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Reproduced with permission from Pharmaceutical Law & Industry Report, 10 PLIR 294, 03/02/2012. Copyright ஽2012 by The Bureau of National Affairs, Inc. (800-372-1033) http://www.bna.com Antitrust Issues That Arise in ANDA Disputes BY PAULA L. BLIZZARD, ASIM M. BHANSALI, AND asserts monopolization offenses under federal law—Section 2 of the Sherman Antitrust Act. Second, ANDA Thestructureofthepharmaceuticalindustryalmost purchasers’’—mayalsoassertstate-lawcausesofaction invariably leads to antitrust issues. Patent protec- and will generally do so when federal law does not af- tion is strong. The patentee, prior to generic entry, usually has a monopoly over the particular pharmaceu-tical dosage, but often not as to a therapeutic category.
A. Monopolization (Sherman Act Section 2) The patent-based monopoly can lead to large profits— sometimes more than a billion dollars per year forblockbuster drugs. When a generic product is intro- Section 2 of the Sherman Act makes it unlawful for a duced to the market, the substitution for the patentee firm to ‘‘monopolize.’’ Monopolization has two ele- product is rapid, often above 90% in the first six ments: ‘‘(1) the possession of monopoly power in the months, and virtually guaranteed, given healthcare and relevant market and (2) the willful acquisition or main- tenance of that power as distinguished from growth or Thus, antitrust issues that follow abbreviated new development as a consequence of a superior product, drug application (ANDA) disputes arise in two main business acumen, or historic accident.’’1 ways: (1) accusations that settlements between the pat- In the ANDA context, three kinds of monopolization entee and the generic allow the brand to extend its claims have appeared most often: (1) sham litigation patent based monopoly; and (2) accusations that the claims charging that the patentee asserted one or more patentee engaged in some form of anticompetitive be- patents against an ANDA holder without a reasonable havior to keep the generic out of the market, such as basis; (2) Walker Process claims arising from alleged sham patent litigation or patent litigation based on a fraud on the U.S. Patent and Trademark office in ob- taining a patent; and (3) product switching claims as-serting that the brand company timed its switch fromone generation of a product to another in order to pre- ANDA antitrust cases usually arise under two kinds The issue in sham litigation cases is whether the of statutory claims. The first and most common claim ANDA litigation’s effect on competition was lawful orunlawful. The first part of the inquiry is whether thebrand drug company has monopoly power. (As noted Paula L. Blizzard and Asim M. Bhansali are above, this inquiry is an element of every monopoliza- partners with Keker & Van Nest LLP inSan Francisco. Sharif E. Jacob is an associate 1 United States v. Microsoft, 253 F.3d 34, 50 (D.C. Cir. 2001) (quoting United States v. Grinnell Corp., 384 U.S. 563, 570-71(1966)) COPYRIGHT ஽ 2012 BY THE BUREAU OF NATIONAL AFFAIRS, INC.
A firm has monopoly power if it can raise prices sub- Second, the question of whether defeating a defen- stantially above the competitive level for a significant dant’s motion for summary judgment is enough to es- period of time. In theory, this power can be established tablish objective reasonableness of suit as a matter of by direct evidence. In practice, whether a firm has mo- law remains an undecided one in the context of ANDA nopoly power is evaluated by a two-step process of de- fining a relevant product market and then looking atwhether the firm has a dominant share of that market, Third, no clear authority exists on who decides the question of whether filing the lawsuit was objectively In ANDA antitrust cases, the relevant product market baseless: the court or the jury. The antitrust defendant dispute often centers on what products are in the mar- (and patent plaintiff) will argue that the court should ket. The legal test for a relevant market involves decide the question as a matter of law, because deter- whether the products are reasonable substitutes for mining whether the litigant could reasonably have an- each other in the buyer’s point of view. In pharmaceuti- ticipated the possibility of prevailing does not require cal markets, this analysis is complicated because the resolving any disputed facts. Indeed, courts may resolve ‘‘buyer’’ is not a single person. Rather, the prescriber, questions of probable cause without reliance on a jury the pharmacist, the insurance carrier and the patient all for fact finding.8 By contrast, the antitrust plaintiffs will take a role in ‘‘buying’’ a drug. The defendants will ar- argue that the objective baselessness standard is akin to gue for a broader market definition so that it does not a negligence standard, which is a question routinely re- have a dominant share. Typically, this broad market solved by juries rather than judges. Indeed, juries can definition will include an entire therapeutic class or at determine in professional malpractice cases whether at- least several different classes of drugs within the thera- torney conduct was objectively reasonable.
