In re cipro cases i & ii petition for review

ESQ. (199643), JORDAN ELIAS, ESQ. (228731), DEAN M. HARVEY, ESQ. (250298), LIEFF CABRASER
HEIMANN & BERNSTEIN, LLP, San Francisco, California, DAN DRACHLER, ESQ. (pro hac vice), ZWERLING,
KALFAYAN BENINK & SLAVENS, LLP, San Diego, California, Attorneys for Plaintiffs-Appellants and all others
similarly situated.
EXPERT NAME: Michael H. Jester
TITLE: Petition for Review
1. Does the law of California forbid a pharmaceutical patent holder from paying its competitors hundreds of millions of dollars-part of its monopoly profits-in exchange for their agreement not to sell cheaper competitive genericdrugs? 2. Do the facts of this case demonstrating egregious patent misuse in the form of a large cash payment, made to head off likely invalidation, that drove up prescription drug prices in an area critical to social welfare, preclude federalpreemption of California law? 2012 CA S. Ct. Briefs 98616; 2011 CA S. Ct. Briefs LEXIS 1902, *1 3. Are the trial court and reviewing court required to expressly rule on evidentiary objections raised at summary judgment under [*2] this Court's decision in Reid v. Google, Inc. (2010) 50 Cal. 4th 512? WHY REVIEW SHOULD BE GRANTED
This Court's review is necessary to establish the law of California with respect to the anticompetitive conduct of pharmaceutical manufacturers under the Cartwright Act, Business and Professions Code section 16700, et seq., and theUnfair Competition Law ("UCL"), Business and Professions Code section 17200, et seq. This appeal presents issues of vital importance to the people of California. The claims focus on Bayer's $ 398.1 million payoff to Barr and others for the explicit purpose of preventing Barr from entering the market and sellinggeneric Cipro at low prices. With prescription drug prices continuing their unchecked rise, drug companies owningprescription drug patents must not be permitted to suppress competition by buying off their would-be rivals. That is whythe California Attorney General's Office has denounced anticompetitive agreements like the one at issue here, findingthey cause "collusive delays" n1 to generic drug competition and the availability of affordable prescription medicines.
n1, at p. 3 (Appellants' Appendix ("AA"), vol. 10, at2337).
The Court of Appeal erroneously blessed Bayer's $ 398.1 million payment to Barr-made to secure Barr's express agreement not to compete or sell affordable generic versions of the antibiotic Cipro for nearly seven years. The paymentwas wrong-way or "reverse" in that Barr, the defendant in the litigation whose generic formulation allegedly infringedthe Cipro patent, received massive consideration instead of paying a dime. Bayer made the payment to avoid trial onBarr's invalidity counterclaim and the resulting patent invalidation that would have taken away its monopoly profits.
This was wrong.
In affirming a grant of summary judgment to these companies, Defendants in this action, the Court of Appeal accepted a misdirected line of recent federal authority that has no place in California jurisprudence. This Court shouldgrant review to prevent the adoption of this flawed line of federal decisions as the law of California. If these decisionswere to become the law of California, the aggrieved patients and consumers who make up this Class, and who paid highprices for Cipro from 1997 to 2004, would be denied their right to pursue recovery of hundreds of millions of dollars in[*4] illegal overcharges.
Denial of review would pave the way for competitors to continue flaunting California law and public policy.
"Pay-for-delay" deals result in American consumers paying an additional $ 3.5 billion every year in inflated prescriptiondrug costs. n2 The present case involves the largest such deal of all time. n3 There is no better vehicle than this case tosafeguard and promote consumer access to reasonably priced prescription drugs.
n2, at p. 2.
n3, at p. 9 (10AA2261).
The Court of Appeal held that Bayer's ownership of a Cipro patent immunized Bayer from Cartwright Act liability, even though the patent had never been upheld in court at the time of Bayer's payment, and even though Bayer's paymentallowed it to share its monopoly-and monopoly profits- with its competitors. The Court committed numerous errors. It 2012 CA S. Ct. Briefs 98616; 2011 CA S. Ct. Briefs LEXIS 1902, *4 misapplied California law and gave [*5] no weight to the harm Bayer's payment not to compete inflicted on patientsand consumers in California. The opinion turned a blind eye to Defendants' naked horizontal market allocation, whichled to drastic price increases borne by California citizens. Such agreements are per se illegal under the Cartwright Act.
In deferring to recent federal decisions, the opinion failed to address applicable high court authority, including decisionsof this Court, and ignored that in legitimate litigation, the patent holder does not pay the alleged infringer to settle. Theopinion also misunderstood patent law, allowing a private agreement surrounding an untested-and unenforceable-patentto supply the same bulwark against competition as a fully litigated patent upheld on its merits. Indeed, the $ 398.1million payment to the patent challenger here is the functional equivalent of a victory by the entity asserting the patentwas invalid. But consumers gained no benefit and ultimately funded the settlement.
The reasoning and result below are abhorrent to the central purposes of the Cartwright Act: requiring competition and protecting consumers from monopolists. See Bus. & Prof. Code section [*6] 16700, et seq.; Marin County Bd. ofRealtors, Inc. v. Palsson (1976) 16 Cal. 3d 920, 935 ("Antitrust laws are designed primarily to aid the consumer."). Thedecision also offends the California public policy and public interest with respect to health care. In particular, healthcare occupies "a special moral status and therefore a particular public interest" in California, as this Court held, and theLegislature declared, "[a]ffordability is critical in providing access to prescription drugs for California residents,particularly the uninsured and those with inadequate insurance." Potvin v. Met. Life (2000) 22 Cal. 4th 1060, 1070;Health & Safety Code § 130500; Stats. 2006, c. 619, s. 1(A.B. 2911).
Further, if adopted as the law of California, the Court of Appeal's holding would vitiate California's patent abuse doctrine, under which California courts have long recognized that a patent holder can be found to violate the CartwrightAct through unlawful acts, even acts confined to the patent parameters. The doctrine looks to whether a patent wasmisused in subversion of the public interest. See Pages 10-19, infra. The Court of Appeal ignored [*7] this completely.
A jury could reasonably find that Bayer's payment was made to avoid invalidation of its Cipro patent and the price competition that would have resulted. The size of the payment (far more than Bayer's competitors stood to earn fromgeneric Cipro sales in a competitive market), and the clear proof of Defendants' intent to foreclose competition, raise aninference of unlawful patent abuse and support a finding of Cartwright Act liability.
