November 29, 2017
Brand-name pharmaceutical companies employ a variety of strategies to preserve and extend their branded drug products’ monopolies. Challenges by generic drug manufacturers and consumers to those efforts as allegedly manipulative of regulatory and administrative processes have met with varying degrees of success. This article focuses on the antitrust implications of three such strategies that have the effect of blocking or delaying lower-priced generic drugs from entering the market: (1) using citizen petitions to inhibit final approval of generics, (2) introducing a reformulated version of a patented drug that effectively prevents generic substitution (a strategy referred to as “product hopping”); and (3) transferring drug patents to entities with sovereign immunity — like Native American tribes — to foreclose certain patent challenges.
Drug companies engage in these strategies to avoid the substantial decline in revenue that coincides with competition from generic drugs, either after the expiration of regulatory exclusivities, or after a patent expires, a concept referred to as the “patent cliff.” Given the significant impact that generic competition has on a company’s bottom line, coupled with long development and testing cycles required to successfully develop and market a new drug, brand-name pharmaceutical companies are incentivized to adopt strategies that could potentially extend the life of their patents.
These “anti-generics” strategies can have a significant negative impact on competition and consumers. Generic manufacturers enter the market with bioequivalent but less expensive alternatives. Delaying the entry of, or blocking access to, affordable generic alternatives results in consumers and insurers paying higher prescription prices. As discussed below, given the potential of these strategies to stymie generic competition, antitrust scrutiny likely will only intensify. The ramifications for generic and brand-name pharmaceutical companies, consumers, payors and sovereign entities could be significant as courts consider more claims challenging these burgeoning strategies.
The U.S. Food and Drug Administration allows individuals and firms to raise safety and efficacy concerns about new generic drug products through “505(q)” citizen petitions. While such petitions are not inherently anti-competitive, certain drug companies have filed allegedly dubious petitions that delay generic entry and extend the branded drug’s exclusivity period, thus raising antitrust concerns. Between 2011 and 2015, brand-name pharmaceutical companies submitted 92 percent of all 505(q) citizen petitions filed with the FDA; only 8 percent overall were successful. Because the FDA generally does not approve a generic drug until it resolves any pending citizen petitions, brand companies can delay the approval process by filing one or more citizen petitions, allowing the branded drug to earn potentially additional monopoly profits during the pendency of the review even if the petition is ultimately rejected.
Accordingly, generic drug manufacturers may seek to challenge their branded counterparts for allegedly abusing the citizen petition process. While these unlawful monopolization challenges require proof of a relevant market, monopoly power, and antitrust injury, they also require analysis as to whether the petitioning activity is protected under the Noerr-Pennington doctrine, which generally immunizes from antitrust liability efforts to petition the government for a redress of grievances. Petitioners are not protected under the doctrine, however, if they use the citizen petition process as a sham to interfere with competitors.
To establish that a citizen petition is a sham, a generic manufacturer must show that (1) a petition is “objectively baseless in the sense that no reasonable [party] could realistically expect success on the merits;” and (2) the subjective intent of the defendant brand-name pharmaceutical company is to inhibit competition, not to petition the FDA for redress. If the petition is shown to be both objectively and subjectively baseless, the Noerr-Pennington doctrine will not immunize the defendant from antitrust liability. In determining whether a citizen petition is a sham, courts have considered the presence of the following four “plus” factors: whether (1) the petition has suspect timing (i.e., is filed on the eve of generic entry); (2) a sophisticated petitioner seeks relief that is contrary to FDA regulations and practice; (3) the FDA, when rejecting a petition, criticizes it for lacking any basis or convincing evidence; and (4) the petition actually caused delay (i.e., final approval was granted on the same day as the FDA denied the citizen petition).
