Printer Friendly

Antitrust law - "hard switch" a violation of the Sherman Act in "product hopping" case.

Section 2 of the Sherman Act prohibits monopolization or any attempt at monopolization by companies transacting business within the United States. (1) In determining whether a company has violated Section 2, courts look to whether the actions of the company were anticompetitive or exclusionary. (2) In New York ex rel. Schneiderman v. Actavis PLC, (3) the United States Court of Appeals for the Second Circuit considered whether the removal of Actavis' twice-daily Alzheimer's drug from the market prior to the expiration of its exclusivity patent, combined with its introduction of a once-daily version of the drug, constituted a violation of the Sherman Antitrust Act. The court also considered whether New York met the standard for a preliminary injunction. (4) The court held that Actavis' withdrawal of Namenda IR from the market violated the Sherman Act because its actions effectively amounted to coercion by impeding generic competition and limiting consumer options. (5) The court further held that without a preliminary injunction, there would have been irreparable harm to competition and consumers and, as such, affirmed the district court's decision to bar Actavis from restricting access to Namenda IR prior to the entry of generic competition. (6)

Actavis manufactures Namenda, a memantine hydrochloride-based drug designed to treat moderate to severe Alzheimer's disease. (7) In January 2004, Actavis began to market Namenda IR, a twice-daily pill that was the first drug of its kind to treat moderate to severe Alzheimer's. (8) In July 2013, Actavis marketed Namenda XR, a once-daily version of Namenda IR. (9) At the time, both products were sold simultaneously, but Actavis discontinued actively marketing Namenda IR. (10) Instead, Actavis spent substantial sums marketing Namenda XR to doctors and pharmacists, and sold XR at a temporary discounted rate, making it less expensive than Namenda IR. (11) These promotional efforts by Actavis, deemed a "soft switch," were intended to influence customers to switch to Namenda XR while Namenda IR was still on the market. (12)

In February 2014, Actavis announced that it would discontinue Namenda IR beginning in the fall of 2014. (13) This announcement came a year before the end of Actavis' patent exclusivity for Namenda IR, which expired in July 2015. (14) Actavis notified the FDA of its plan and published letters on its website urging caregivers to "discuss switching to Namenda XR" with their patients. (15) Before Namenda IR was withdrawn from the market, the State of New York filed a complaint seeking an injunction against Actavis in the United States District Court for the Southern District of New York, alleging that the withdrawal of Namenda IR violated antitrust laws because it both effectively forced consumers to switch to Namenda XR, the only other available memantine drug alternative, and impeded generic competition. (16) Following the filing of this complaint, Actavis entered into an agreement with Foundation Care, a mail-order-only pharmacy, that authorized Foundation Care to provide Namenda IR in limited quantities to patients. (17)

In considering New York's motion for preliminary injunction, the district court held that New York demonstrated that consumers would suffer irreparable harm by being forced to pay a higher cost for Namenda XR, and that Actavis' explicit purpose in withdrawing Namenda IR from the market was to impede generic competition and therefore avoid the loss of market share that would result when generics entered the market. (18) As such, the district court granted the motion for a preliminary injunction effective December 15, 2014, until thirty days after July 11, 2015, the date of expiration of the patent exclusivity. (19) The United States Court of Appeals for the Second Circuit affirmed, holding that Actavis violated the Sherman Act by withdrawing Namenda IR from the market prior to the expiration of its patent. (20)

Patent law and antitrust law are two areas of inherent contention, in that patent law serves to promote monopolies whereas antitrust law serves to curb monopolies. (21) Antitrust law is governed by the Clayton Act and the Sherman Antitrust Act, which were enacted to promote and protect competition by ensuring that consumers have access to lower priced goods and more choices. (22) Section 2 of the Sherman Antitrust Act prohibits the creation of monopolies or attempted monopolies that pose a risk to competition in the relevant markets. (23) Patent law intersects with antitrust law via Section 2 of the Sherman Act where patent holders are permitted to engage in a limited monopoly within the scope of their patent rights. (24) One prominent right that patents grant is the right to exclude others from making, selling, and offering for sale the patented product or process. (25)

In 1984, Congress effectively extended the term of patents by enacting the Hatch-Waxman Act. (26) The purpose of the Hatch-Waxman Act was to incentivize innovation for brand name pharmaceutical manufacturers and to encourage generic drug competition by lowering drug prices. (27) The Hatch-Waxman Act grants a five-year extension to the standard twenty-year term of the patent, which compensates for lost time resulting from the FDA regulatory process that takes place during the first years of the patent term. (28) The Hatch-Waxman Act further grants an additional six-month term for manufacturers that elect to conduct pediatric studies. (29) Not only does the Hatch-Waxman Act benefit brand manufacturers by extending the length of their patents, it also allows for generic manufacturers to piggy-back on the clinical trials and labeling of the brand manufacturers. (30) Generic manufacturers can avoid performing safety and efficacy testing, and therefore expedite the introduction of generic drugs into the market, by filing an Abbreviated New Drug Application, showing that their drugs are bioequivalent to, or perform the same as, the brand name drugs. (31)

"Product hopping" is a relatively new development where a brand name drug manufacturer withdraws its original product from the market with the intention of forcing consumers to switch to a similar, reformulated version of the original product in order to impede generic competition. (32) "Product hopping" has created tension between patent law and antitrust law, and has also given rise to the question of whether a preliminary injunction is the appropriate remedy to this problem; in particular, issues arise where alleged anticompetitive conduct, prohibited by antitrust law, is committed within the scope of a brand manufacturer's patent term. (33) Decisions from three major antitrust cases involving "product hopping" have not provided a clear answer as to whether it constitutes anticompetitive conduct. (34) Courts have looked to a combination of factors to determine whether there has been anticompetitive conduct, such as: (1) the scope of the patent, (2) choices available to consumers, and (3) exclusionary practices of manufacturers. (35) The independent facts of each "product hopping" case determined whether a preliminary injunction was a sufficient remedy or inappropriate remedy, thus resulting in varied outcomes for these complex cases. (36)

In New York ex rel Schneiderman v. Actavis PLC, the Second Circuit upheld the district court's grant of a preliminary injunction after finding that Actavis' "product hopping" violated Section 2 of the Sherman Act. (37) In conducting its analysis, the court first confirmed that Actavis' patent granted Actavis a monopoly in the memantine drug market, but this mere finding was not enough to constitute a violation. (38) As such, the court examined whether Actavis engaged in any anticompetitive or exclusionary' conduct that would impede competition or coerce consumers. (39) While neither withdrawal from the market, nor product improvement alone are considered anticompetitive conduct, the court determined that Actavis' "hard switch" of pulling Namenda 1R from the market and introducing Namenda XR prior to Namenda IR's patent expiration was anticompetitive conduct. (40) The court further looked into whether Actavis' conduct coerced consumers, and found that the "hard switch" deprived consumers of a choice because the only available option to continue drug treatment was to switch to Namenda XR. (41) Actavis' conduct was also found to impede competition where the "hard switch" would prevent generic substitutions for Namenda XR, and where the high transaction costs associated with consumers switching from one formulation of a drug to a new formulation and back again would keep consumers from switching back to generic Namenda IR, even if it were priced lower. (42)