Payoffs to generic drug competitors are troubling. First, they eliminate competition. Second, they foreclose the testing of patents, a core focus of the case law regarding patents and patent litigation. n4 Third, they lead to higher drugprices, adversely affecting the public health and welfare. n5 See Brief Amici Curiae of 78 Intellectual Property Law,Antitrust Law, Economics, and Business Professors in Support of Appellant, filed in the Court of Appeal on November29, 2010. Fourth, in the area of pharmaceutical pricing, such payments blocking generic competition directly underminethe purpose of the Drug Price Competition and Patent Term Restoration Act of 1984 ("Hatch-Waxman Act"), 21 U.S.C.
§ 355
, which [*8] was designed to "get generic drugs into the hands of patients at reasonable prices-fast." In re BarrLabs., Inc. (D.C. Cir. 1991) 930 F.2d 72,76. n4 Far from being sacrosanct, patents, especially pharmaceutical patents, are frequently challenged andinvalidated. (6AA 1177.)n5 Scientific studies in peer-reviewed journals have found that many patients do not take some or all of theirprescribed medicine when it is too expensive and becomes unaffordable. See, e.g., Emily R. Cox, et al.,Medicare Beneficiaries' Management of Capped Prescription Benefits, Medical Care, vol. 3, at 296 (2001)(finding that 23.6 percent of Medicare beneficiaries who were at risk of reaching their prescription cap took lessthan the prescribed amount of medication, 16.3 percent stopped using medications, and 14.7 percent wentwithout food, clothing, or shelter) (9AA 1999; see also 9AA 1970-2002).
The California Attorney General's Office, thirty-seven other state attorneys general, the Federal [*9] Department of 2012 CA S. Ct. Briefs 98616; 2011 CA S. Ct. Briefs LEXIS 1902, *9 Justice and the Federal Trade Commission have beseeched courts to overrule the rule applied below, as have a broadarray of public policy, consumer protection and other non-profit organizations: the American Medical Association;AARP; the American Antitrust Institute; Consumers Union; the National Association of Chain Drug Stores;Prescription Access Litigation; Consumer Federation of America; the Public Patent Foundation; the NationalLegislative Association for Prescription Drug Prices; and U.S. PIRG.
The Court of Appeal's secondary, wide-reaching federal preemption ruling might be even more disturbing than its unquestioning adoption of the unsound federal standard. The preemption ruling will unwisely and unduly limit theability of California courts to adjudicate disputes touching upon issues of patent law. See Pages 19-24, infra. The Courtof Appeal incorrectly determined that Petitioners' basis for seeking liability conflicts with federal law. Rather, theFederal Trade Commission has found that, under federal law, these kind of anticompetitive "pay-for-delay" agreementsrepresent "one of the greatest threats American consumers face today." n6 n6, at p. 4 (10AA 2182).
To counteract that threat, to settle legal issues of vital importance to California patients, consumers and public law enforcement officials, to provide guidance to litigants in California and throughout the United States where Californialaw is applied, and to establish the proper balance between California competition law and federal patent law, this Courtshould grant review and resolve the question of first impression presented by this appeal. The opinion below should bevacated and the grant of summary judgment reversed so the claims may proceed to trial, consistent with a correctunderstanding of California law.
These Cartwright Act claims derive from agreements among several competitors. Defendants Bayer AG and Bayer Corp. ("Bayer") held the patent to the blockbuster anti-infection drug ciprofloxacin hydrochloride ("Cipro"). In late1996, Bayer stood at a crossroads. Its internal financial projections showed it would earn at least $ 1,614 billion inmonopoly profits if it could continue to sell Cipro without competition through December 2003. However, after fiveyears of a patent infringement action against a generic competitor, Defendant Barr Laboratories, [*11] Inc. ("Barr"),Bayer faced trial on Barr's counterclaims that the Cipro patent was invalid and unenforceable. Discovery in that case,including the testimony of Bayer's patent lawyers, established that Bayer deliberately concealed prior art from the U.S.
Patent and Trademark Office ("PTO"), rendering the Cipro patent void, unenforceable, and incapable of being infringed.
Trying to rebut this and other evidence of bad faith, Bayer was reduced to claiming those lawyers suffered from mentalinfirmities that made their testimony incredible. (7AA 1478-79.) Confronting the likelihood that it would lose a trial on the merits-and the resulting "patent destruction," the phrase used in a Bayer Board presentation (1AA 150)-Bayer projected that nearly a billion dollars in corporate profits were atrisk. Affordable generic medicine would capture 90 percent of the Cipro market within one year, and "there is nocredible cost reduction strategy that would overcome such a massive hemorrhage," a Bayer vice-president wrote. (6AA1283.) Rather than compete, Bayer conspired. Bayer paid Barr and its financial backers a $ 398.1 million bribe to droptheir patent challenge and terminate their efforts to [*12] compete with Bayer. (4AA 701-813.) This was an offer Barrcould not refuse: it was more than double the $ 148 million to $ 177 million Barr predicted it would earn selling genericciprofloxacin in a competitive market through 2003. (6AA 1203; 10AA 2352-2401.) After making this large payment to secure the generics' agreement to stay out of the market, Bayer increased the price of Cipro by 16 percent. (6AA 1167.) Between 1997 and 2003, Bayer gained revenues of approximately $ 5.717billion, and profits of approximately $ 4.859 billion, from sales of Cipro tablets including to the California residents 2012 CA S. Ct. Briefs 98616; 2011 CA S. Ct. Briefs LEXIS 1902, *12 who make up the Class here. (6AA 1202.) Pursuant to their agreement, Bayer funded the payment to Barr and others bycharging supra-competitive prices for Cipro.
Petitioners represent the certified Class of "hundreds of thousands" of California consumers and third-party payor insurers who purchased Cipro during the Class period. In re Cipro Cases I and II (Fourth Dist. 2004) 121 Cal. App. 4th402,408. Petitioners filed their consolidated amended complaint on August 5, 2002, alleging violations of theCartwright Act, the UCL, and the common law doctrine prohibiting monopolistic [*13] acts. The case was removed tofederal court, then remanded to Superior Court in San Diego.