in approval of the generic entrant, even if the FDA does Like all litigation, a brand company’s patent infringe- not agree with any of the arguments.
ment lawsuit in response to a Paragraph IV certification Antitrust plaintiffs thus can view brand Citizen Peti- constitutes protected petitioning activity under the First tions as another form of anticompetitive act designed to Amendment.4 Sham litigation is not, however, immune delay generic entry. Generally a Citizen Petition is from antitrust liability as petitioning activity. As noted viewed as another form of government petitioning and above, sham litigation has two required elements: First, thus treated the same as litigation under the PRE test.
the lawsuit must be objectively baseless such that no The concern over sham Citizen Petitions by brand com- reasonable litigant could realistically expect success on panies led to legislation in 2007 and subsequently to the merits.5 By definition, if probable cause to sue ex-ists, then no finding of sham litigation can arise. Sec- ond, if a challenged lawsuit is objectively meritless, acourt must examine the litigant’s subjective motivation.
6 Cf. Q-Pharma Inc. v. Andrew Jergens Co., 360 F.3d 1295, The subject element of the sham litigation test requires 1302 (Fed. Cir. 2004) (rejecting defense argument that chemi- showing that the objectively baseless lawsuit sought to cal analysis of product was required in pre-filing investiga- use governmental process as an anticompetitive device.
7 See Tricor, 432 F. Supp. 2d at 426 (summary judgment not sufficient to establish objective reasonableness as a matter of law); Teva Pharms. USA, Inc. v. Abbott Laboratories, Inc. 3 See Meijer, Inc. v. Barr Pharm., Inc., 572 F. Supp. 2d 38, 580 F. Supp. 2d 345, 365-366 (D. Del. 2008) (sham litigation 65 (denying summary judgment where plaintiff attempted to claim permitted as to claims that went past summary judgment define market as branded drug and its generics); Kaiser Foun- dation v. Abbott Laboratories, No. CV-02-2443-JFW, 2009 Dist.
8 See, e.g., Ethypharma S. A. France v. Abbott Labs, Inc., Lexis 107512, at *28 (C.D. Cal. Oct. 8, 2009) (granting sum- Civ. No. 08-126, 2011 U.S. Dist. LEXIS 93879, at *30 (D. Del.
mary judgment on multiple grounds, including failure of single-product market proposed by plaintiffs).
9 FDC Act § 505(q). The final FDA guidance interpreting 4 PRE, 508 U.S. at 56-57; Eastern R.R. Presidents Confer- this legislation was issued in June 2011 and is available at: ence v. Noerr Motor Freight, Inc., 365 U.S. 127, 136-37 (1961).
5 PRE, 508 U.S. at 60-61; In re Tricor Antitrust Litig., 432 GuidanceComplianceRegulatoryInformation/Guidances/ COPYRIGHT ஽ 2012 BY THE BUREAU OF NATIONAL AFFAIRS, INC.
prior to when the 30-month stay expires, meaning that Under Walker Process Equipment, Inc. v. Food Ma- only the 30-month stay arising from litigation is keep- chinery & Chemical Corp.,10 the maintenance and en- ing the generic from entering the market. Numerous forcement of a patent obtained ‘‘by knowingly and will- courts have recognized this kind of claim as stating fully misrepresenting facts to the Patent Office’’ may be the basis of monopolization claims under Section 2 of Product switching claims may give rise to claimed in- the Sherman Act. In the ANDA context, a plaintiff jury distinct from delayed generic entry. In product would invoke Walker Process where the defendant en- switching claims, which may be coupled with delay gaged in ‘‘intentional fraud’’ to obtain a patent, and claims, the claimant argues that the generic entered but then used that patent against an ANDA filer. Because could not effectively sell its product because the brand asserting an Orange Book-listed patent against an eliminated demand for the original product (that is the ANDA filer gives rise to the automatic 30-month stay, a subject of the ANDA application) and replaced it with a successful Walker Process claim, like a sham litigation new formulation. A purchaser plaintiff would claim in- claim, can give rise to injury through delay in market jury from having to pay for a higher-priced brand drug entry or legal fees, or both. Although a Walker Process rather than a generic, due to the brand drug maker’s ef- claim can co-exist with a sham litigation claim, the Fed- fectively eliminating demand for the cheaper generic eral Circuit has set a high bar for Walker Process anti- trust claims. A claimant must demonstrate additionalevidence ‘‘separable from the simple fact of the omis- Long-established federal law limits money-damages recovery to direct purchasers of goods allegedly af- fected by anticompetitive conduct. Thus, in ANDA anti- Another kind of antitrust claim that has arisen in con- trust cases, this means that only direct purchasers (i.e.