After concluding that Actavis' conduct was anticompetitive, the court next reexamined the district court's grant of a preliminary injunction and determined that a heightened standard for injunctive relief applied. (43) The heightened standard the court applied required that the injunction provide the movant with substantially all the relief sought and that movants have a clear or substantial likelihood of success on the merits. (44) However, the court held that New York had already met that heightened standard by showing that, without an injunction, consumers would suffer irreparable economic harm and generic competition would be obstructed. (45) Furthermore, the court determined that an injunction would be a successful remedy for New York because the injunction clearly prevented Actavis from withdrawing Namenda IR from the market and from raising the price on the drug. (46)

The court in Actavis properly held that Actavis' "hard switch" from Namenda IR to Namenda XR violated Section 2 of the Sherman Act where the combination of Actavis' withdrawal of Namenda IR from the market with the introduction of Namenda XR to the market limited consumer choice in the marketplace and impeded generic competition. (47) This anticompetitive "hard switch" essentially forced consumers to switch to Namenda XR, which was the only other available drug on the market at the time. (48) The switch deprived consumers of a choice of Alzheimer's medications in the market and coerced consumers into switching to Namenda XR for the time period prior to the introduction of generic Namenda IR. (49) The court properly found that this had the overall effect of inflicting substantial harm on consumers, primarily in the form of economic harm, as no lower priced generic version of Namenda XR would be available until 2029. (50)

Although the court properly held Actavis' conduct was anticompetitive, the court improperly upheld the lower court's issuance of a preliminary injunction because there was no real or immediate harm to competition. (51) The court reasoned that New York made a "strong" showing that competition and consumers would suffer irreparable harm without the issuance of a preliminary injunction. (52) The court further reasoned that generic competition would be obstructed due to consumers' reluctance to switch to the generic 1R after switching to Namenda XR, even if the generic 1R were less expensive. (53) The harm the court contemplated was merely speculative or conjectural, as generic competition was scheduled to enter the market at the expiration of Actavis' Namenda 1R patent, and Actavis' "hard switch" did not change or alter this planned entrance. (54) The court's conclusion considers harm that is merely speculative, whereas plaintiffs must have realized actual harm in order for the harm to be irreparable. (55)

Additionally, the court did not need to grant a preliminary injunction, as monetary damages were an adequate alternative remedy. (56) Any harm that may come to fruition as a result of Actavis' "product hopping" will be financial harm, which is harm that can be readily remedied by monetary damages. (57) The court predicted that generic competition would suffer a loss in sales even if the generic IR were sold at a lower price, which is a loss that would be best remedied through quantifiable monetary damages. (58) The court also expressed concern that consumers would suffer economic harm by paying full price for Namenda XR as a result of the "hard switch," which is another harm that could be resolved with monetary damages, thus precluding the need for a preliminary injunction. (59) The court's error in upholding the district court's preliminary injunction may set a new precedent that incorrectly expands the circumstances in which a preliminary injunction applies. (60) A resultant precedent from this case may allow preliminary injunctions to apply in situations where other remedies are available and are less harmful to both parties. (61)

In Actavis, the United States Court of Appeals for the Second Circuit considered whether Actavis' withdrawal of Namenda IR, coinciding with the introduction of Namenda XR, violated the Sherman Antitrust Act, and further considered whether New York met the standard for a preliminary injunction. (62) The court properly reasoned that the combination of Actavis' withdrawal and introduction of Namenda formulations was anticompetitive conduct that deprived the consumer of choice in the marketplace and coerced the consumer into switching to Namenda XR. (63) The court improperly upheld the lower court's issuance of a preliminary injunction where competitive harm was merely speculative and where a monetary remedy was available. (64) The court's error in upholding the district court's preliminary injunction may set a troubling precedent that erroneously expands the circumstances in which a preliminary injunction applies, allowing for a more harmful remedy where a less restricting remedy is more suitable. (65)

(1) See 15 U.S.C. [section] 2 (2012); New York ex rel. Schneiderman v. Actavis PLC, 787 F.3d 638, 651 (2d. Cir. 2015). The Sherman Act prohibits actions of companies that "monopolize, or attempt to monopolize ... any part of the trade or commerce among the ... States." 15 U.S.C. [section] 2.

(2) Actavis, 787 F.3d at 652. Once a monopolist's conduct is determined to be anticompetitive or exclusionary, the monopolist can offer "nonpretextual" justifications for its conduct. Id. The plaintiff can rebut those justifications or demonstrate that the anticompetitive harms outweigh the precompetitive benefits. Id.

(3) 787 F.3d at 642-43, 650-51, 660-62. This practice where a monopolist perpetuates patent exclusivity through successive products is known as "product hopping." Id. at 643. "Product hopping" was a term coined by Herbert Hovenkamp. Id. at 643 n.2.

(4) Id. at 650-51.

(5) Id. at 654-55. The court stated:
   Defendants' hard switch crosses the line from persuasion to
   coercion and is anticompetitive.... By effectively withdrawing
   Namenda IR prior to generic entry, Defendants forced patients to
   switch from Namenda IR to XR--the only other memantine drug on the
   market.... By removing Namenda IR from the market prior to generic
   IR entry, Defendants sought to deprive consumers of that choice. In
   this way, Defendants could avoid competing against lower-cost
   generics based on the merits of their redesigned drug by forcing
   Alzheimer's patients to take XR, with the knowledge that
   transaction costs would make the reverse commute by patients from
   XR to generic IR highly unlikely.


Id.

(6) Actavis, 787 F.3d at 643. Generic drugs may enter the market at the conclusion of the exclusivity period for the brand name drug and compete with the brand name drug at a lower price. Id. at 647. Generic drugs "are copies of brand name drugs and are the same as those brand name drugs in dosage form, safety', strength, route of administration, quality', performance characteristics and intended use." Id. at 643 n.3.

(7) Id. at 646.

(8) Id. at 646-47. Namenda IR and XR occupied the entire memantine drug market. Id. at 647. They were the only drugs in their class on the market. Actavis, 787 F.3d at 647. When a pharmaceutical manufacturer brings a new drug to market, they must file a New Drug Application with the U.S. Food and Drug Administration. Id. at 643. The New Drug Application requires scientific evidence that the drug is safe and effective. Id. This is often proven by a lengthy and involved testing of the drug. Id. See also 21 U.S.C. [section] 355(b)(1) (2012 & Supp. I 2013) (describing investigational process of New Drug Application).

