Holman: A Contrarian Law Professor’s Two Cents on the Arkansas Carpenter’s (Ciprofloxacin) Petition for Certiorari

By Christopher M. Holman, Ph.D., J.D., Associate Professor at UMKC Law School

Professor Mark Lemley recently filed an amici curiae brief on behalf of himself and a cohort of prominent professors of law, economics, and business in support of a petition for certiorari in Arkansas Carpenter's Health and Welfare Fund v. Bayer (the "Professors’ Brief").[1] Joining the professors as amici on the brief are the American Antitrust Institute, the Public Patent Foundation, and AARP. These professors and organizations are asking the Supreme Court to review and reverse the Federal Circuit's decision in In re Ciprofloxacin Hydrochloride Antitrust Litigation.[2] Arkansas Carpenter's is the latest in a string of certiorari petitions that have been filed in cases involving an unsuccessful antitrust challenge to a so-called “reverse payments settlement” between a drug patent owner and a potential generic competitor. So far the Supreme Court has denied all of the petitions.

The defining characteristic of a reverse payments settlement is the transfer of some form of consideration, often but not always cash, from the patent owner to the alleged infringer. In most settlements of patent infringement suits any payment typically flows from the alleged infringer to the patent owner, i.e., in the "forward" direction. Reverse payment settlements of challenges brought against prescription drug patents under the Hatch-Waxman Act have been controversial for years. The FTC and others charge that these agreements are anti-competitive and result in substantially higher prescription drug prices for consumers (and ultimately third-party payers such as the government). The atypical direction of the payment is considered suspect by many who view it as evidence that the merits of the patent case must be weak, and argue that the branded drug company is in effect paying the generic company to stay off the market and using the patent as a mere pretense to skirt antitrust liability. Clearly, absent the patent a naked agreement by a generic drug company to stay off the market in exchange for cash would constitute an antitrust violation.

Nonetheless, courts who have considered the legality of reverse payment settlements have repeatedly concluded that, in view of the incentives and dynamics created by the unique structure of a patent infringement suits brought under the Hatch-Waxman Act, it is neither surprising nor particularly suspicious to find payments flowing from the patent owner to the alleged infringer in the settlement of these suits. In fact, even the FTC has acknowledged that at least some reverse payment settlements are legitimate and even pro-competitive. In most patent infringement litigations, the alleged infringer faces the prospect of potentially large money damages based on its past infringement, so there is often an incentive to pay the patent owner to settle the lawsuit and avoid this risk. In contrast, Hatch-Waxman litigation generally occurs before the potentially infringing generic drug goes on the market. The generic drug company typically faces no risk of money damages for past infringement. At the same time, the drug patent owner faces huge potential financial losses if even one court finds its patent invalid or not infringed, and given the uncertainty patent litigation, particularly at the district court level, it is not surprising that some patent owners would be willing to pay to settle the lawsuit and resolve the uncertainty.

The Professor's Brief is essentially an updated version of a brief Professor Lemley filed in 2006 in support of a petition for certiorari in In re Tamoxifen, a reverse payment settlement antitrust challenge arising out of the Second Circuit. In 2006, I seriously considered signing on to his Tamoxifen amici brief; without having delved into the issue, the notion of reverse payments settlements as characterized by Professor Lemley and others struck me as suspicious and anti-competitive . After all, why would a patent owner pay an alleged infringer to settle a lawsuit unless the merits of the patent case were weak? Under these circumstances, is it not logical to infer that the parties are using the patent lawsuit as a mere pretense to provide cover for what is in actuality an agreement between potential competitors not to compete? However, before I signed on to the brief I decided to read the Second Circuit'sTamoxifen decision, as well as the reverse payments settlement decisions that had already been issued by the Sixth and Eleventh circuits. In his brief, Professor Lemley argued that the decisions from these other circuits were in conflict with the Second Circuit's decision in Tamoxifen. After reading the cases, I found that I disagreed with Professor Lemley's interpretation of the decisions, and concluded that in fact there is no split between the circuits. In fact, the decisions by the Second, Sixth and Eleventh circuits (and now the Federal Circuit) are all quite consistent, taking into account that each case involves its own unique settlement agreements and other surrounding facts, and that the decisions necessarily reflect the facts of the individual case being decided.