In a significant development in the sham petition arena, the Federal Trade Commission filed an enforcement action in February, alleging that Shire ViroPharma Inc. violated the antitrust laws through “repetitive, serial, and meritless petitioning” to delay the approval of a generic drug and exclude competition. According to the FTC, between 2006 and 2012, “ViroPharma made at least forty-three submissions to the FDA and initiated three more proceedings in federal court to obstruct and delay the FDA’s approval of [the generic competitor], including: [t]wenty-four citizen petition filings.” ViroPharma’s motion to dismiss (on Noerr-Pennington and other grounds) is currently pending. How this case plays out could have significant antitrust ramifications for citizen petition challenges going forward.
While introducing a reformulated version of a drug alone typically does not raise anti-competitive issues, courts have increasingly scrutinized product reformulations combined with other anti-competitive conduct aimed at avoiding the patent cliff or maintaining a monopoly. This so-called “product hopping” strategy gained prominence in Abbott Laboratories v. Teva Pharmaceuticals USA Inc. (“TriCor”).
In TriCor, the defendant introduced a slightly reformulated product (switching from capsules to tablets), stopped selling the old capsules, bought back existing supplies of capsules, and changed the National Drug Data File code for the old capsules, essentially preventing pharmacies from filling prescriptions with a generic capsule formulation. In denying defendant’s motion to dismiss, the court applied a rule of reason analysis, concluding that “if Plaintiffs show anticompetitive harm from the formulation changes, that harm will be weighed against any benefits presented by Defendants.”
Other courts have since applied their own interpretations of TriCor and its progeny. In Walgreen, for example, the plaintiffs alleged that defendant AstraZeneca (1) introduced Nexium as the patent for its equivalent drug, Prilosec, was about to expire; (2) aggressively promoted Nexium to doctors; and (3) stopped promoting Prilosec. In granting defendant’s motion to dismiss, the court distinguished TriCor because AstraZeneca had not removed the old formulation from the market. “AstraZeneca added choices,” the court concluded, by introducing a new drug to compete with its own drug and other generic substitutes. The marketplace, not courts, could and should determine which product was superior.
Subsequent decisions have grappled with TriCor and Walgreen, which established “endpoints” — with “hard switches” (introducing a reformulated drug and withdrawing the old drug) at one end and “soft switches” (introducing a reformulated drug to compete alongside the old drug and generic substitutes) at the other. The Suboxone court in 2014, in finding that the defendant’s conduct fell “somewhere between that alleged in Walgreen and TriCor,” examined whether the defendant’s combination of its reformulation with other wrongful conduct sufficiently reduced consumer choice. The court concluded that defendant’s introduction of a new formulation combined with the threatened removal and disparagement of the old formulation plausibly constituted anti-competitive conduct.
In Namenda, the Second Circuit upheld a preliminary injunction precluding the defendant from withdrawing Namenda IR in favor of its new formulation, Namenda XR. The court focused on the potential for consumer coercion had the defendant removed its old formulation from the market prior to generic entry, thus appearing to adopt the hard switch/soft switch test. But in Doryx, despite allegations of product withdrawal, buybacks, inventory destruction, and new formulation promotion, the Third Circuit took a different approach in affirming summary judgment to a defendant. The Doryx court distinguished Namenda by emphasizing (1) the different procedural postures; (2) that plaintiff was not foreclosed from the market but rather entered the market with 180-day regulatory exclusivity, set its generic price higher than the brand drug, and profited on the generic sales; and (3) the defendant’s nonpretextual reasons for various product changes.
Recent decisions have tried to reconcile these differing product hopping analyses. In Asacol, the court upheld a product hopping claim as to one new formulation (via hard switch) but not another (via soft switch), specifically noting the Second Circuit’s “important distinction between hard and soft switches” in Namenda.