(9) Actavis, 787 F.3d at 647. Namenda IR is an immediate-release, twice-daily drug while Namenda XR is an extended-release, once-daily drug. Id. at 646. The two drugs have the same active ingredient and the same effect. Id. at 647. The only difference is that the IR is released immediately into the bloodstream and the XR is released gradually into the bloodstream. Id. at 647.

(10) Id. at 648 (discussing Actavis' first steps towards withdrawal of IR).

(11) Id. (discussing Actavis' marketing efforts to get consumers to switch to XR). See also Beth Snyder Bulik, Who Needs a Hard Sndtch? Namenda XR Ad Campaign is Already Bolstering Conversions, Fierce Pharma Marketing (May 27,2015), http://www.fiercepharmamarketing.com/story/who-needs-hard-switch-namenda-xr-adcampaign-already-bolstering- conversions/2015-05-27 (discussing television advertisements for Namenda XR).

(12) Actavis, 787 F.3d at 648 (defining "soft switch" as marketing of one product over other while both on the market).

(13) Actavis, 787 F.3d at 648. Actavis originally set a discontinue date of August 15, 2014, but this planned discontinuation was disrupted by a delay in XR production. Id. at 649.

(14) Id. at 647-48. The patent exclusivity for Namenda XR does not expire until 2029. Id. at 647. Actavis received patent extensions on their Namenda IR drug through the Drug Price Competition and Patent Term Restoration Act (the "Platch-Waxman Act"). Id. at 643-44. The Hatch-Waxman Act was meant to encourage generic drug competition and incentivize brand name pharmaceutical manufacturers to innovate through patent extensions. Id. at 643. The Hatch-Waxman Act allows brand name pharmaceutical manufacturers to obtain a patent extension of five years to compensate for the time that passed during the FDA regulatory process. Actavis, 787 F.3d at 644. An additional six-month extension is granted if the manufacturer conducts pediatric studies. 21 U.S.C. [section] 355a (2012); 35 U.S.C. [section] 271(e)(1) (2012). See also Actavis, 787 F.3d at 643-44. Patent owners have the authority to make, use, and offer for sale their patented invention. 35 U.S.C. [section] 271(a) (2012).

(15) Actavis, 787 F.3d at 648. The court determined that the "hard switch" began on February 14, 2014, with the announcement of Actavis' intention to withdraw Namenda IR. Id. The court and parties identified the "hard switch" or "forced switch" as Actavis' efforts to withdraw Namenda IR from the market. Id. Actavis also wrote a letter to the Centers for Medicare & Medicaid Services and requested they remove Namenda IR from the formulary list so that it would no longer be covered by Medicare health plans. Id.

(16) Id.

(17) Id. (explaining Namenda IR was still available through mail-order pharmacy).

(18) Actavis, 787 F.3d at 649. This loss of market share that occurs after generic entry into the market is called a "patent cliff," which occurs at the end of a drug's exclusivity period when generics gain market share through state substitution laws. Id. The district court made several enumerated determinations in coming to its decision:
   (1) Withdrawing Namenda IR from the market prior to generic entry
   forces Alzheimer's patients dependent on memantine therapy to
   switch to Namenda XR because it is the only available alternative;
   (2) The generic versions of IR poised to enter the market in July
   and October of 2015 will not be AB-rated to XR because they have
   different strengths and dosages; (3) Pharmacists will not be
   permitted to substitute generic IR for Namenda XR under New York
   and many other states' substitution laws because generic IR is not
   therapeutically equivalent to Namenda XR; (4) If Defendants forced
   Alzheimer's patients to switch to Namenda XR prior to genetic
   entry, those patients would be very unlikely to switch back to
   twice-daily IR therapy even after less-expensive generic IR becomes
   available, due to the high transaction costs associated with
   Alzheimer's patients first switching from one
   formulation of a drug to a new formulation and then back to the
   original formulation ("reverse commuting"); (5) Preventing generic
   IR from competing under state drug substitution laws would likely
   thwart generic entry into and competition in the memantine-drug
   market; and (6) In withdrawing Namenda IR from the market,
   Defendants' explicit purpose was to impede generic competition and
   to avoid the patent cliff--which occurs at the end of a drug's
   exclusivity period when generics gain market share through state
   substitution laws.


Id.

(19) Id. at 650 (discussing preliminary injunction forcing Actavis to continue Namenda IR well past entry of generics).

(20) Id. at 638 (finding Actavis' withdrawal of Namenda IR a violation of Sherman Act).

(21) See Robin Feldman, Patent and Antitrust: Differing Shades oj Meaning, 13 VA. J.L. &TECH. 5, 31 (2008), available at https://web.stanford.edu/dept/law/ipsc/pdf/feldman-robin.pdf (discussing complicated overlap of patent and antitrust law).

(22) See 15 U.S.C. [section][section] 1,12 (2012). The Sherman Act was first enacted in 1890. 15 U.S.C. [section]1. The Clayton Act was enacted in 1914 as an amendment to clarify and supplement the Sherman Act. 15 U.S.C. [section][section] 1, 12. Congress explained the economic and competitive interests behind the implementation of the Sherman Act:
   [T]he Sherman Act was designed to be a comprehensive charter of
   economic liberty aimed at preserving free and unfettered
   competition as the rule of trade. It rests on the premise that the
   unrestrained interaction of competitive forces will yield the best
   allocation of our economic resources, the lowest prices, the
   highest quality and the greatest material progress, while at the
   same time providing an environment conducive to the preservation of
   our democratic political and social institutions. But even were
   that premise open to question, the policy unequivocally laid down
   by the Act is competition.