The Superior Court granted the Defendants' motions for summary judgment on August 21, 2009, entering final judgment on September 24, 2009. The Court of Appeal affirmed, in an opinion issued on October 31, 2011. Neither theSuperior Court nor the Court of Appeal applied the antitrust law of California. Instead, they limited the Cartwright Actby adopting the rule from the heavily criticized majority opinion in In re Tamoxifen Citrate Antitrust Litigation (2d Cir.
2006) 466 F.3d 187
Whether California law forbidding payments not to compete should be limited by Tamoxifen presents an important question, a question of first impression.
In evaluating Cartwright Act claims, "federal precedents must be used with caution because the acts, although similar, are not coextensive." Freeman v. San Diego Ass'n of Realtors (Fourth Dist. 1999) 77 Cal. App. 4th 171,183 n.9(citation omitted). The Legislature enacted the Cartwright Act in 1907 "in reaction to perceived ineffectiveness" of theSherman Act. ABA SECTION OF ANTITRUST [*14] LAW, STATE ANTITRUST PRACTICE AND STATUTES,California 6-1 (3d ed. 2004). The Cartwright Act supplies the utmost protection to California citizens, "maximizingeffective deterrence of antitrust violations." Clayworth v. Pfizer, Inc. (2010) 49 Cal. 4th 758, 764. The most recent federal appellate court to have reviewed the Tamoxifen standard expressed grave reservations about its soundness: "we believe there are compelling reasons to revisit Tamoxifen " Arkansas Carpenters Health andWelfare Fund v. Bayer AG (2d Cir. 2010) 604 F.3d 98, 110. That court, however, was bound by its prior decision inTamoxifen, and thus unable to reach a different conclusion. Id. at 108. This Court, on the contrary, is not so bound. n7This standard cannot be reconciled with long-settled principles of antitrust law and patent law and should be rejected forCalifornia.
n7 Tamoxifen adopted a rule of per se legality that gives a free pass to an exclusion-payment settlement exceptwhere: (1) the agreement goes outside the "exclusionary zone" of the patent; (2) the infringement suit was asham; or (3) the patent was fraudulently procured. 466 F.3d at 213. Additionally, the preemption holding will allow litigants to deny access to California courts simply by invoking a patent law element to otherwise redressable business and consumer disputes.
Finally, the evidentiary ruling overlooks precedent of this Court.
A. The Court of Appeal Wrongly Eliminated the Ability of a Reasonable California Jury to Find the Cipro
Market Exclusion Payment Unlawful.
Triable issues of fact exist under the Cartwright Act. Bayer's anticompetitive agreements and $ 398.1 million payment violate the Cartwright Act. The agreements obtained more exclusion than was warranted in light of the 2012 CA S. Ct. Briefs 98616; 2011 CA S. Ct. Briefs LEXIS 1902, *15 prospect of patent invalidation. As a result, the agreements unreasonably restrained trade. See Bus. & Prof. Code section16700, et seq. The court below erroneously concluded that a patent-based agreement is immune from antitrust scrutiny if the agreement does not affect rights outside the patent's own parameters. See, e.g., Opinion at 38 ("We conclude thatbecause the Cipro agreements undisputedly did not restrain competition beyond the exclusionary scope of the . patent,they do not violate the Cartwright Act."). This is incorrect. While a patent [*16] may confer a limited monopoly, it alsocreates opportunities for abuse. When such abuse has occurred, restraints beyond a patent's technical scope are notnecessary to a finding of liability. It is settled that the antitrust law prohibits a patent owner from entering into anyagreement, even one limited to the patent's scientific and temporal scope, that unreasonably restrains trade. The courtbelow relied on a different, erroneous understanding to foreclose application of the Cartwright Act to address the Ciproagreements' unreasonably anticompetitive purpose and effect.
Consider four seminal cases that go unmentioned in the Court of Appeal's opinion. First, in United States v. Univis Lens Company (1942) 316 U.S. 241, 248-49, the U.S. Supreme Court deemed it "unnecessary" to antitrust liability todetermine whether the defendant's patents covered the products subjected to vertical price restraints.
Second, in United States v. Sealy, Inc. (1967) 388 U.S. 350, 356 n.3, the Court held that it was "not consequential" whether the scheme to allocate markets affected activity "beyond the protection of the trademark[.]" Third, the patent-based price-fixing [*17] agreement found unlawful in United States v. Masonite Corp. (1942) 316 U.S. 265, 376, did not confer any "monopoly or restraint other than the monopoly or restraint granted by thepatents[.]" The Masonite Court explained that, in cases where antitrust and patent law intersect, the rights and welfare of the community must be fairly dealt with and effectually guarded.
Considerations of individual emolument can never be permitted to operate to the injury of these. Thatmust be the point of departure for decision on the facts of cases such as the present one lest the limitedpatent privilege be enlarged by private agreements so as to by-pass the Sherman Act. Active andvigorous competition then tend to be impaired not from any preference of the public for the patentedproduct but from the preference of the competitors for a mutual arrangement.
316 U.S. at 278, 281. That aptly describes what happened here. n8 n8 Judge Easterbrook has described Masonite in terms particularly appropriate to application in this case:"Several makers of particle board reached an agreement under which all but Masonite retired from the business;those who quit became Masonite's 'del credere agents' and sold its product at fixed prices. This was horizontal inan economically meaningful way. Producers to which consumers might turn for supply suddenly withdrew fromthe market. With supply down price had to rise, producing a monopoly overcharge. Although the (former) rivalscontended that they were just knuckling under to the force of Masonite's patents, the Supreme Court saw a moresinister arrangement-properly so unless the patent was both broad and iron-clad, which could not be known oncethe former rivals started cooperating." Illinois Corporate Travel v. American Airlines (7th Cir. 1989) 889 F.2d751,753. While the Cipro patent may have been broad, the evidence shows it was far from iron-clad. Indeed,Bayer paid as much as it did in clear-eyed recognition of the likelihood of invalidity. Fourth, the Court of Appeal also failed to mention the seminal decision in United States v. Singer Mfg. Co. (1963) 374 U.S. 174, involving a clear antitrust violation: American, Italian, and Swiss sewing machine companies arrived atpatent settlements to head off an open destructive fight over validity. 374 U.S. at 180,185. "There is a public interest 2012 CA S. Ct. Briefs 98616; 2011 CA S. Ct. Briefs LEXIS 1902, *18 here," Justice White wrote in concurrence, "which the parties have subordinated to their private ends" throughagreements "between business rivals to encroach upon the public domain and usurp it to themselves." Id. at 200 (White,J., concurring). That is what happened here.