The Suboxone court built upon its 2014 opinion with subsequent decisions in September and October 2017. Applying the “cumulative lessons” of product hopping cases, the court again denied certain defendants’ motion to dismiss, noting plaintiffs’ allegations of (1) new product introduction without substantial benefits over the old product in an attempt to avoid the expiration of a regulatory exclusivity, similar to a “patent cliff;” (2) “extreme coercion of physician prescribing decisions;” and (3) a “hard switch” from tablets to film. The court did grant one defendant’s motion to dismiss because it participated only in the development and introduction of a new product, and not any additional exclusionary conduct, as required for a viable product hopping claim. Finally, the court again allowed claims against two other defendants for conspiring to restrain trade and monopolize in violation of Sherman Act Sections 1 and 2.
Despite the uncertainty of the case law in this evolving area, three principles have emerged. First, product hopping claims by consumers, competitors, and states remain viable, even in the wake of Doryx. Second, the distinction between hard and soft product switches remains relevant, though not dispositive. Finally, product reformulations absent additional exclusionary conduct are unlikely to form the basis of a viable claim — though it remains unclear exactly what and how much exclusionary conduct is required to make such a claim plausible.
Patent Transfers to Entities with Sovereign Immunity
Drug manufacturer Allergan PLC recently made headlines when it transferred patents for its eye drug, Restasis, to New York’s St. Regis Mohawk Tribe. In exchange for a $13.75 million up-front payment and $15 million in annual royalties, the tribe agreed not to waive its sovereign immunity defense in inter partes review proceedings before the Patent Trial and Appeal Board. Because such a defense could block a PTAB challenge to branded drug patents, thus extending their exclusivity period, brand-name pharmaceutical companies and entities with sovereign immunity should be aware of the intense antitrust scrutiny such a strategy draws.
Though not unprecedented — the tribe recently sued Amazon.com Inc. and Microsoft Corp. for allegedly infringing patents the tribe acquired from SRC Labs, a technology firm — Allergan’s actions immediately drew legal and political criticism. Senators called the deal “blatantly anti-competitive” and vowed to investigate. Sen. Claire McCaskill, D-Mo., introduced a bill to block tribal immunity in IPR proceedings. Senior U.S. Circuit Judge William Bryson — in a related patent infringement proceeding — expressed “serious concerns” about the transfer, writing that “sovereign immunity should not be treated as a monetizable commodity that can be purchased by private entities as part of a scheme to evade their legal responsibilities ... [b]ecause that is in essence ... what the agreement between Allergan and the Tribe does.” Consumer groups have urged the FTC to investigate Allergan’s “anti-competitive ploy to shield Allergan’s patents from appropriate review [as it] will artificially prolong its monopoly profits;” several other groups asked the Senate Judiciary Committee to investigate, worried that “lost competition will force Americans to pay many billions more.”
Allergan is now facing a host of monopolization lawsuits that refer to its agreement with the tribe as a sham and an anti-competitive conspiracy. Many others nonetheless worry that such patent transfer agreements will gain popularity as drug manufactures continue to explore ways to avoid the patent cliff. Key questions remain: whether such agreements should be disregarded as mere “shams;” whether the act of transferring a patent for the purposes of derailing IPR proceedings constitutes anticompetitive conduct to maintain a monopoly; or how plaintiffs will prove causation, antitrust injury, or damages arising from patent transfers.
The three strategies discussed above that brand-name pharmaceutical companies employ to extend their drugs’ exclusivity period can have far-reaching antitrust implications for consumers and competition alike. Accordingly, brand-name and generic pharmaceutical companies should consult with antitrust counsel when respectively engaging in and responding to strategies that have the potential to stymie generic competition.
Miriam R. Vishio is counsel and Nicholas S. Cheolas is a senior associate in the Washington, D.C., office of Zelle LLP.
The opinions expressed are those of the author(s) and do not necessarily reflect the views of the firm, its clients, or Portfolio Media Inc., or any of its or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal advice.