See 1 Health care and Antitrust L. [section] 1:2 (2015). Antitrust laws are meant to prevent companies from contracting with and "arranging treaties" with competitors. Id. The Sherman Act also serves to prohibit "[e]very contract, combination ... or conspiracy, in restraint of trade or commerce among the several States." N. Pac. Ry. Co. v. United States, 356 U.S. 1, 4-5 (1958) (quoting Standard Oil Co. of N.J. v. United States, 221 U.S. 1, 49 (1911)). "Although this prohibition is literally all-encompassing, the courts have construed it as precluding only those contracts or combinations which 'unreasonably' restrain competition." Id. See also Nat'l Soc'y of Profl Eng'rs v. United States, 435 U.S. 679, 695 (1978) (discussing how competition not only produces lowers prices, but also better goods and sendees); Geneva Pharm. Tech. Corp. v. Barr Labs., Inc., 386 F.3d 485, 489 (2d Cir. 2004) (explaining it is a violation of Sherman Act to enter into a monopoly); Town of Concord, Mass. v. Bos. Edison Co., 915 F.2d 17, 21-22 (1st Cir. 1990) (explaining competition's basic goals include lower prices, better products, and more efficient methods of production); In re Skelaxin Antitrust Litig., 292 F.R.D. 544, 546 (E.D. Tenn. 2013) (discussing antitrust class action suit where manufacturer illegally delayed entry of generic into market); In re Terazosin Hydrochloride Antitrust Litig., 352 F. Supp. 2d 1279, 1286 (S.D. Fla. 2005) (holding agreement between brand and generic manufacturers exclusionary and unlawful under Act); In re Cardizem CD Antitrust Litig., 105 F. Supp. 2d 618, 647 (E.D. Mich. 2000) (discussing agreement between parties to restrain trade of drug as violation of Act); Abbott Labs, v. Durrett, 746 So. 2d 316, 317 (Ala. 1999) (describing alleged conspiracy to control prices of pharmaceuticals); Eric L. Cramer & Daniel Berger, Article, The Superiority of Direct Proof of Monopoly Power and Anticompetitive Effects in Antitrust Cases Involving Delayed Enty of Generic Drugs, 39 U.S.F.L. Rf.V. 81, 91-94 (2004) (discussing anticompetitive effects in delayed generic entry cases); Daniel E. Feld, What Constitutes 'Attempt to Monopolize, " within the Meaning of [section] 2 of Sherman Act (15 U.S.C.A. [section]2), 27 A.L.R. FED. 762 (2015) (discussing meaning of "monopolize" in context of Sherman Act);John Kirkwood, The Essence of Antitrust: Protecting Consumers and Small Suppliers from Anticompetitive Conduct, 81 FORDHAM L. REV. 2425, 2434-39 (2015) (detailing legislative intent and history behind enactment of Sherman Act). The Supreme Court explained that antitrust laws are intended to maximize consumer benefit "by promoting low prices ... high quality', varied products and services, innovation, access, and efficiency in production and distribution." Health care AND Antitrust L., supra note 22, [section] 1:2 (quoting Broadcom Corp. v. Qualcomm Inc., 501 F.3d 297, 308 (3d Cir. 2007)). The Sherman and Clayton Acts protect the relevant market as a whole, the market in which a particular product or service is sold, as opposed to the individual competitors in the market. Id. [section]1:2 n.25.

(23) 15 U.S.C. [section] 2. See also HEALTH CARE AND ANTITRUST L., supra note 22, [section] 5:1 (explaining [section] 2 of the Sherman Act prohibits monopolization and attempted monopolization). A plaintiff must satisfy two elements in bringing a claim under [section] 2:
   To prevail on a monopolization claim under Section 2 of the Sherman
   Act, a plaintiff must show: (1) the possession of monopoly power in
   the relevant market and (2) the willful acquisition or maintenance
   of that power as distinguished from growth or development as a
   consequence of a superior product, business acumen, or historic
   accident.


URL Pharma, Inc. v. Reckitt Benckiser, Inc, CA15-505, 2015 U.S. Dist. LEXIS 112859, at *11-12 (E.D. Pa. Aug. 25, 2015) (quoting Queen City Pizza, Inc. v. Domino's Pizza, Inc, 124 F.3d 430, 437 (3d Cir. 1997)). Monopoly power alone is not unlawful; there must be a showing of anticompetitive conduct in addition to monopoly power. Verizon Commc'ns, Inc. v. Law Offices of Curtis v. Trinko, LLP, 540 U.S. 398, 407 (2004). Anticompetitive conduct, or exclusionary conduct, is a requirement for monopolization and attempted monopolization claims. Id. See also Behrend v. Comcast Corp., No. 03-6604, 2012 U.S. Dist. LEXIS 51889, at * 75 (E.D. Pa. Apr. 12, 2012); Mylan Pharms., Inc. v. Warner Chilcott Pub. Ltd. Co., No. 12-3824, 2015 U.S. Dist. LEXIS 50026, at *45 (E.D. Pa. Apr. 16, 2015) (stating plaintiff s attempted monopolization claim fails where conduct was not anticompetitive).

(24) See 35 U.S.C. [section] 271(a). See also General Information Concerning Patents, UNITED STATES PATENT AND TRADEMARK Office (October 2014), http://www.uspto.gov/patents-gettingstarted/general-information-concerning-patents (stating patent rights derived from Constitution complicating which law rules where antitrust intersects patent). Patent holders have the right to use, make, sell, or offer for sale "any patented invention, within the United States or [import] into the United States any patented invention during the term of the patent." Id. See also F.T.C. v. Actavis, Inc., 133 S. Ct. 2223, 2238 (2013) (Roberts, J., dissenting). "The point of antitrust law is to encourage competitive markets to promote consumer welfare." Id. "The point of patent law is to grant limited monopolies as a way of encouraging innovation." Id. Patent law "provides an exception to antitrust law, and the scope of the patent--i.e., the rights conferred by the patent--forms the zone within which the patent holder may operate without facing antitrust liability." Id. "Where a patent had been lawfully acquired, subsequent conduct permissible under the patent laws cannot trigger any liability under the antitrust laws." SCM Corp. v. Xerox Corp., 645 F.2d 1195, 1206 (2d Cir. 1981). Compare United States v. United Shoe Mach. Co., 247 U.S. 32, 32 (1918) (explaining "exerting" patent rights is not "offense" to Sherman Act), with United States v. Singer Mfg. Co., 374 U.S. 174, 196-97 (1963) (holding patent owners subject to antitrust liability where settlement exceeded scope of patent rights). See also 2 ANTITRUST LAW DEVELOPMENTS 1197 (7th ed. 2012) (stating a "[u]nilateral refusal to use ... a patent ... cannot form the basis for an antitrust claim"). Explaining patent law as an exception to antitrust law:
   Just as any regulatory provision, the Patent Act removes certain
   activities from antitrust scrutiny. For example, once the Patent
   Act authorizes a patent for a given term, exclusion by patent
   enforcement during that term cannot be unlawful under the antitrust
   laws. The same thing is true of other practices that the statute
   authorizes, including exclusive and nonexclusive production
   licenses, ties in the absence of market power, simple refusals to
   license, and patent assignments.


H.J. Hovenkamp, Antitrust and the Patent System: A Reexamination, 76 OHIO St. L.J. 467, 481 (2015). See also United States v. Line Material Co., 333 U.S. 287, 309-10 (1948) (recognizing patent rights as exception to Sherman Act); Precision Instrument Mfg. Co. v. Auto. Maint. Mach. Co., 324 U.S. 806, 816 (1945) (stating a patent is an exception to monopoly rule and to right "to access a free ... market").