As these and other cases demonstrate, a patent holder "may commit patent misuse in improper exploitation of the patent either by violating the antitrust laws or extending the patent beyond its lawful scope." Transitron Elec. Corp. v.
Hughes Aircraft Co. (D. Mass. 1980) 487 F. Supp. 885, 893
(emphasis added). The present case involves the former,not the latter situation-and the question of whether Bayer misused its patent is for the jury.
Despite the triable issues arising from the Cipro agreements and from [*19] Bayer's $ 398.1 million payment to avert competition, the Court of Appeal held that the payment deserves a presumption of legality because it was made tosettle litigation and the law generally favors settlement. n9 See Opinion at 28-30. To the contrary, California law doesnot authorize or condone settlements that violate public policy, particularly a settlement where competitors are paid offto prevent competition. Timney v. Lin (First Dist. 2003) 106 Cal. App. 4th 1121, 1127; River Garden Farms, Inc. v.
Super. Ct. (Third Dist. 1972) 26 Cal. App. 3d 986, 1000; see also Singer, 374 U.S. 174
(patent settlements violated theantitrust laws).
n9 There is no California statute-or for that matter a federal analogue-that specifically authorizes or protectssettlements.
Apparently, the Court of Appeal was concerned that scrutiny of these agreements under antitrust law might chill patent litigation or settlements. See Opinion at 35-36. The concern [*20] is entirely misplaced. For example, the recordshows that pharmaceutical companies do not need to make cash payments in order to settle patent litigation. Between2000 and 2004-when such payments were held to be per se illegal under In re Cardizem CD Antitrust Litigation (6thCir. 2003) 332 F.3d 896-"not one of twenty reported agreements involved a brand firm paying a generic filer to delayentering the market. During this period, parties continued to settle their disputes, but in ways less restrictive ofcompetition, such as through licenses allowing early generic entry." Michael A. Carrier, Unsettling Drug PatentSettlements: A Framework for Presumptive Illegality, 108 MICH. L. REV. 37, 75 (2009). During this period, when suchagreements were treated as illegal and pharmaceutical companies conducted themselves accordingly, the patent systemcontinued to operate, innovation continued, new products came to market and parties litigated their patent disputes incourt, settling virtually all of them. In contrast, the subsequent retreat by certain federal courts from the Cardizemregime has led to growing numbers of anti-consumer "pay-for-delay" [*21] settlements featuring monetaryconsideration. Fourteen such deals were reached in 2007, 16 in 2008, 19 in 2009, 31 in 2010, and 28 (to date) in 2011.
n10 No one seriously disputes that such agreements are anticompetitive and lead to higher prices.
The Court of Appeal further based its erroneous holding on the rebuttable presumption of patent validity. See Opinion at 31, 33. The Court of Appeal misinterpreted this presumption as irrebuttable, foreclosing plaintiffs fromoffering evidence to overcome it. Yet a presumption that cannot be rebutted is no presumption at all. The "only effect"of a rebuttable presumption is "to shift the burden of producing evidence with regard to the presumed fact. If thatevidence is produced by the adversary, the presumption is spent and disappears." 2 McCormick on Evid. § 344 (6th ed.
The Court of Appeal wrongly treated patents as conclusively valid when they are only presumptively valid. See 35 2012 CA S. Ct. Briefs 98616; 2011 CA S. Ct. Briefs LEXIS 1902, *21 U.S.C. § 282. [*22] In fact, the statutory presumption of patent validity is only "a procedural device, not substantivelaw," and it does not apply except in a full adjudication on the merits. Stratoflex, Inc. v. Aeroquip Corp. (Fed. Cir.
1983) 713 F.2d 1530, 1534; Nutrition 21 v. United States (Fed. Cir. 1991) 930 F.2d 867, 869.
Nevertheless, adopting Tamoxifen, the Court of Appeal held that holders of "fatally weak" patents can maintain their monopolies with cash payments even when those payments violate the Cartwright Act by eliminating competitionto an unreasonable degree. 466 F.3d at 212. The "fatally weak" concession reveals Tamoxifen's fatal flaw-its affront tothe important principle "that competition should not be repressed by worthless patents[.]" United States v. Glaxo GroupLtd. (1973) 410 U.S. 52, 58. In 2009, the United States Department of Justice opposed Tamoxifen on this ground, statingit "offers no protection to the public interest in eliminating undeserved patents" and "[t]here is no basis for a standardthat treats the presumption of validity as virtually conclusive and allows it to serve as a substantive [*23] basis to limitthe application of antitrust law. n11 See also Tamoxifen, 466 F.3d at 224 (Pooler, J., dissenting) (finding that themajority's rule "is not soundly grounded in Supreme Court precedent and is insufficiently protective of the consumerinterests safeguarded by the Hatch-Waxman Act and the antitrust laws.").
n11 (11AA 2569, 2572-73). The DOJ has consistentlytaken the position that Tamoxifen should be revisited and overturned. In 2007, Paul Clement-the United StatesSolicitor General under the Administration of George W. Bush-criticized the Tamoxifen standard as "erroneous"and "insufficiently stringent. for scrutinizing patent settlements.", at pp. 12-13.
Likewise, FTC Commissioner Thomas Rosch observed that "[s]ince this issue first arose in 1998, every single member of the Commission, past and present-whether Democrat, Republican, or Independent-hassupported the Commission's challenges to anticompetitive 'pay-for-delay' deals.The threat that theseagreements pose to our nation's health care system is a matter of pressing national concern [T]hese settlementsare harmful because the parties are resolving their dispute at the expense of consumers." (9AA 2008, 2018.) In 2009, then-Attorney General Brown joined the FTC in filing antitrust claims against pharmaceutical companies that-through exclusionary settlement agreements-"plotted to keep cheap generic drugs off the market,costing consumers millions. This was a predatory move pure and simple, increasing drug company profits at theexpense of critically ill patients." (9AA 2004.) Judge Pooler is correct. The United States Supreme Court has "emphasiz[ed] the necessity of protecting our competitive economy by keeping open the way for interested persons to challenge the validity of patents which mightbe shown to be invalid," to further the "often expressed policy that 'It is the public interest which is dominant in thepatent system,' Mercoid Corp. v. Mid-Continent Investment Co. [1944] 320 U.S. 661, 665, and that the right tochallenge 'is not only a private right to the individual, but it is founded on public policy, which is promoted by hismaking the defense, and contravened by his refusal to make it.' Pope Mfg. Co. v. Gormully [1892] 144 U.S. 224, 235."Edward Katzinger Co. v. Chicago Metallic Mfg. Co. (1947) 329 U.S. 394, 399-401. The public stands to gain, in theform of lower aggregate prices, from adversarial testing of vulnerable patents; so the law "encourage[s] authoritativetesting of patent validity." Blonder-Tongue Labs., Inc. v. Univ. of Ill. Found. (1971) 402 U.S. 313, 343-44 (citing, inpart, Precision Instrument Mfg. Co. v. Automotive Maint. Mach. Co. (1945) 324 U.S. 806, 816); [*25] see also UnitedStates v. Line Material Co. (1948) 333 U.S. 287, 319 (Douglas, J., concurring) (directing courts to condemnpatent-based arrangements which create "a powerful inducement for the abandonment of competition, for the cessationof litigation concerning the validity of patents"). Tamoxifen, on the other hand, allows the owner of an invalid patent toshort-circuit adversarial testing of that patent by doling out a large chunk of its monopoly profits.
