American Sales Co. v. AstraZeneca LP

842 F.3d 34, 2016 WL 6833338, 2016 U.S. App. LEXIS 20845
CourtCourt of Appeals for the First Circuit
DecidedNovember 21, 2016
DocketNos. 15-2005, 15-2006, 15-2007
StatusPublished
Cited by35 cases

This text of 842 F.3d 34 (American Sales Co. v. AstraZeneca LP) is published on Counsel Stack Legal Research, covering Court of Appeals for the First Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
American Sales Co. v. AstraZeneca LP, 842 F.3d 34, 2016 WL 6833338, 2016 U.S. App. LEXIS 20845 (1st Cir. 2016).

Opinion

LYNCH, Circuit Judge.

This appeal , arises from the first pharmaceutical-settlement antitrust action tried before a jury since the Supreme Court’s decision in FTC v. Actavis, Inc., — U.S. -, 133 S.Ct. 2223, 186 L.Ed.2d 343 (2013). The jury found that although the plaintiffs had proved an antitrust violation in the form of a large, and unjustified reverse payment from AstraZeneca to Ranbaxy, the plaintiffs had not shown that they had suffered an antitrust injury that entitled them to damages.

Defendant AstraZeneca is a brand-name drug manufacturer that owns the patents covering Nexium^ a prescription heartburn medication that has grossed billions of dollars in annual -sales. After defendant Ranbaxy notified the Food and Drug Administration (“FDA”) that it sought to -market a generic version of Nexium, AstraZeneca sued Ranbaxy for patent infringement. The two companies reached a settlement agreement,, under which Ranbaxy agreed to delay the launch of its generic until a certain date in return for various promises from AstraZeneca. AstraZeneca similarly sued and subsequently settled two patent infringement suits with generic manufacturers Teva and Dr. Reddy’s, who were (but no longer remain) defendants in this case. The plaintiffs—various pharmaceutical retail outlets and certified classes of direct purchasers and end payors— brought suit, arguing that the terms of these settlement agreements violated federal antitrust laws and state analogues.

After summary judgment proceedings that winnowed down the number of causal mechanisms through which the plaintiffs could attempt to prove antitrust violation and injury, the case proceeded to a jury, which found as we have described. Following the verdict, the district court denied the plaintiffs’ motions for a permanent injunction and for a new trial.

The plaintiffs appeal, raising four, categories of claims. First, they challenge various evidentiary rulings. Second, they argue that the district court erroneously granted judgment as a matter of law in the defendants’ favor on the issue of overarching conspiracy. Third, they argue that the special verdict form and jury instructions contained reversible error. The final argument, which lies at the heart of this appeal, is that the district court, at summary judgment, impermissibly cut down the number of causal mechanisms through which the plaintiffs could make their case to the jury. See In re Nexium (Esomeprazole) Antitrust Litig. (“In re Nexium [Summary Judgment]”), 42 F.Supp.3d 231 (D. Mass. 2014). This error at summary judgment pervaded the entire trial, the plaintiffs argue, and constitutes grounds to vacate the jury verdict and award a new trial.

We find no reversible error in the district court’s evidentiary rulings, the formulation of the special verdict form and jury instructions, or its judgment as a matter of law on overarching conspiracy. In fact, many of the plaintiffs’ objections have [40]*40been forfeited or mooted by the jury’s findings. We further hold that the jury verdict, finding an antitrust violation but not an antitrust injury, coupled with developments at trial on the issue of patent invalidity, renders harmless any error that may have occurred during the summary judgment proceedings. Accordingly, we need riot, and indeed should not, review the summary judgment order for error. We affirm.

I. REGULATORY FRAMEWORK

An overview of the intricate pharmaceutical regulatory framework is necessary to understand the issues presented. A manufacturer that seeks to market a new brand-name drug must file a New Drug Application (“NDA”) with the FDA and “undergo a long, comprehensive, and costly testing process.” Actavis, 133 S.Ct. at 2228. Generic-drug manufacturers formerly underwent similarly rigorous processes to obtain FDA approval to market generic versions of the brand-name drug. Iri order to accelerate the entry of generic competitors into the market and decrease healthcare, costs, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (“Hatch-Waxman Act”), Pub. L. No. 98-417, 98 Stat. 1585. The Hatch-Waxman Act has three regulatory components that are relevant here.

First, the Act permits generic manufacturers to file the notably less costly Abbreviated New Drug Application (“ANDA”), “specifying that the generic has the ‘same active ingredients as,’ and is ‘biologically equivalent’ to, the already-approved brand-name drug.” Actavis, 133 S.Ct. at 2228 (quoting Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 566 U.S. 399, 132 S.Ct. 1670, 1676, 182 L.Ed.2d 678 (2012)). “[B]y allowing the generic to piggy-back on the pioneer’s approval efforts, [the Hatch-Waxman Act] ‘speedfs] the introduction of low-cost generic drugs to market,’ thereby furthering drug competition.” Id. (third alteration in original) (quoting Caraco, 132 S.Ct. at 1676).

Second, the Act requires brand-name manufacturers to list the numbers and expiration dates of all relevant patents, in their NDAs, which are then published in the FDA’s “Orange Book,” an annual publication of all approved drugs and the reported patents or statutory exclusivities that cover those drugs. In turn, generic manufacturers filing ANDAs must “ ‘assure the FDA’ that the-generic ‘will not infringe’ the brand-name’s patents,” and may provide this assurance in one of four ways. Id. (quoting Caraco, 132 S.Ct. at 1676). The generic manufacturer may (1) certify that the brand-name manufacturer has failed to list any relevant patents; (2) certify that any relevant patents have expired; (3) request the FDA’s approval to market its generic upon the expiration of any still active patents covering the brand name; or' (4) certify that “any listed, relevant patent ‘is invalid or will not be infringed by the manufacture, use, or sale’ of the drug described in the [ANDA].” Id. (quoting 21 U.S.C. § 355(j)(2)(A)(vii)(IV)).

This last route, known as a “paragraph IV certification,” usually triggers an immediate patent infringement suit from the brand-name manufacturer. If that suit is brought within 45 days -of the paragraph IV certification, the FDA must withhold approval of the generic ANDA, usually for a 30-month period, during the course of litigation on patent validity or infringement. Id. If the court decides the patent matter within 30 months, the FDA follows the court’s determination. But if the court does not, the FDA may approve an ANDA before a court rules on patent validity or infringement. Id. (citing 21 U.S.C. § 355(j)(5)(B)(iii)). This pre-ruling approval, in turn, allows the generic manufactur[41]*41er to launch its product “at risk”—that is, “with the risk of losing the infringement case against it hanging over its head. Losing an infringement case after launching at risk can result in significant liability for the generic manufacturer, as damages typically are calibrated by the amount of its at risk sales.” In re Nexium [Summary Judgment], 42 F.Supp.3d at 245.

The final relevant component of the Hatch-Waxman Act is that it rewards the first generic manufacturer to file an ANDA with a paragraph IV certification by granting that first filer a 180-day period of exclusivity. Actavis, 138 S.Ct. at 2228-29. During that 180-day window, the FDA cannot approve ANDAs from competing manufacturers for the same generic, leaving only the first filer with the ability to market its generic. Accordingly, this period of exclusivity can be “worth several hundred million dollars.” Id.

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Bluebook (online)
842 F.3d 34, 2016 WL 6833338, 2016 U.S. App. LEXIS 20845, Counsel Stack Legal Research, https://law.counselstack.com/opinion/american-sales-co-v-astrazeneca-lp-ca1-2016.