(25) 3 5 U.S.C. [section] 154 (2012). See also Dawson Chemical Co. v. Rohm & Haas Co., 448 U.S. 176, 215 (1980) (stating patent holders have right to exclude others from profiting from their invention). Patent holders will not incur antitrust liability if they chose to exclude others from producing their patented invention. Valley Drug Co. v. Geneva Pharms., Inc., 344 F.3d 1294, 1305 (11th Cir. 2003). Antitrust law cannot forbid "the right of the patentee to refuse to sell or license in markets within the scope of the statutory patent grant." CSU, L.L.C. v. Xerox Corp. (In re Indep. Serv. Orgs. Antitrust Litig.), 203 F.3d 1322, 1327 (Fed. Cir. 2000).

(26) See Drug Price Competition and Patent Term Restoration Act of 1981, Pub. L. No. 98-417, 98 Stat. 1585 (1984) (codified as amended at 21 U.S.C. [section] 355 and 35 U.S.C. [section] 271(e) (1994)). See also Stephanie Plamondon Bair, Adjustments, Extensions, Disclaimers, and Continuations: When Do Patent Derm Adjustments Make Sensei, 41 CAP. U.L. RliV. 445, 458-60 (2013) (discussing provisions of patent extension under Hatch-Waxman).

(27) See Gerald J. Mossinghoff, Striking the Right Balance Between Innovation and Drug Price Competition - Understanding the 1 latch-Waxman Act: Overview of the I Iatch-Waxman Act and Its Impact on the Drug Development Process, 54 FOOD & DRUG L.]. 187, 189-91 (1999) (providing overview of Hatch-Waxman Act and its legislative history); Elizabeth Stotland Weiswasser & Scott Danzis, The Hatch-Waxman Act: History, Structure, and Legacy, 71 ANTITRUST L.J. 585, 587-91 (2003) (providing historical background of 1 Iatch-Waxman Act). Henry Grabowski expounds on the purpose of the act:
   Patents play a critical role for both the level of R&D investment
   in pharmaceuticals and the timing of generic competition. The
   Hatch-Waxman Act was designed to balance the trade offs between
   these two objectives. In particular, it sought to produce patent
   lifetimes sufficient to encourage increased levels of R&D
   investment by innovators while promoting intense price competition
   by easing entry regulations to generics when patents expire.


Henry Grabowski, Pharmaceuticals: Politics, Policy and Availability: Patents and New Product Development in the Pharmaceutical and Biotechnology' Industries, 8 Geo. Pub. Pol'y Rev. 7, 20 (2003). See also supra note 14, at 644 (discussing purpose of the Hatch-Waxman Act).

(28) See Merck & Co. v. Kessler, 80 F.3d 1543, 1547 (Fed. Cir. 1996) (discussing patent extension as compensation for delay in obtaining FDA approval). Explaining the rationale behind granting a patent extension:
   Because firms apply for patents at the beginning of the clinical
   development process, significant patent protection is lost by the
   length of FDA approval time. This implies a significant reduction
   in the effective patent life of drugs relative to the nominal life
   of 20 years. In light of this, the United States, the European
   Community and Japan have all enacted patent term restoration laws.
   The U.S. law in this regard, the Hatch-Waxman Act, has been in
   existence since 1984. Hatch-Waxman provides for patent term
   restoration of time lost
   during the clinical development and regulatory approval periods, up
   to a maximum of five years additional patent life.


See Grabowski, supra note 27, at 11-12.

(29) See Weiswasser & Danzis, supra note 27, at 592 n.42 (discussing extension under Hatch-Waxman for data on testing of drugs in pediatric populations).

(30) See Ann K. Wooster, Construction and Application of Hatch-Waxman Act, Pub. L. No. 98-417, 98 Stat. 1585 (1984) (codified and amended at 21 U.S.C. [section] 355 and 35 U.S.C. [section] 271(e) (1994)), 180 A.L.R. FED. 487, 2a (2002). "The degree of generic competition has increased dramatically since the 1984 act was passed, with more than half of all new prescriptions accounted for by generic products in 2002. The Hatch-Waxman Act has fostered a vigorous generic industry with substantial benefits to consumers from price reduction." Grabowski, supra note 27, at 20.

(31) 21 U.S.C. [section] 3550(2)(A)(iv) (2012). Discussing the benefit to generic manufacturers:
   This law also facilitates faster generic product introduction by
   allowing generic firms to file abbreviated new drug application, in
   which generic firms must only demonstrate bioequivalence to the
   pioneer's products to obtain FDA approval. Prior to the passage of
   Hatch-Waxman, generic firms had to submit their own proof of a
   compound's safety and efficacy, as well as show bioequivalence.


Grabowski, supra note 27, at 11 (discussing the streamlining of the generic drug process).

(32) See supra note 3 and accompanying text (defining product hopping). See generally Jessie Cheng, Note, An Antitrust Analysis of Product Hopping in the Pharmaceutical Industry, 108 COLUM. L. Rev. 1471, 1471 (2008) (discussing generally the strategy and history of product hopping in pharmaceuticals). "As a general rule, any firm, even a monopolist, may . . . bring its products to market whenever and however it chooses." Steamfitters Local Union No. 420 Welfare Fund v. Philip Morris, Inc., 171 F.3d 912, 925 n.7 (3d Cir. 1999) (quoting Berkey Photo, Inc. v. Eastman Kodak Co., 603 F.2d 263, 286 (2d Cir. 1979)). A company that holds a patent monopoly may replace an older product with a newer one during the patent exclusivity period, even if doing so impedes competitors' market entry after the old patent expires. See, eg., Cal. Computer Prods., Inc. v. IBM, 613 F.2d 727, 744 (9th Cir. 1979).

(33) See New York ex rel Schneiderman v. Actavis PLC, 787 F.3d 638, 650-51 (2d. Cir. 2015) (describing the standard for preliminary injunction and discussing how plaintiffs met standard). See also Mylan Pharms., Inc. v. Warner Chilcott Pub. Ltd. Co., No. 12-3824, 2015 U.S. Dist. LEXIS 50026, at *34 (E.D. Pa. Apr. 16, 2015) (holding reformulation and introduction of new versions of a drug into marketplace was not anticompetitive). "Conduct that merely harms competitors ... while not harming the competitive process itself, is not anticompetitive." Broadcom Corp. v. Qualcomm Inc., 501 F.3d 297, 308 (3d Cir. 2007). To establish anticompetitive conduct, "it is not necessary that all competition be removed from the market." United States v. Dentsply Int'l, Inc., 399 F.3d 181, 191 (3d Cir. 2005). "The test is not total foreclosure, but whether the challenged practices bar a substantial number of rivals or severely restrict the market's ambit." Id. at 191. See also F.T.C. v. Actavis, Inc., 133 S. Ct. 2223, 2238 (2013) (Roberts, C.J., dissenting) (discussing rights within the scope of patent as safe from reach of antitrust law); United States v. Microsoft Corp., 253 F. 3d. 34, 58 (D.C. Cir. 2001) (quoting United States v. Grinell Corp., 384 U.S. 563, 571 (1966)) (distinguishing exclusionary conduct from company growth or development).