2012 CA S. Ct. Briefs 98616; 2011 CA S. Ct. Briefs LEXIS 1902, *25 The sheer enormity of Bayer's payment-more money even than Barr stood to gain from selling generic Cipro-raises a powerful inference that the Cipro patent was a "paper tiger" with no bite or ability to defend Bayer's monopoly. n12Cardizem, 332 F.3d at 915. Valid patents are enforced against infringers through injunctions, not private deals and cashpay-offs. Bayer must not be permitted to pay for a monopoly that its patent likely could not sustain. The court belowruled to the contrary.
n12 The leading antitrust law treatise concludes that market-exit payments to generic manufacturersdisproportionately larger than the cost of litigation "indicate that the parties harbored significant doubt that thepatents in question were valid or infringed, which entails a significant possibility that, if pursued to a judicialoutcome, generic competition would have entered the market. Such amounts are presumptively unreasonable." 12 Philip E. Areeda & Herbert Hovenkamp, Antitrust Law: An Analysis of Antitrust Principles and TheirApplication P 2046, at 333 (2d ed. 2003).
The Court of Appeal mistakenly relied on subsequent litigation in which Bayer defended an amended, "cleaned up" Cipro patent, failing to see that Bayer's intervening petition seeking reexamination of the patent itself raises suspicionthat the original Cipro patent would have been found unenforceable. In re Etter (Fed. Cir. 1985) 756 F.2d 852, 857-58(en banc) (purpose of a re-examination petition is to "cur[e] defects" in "patents thought 'doubtful.'") (citation omitted).
Moreover, the court also ignored that such evidence is inadmissible because it postdates the restraint under scrutiny:Bayer's 1998 bribe. See Page 25, infra. Neither the general policy in favor of settlement, nor the rebuttable presumption of patent validity, overcomes the venerable California rule against such cash payments to perpetuate monopolies. "Contracts which go to the totalrestraint of trade, as that a man will not. carry on his business anywhere in the State, are void, upon whatsoeverconsideration they may be made." Wright v. Ryder (1868) 36 Cal. 342, 359 (emphasis in original) (citations omitted)(nullifying payment made to block a competing steamship [*27] firm from entering the California market).
In Vulcan Powder Company v. Hercules Powder Company (1892) 96 Cal. 510, this Court invalidated a horizontal market allocation contract between competitors who claimed they were harmlessly exchanging their patent rights todynamite. Rejecting this defense, the Court found it significant that the plaintiff and another party to the contract did notown a dynamite patent. This fact established that the money those parties received did not result from their sale orexchange of patent rights. Instead-like Barr in the present case-they received money only in exchange for theiragreement not to compete, not because of a valid patent. Id. at 515 ("[I]t is obvious that the consideration moving fromthem was their covenant to refrain from competition in the dynamite business, and that they had no patent rights to'interchange.'"). The Court went on to note that the restraints in question exceeded the technological scope of the patentat issue. This was presented as an aggravating, not a dispositive, factor in the antitrust analysis. Id. The Court of Appeal ignored Vulcan and its teachings, while misconstruing [*28] another relevant California precedent, Fruit Machinery Company v. F. M. Ball & Company (First Dist. 1953) 118 Cal. App. 2d 748. n13 See
Opinion at 34-35. The divergent royalty rates challenged in Fruit Machinery passed scrutiny under the Cartwright Act,
not because the licenses were restricted to the patented products, but because the "differential in royalty rates" bore "a
reasonable relationship to differences in costs and capital risks between the two types of uses" at issue under the
licenses. Id. at 762. Indeed, the court acknowledged that a patent holder can be subjected "to the proscriptions and
penalties of the antitrust laws" when the circumstances raise an inference of patent abuse or subversion of public
interest. Id. The Court of Appeal in this case quoted Fruit Machinery's disjunctive ruling without recognizing its true
import: "Defendant has not shown that the parties . exercised rights or powers not accorded them by the patent law or
abused any rights or powers accorded them by that law." Opinion at 34 (quoting Fruit Machinery, 118 Cal. App. 2d at
(emphasis added).
2012 CA S. Ct. Briefs 98616; 2011 CA S. Ct. Briefs LEXIS 1902, *28 n13 According to the California Court of Appeal, "[t]he leading federal authority" on antitrust injury arisingfrom patent litigation is Dairy Foods Inc. v. Dairy Maid Prods. Co-op. (7th Cir. 1961) 297 F.2d 805. Classen v.
Weller (First Dist. 1983) 145 Cal. App. 3d 27, 38.
But elements of the Tamoxifen rule upend a key holding inDairy Foods, that an "adjudication that claimed patent rights are unenforceable is not an element prerequisite tothe maintenance of an antitrust action for damages or injunctive relief based on misuse of the patent." 297 F.2dat 809-10 (emphasis added).