 See PhRMA, Prescription Medicines: Costs in Context, June 2017, at 22, available at http://phrma-docs.phrma.org/files/dmfile/Prescription-Medicines---Costs-in-Context---June-2017.pdf (“On average, it takes more than 10 years and $2.6B to research and develop a new medicine.”); see also Rick Mullin, Cost to Develop New Pharmaceutical Drug Now Exceeds $2.5B, SCIENTIFIC AMERICAN, Nov. 24, 2014, available at https://www.scientificamerican.com/article/cost-to-develop-new-pharmaceutical-drug-now-exceeds-2-5b/. But see Aaron E. Carroll, $2.6 Billion to Develop a Drug? New Estimate Makes Questionable Assumptions, N.Y. TIMES, Nov. 18. 2014, available at https://www.nytimes.com/2014/11/19/upshot/calculating-the-real-costs-of-developing-a-new-drug.html.
 505(q) citizen petitions under the Federal Food, Drug, and Cosmetic Act (FDCA) as amended by the Food and Drug Administration Amendments Act and the Food and Drug Administration Safety and Innovation Act, involve a pending generic application. 21 U.S.C. § 355(q).
 See Michael A. Carrier & Carl J. Minniti, Citizen Petitions: Long, Late-Filed, and At-Last Denied, 66 Am. U. L. REV. 305, 306, 308 (Aug. 30, 2016) (finding “39% of petitions are filed within 6 months of the expiration of a patent or FDA exclusivity, with almost all of these petitions denied”).
 The FDCA, which requires the FDA to close 505(q) citizen petitions within 180 days, authorizes the FDA to summarily deny any citizen petition if the FDA determines that the petition’s primary purpose is to delay competition. While Section 505(q)(1)(A) of the FDCA includes important language to prevent generic approval delays unless “necessary to protect the public health,” the FDCA’s effectiveness in eliminating abuses of the citizen petition process to thwart generic competition remains unclear. See Department of Health & Human Services, FDA, Eighth Annual Report on Delays in Approvals of Applications Related to Citizen Petitions and Petitions for Stay of Agency Action for Fiscal Year 2015, at 8, available at https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ReportsBudgets/UCM517279.pdf.
 For recent cases involving citizen petition challenges against brand-name pharmaceutical companies by generic drug manufacturers, drug wholesalers, and direct and indirect purchasers, see In re Wellbutrin XL Antitrust Litig., No. 08-2433 (E.D. Pa. 2011) (pending); In re Flonase Antitrust Litig. (Roxane Labs., Inc. v. SmithKline Beecham Corp., No. 09-cv-1638 (E.D. Pa. April 17, 2009)) (pending); La. Wholesale Drug Co., Inc. v. Sanofi-Aventis, No. 07-cv-7343(HB), 2008 WL 169362 (S.D.N.Y. Dec. 9, 2008) (unanimous judgment for defendant Aventis following full trial on the merits). See also In re DDAVP Direct Purchaser Antitrust Litig., 585 F.3d 677, 694 (2d Cir. 2009). The case settled in August 2011.
 See E. R.R. Presidents Conference v. Noerr Motor Freight, 365 U.S. 127 (1961) (Noerr); United Mine Workers v. Pennington, 381 U.S. 657, 669 (1965) (Pennington).
 Noerr, 365 U.S. at 144.
 Prof’l Real Estate Investors, Inc. v. Columbia Pictures Industries, Inc., 508 U.S. 49, 60 (1993).
 Compl., FTC v. Shire ViroPharma Inc., Civil Action No. 17-cv-00131-RGA (D. Del. Feb. 7, 2017), at 41 ¶ 144, available at https://www.ftc.gov/system/files/documents/cases/170216viropharma_unredacted_sealed_complaint_.pdf.  Id. at 14 ¶ 49.
 432 F. Supp. 2d 408, 416 (D. Del. 2006).
 Id. at 422.
 Walgreen Co. v. AstraZeneca Pharm., 534 F. Supp. 2d 146 (D.D.C. 2008).
 Id. at 151.