nection with ANDA litigation involves product switch- drug wholesalers, large pharmacy chains, and some in- ing. In these cases, the ANDA applicant alleges that the tegrated providers) and, if appropriate, the generic drug brand drug maker switched formulations in a manner makers themselves, can bring antitrust claims. Numer- timed to preclude generic entry. For example, the brand ous states have therefore passed laws to allow indirect may begin the process of converting the market to a purchaser antitrust claims, even though federal law new formulation during the automatic 30-month stay does not allow such claims. Plaintiffs in ANDA antitrust arising from ANDA litigation such that little or no de- cases routinely rely on these state statutes to get around mand exists for the original product when a generic re- the federal law’s bar on indirect purchaser claims.16 ceives FDA approval.12 The claimant will argue that the Given the large numbers of indirect purchasers and the brand drug maker engaged in monopolizing conduct in- cost of prosecuting claims relative to the size of most tended to exclude competition, without justification.13 (though not all) indirect purchaser claims, antitrust By contrast, the brand drug maker will argue that the plaintiffs may seek class treatment.
product changes are commercial decisions regardingimprovements that courts should not meddle in underthe antitrust laws. The Federal Circuit has not ad- dressed this kind of claim in a published, precedential decision. Both sides can point to helpful precedent fromleading antitrust cases: some where courts have refused The FTC is the primary government investigator and to review a defendant’s conduct in product line changes litigator in ANDA antitrust cases and tends to bring and others where the courts have treated such conduct what it calls ‘‘pay for delay’’ claims. In these types of claims, the FTC alleges that the brand manufacturerpays the accused patent infringer (the generic manufac- turer) to settle a patent infringement case and delay its The sham litigation claimant will claim injury be- entry into the market. The FTC argues that the brand cause the litigation delayed generic drug entry and manufacturer fears that its patent will be invalidated or caused it either to lose profits on generic drug sales (ge- the generic found not to infringe, so to avoid that result neric drug makers) or to pay more for the brand drug it ends the case prematurely by paying off the generic rather than a less expensive generic (generic drug pur- drug maker. The generic, so the FTC argues, gets a pay- chasers). Specifically, when the patentee brings such an ment that compensates (or more than compensates) it ANDA case, it benefits from an automatic 30-month for any profits it would have made had it entered the stay on the FDA’s authority to approve the generic market. Thus, the brand keeps a steady flow of mo- drug. This delay arises because the FDA often will grant nopoly products, the generic receives a payment, and ‘‘tentative approval’’ to a generic drug some months the consumers are left still paying brand prices. TheFTC argues that this amounts to an anticompetitivescheme in violation of Section 2, or alternatively that the settlement agreement is a per se violation of Section 11 Dippin’Dots, Inc. v. Mosey, , 476 F.3d at 1348 (Fed. Cir.
12 See e.g., Tricor, 439 F. Supp. 2d at 423-424; Walgreen Co. v. AstraZeneca Pharm., L.P. 534 F. Supp. 2d 146, 152-153 15 See e.g., King Drug Co. of Florence, Inc. v. Cephalon, Inc. (D. D.C. 2008); In re: Omeprazole Patent Litig., MDL No. 1291, 702 F. Supp. 2d 514, 537 (E.D. Pa. 2010); Tricor, 432 F. Supp.
2010 U.S. Dist LEXIS 50049 (S.D.N.Y. May 19, 1010).
2d at 428; In re: Wellbutrin SR/Zyban Antitrust Litig. 281 13 Tricor, 439 F. Supp. 2d at 431.