Bayer's horizontal allocation of monopoly profits from the likely unenforceable Cipro patent was abusive. Between its oversize cash payment to the alleged infringer, its subsequent price hikes, and its weak defense of its patent (basedon contentions that its patent agents were insane), n14 the record here contains strong evidence of abusive conduct,more than enough to reach a jury. Corwin v. Los Angeles Newspaper Serv. Bureau, Inc. (1971) 4 Cal. 3d 842, 855("Whether a restraint of trade is reasonable in the context of the Cartwright Act is a question of fact to be determined attrial."). Had the Court of Appeal properly applied California law, a jury could also have concluded that the Ciproagreements lacked "any redeeming virtue." Opinion at 32. n15 n14 As Petitioners' expert in patent practice, Michael H. Jester, observed, Bayer's assertions that its patent agents"had mental problems and by inference that this somehow demonstrates a lack of intent to deceive, areincredible and unbelievable. No person could perform such meticulous and complex legal work involvingsophisticated pharmaceutical chemistry over such an extended period of time without comprehending theconsequences of his intended actions." (8AA 1856.) n15 The Court of Appeal's final comment regarding this important question of law (see Opinion at 38, fn. 9)reflects nothing less than a complete abdication of its judicial responsibilities. "[T]he courts are the ultimatearbiters of the construction of a statute." California Ass'n of Psychology Providers v. Rank (1990) 51 Cal. 3d 1,7. It is clear that the Hatch-Waxman Act was intended to prohibit the agreements at issue here. "As co-author ofthe [Hatch-Waxman] Act, I can tell you that I find these type of reverse payment collusive arrangementsappalling," Senator Hatch said. (10AA 2234.) See Arkansas Carpenters, 604 F.3d at 109 ("[R]emarks by anAct's author do not trigger the typical concern about post-enactment legislative history, namely that 'the losers inthe legislative arena hope to persuade the courts to give them the victory after all.'" (citations omitted)).
B. The Preemption Ruling Incorrectly and Imprudently Restricts the Scope of California Law.
Because patents restrain competition, California courts strictly construe [*31] the rights of patent holders in light of the California "policy favoring free competition, dissemination of ideas and maximum utilization of intellectualresources." Sinclair v. Aquarius Elec, Inc. (First Dist. 1974) 42 Cal. App. 3d 216, 224 (citation omitted). The Court ofAppeal's preemption ruling, however, threatens to prevent state courts from adjudicating cases touching on patents atall. That is why the attorneys general of thirty-eight States, including California, opposed federal preemption in thiscontext, noting it would "thwart the states' express intention to provide monetary recovery to their consumers forantitrust violations." Amici Curiae Brief of Thirty-Eight States, 2008 WL 576744, at *3 (Fed. Cir. 2008).
The Court of Appeal did not apply California law but instead limited it, based on its wholesale adoption of Tamoxifen. The court held that, because the Cipro agreements did not go beyond the scope of the patent (and because 2012 CA S. Ct. Briefs 98616; 2011 CA S. Ct. Briefs LEXIS 1902, *31 Petitioners do not claim fraudulent patent procurement), Petitioners must establish sham litigation to maintain aCartwright Act claim. The court then held that any effort to establish sham litigation is [*32] preempted by federal law.
Under this analysis, the scope of the Cartwright Act is-exactly zero. That cannot be.
The court's footnote 15 (see Opinion at 49) will provide small comfort to future litigants hoping to use California law to vindicate their rights in patent-related disputes. The footnote betrays the court's recognition that its sweeping andunprecedented preemption ruling will shut the courthouse door, at a minimum, to any aggrieved party whose claiminvolves purportedly baseless infringement litigation.
As an initial matter, Noerr-Pennington antitrust immunity and its sham litigation requirement do not belong in this analysis. The decision to apply Noerr-Pennington immunity is plainly wrong and alone warrants review. TheNoerr-Pennington doctrine safeguards the First Amendment as well as comity between branches of government-neitherof which is implicated by Bayer's payoff. Compare Blank v. Kirwan (1985) 39 Cal. 3d 311, 320-28 (discussing the FirstAmendment and comity interests which justify Noerr-Pennington antitrust immunity), with Tamoxifen, 466 F.3d at 213(importing the sham litigation requirement from Noerr-Pennington [*33] jurisprudence).
A California court should be empowered to adjudicate these damage claims, even if liability depends on whether Bayer's infringement suit was baseless. The claims arise under state law, so jurisdiction exists; and they are notdisplaced by federal law because they entail separate, extra showings, beyond Bayer's deceptive conduct before thePTO, in order for liability to be established. Under the Cartwright Act, the fact finder would necessarily have to decidewhether the payment had anticompetitive effects. But, the fact finder would not need to decide whether the originalCipro patent was unenforceable to find the Cartwright elements satisfied. Dairy Foods, 297 F.2d at 809-10. Unfair competition claims that depend on patent validity determinations can proceed in California court. Mattel, Inc. v. Luce, Forward, Hamilton & Scripps (Second Dist. 2002) 99 Cal. App. 4th 1179, 1186 (citing Miller v. Lucas(Second Dist. 1975) 51 Cal. App. 3d 774, 776 (citing American Well Works Co. v. Layne & Bowler Co. (1916) 241 U.S.
(Holmes, J.) (allowing a state-law competitor claim to proceed where the defendant [*34] allegedly filed baselesspatent infringement suits for business advantage; explaining "[t]he fact that the justification may involve the validityand infringement of a patent is no more material to the question under what law the suit is brought than it would be inan action of contract . The State is master of the whole matter "); see Dow Chem. Co. v. Exxon Corp. (Fed. Cir. 1998)139 F.3d 1470, 1475 ("[A]lthough a state court is without power to invalidate an issued patent, there is no limitation onthe ability of a state court to decide the question of validity when properly raised in a state court proceeding.") (citationomitted); Lear v. Adkins (1969) 395 U.S. 653, 675-76 (instructing California courts to resolve patent invalidity defensein state-law breach of contract action); Kewanee Oil Co. v. Bicron Corp. (1974) 416 U.S. 470, 492 (vacating andremanding case to "the California Supreme Court. to pass on the question of patent validity"). In cases arising understate law, then, California courts have the express authority "to determine matters of title, infringement or validity ofpatents where such determination is [*35] ancillary and necessary to the main action." Blumenfeld v. Arneson Prods.,Inc. (First Dist. 1971) 172 U.S.P.Q. 76, 78. Although Petitioners' claims unmistakably arise under California law, the Court of Appeal neglected to apply the "strong presumption against preemption" of California law. In re Farm Raised Salmon Cases (2008) 42 Cal. 4th 1077,1088 (emphasis added). This presumption applies with particular force to statutes, such as the Cartwright Act, that fallwithin the State's historic police powers because they deter businesses from taking advantage of consumers. Id.; R.E.