 Some commentators have criticized this approach. See, e.g., Michael A. Carrier & Steve D. Shadowen, Product Hopping: A New Framework, 92 Notre Dame L. Rev. 167, 194, 210-22 (2016). Others have questioned whether competition law is suited to address product hopping claims at all. See, e.g., Joshua D. Wright & Douglas H. Ginsburg, Comment on the Canadian Competition Bureau’s Draft Updated Intellectual Property Enforcement Guidelines (Aug. 10, 2015), available at https://www.ftc.gov/system/files/ documents/public_statements/734661/150810canadacomment.pdf.
 In re Suboxone (Buprenorphine Hydrochloride and Naloxone) Antitrust Litig., 64 F. Supp. 3d 665, 681–83 (E.D. Pa. 2014).
 New York ex rel. Schneiderman v. Actavis PLC (Namenda), 787 F.3d 638 (2d Cir. 2015).
 Mylan Pharm. Inc. v. Warner Chilcott Pub. Ltd. Co. (Doryx), 838 F.3d 421 (3d Cir. 2016).
 Id. at 430-31, 439.
 In re Asacol Antitrust Litig., 233 F. Supp. 3d 247, 267-270 (D. Mass. 2017).
 In re Suboxone, No. 13-MD-2445, 2017 WL 3967911, at *12 (E.D. Pa. Sept. 8, 2017).
 In re Suboxone, No. 13-MD-2445, 2017 WL 4642285, at *9 (E.D. Pa. Oct. 17, 2017).
 In re Suboxone, No. 13-MD-2445, 2017 WL 4910673, at *6-11 (E.D. Pa. Oct. 30, 2017).
 https://www.law360.com/articles/962125/allergan-transfers-restasis-patents-to-ipr-immune-tribe. Pharmaceutical companies are not fond of IPR proceedings, which they argue subject companies to duplicative litigation and different standards of proof than in district court challenges under the Hatch-Waxman Act. See, e.g., Cuozzo Speed Technologies, LLC v. Lee, 136 S. Ct. 2131 (2016).
 Some have questioned whether sovereign immunity could defeat patent challenges outside IPR proceedings. See http://blogs.harvard.edu/billofhealth/2017/09/09/be-very-very-concerned-about-what-allergan-just-did/. Other commentators see the agreement as a justifiable maneuver around to avoid unfair and duplicative IPR proceedings. See https://truthonthemarket.com/2017/09/14/the-allergan-mohawk-deal-an-ingenious-strategy-to-avoid-an-unbalanced-ipr-process/.
 https://www.law360.com/articles/975877/ny-tribe-texas-co-slap-patent-suits-on-amazon-microsoft. State universities have also asserted sovereign immunity on behalf of patent licensees. See also https://www.law360.com/articles/885432/patent-board-s-immunity-finding-a-win-for-state-universities.
 Allergan, Inc. v. Teva Pharm. USA, Inc., 2:15-CV-1455-WCB, 2017 WL 4619790, at *2-3 (E.D. Tex. Oct. 16, 2017).
 https://www.citizen.org/system/files/case_documents/civil-society-to-senate-judiciary-re-allergan-mohawk- restasis-deal.pdf.
 See, e.g., Compl., 1199 SEIU Nat’l Benefit Fund v. Allergan, Inc., No. 17-cv-06755 (E.D.N.Y. Nov. 17, 2017); Compl., FWK Holdings, LLC v. Allergan, Inc., No. 17-cv-00747 (E.D.T.X. Nov, 17, 2017); Compl., AFSCME Dist. Council 37 Health & Sec. Plan v. Allergan, Inc., No. 1:17-cv-06684 (E.D.N.Y. Nov. 15, 2017). See also Compl., Cesar Castillo, Inc. v. Allergan, Inc., No. 17-cv-06474 (E.D.N.Y. Nov. 6, 2017); Shire US, Inc. v Allergan, Inc., No. 17-cv-07716 (D.N.J. Oct. 2, 2017); https://www.law360.com/articles/970189.