F. Supp. 2d 751, 755 (E.D. Pa. 2003).
14 See e.g., Microsoft, 253 F. 3d at 65-66; Berkey Photo, Inc., 16 See e.g., In re: Wellbutrin XL Antitrust Litig., 260 F.R.D.
v. Eastman Kodak Co. 603 F. 2d 263, 287, n. 39.
PHARMACEUTICAL LAW & INDUSTR Y REPOR T A main tenet of the FTC theory is that in order to as- versed.19 The Eleventh Circuit ruled that, when analyz- sess anticompetitive intent and effect, the fact finder ing the anticompetitive effects of ANDA settlements, should investigate the strength of the brand’s patent the district court was required to—but failed to— claims and the status of the underlying patent litigation.
determine whether the alleged anticompetitive effects If the brand had very weak claims and had lost key ar- of the settlement are broader than the exclusionary ef- guments, such as claim construction, and then settled fects of the patent.20 On remand, the district court again with a large payment to the accused infringer, the FTC granted summary judgment in favor of plaintiffs on believes it would show anticompetitive intent and ef- their Section 1 claim, again finding the agreement per se illegal because it exceeded the scope of the patent As discussed in the cases below, the main problem protection.21 After the District Court rendered its deci- with the FTC theory is that the courts generally have sion, Abbott settled with most of the plaintiffs.22 not agreed. Courts have repeatedly found that a patent 2. FTC v. Hoechst Marion Roussel/Andrx23 holder may settle patent litigation or license a patent onmost any terms it chooses. The key fact for the court to In one of the first cases to be litigated, the FTC consider in looking at antitrust claim is whether the charged that Hoechst Marion Roussel (now Aventis), terms of the settlement exceed the bounds of the patent: the maker of Cardizem CD, a widely prescribed drug does it cover other products or a longer period of time for treatment of hypertension and angina, paid Andrx than the patent, thus extending the patent monopoly.
Corporation over $80 million to refrain during the pen- Barring such an over-extension of the patent term, dency of patent litigation from bringing to market any courts have generally found that the lawful monopoly competing generic drug, without regard to whether it afforded by the patent precludes the FTC’s theory.
was allegedly infringing. This case was settled beforetrial, and the Commission issued final consent orderson May 11, 2001. The orders entered against Hoechst and Andrx contain relief similar to that in the Abbottand Geneva orders.
1. FTC v. Abbott Laboratories And Geneva Direct and indirect purchasers also sued Hoechst and Andrx alleging that plaintiffs were harmed because, but One of the first FTC ANDA antitrust actions involved for the reverse exclusionary payments, Andrx would an investigation and settlement with the FTC. In FTC v. have brought its generic product to market once it re- Abbott and Geneva, the FTC alleged that Abbott paid ceived FDA approval. The district court granted partial Geneva approximately $4.5 million per month to keep summary judgment to plaintiffs that the Hoechst-Andrx Geneva’s version of Abbott’s patented drug Hytrin off agreement was per se illegal, and, on appeal, the Sixth the market. Geneva was at the time in patent litigation Circuit agreed.24 The Sixth Circuit reasoned that the over the tablet form of Hytrin; but due to Abbott’s fail- agreement prohibited Andrx from marketing compet- ure to timely file litigation, there was no litigation and ing generic drugs that were not infringing, thereby ex- no 30-month stay as to the capsule form of the drug.
ceeding the exclusionary effect of Hoechst’s patent.25 Geneva received FDA approval to market the capsule Shortly after the Sixth Circuit’s ruling, the District Court granted final approval to an $80 million settle- According to the complaint, Geneva agreed not to en- ment for the state law private plaintiffs and the state at- ter the market with any generic version of Hytrin (tab- let or capsule), even if it were non-infringing, until cer- 3. FTC v. Watson Pharmaceuticals, Inc.27 tain triggering events. The provisions ensured that no In January 2009, the FTC, joined by direct purchas- other company’s generic version of Hytrin could obtain ers, indirect purchasers, and the State of California, FDA approval and enter the market during the term ofthe agreement, because Geneva’s agreement not tolaunch its product meant the 180-day exclusivity period 19 Valley Drug Co. v. Geneva Pharms., 344 F.3d 1294, 1304 Under the terms of the FTC settlement obtained in May 2000, Geneva was required to waive its right to a In re Terazosin Hydrochloride Antitrust Litig., 352 180-day exclusivity period for the tablet formulation F. Supp. 2d 1279, 1285-86 (S.D. Fla. 2005).