Spriggs Co. v. Adolph Coors Co. (Second Dist. 1974) 37 Cal. App. 3d 653, 664-66.
Nor did the Court of Appeal evenpay lip service to this Court's recent guidance that conflict preemption exists only when "simultaneous compliance withboth state and federal directives is impossible," and that California law "will be displaced only when affirmativecongressional action compels the conclusion it must be." Viva! Int'l Voice for Animals v. Adidas Promotional RetailOperations, Inc. (2007) 41 Cal. 4th 929, 936; In re Jose C. (2009) 45 Cal. 4th 534, 550. [*36] Applying these standards, the Defendants easily could have complied with both federal law and California law, had they simply refrained from trying to make a $ 398.1 million deal to protect a tenuous monopoly and avoid a trial on the 2012 CA S. Ct. Briefs 98616; 2011 CA S. Ct. Briefs LEXIS 1902, *36 weak Cipro patent. As for Congress, it has never suggested that federal law displaces state-law claims against drugcompanies that transfer millions of dollars to perpetuate dubious monopolies. Senator Hatch has called such deals"appalling," n16 and a Senate Judiciary Committee report strongly condemned "pacts between big pharmaceutical firmsand makers of generic versions of brand name drugs, that are intended to keep lower-cost drugs off the market.
Agreeing with smaller rivals to delay or inhibit competition is an abuse . ." n17 n16 148 Cong. Rec. S 7566 (daily ed. July 30, 2002) (10AA 2234).
n17 Report entitled "The Drug Competition Act of 2001," S. Rep. No. 107-167 (2002), at 4 (emphasis added)(10AA 2239).
That one source of proof in the analysis would [*37] be Bayer's inequitable conduct before the PTO scarcely renders these claims preempted. In Dow, the court reversed a holding that federal patent law preempted a state-lawunfair competition claim grounded in allegations that Exxon had threatened baseless infringement litigation. Id. at1471-72. Even though the claim depended on a showing of Exxon's alleged inequitable conduct before the PTO, theclaim did not impermissibly conflict with federal law. The business tort at issue in Dow, like the Cartwright Act andUCL claims here, is not premised upon bad faith misconduct in the PTO, but rather is premised upon bad faith misconductin the marketplace.[I]t plainly is not a preempted alternative or additional state law remedy forinequitable conduct. Rather it is a long-established independent tort remedy for improprieties in themarketplace.
Id. at 1477. Moreover, "that the source of proof of bad faith, just one element of the tort, was purported inequitableconduct before the PTO, does not make this tort a patent issue preempted by federal law " Id. at 1477-78 (emphasishere).
Dow is instructive here. Even if Petitioners' Cartwright [*38] Act claim were to require proof that Bayer's infringement suit was a sham, and even if such proof, in turn, depended on a showing of Bayer's inequitable conductbefore the PTO, Petitioners can prevail only if they also show that Bayer's $ 398.1 million payment had anticompetitiveintent and effects. See CACI 3411 (Cartwright Act jury instructions setting forth traditional Rule of Reason antitrustanalysis). Therefore, the state-law claims here are not coterminous with or dependent upon the federal defense ofinequitable conduct, and, like the business competitor claim in Dow, are not preempted.
Petitioners' claims under California law are consistent with the objectives of federal law. See Palmer v. BRG of Ga., Inc. (1990) 498 U.S. 46, 50 (under federal law, an agreement that precludes a potential competitor from market entry is"unlawful on its face."). The Court of Appeal's preemption ruling is not only wrong, but it abandons the citizens ofCalifornia.
C. The Court of Appeal Misapplied California Supreme Court Precedent by Condoning the Trial Court's
Blanket Overruling of Petitioners' Evidentiary Objections, and by Failing to Resolve the Objections. [*39]
The Court of Appeal failed to require the trial court to rule on Petitioners' written objections to the evidence, contravening this Court's recent ruling in Reid v. Google, Inc. (2010) 50 Cal. 4th 512. In Reid, the Court held that "[t]hetrial court must rule expressly on" evidentiary objections raised with a motion for summary judgment. Id. at 532. TheCourt disapproved of Biljac Associates v. First Interstate Bank (First Dist. 1990) 218 Cal. App. 3d 1410, "to the extentit permits the trial court to avoid ruling on specific evidentiary objections." Reid, 50 Cal. 4th at 532 n.8. The Court of Appeal failed to hold the trial court to this Court's clear directive in Reid that each evidentiary 2012 CA S. Ct. Briefs 98616; 2011 CA S. Ct. Briefs LEXIS 1902, *39 objection must be separately addressed. Instead, the Court of Appeal created a false distinction between sustaining anobjection and overruling it, excusing a trial court's blanket ruling so long as it only overrules objections. Opinion at51-52. This distinction has no basis in law and creates confusion around the Court's ruling in Reid. Petitioners filed 30 evidentiary objections prior to the summary judgment [*40] hearing and preserved several specific objections at the hearing. (1AA 233-241; Tr. of Aug. 21, 2009 Hearing, Reporter's Transcript, at 264:8-22.)Petitioners at all times, for example, maintained a specific objection to the admission of evidence concerning Bayer'ssuccessful defense of a re-examined Cipro patent in four post-1998 cases. (Opening Br. at 54-55, 65-55; Reply Br. at22-23,40-41; MSJ Opp. at 67 (1AA 215).) This evidence is inadmissible because the trier of fact must weigh a given restraint's effect on active and vigorous competition against the extent to which it "promoted enterprise and productivity at the time it was adopted." Polk Bros.,Inc. v. Forest City Enters., Inc. (7th Cir. 1985) 776 F.2d 185, 189 (emphasis added); see International Travel Arrangersv. NWA, Inc. (8th Cir. 1993) 991 F.2d 1389, 1400 (holding that a government study of airline competition was"properly excluded as irrelevant because it dealt with a time subsequent to the events involved in this case.").