Reading these decisions sparked my curiosity, particularly since my interpretation of the case law diverged substantially from that of Lemley and many other academic commentators. I decided to research the topic, and in 2007 I published an article entitled “Do Reverse Payments Settlements Violate the Antitrust Laws?”[3] In the article, I survey the diverse array of patent settlements that have been lumped together under the imprecise label "reverse payment settlement,” and explain the factors that motivate the structure of these settlements. After reviewing the facts surrounding specific settlement agreements, and considering the well reasoned explanations of various judges who have rejected the notion that the mere presence of a reverse payment can render an otherwise legitimate patent settlement illegal, I came to disagree with the position propagated by the FTC and academics such as Professor Lemley, i.e., that the mere inclusion of a reverse payment in an otherwise legal patent litigation settlement renders the agreement per se or presumptively in violation of the antitrust laws. Moreover, my view is aligned with that of the vast majority of courts that have addressed the issue. After a close reading of the decisions, it is clear to me that the purported split between the circuits has so far failed to materialize, although the situation could change if and when other circuits weigh in on the issue.

In this short article penned for Patently-O, I will challenge some of the specific assertions made in the Professors’ Brief. For simplicity, many of the citations in this article are to my law review article. Those interested in a more expansive treatment of the subject are encouraged to consult the law review article, which includes primary cites to the cases and other authorities.

“The Second/Federal Circuit Rule Is Unprecedented and Conflicts with the Approaches of the Sixth Circuit, the Eleventh Circuit, and the Federal Trade Commission”[4]

The section header from the Professors’ Brief quoted above is virtually identical to a header that appears in Professor Lemley’s 2006 Ciprofloxacin brief, except that of course in 2006, prior to Ciprofloxacin, he could only assert that “The Second Circuit Rule Is Unprecedented . . . .” At this point in 2009, however, both the Federal Circuit and Second Circuit have arrived at essentially the same conclusion with respect to reverse payments settlements, as suggested by the fact that Professor Lemley can use the same brief in support of his Tamoxifen and Ciprofloxacin certiorari petitions. It is hard to see how either circuit’s decision can be unprecedented in light of the virtually identical outcome in both circuits. The Professors' Brief suggests in a footnote that the Federal Circuit might have been applying Second Circuit antitrust law in deciding Ciprofloxacin. I agree that there is some uncertainty as to whether the Federal Circuit should have applied regional circuit law in deciding a question concerning antitrust law. The Second Circuit transferred the appeal to the Federal Circuit because it includes a Walker Process claim, which the Second Circuit concluded rests entirely on patent law; it probably would not have transferred the case if it had only involved a challenge to the settlement agreement. However, in reading the Federal Circuit’s decision I think it is apparent that the court did not feel constrained to follow the Second Circuit precedent. In deciding Ciprofloxacin, the court considered decisions from the Second Circuit, the Sixth Circuit and the Eleventh Circuit, but did not evince any deference to Second Circuit precedent over precedent arising out of the other circuits.

In any event, the decisions by the Second Circuit and the Federal Circuit in Tamoxifen and Ciprofloxacin are both entirely consistent with earlier decisions by the other circuits that have considered the legality of reverse payments settlements. Essentially, federal appellate courts that have addressed the issue had concluded that a reverse payment settlement violates the antitrust laws if (1) the patent was obtained by fraud, (2) the patent litigation was a sham, or (3) the settlement agreement exceeds the “exclusionary potential” of the patent. An example of a sham patent litigation would be one in which it is readily apparent that the asserted patent is either invalid or not infringed. A settlement agreement exceeds the exclusionary potential of the patent if it (1) encompasses products clearly outside the scope of the patent’s claims, or (2) results in a regulatory bottleneck that blocks other generic companies from entering the market with a competing generic product. Absent these factors, the courts have overwhelmingly upheld the legality of reverse payments settlements. In particular, no circuit court has ever held that the mere presence of a reverse payment raises a presumption of an antitrust violation, the position that has been advanced by the FTC and many of the signatories of the Professors’ Brief.

“The Sixth Circuit Considers [Reverse Payment Settlement] Agreements Per Se Illegal”[5]

The assertion that reverse payments settlements are per se illegal in the Sixth Circuit has been made so many times that it has become something akin to an urban legend. While the Professors’ Brief cites to In In Re Cardizem CD Antitrust Litigation for this proposition, tellingly, the brief does not cite to any particular page in the decision for this supposed holding. In fact, a close reading of Cardizem reveals that the Sixth Circuit never suggested that the presence of a reverse payment renders a settlement agreement illegal. Instead, the Sixth Circuit found the particular agreement at issue in Cardizem per se illegal because it exceeded the exclusionary potential of the patent by creating a bottleneck that prevented any other generic competitor from entering the market.[6] The flawed logic of inferring that the decision implies that all reverse payments settlement agreements are per se illegal in the Sixth Circuit should be apparent upon its face. Just because a court finds a contract to violate the antitrust laws does not imply that all contracts violate antitrust laws, and similarly, just because the Sixth Circuit found a reverse payment settlement to be a per se antitrust violation does not mean it held that all reverse payments settlements are antitrust violations.