22 See In re Terazosin Hydrochloride Antitrust Litig., No.
such that other generic Hytrin products could immedi- 99-7143, 2005 U.S. Dist. LEXIS 43082 (S.D. Fla. Apr. 19, 2005).
ately enter the market. Part of what the FTC found par- Plaintiff Kaiser Foundation Health Plan went to trial and the ticularly troubling was that Geneva made agreements jury rendered a verdict in favor of Abbott. See Judgment, Kai- as to the capsule form even though that product was not ser Found. Health Plan, Inc. v. Abbott Labs., No. 02-2443 (C.D.
Subsequent to the FTC settlement, private litigants brought suit over the same conduct against Abbott and In re Cardizem CD Antitrust Litig., 332 F.3d 896, 915 (6th Geneva. The private parties alleged that they had been damaged by their inability to buy or sell a lower cost ge- 26 In re Cardizem CD Antitrust Litig., 218 F.R.D. 508 (E.D.
neric during the 16 months that the agreement was in Mich. October 10, 2003), aff’d in part, dismissed in part, 391 place. Although the district court initially granted plain- F.3d 812 (6th Cir. 2004). The Sherman Act plaintiffs (i.e., the tiffs’ motion for partial summary judgment on a theory direct purchasers) had previously settled in 2002 with Andrx that the Abbott-Geneva agreement was per se illegal and Aventis Pharmaceuticals for $110 million.
under § 1 of the Sherman Act, the Eleventh Circuit re- 27 (‘‘Generic AndroGel’’), CV-09-00598 (civil complaint filed in U.S. District Court for the Central District of Califor-nia, January 27, 2009), FTC File No. 0710060; In Re: AndroGel 17 FTC File No. 981 0395. Docket No. C-3945.
Antitrust Litigation (No. II), MDL Docket No. 2084 (All Cases), 18 http://www.ftc.gov/speeches/anthony/sfip000601.shtm 1:09-MD-2084-TWT (N.D. Ga. Feb. 22, 2010) COPYRIGHT ஽ 2012 BY THE BUREAU OF NATIONAL AFFAIRS, INC.
filed suit against Watson Pharmaceuticals, Par Pharma- condemned as a per se unreasonable restraint of ceutical Companies, Paddock Laboratories, and Solvay trade.’’31 After the district court issued its order, Barr Pharmaceuticals. The complaint challenged agree- settled with the remaining plaintiffs for $13 million.32 ments in which Solvay allegedly paid generic drug mak-ers Watson and Par to delay generic competition to 5. FTC v. Schering-Plough Corporation33 Solvay’s branded testosterone-replacement drug An- The FTC complaint alleged that Schering-Plough Corporation, Upsher-Smith Laboratories and American In February 2010, the district court granted defen- Home Products Corporation entered into anticompeti- dants’ motions to dismiss the FTC complaint.28 The tive agreements in which Schering paid Upsher and court held that the extent of the settlement’s exclusion- American Home Products to forgo launching a competi- ary effect is the only relevant issue, not the presence of tive generic alternative to K-Dur 20, an extended- reverse payments or the possible subsequent invalidity release potassium chloride supplement manufactured of the patent. The court found that any alleged exclu- by Schering. According to the complaint, Schering and sionary effects from the settlement fell within the scope Upsher reached an agreement in 1997 to settle a patent of the purported patent and accordingly dismissed the infringement lawsuit, whereby Schering paid Upsher $60 million dollars and Upshur agreed not to marketany generic version of K-Dur 20 until September 2001.