(34) See Mylan Pharms., 2015 U.S. Dist. LEXIS 50026, at *45 (holding reformulation of drug and subsequent introduction into marketplace was not anticompetitive conduct); Walgreen Co. v. AstraZeneca, 534 F. Supp. 2d 146, 146 (D.D.C. 2008) (granting motion to dismiss where AstraZeneca introduced new drug alongside alternative drug expanding consumer choice); Abbott Labs. v. Teva Pharms. USA, Inc., 432 F. Supp. 2d 408, 408 (D. Del. 2006) (holding conduct that results in consumer coercion is potentially anticompetitive). See also M. Sean Royall, Ashley E. Johnson, and Jason C. McKenney, Article, Antitrust Scrutiny of Pharmaceutical "Product Hopping," 28 ANTITRUST 71, 72-73 (2013) (discussing the current state of the law on product hopping).

(35) See, eg., Mylan Pharms., 2015 U.S. Dist. LEXIS 50026, at *37-40 (focusing analysis on exclusionary practices); Walgreen Co., 534 F. Supp. 2d at 151 (focusing analysis on the consumers choice); Abbott Labs., 432 F. Supp. 2d at 422 (expressing concern over the elimination of the consumer's option to choose generic alternatives). See also Mylan Pharms., 2015 U.S. Dist. LEXIS 50026, at *48 (granting drug manufacturer's motion for summary judgment where reformulation of drug not anticompetitive); In re Suboxone (Buprenorphine Hydrochloride & Naloxone) Antitrust Litig., 64 F. Supp. 3d 665, 672 (E.D. Pa. 2014) (denying branded drug manufacturer's motion to dismiss where defendant engaged in "product hopping" scheme); Walgreen Co., 534 F. Supp. 2d at 152-53 (granting brand drug manufacturer's dismissal where newer drug was introduced without removal of original drug); Abbott Mbs., 432 F. Supp. 2d at 434 (denying drug manufacturer's motion to dismiss where there was conspiracy to control prices of drugs).

(36) See Actavis, 787 F.3d at 650-51 (describing the standard for preliminary injunction). One alternative remedy to monetary damages is an injunction:
   Section 16 of the Clayton Act empowers any person threatened with
   loss or damage by a violation of the Sherman or Clayton Acts to
   seek injunctive relief in the federal courts. [Requirements are...
   proof that the plaintiff is threatened with loss or damage caused
   by the defendant's antitrust violation that is real and immediate
   and not merely conjectural or speculative, that such injury
   outweighs the harm to the defendant that will result from the
   injunction as well as any harm to the public interest, that money
   damages are not an adequate alternative remedy, and (if preliminary
   injunctive relief is sought) that the plaintiff is likely to
   succeed on the merits.


William Holmes & Melissa Mangiaracina, Antitrust Law Handbook [section] 9:26 (2015). See also Faiveley Transp. Malmo AB v. Wabtec Corp., 559 F.3d 110, 116 (2d Cir. 2009) (discussing the absence of evidence of irreparable harm bars a preliminary injunction); County of Nassau, N.Y. v. Leavitt, 524 F.3d 408, 414 (2d Cir. 2008) (laying out the requirements of a preliminary injunction). "To obtain injunctive relief, the plaintiff bears the burden of showing a significant threat of antitrust injury' from an antitrust violation--i.e., some cognizable danger that a violation will occur or recur." HEALTH CARE AND ANTITRUST L., supra note 22, at [section] 9:15. When an injunction is issued, the terms of the injunction must be specifically stated. FED. R. CIV. P. 65(d); Schmidt v. Lessard, 414 U.S. 473, 476-77 (1974) (vacating injunctions that vaguely enjoined defendants from "enforcing their present scheme"); New York v. Mickalis Pawn Shop, LLC, 645 F.3d 114, 144 (2d Cir. 2011) (vacating injunction where defendants instructed to alter their behavior to be in compliance with law). There can be no irreparable injury and thus no injunction when the court can "wait until the end of trial to resolve the harm." Freedom Holdings, Inc. v. Spitzer, 408 F.3d 112, 114 (2d Cir. 1979). See also Mickalis Pawn Shop, 645 F.3d at 144 (quoting Peregrine Myanmar Ltd. v. Segal, 89 F.3d 41, 50 (2d Cir. 1996) (internal quotation marks omitted)) (stating "injunctive relief should be 'narrowly tailored to fit specific legal violations'").

(37) Actavis, 787 F.3d at 643.

(38) Id. at 651-52. See also Verizon Commc'ns Inc. v. Law Offices of Curtis v. Trinko, LLP, 540 U.S. 398, 407 (2004) (explaining that to violate section two, defendant must have willfully acquired or maintained monopoly); Geneva Pharm. Tech. Corp. v. Barr Labs. Inc., 386 F.3d 485, 495 (2d Cir. 2004) (explaining it is a violation of the Sherman Act to "monopolize or attempt to monopolize"); Berkey Photo, Inc. v. Eastman Kodak Co., 603 F.2d 263, 273 (2d Cir. 1979) (characterizing monopoly power as "inherently evil"). The court also conducted an analysis on patent rights as a defense to liability. Actavis, 787 F.3d at 659-60. The court determined that while patent rights afford the patent holder a temporary monopoly on the individual drugs, patent rights do not grant the right to freely violate antitrust laws. Id. at 660. The court found that Actavis essentially tried to extend the exclusivity period for all their memantine-therapy drugs and determined that the hard switch was conduct beyond the scope of its patent rights. Id. at 659-60. See also id. at 653 (distinguishing between anticompetitive versus exclusionary conduct); F.T.C. v. Actavis, Inc., 133 S. Ct. 2223, 2231 (2013) (discussing scope and treatment of patent rights when they intersect with antitrust law). See also Actavis, 787 F.3d at 654 (acknowledging that mere withdrawal alone would not be anticompetitive); United States v. Microsoft Corp., 253 F.3d 34, 58-60 (D.C. Cir. 2001) (establishing framework to determine when product change constitutes violation of section two); Berkej Photo, 603 F.2d at 274 (explaining monopoly power only violates section two if coupled with other conduct).