The trial court nevertheless overruled all of Petitioners' objections in a one-line blanket statement: "Plaintiffs' evidentiary objections are overruled." (11AA [*41] 2688.) Neither the trial court nor the Court of Appeal actually ruledon Petitioners' individual objections, and, in finding no error in the trial court's terse blanket overruling, the Court ofAppeal seemed to miss the entire point of Petitioners' objections to Bayer's subsequent patent cases. "We do not find theadmission of this evidence to be prejudicial,. because the essential facts of those suits were established as undisputedby plaintiffs' responses to Bayer's separate statement of undisputed facts in support of its motion for summary judgment,Nos. 29-33." Opinion at 52, fn. 16 (emphasis added). Petitioners did not dispute whether the subsequent patent casesoccurred, but instead sought to exclude evidence of them as irrelevant and inadmissible. (See Opening Br. at 54-55;Reply Br. at 22-23.) Indeed, Petitioners reiterated their position on irrelevancy and inadmissibility in the very responsesthe Court of Appeal cited. (2AA 253-54.) To prevent confusion and similar misapplication of law, this Court should grant review and reiterate that courts must rule on specific evidentiary objections.
"Consumer welfare is a principal, if not the sole, [*42] goal" of California's antitrust laws. Cianci v. Super. Ct. (1985) 40 Cal. 3d 903, 918. The federal courts whose faulty analysis the Court of Appeal adopted do not share thisCourt's obligation to protect the citizens of California. Adopting Tamoxifen misconstrues the Cartwright Act and theUnfair Competition Law. It imposes a new standard on California, impairing the ability of the State and private citizensto vindicate their rights. The Court should grant review to fulfill its obligation to the People and to settle these importantquestions of law.
LIEFF, CABRASER, HEIMANN &BERNSTEIN, LLP Joseph R. Saved (State Bar No. 130064)Eric B. Fastiff (State Bar No. 182260) 2012 CA S. Ct. Briefs 98616; 2011 CA S. Ct. Briefs LEXIS 1902, *42 Brendan Glackin (State Bar No. 199643)Jordan Elias (State Bar No. 228731)Dean M. Harvey (State Bar No. 250298)275 Battery Street, 29th FloorSan Francisco, CA 94111-3339Telephone: (415) 956-1000Facsimile: (415) 956-1008 Dan Drachler (Pro Hac Vice)1904 Third Avenue, Suite [*43] 1030Seattle, WA 98101Telephone: (206) 223-2053Facsimile: (206) 343-9636 Ralph B. Kalfayan (State Bar No. 133464)KRAUSE, KALFAYAN, BENINK &SLAVENS625 Broadway, Suite 635San Diego, CA 92101Telephone: (619) 232-0331Facsimile: (619) 232-4019 Attorneys for Plaintiffs, Appellants, and Petitioners CERTIFICATE OF WORD COUNT
[California Rule of Court 8.204(c)(1)] The text of this brief, including footnotes, consists of 7,622 words as counted by the word-processing program used LIEFF, CABRASER, HEIMANN &BERNSTEIN, LLP 2012 CA S. Ct. Briefs 98616; 2011 CA S. Ct. Briefs LEXIS 1902, *43 I, Kirstin Largent, declare that I am not a party to the action, am over 18 years of age and my business address is: 354 South Spring St., Suite 610, Los Angeles, California 90013.
On 12/12/2011 declarant served the within: Petition for Review upon:
Court [*44] of AppealFourth Appellate District, Division OneSymphony Towers750 "B" Street, Suite 300San Diego, California 92101 the address(es) designated by said attoraey(s) for that purpose by depositing the number of copies indicated above, of
same, enclosed in a postpaid properly addressed wrapper in a Post Office Mail Depository, under the exclusive custody
and care of the United States Postal Service, within the State of California, or properly addressed wrapper in an Federal
Express Official Depository, under the exclusive custody and care of Federal Express, within the State of California
I further declare that this same day the original and copies has/have been hand delivered for filing OR the original and
13 copies has/have been filed by [checkmark] third party commercial carrier for next business day delivery to:
Clerk of the CourtSUPREME COURT OF CALIFORNIA350 McAllister StreetSan Francisco, California 94102-4797 I declare under penalty of perjury that the foregoing is true and correct: SERVICE LIST
Christopher J. Healey, Esq.
Luce, [*45] Forward, Hamilton & Scripps600 West Broadway, Suite 2600San Diego, California 92101 2012 CA S. Ct. Briefs 98616; 2011 CA S. Ct. Briefs LEXIS 1902, *45 Peter B. Bensinger, Esq.
54 West Hubbard Street, Suite 300Chicago, Illinois 60654 Kevin D. McDonald, Esq.
51 Louisiana Avenue, NWWashington, D.C. 20001 Attorneys for Defendant-Respondent Bayer Corporation David E. Everson, Esq.
Stinson Morrison Hecker LLP1201 Walnut, Suite 2600P.O. Box 419521Kansas City, Missouri 64141-6251 Kathryn E. Karcher, Esq.
401 B Street, Suite 2450San Diego, California 92101 Joann F. Rezzo, Esq.
EDELSON & REZZO402 West Broadway, Suite 2700San Diego, California 92101 Attorneys for Defendants-Respondents Hoechst Marion Roussel, Inc.,The Rugby Group, Inc., Barr Laboratories, Inc., and Watson Pharmaceuticals, Inc. Victoria Smith, Esq.
Stinson Morrison Hecker LLP1201 Walnut, Suite 2600P.O. Box 419521Kansas City, Missouri 64141-6251 Heather S. Woodson, Esq.
Stinson Morrison Hecker LLP1201 Walnut, Suite 2900P.O. Box 419521Kansas City, Missouri 64141-6251 Attorneys for Defendants-Respondents Hoechst Marion Roussel, Inc.,The Rugby Group, Inc., and Watson Pharmaceuticals, Inc. [*46] Gregory Skidmore, Esq.,Edwin John U., Esq. and Karen N. Walker, Esq.
Kirkland & Ellis LLP655 Fifteenth Street, NWWashington, D.C. 20005 Attorneys for Defendant-Respondent Barr Laboratories, Inc. 2012 CA S. Ct. Briefs 98616; 2011 CA S. Ct. Briefs LEXIS 1902, *46 Clerk for Hon. Richard E. L. StraussSUPERIOR COURT OF CALIFORNIACounty of San DiegoHALL OF JUSTICE330 West BroadwaySan Diego, California 92101 OFFICE OF THE ATTORNEY GENERALP.O. Box 85266San Diego, California 92186-5266 Appellate DivisionOFFICE OF THE DISTRICT ATTORNEYP.O. Box X-1011San Diego, California 92112 Carlotta TillmanADMINISTRATIVE OFFICE OF THE COURTS455 Golden Gate AvenueSixth FloorSan Francisco, California 94102


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