4. FTC v. Warner Chilcott Corp. and Barr Under the agreement, Schering received licenses to market five of Upsher’s products, but despite this fact The FTC filed a complaint against Warner Chilcott the complaint charged Schering paid Upsher to secure and Barr concerning an agreement allegedly to prevent its agreement to the 2001 entry date, and to ensure that entry of Barr’s generic version of Warner Chilcott’s no other company’s generic K-Dur 20 could obtain FDA Ovcon 35 oral contraceptive. In 2004 Warner Chilcott agreed to pay Barr $20 million in exchange for Barr’s The case as to Schering and Upsher was tried before delaying entry of its generic version of Ovcon for five an FTC administrative law judge (ALJ). In an initial de- years. The FTC filed for a preliminary injunction in Sep- cision issued in June 2002, the ALJ ruled that Scher- tember 2006, because it believed that Warner Chilcott ing’s payments to Upsher were solely for licenses to Up- was planning to launch a new chewable version of sher’s products and not in exchange for agreement to Ovcon, switch patients over to the new product, and the 2001 entry date. The ALJ also held that complaint then stop selling Ovcon. Because generic substitution counsel could not prevail absent proof that Upsher and would be unavailable if regular Ovcon was no longer American Home Products did not infringe Schering’s available at the pharmacy, the FTC believed this switch patent. In addition, the ALJ found that the relevant strategy would have destroyed the market for generic product market was all oral potassium supplements, Ovcon. Shortly after the FTC filed the request for a pre- and that Schering did not have monopoly power in that liminary injunction, Warner Chilcott abandoned the market. Complaint counsel appealed to the full Com- provision in the 2004 agreement that prevented Barr from entering the market with its generic version, and On December 8, 2003, the FTC reversed the ALJ’s de- Barr launched its generic version. In settling with the cision. It ruled that Schering paid Upsher to delay the FTC, the companies agreed not to enter into any agree- entry of generic competition, and not merely for the products licensed. The FTC also ruled that Schering’s Direct purchasers and their assignees also sued, al- agreements with both Upsher and AHP were anticom- leging that the Warner Chilcott-Barr agreement delayed petitive because Schering’s payments resulted in the entry of Barr’s generic version of Ovcon. After the greater protection from competition than the parties ex- district court granted an amended class, Warner pected from continued litigation. In addition, the FTC Chilcott settled with the direct purchasers for $9 mil- considered it not necessary or desirable to adjudicate lion. The district court later denied the remaining plain- the merits of the underlying patent disputes in order to tiff’s summary judgment motion, and granted in part assess the competitive effects of the agreements.
defendants’ summary judgment motion, ruling that the Schering Plough appealed the FTC decision. In 2005, agreement was not per se illegal, but must instead be the Eleventh Circuit set aside the FTC decision, and va- evaluated under the rule of reason.30 The court ex- cated the cease and desist order. The Eleventh Circuit plained that it was unable to determine on summary held the FTC did not establish that the challenged judgment whether the proper market was Ovcon and its agreements restricted competition beyond the exclu- generic equivalent—as plaintiffs alleged—or branded sionary effects of Schering’s patent, which it believed to and generic contraceptives—as defendants alleged.
be the appropriate test. The FTC petitioned for a rehear- ‘‘Because the economic effects of the Agreement de- ing en banc and then to the Supreme Court, both of pend on the proper definition of the market (and the competitive effects therein), the Agreement cannot be 31 Meijer, Inc. v. Barr Pharms. Inc., 572 F. Supp. 2d 38, 50 28 In re AndroGel Antitrust Litigation, MDL No. 2084, 2010 WL 668291 (N.D. Ga. Feb. 22, 2010). The court granted in part 32 Final Judgment, Meijer, Inc. v. Barr Pharms. Inc., No. 05- and denied in part some of the motions to dismiss the com- 2195 (D.D.C. Apr. 20, 2009), ECF No. 210.
33 Docket 9297, Initial Decision issued June 26, 2003, rev’d 29 Civil Action No. 1:05-CV-2179-CKK (D.D.C) (complaint by Commission Decision and Order, December 8, 2003 (136 filed November 7, 2005, amended complaint filed December 2, F.T.C. 956 (2003)); rev’d 402 F.3d 1056 (11th Cir. 2005); order denying rehearing en banc issued May 31, 2005 (Pet. App. 36a- 30 Meijer, Inc. v. Barr Pharms. Inc., 572 F. Supp. 2d 38, 40 153a (unreported); Petition for Certiorari filed August, 2005, PHARMACEUTICAL LAW & INDUSTR Y REPOR T Direct purchasers also challenged the agreement as a over a decade in order to delay generic competition and reverse exclusionary payment under § 1 of the Sherman maintain its monopoly over the anti-anxiety drug, BuS- Act. On March 24, 2010, the district court granted par, and two anticancer drugs, Taxol and Platinol. The Schering-Plough’s and Upsher-Smith’s motions for allegations as to the three drugs were similar, alleging summary judgment.34 The court found Schering- that Bristol-Myers Squibb paid potential generic com- Plough’s payments to settle the patent lawsuits were petitors to settle patent litigation to prevent introduc- not per se illegal.35 The court explained that the reverse tion of generic competitors, filed false information with payment agreements were within the exclusionary the FDA in order to list patents in the Orange Book, scope of the patent because they permitted Upsher- thereby automatically obtaining additional 30-month Smith to market a generic version of K-Dur 20 for ap- stays, and filed baseless patent infringement suits proximately five years before the patent expired and against potential generic competitors.