(39) Actavis, 787 F.3d at 653-54. See Berkey Photo, 603 F.2d at 274 (explaining even if monopoly power was rightfully acquired it cannot be used to impede competition).

(40) See Actavis, 787 F.3d at 653-54. The court reasoned that product withdrawal combined with some other conduct is generally considered anticompetitive. Id. at 654. See also Berkej Photo, 603 F.2d at 287-88 (stating mere introduction of product does not create consumer coercion without other anticompetitive conduct); supra note 15 and accompanying text (describing "hard switch"). In discussing the Berkej Photo case, the court pointed out that "the situation might be completely different if, upon the introduction of the 110 system, Kodak had ceased producing film in the 126 size, thereby compelling camera purchasers to buy a Kodak 110 camera." Actavis, 787 F.3d at 653 (quoting Berkey Photo, 603 F.2d at 287 n.39) (internal quotation marks omitted).

(41) See Actavis, 787 F.3d at 654-55. Actavis removed Namenda IR from the market, but still made it available in limited access to patients that medically required it. Id. at 648. Actavis made IR available through Foundation Care, a mail-order pharmacy. Id. The patient's doctor would fill out a form stating that it was medically necessary for the patient to use Namenda IR, and the patient would be able to access it through Foundation Care. Id. However, the court found, by Actavis' own admission, that less than three percent of current Namenda users would be able to obtain IR through this process. Id. Namenda IR was the first drug approved for individuals suffering from Alzheimers. Id. at 647. Namenda IR and XR are the only drugs in their class, N-Methyl D-Aspartate ("NMDA") receptor antagonists, that are currently on the market. Actavis, 787 F.3d at 647.

(42) Id. at 655-56. See also supra note 18 and accompanying text (determining that because of its AB rating, generic IR cannot be substituted for Namenda XR). Since IR is a twice-daily pill and XR is a once-daily pill, they contain different strengths and dosages, despite being used for the same-treatment. Id. at 647. As they contain different dosages and strengths, they are ascribed different AB ratings and, as such, one drug cannot be substituted for the other. Id. at 656-57. Not all states ascribe to the AB ratings in the Orange Book. Id. Some states, like Iowa, look to whether the drugs are bioequivalent in determining if pharmacists can substitute one drug for the other. Id. Bioequivalence is when a generic version of a drug "releases its active ingredient (the drug) into the blood stream at virtually the same speed and in virtually the same amounts as the original drug." Eva M. Vivian, Bioequivalence and Interchangeability of Generic Drugs, MERCK MANUAL, http://www.merckmanuals.com/home/drugs/brand-name-and-generic-drugs/bioequivalence-and-interchangeability-of-generic- drugs (last visited Feb. 25, 2016).

(43) Actavis, 787 F.3d. at 650-51. The court determined that a heightened standard applies "where: (i) an injunction is 'mandatory,' or (ii) the injunction will provide the movant with substantially all the relief sought and that relief cannot be undone even if the defendant prevails at a trial on the merits." Id. See also supra note 36 and accompanying text (explaining the application of injunctive relief arising under Section 16 of the Clayton Act).

(44) Actavis, 787 F.3d at 650-51 (describing the standard the court applied for the injunctive relief sought by plaintiffs).

(45) Actavis, 787 F.3d at 660-62. The court determined that, although the district court applied the wrong standard, the outcome would not have changed, and the injunction would have been granted because New York's showing of harm still met the heightened standard, Id. at 650. Section 16 of the Clayton Act entitles parties "to sue for and have injunctive relief ... against threatened loss or damage by a violation of the antitrust laws ... when and under the same conditions and principles as injunctive relief ... is granted by courts of equity." See Clayton Act, 15 U.S.C. [section] 26 (2012). See also Actavis, 787 F.3d at 650 (quoting California v. Am. Stores Co., 495 U.S. 271, 280 (1990)). In order to obtain injunctive relief, a party seeking a preliminary injunction must establish: (1) "irreparable harm"; (2) "either (a) a likelihood of success on the merits, or (b) sufficiently serious questions going to the merits of its claims to make them fair ground for litigation, plus a balance of the hardships tipping decidedly in favor of the moving party"; and (3) "that a preliminar)' injunction is in the public interest." Id. (quoting Oneida Nation of New York v. Cuomo, 645 F.3d 154, 164 (2d Cir. 2011)). See also supra note 43 (outlining standard for preliminary injunction). For a showing of irreparable harm, the harm has to be "actual and imminent," and must be harm that "cannot be remedied by an award of monetary damages." Actavis, 787 F.3d at 660 (quoting Forest Citv Daly Hous., Inc. v. Town of N. Hempstead, 175 F.3d 144, 153 (2d Cir. 1999)). The court found that there was irreparable harm to competition where the generic distributors could not compete even if they lowered their prices and would not be able to introduce a generic version of Namenda XR until Actavis' patent term expired in 2029. Actavis, 787 F.3d at 660-61. Further, the court found irreparable harm to consumers in the form of economic harm. Id. at 661. Consumers would be stuck paying a higher cost overall for Namenda XR without the option of a lower priced generic version. Id. at 660-61.

(46) Actavis, 787 F.3d at 662. The court determined that an injunction would be the appropriate remedy to prevent harm to consumers and to prevent harm to competition. Id. at 661-62. Granting an injunction would also resolve issues surrounding consumer coercion because consumers would have more than one option. Id. at 662. Actavis also contended that the injunction was overbroad. Id. at 662. They stated that in twenty other states where drug substitution laws would allow generic IR to be substituted for Namenda XR, there would be no antitrust violations. Id. The court did not consider the argument, however, because Actavis failed to raise the argument before the district court and therefore forfeited it. Id. This was a case of first impression. Actavis, 787 F.3d at 662.

(47) See Actavis, 787 F.3d at 653-54. See also Berkey Photo, 603 F.2d at 287 (establishing standards for determining anticompetitive conduct); supra note 40 and accompanying text (explaining some other conduct was needed in addition to withdrawal to constitute anticompetitive conduct). The withdrawal of Namenda IR from the market without any other conduct would be proper and not considered anticompetitive. See supra note 40 and accompanying text (discussing how withdrawal from the market alone is not anticompetitive conduct). In the same vein, the introduction of Namenda XR to the market without any other conduct would be proper and not considered anticompetitive. See supra note 40 and accompanying text (discussing how anticompetitive conduct requires at least two actions: withdrawal and introduction to the market). One without the other is fine, but combined, according to Berkey Photo, the conduct is anticompetitive. See Berkey Photo, 603 F.2d at 287. See also HEALTH CARE AND ANTITRUST L., supra note 22, [section] 5:1 (explaining that the court looks at the aggregate anticompetitive conduct).

