629, 650 (2009) (estimating the exclusion payments have already cost consumers over $12 billion).
. Nor, it should be noted, are exclusion payments a patent holder's only means of hedging against this probability. Instead, the probability of invalidation could be reflected in a settlement by means of which the patent holder agrees to some reduction in the unexpired term of the patent.
. See 148 Cong. Rec. S7566 (July 20, 2002) (remarks of Sen. Hatch); Protecting Consumer Access to Generic Drugs Act of 2007, Hearing No. 110-39 Before H. Comm, on Energy and Commerce, 110th Cong. At 7 (May 2, 2007) (statement of Rep. Waxman).
. H.R.Rep. No. 98-857(1), at 14-15 (1984), reprinted in 1984 U.S.C.C.A.N. 2647, 2647-48.
. Br. of the United States, Joblove v. Barr Labs., Inc., S.Ct. No. 06-830, available at http://www.justice.gOv/osg/briefs/2006/2pet/6 invit/ 2006-0830.pet.ami.inv.html, at 1 (2007).
. See Br. of the United States, supra note 5.
. See Br. of 34 State Attorneys General, available at http://www.prescriptionaccess.org/ docs/Cipro 2010 May AG Amicus.pdf.
. See Br. of FTC, available at http://www. ftc. gov/o s/2010/05/051202amicuscarpenters health.pdf.
. See Br. of AARP & AMA, available at http:// www.fdalawblog.net/files/cipro — aarpama.pdf.
. See generally http://blog.prescriptionaccess. org/?cat=422 (collecting links to amicus briefs in this case).
. Br. of 86 Law, Economics, Pub. Pol’y, & Bus. Professors, at 6-7, available at http:// www.law.stanford.edu/news/details/3793/ Profs% 20File % 20Amici% 20Curiae% 2 0Seeking% 20En% 20Banc% 20Rehearing% 20 of% 20Second% 20Circuit% 20Pharma% 20Reverse% 20Payment% 20 Antitrust% 20Decision% 20/.
Opinion of the Court
ORDER
Following disposition of this appeal on April 29, 2010, Plaintiffs-Appellants Louisiana Wholesale Drug Co., Inc.; Arthur’s Drug Store, Inc.; CVS Pharmacy, Inc.; and Rite Aid Corporation filed a petition for rehearing in banc. An active judge requested a poll on whether to rehear the ease in banc. A poll having been conducted and there being no majority favoring in banc review, rehearing in banc is hereby DENIED.
Reference
- Full Case Name
- ARKANSAS CARPENTERS HEALTH AND WELFARE FUND, Maria Locurto, Paper, Allied-Indus, United Food and Commercial Workers Union-Employer, Louisiana Wholesale Drug Co., Inc., CVS Pharmacy, Inc., Rite Aid Corporation, Arthur’s Drug Store, Inc., Plaintiffs-Appellants, Sol Lubin, Ann Stuart, Linda K. McIntyre, Plaintiffs, v. BAYER AG, Bayer Corp., Formerly Doing Business as Miles Inc., Hoechst Marion Roussel, Inc., the Rugby Group, Inc., Watson Pharmaceuticals, Inc., Barr Laboratories Inc., Defendants-Appellees
- Cited By
- 3 cases
- Status
- Published