ESI Lederle, Inc. to market a generic for approximately The case settled with a consent order that prohibited three years before the patent expired.36 Plaintiffs’ ap- Bristol-Myers Squib from late listing patents in the Or- peal is currently pending before the Third Circuit.
ange Book after ANDA applications have been filed, aswell as a prohibition against listing any patent relating to products with the same active ingredient, or taking The FTC and private plaintiffs filed complaints any action that would trigger an additional 30-month against Cephalon for engaging in an overall course of stay of a generic form of Taxol or BuSpar.
anticompetitive conduct to prevent generic competitionto Provigil. The complaint alleged that Cephalon paidthe generic manufacturers over $200 million dollars to B. FTC Cases Under Other Exclusionary Conduct abandon the patent litigation and agree to refrain from selling a generic version of Provigil until 2012. Accord-ing to the complaint, the agreements not only prevented Not all FTC cases involve brand-generic settlements.
competition from the first filers but also blocked com- In FTC v. Mylan39 the FTC charged Mylan Laboratories petition from other generic manufacturers because of with restraining competition through exclusive licens- the 180-day exclusivity held by the first filers under the ing arrangements for the supply of the raw material necessary to produce the lorazepam and clorazepate In March 2010, the district court denied the defen- tablets, thereby allowing Mylan to dramatically in- dants’ motion to dismiss.37 The court declined to apply crease its prices. The FTC was joined in this action by per se treatment as urged by the FTC, but found suffi- 34 state attorneys general. The FTC filed this case in cient allegations that the settlement exceeded the exclu- federal court under Section 13(b) of the FTC Act seek- sionary rights of the Cephalon patent. The FTC alleged ing injunctive and other equitable relief, including dis- facts suggesting that Cephalon knew that its patent was gorgement of ill-gotten profits. Mylan ultimately settled invalid and unenforceable when it brought its infringe- the case, agreeing to pay $100 million for distribution to ment claim, thus the alleged sham litigation exceeded direct purchasers, injured consumers, and state agen- the scope of the patent. The court found the patent scope could have been exceeded by settlement provi- In FTC v. Biovail Corporation40 the FTC charged Bio- sions prohibiting the marketing of future and different vail with illegally acquiring the exclusive license to a generic forms of Provigil than the one that allegedly in- drug patent in order to prevent generic competition for its anti-hypertension drug Tiazac. The parties settledthe matter and Biovail agreed to divest part of the ex- clusive rights of the acquired patent back to the original In this action, the FTC alleged that Bristol-Myers owner, and to refrain from taking any action that would Squibb engaged in a pattern of anticompetitive activity trigger an additional 30-month stay. Andrx, the genericmanufacturer, filed an antitrust action against Biovail, alleging that Biovail unlawfully delayed the approval of In re K-Dur Antitrust Litig., No. 01-1652, 2009 U.S. Dist.
LEXIS 126249 (D.N.J. Feb. 6, 2009), adopted by 2010 U.S. Dist.
Andrx’s ANDA. In February 2002, Andrx and Biovail settled, agreeing that Biovail would give Andrx a non- exclusive license to its patents and Andrx would pay Biovail royalties on Andrx’s generic Tiazac product.
37 King Drug Co. of Florence, Inc. v. Cephalon, Inc., No.
2:06-CV-1797, 2010 U.S. Dist. LEXIS 29905 (E.D. Pa. Mar. 29,2010).
COPYRIGHT ஽ 2012 BY THE BUREAU OF NATIONAL AFFAIRS, INC.

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