(48) See Actavis, 787 F.3d at 647-48. Namenda IR was technically still available, but consumers had to go through a cumbersome process to obtain or maintain their prescriptions for it. Id. at 648. Consumers had to apply for Namenda IR through a mail-order service and provide documentation from their doctors stating that it was "medically necessary" for the patients to access the drug. Id. While Namenda IR was technically available, it was not readily accessible; only Namenda XR was readily accessible through the standard channels. Id. See also supra note 41 and accompanying text (describing how mail-order is the only way to obtain Namenda IR after its withdrawal).

(49) See Actavis, 787 F.3d at 647-49. See also supra note 35 and accompanying text (describing how courts look to consumer coercion as a major factor in considering anticompetitive conduct). Namenda IR was withdrawn from the market in Fall 2014, and generic IR was slated for introduction after Actavis' patent expiration date in July 2015. Actavis, 787 F.3d at 647-49.

(50) See supra note 43 and accompanying text (explaining the Actavis court's ruling).

(51) See supra notes 43, 45 and accompanying text (detailing the court's ruling on the preliminary injunction and its reasoning behind it). See also Freedom Holdings, Inc. v. Spitzer, 408 F.3d 112,

114 (2d Cir. 1979) (stating harm cannot be remote or speculative and must be resolved immediately); HEALTH CARE AND ANTITRUST L., supra note 22, [section] 9:15 (describing irreparable harm as a cognizable danger).

(52) Actavis, 787 F.3d at 650-51 (describing the standard for preliminary injunction and discussing how plaintiff met heightened standard); supra note 45 and accompanying text (defining irreparable harm). See also HOLMES & MANGIARACINA, supra note 36, [section] 9:26 (explaining irreparable harm). Under the Clayton Act, injunctive relief is available where there was a violation arising under the Sherman or Clayton Acts. Id. A grant of injunctive relief under the Clayton Act requires proof of irreparable harm--real and immediate harm, not speculative or conjectural.

(53) See supra note 42 and accompanying text (discussing the court's concern over potential harm to generic competition).

(54) See Actavis, 787 F.3d at 647. See HOLMES & MANGIARACINA supra note 36 and accompanying text (discussing irreparable harm as real and immediate, not conjectural). See also supra note 18 and accompanying text (describing the patent cliff).

(55) See HOLMES & MANGIARACINA, supra note 36 [section] 9:26 (stating that irreparable harm must be real and immediate, not speculative or conjectural). In order for a court to grant a preliminary injunction, the plaintiff must have suffered a real and demonstrated harm that cannot be resolved but for the preliminary injunction. Id. See also Freedom Holdings, Inc., 408 F.3d at 114 (stating no harm when court can wait to resolve harm at end of trial); supra note 45 and accompanying text (defining irreparable harm).

(56) See Chotin Transp., Inc. v. Harbor Towing & Fleeting, Inc., 814 So. 2d 1289 (La. 2002) (denying motion for preliminary injunction where plaintiffs had adequate remedy by monetary damages). See also supra note 45 and accompanying text (explaining the requirements for a preliminary injunction); Delaware River & Bay Auth. v. York Hunter Const., Inc., 344 N.J. Super. 361, 364 (N.J. Super. Ct. 2001) (stating "[t]he availability of adequate monetary damages belies a claim of irreparable injury"). No other "product hopping" cases have employed a preliminary' injunction as a remedy. See supra notes 34-35 and accompanying text (listing the outcome of preceding "product hopping" cases). See also infra notes 59, 63 and accompanying text (discussing the remedy of monetary damages as a bar to a preliminary injunction).

(57) See e.g., Abbott Laboratories v. Mead Johnson & Co., 971 F.2d 6, 9 (7th Cir. 1992) (denying preliminary injunction when monetary damages based on lost sales would make plaintiff whole); Toney-Dick v. Doar, 12 Civ. 9162, 2013 U.S. Dist. LEIXIS 50050, at *37-40 (S.D.N.Y. Mar. 18, 2013) (denying motion for preliminary injunction where plaintiffs sought damages based on being denied food stamps). See also Faiveley Transp. Malmo AB v. Wabtec Corp., 559 F.3d 110, 119 (2d Cir. 2009) (describing a loss of sales to competition as fully compensable by monetary damages).

(58) Actavis, 787 F.3d at 655-56. See supra note 59 (explaining loss of sales is remedied by monetary damages).

(59) Actavis, 787 F.3d at 650-51. See also supra notes 56-57 (explaining monetary loss can be resolved by monetary damages). Namenda XR was actually introduced to the market at a discounted rate, and was priced lower than Namenda IR. Actavis, 787 F.3d at 648. In granting a preliminary injunction, courts balance the harms. See HOLMES & MANGIARACINA, supra note 36, [section] 9:26. The court balances the harm to the manufacturer against the harm to the consumer. Id. Here, the court should have considered the potential harm Actavis would have suffered as a result of reproducing Namenda IR in its factory and the harm to Actavis' patent rights that would have resulted from the injunction. See Actavis, 787 F.3d at 660-62.

(60) See supra notes 45 and 55 and accompanying text (explaining the circumstances under which preliminary injunction applies).

(61) See supra note 59 and accompanying text (explaining balancing of harms consideration in granting preliminary injunction).

(62) Actavis, 787 F.3d at 642-43.

(63) Id. at 654-58. See supra note 40 and accompanying text (explaining that withdrawal of drug combined with some other conduct is anticompetitive).

(64) See Actavis, 787 F.3d at 638; supra notes 45, 56-59 and accompanying text (discussing that there is no need for an injunction where monetary damages are sufficient remedy); supra note 52 and accompanying text (stating that harm must be immediate and not speculative to be irreparable). See also supra note 45 and accompanying text (outlining requirements for preliminary' injunction).

(65) See supra notes 34, 44, 54 and accompanying text (explaining circumstances under which a preliminary injunction applies). See also supra notes 34, 58, 60 and accompanying text (explaining balancing of harms in granting preliminary injunction).

Emily Lacy, J.D. Candidate, Suffolk University Law School, 2016; B.A., University of Richmond, 2012. Ms. Lacy may be contacted at liping.lacy@gmail.com.
COPYRIGHT 2016 Suffolk University Law School
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2016 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Author:Lacy, Emily
Publication:Journal of Health & Biomedical Law
Article Type:Case note
Date:Mar 22, 2016
Words:9034
Previous Article:Getting high on profits: an analysis of current state and federal proposals to rein in soaring drug prices.
Next Article:Hellerstedt - 2016 - how the United States Supreme Court aborted the Texas abortion statute.
Topics:

Terms of use | Privacy policy | Copyright © 2019 Farlex, Inc. | Feedback | For webmasters