Not only did the Sixth Circuit explicitly find that the agreement at issue was illegal because it blocked market entry by other potential generic competitors, it implicitly endorsed the district court’s determination that the scope of the agreement exceeded the scope of the patent. In particular, the patent at issue only claimed certain timed-release formulations of the drug, while the agreement prevented the generic company from marketing generic versions of Cardizem that the district court found fell outside the scope of the claims.[7] Based on these findings, all of the other circuits would have likewise found that the agreement violates the antitrust laws by exceeding the exclusionary potential of the patent. In fact, in footnotes 12 and 13 of Cardizem the Sixth Circuit specifically distinguishes its decision from the district court decisions in Ciprofloxacin and Tamoxifen by noting that those cases did not involve settlement agreements exceeding the exclusionary potential of the patent.

"The Eleventh Circuit Applies Its Own Modified Version of the Rule of Reason That Inquires into the Underlying Validity of the Patent before Characterizing the Conduct”[8]

The Professors’ Brief cites to the Eleventh Circuit’s Valley Drug v. Geneva Pharmaceuticals decision for the assertion that the Eleventh Circuit engages in a validity analysis of the underlying patent that is precluded in the Second Circuit and Federal Circuit. The brief does not cite to any particular page in the Valley Drug decision, nor does it provide any explanation for this interpretation of Valley Drug. In Valley Drug, the Eleventh Circuit reversed the district court's determination that a reverse payment settlement was per se illegal. In doing so, it rejected the plaintiff’s argument that the agreement was per se illegal because the subject patent was subsequently found to be invalid. The Eleventh Circuit held:

The mere subsequent invalidity of the patent does not render the patent irrelevant to the appropriate antitrust analysis. . . . Exposing settling parties to antitrust liability for the exclusionary effects of a settlement reasonably within the scope of the patent merely because the patent is subsequently declared invalid would undermine the patent incentives. Patent litigation is too complex and the results too uncertain for parties to accurately forecast weather in forcing the exclusionary right to settlement will expose them to trouble damages if the patent immunity were destroyed by the mere invalidity of the patent this uncertainty, coupled with a treble damages penalty, with tend to discourage settlement of any validity challenges except those of the patent is certain to win a trial and the infringer is certain to lose. By restricting settlement options, which would effectively increase the cost of patent enforcement, the proposed rule would impair the incentives for disclosure and innovation.

In Valley Drug, the Eleventh circuit never advocates any sort of probing inquiry into the underlying validity of the patent. Instead, in discussing patent validity the court is merely explaining that the existence of a legitimate “non-sham” patent litigation will generally render a reverse payment settlement legal, even if the patent is subsequently found to be invalid. In footnote 19 of Valley Drug, the Eleventh circuit does recognize that there might be antitrust consequences if the plaintiff had alleged that the patent was procured by fraud, or that the parties to settlement knew that the patent was invalid at the time of the settlement, or had no objective basis to believe that the patent was valid – in other words, the underlying patent litigation was a sham. This is entirely consistent with the Second Circuit and Federal Circuit approaches, which would find a reverse payment settlement of a sham patent litigation to be a violation of the antitrust laws.

After Valley Drug, the Eleventh Circuit decided another reverse payment settlement case, Schering-Plough v. FTC, an appeal of an antitrust action brought by the FTC. Consistent with its decision in Valley Drug, in Schering-Plough the Eleventh Circuit did not advocate any probing inquiry into the validity of the patent underlying the settlement. It is important to recognize that the Eleventh Circuit did not consider or rely on evidence of patent invalidity in either Valley Drug or Schering-Plough, belying any assertion that the Eleventh circuit “inquires into the underlying validity of the patent before characterizing the conduct.”

This is not just my interpretation of Schering-Plough – at the time, prior to Tamoxifen and Ciprofloxacin, the FTC agreed that the Eleventh Circuit approach was consistent with the approach subsequently adopted by the Second Circuit and Federal Circuit. For example, in its Petition for Certiorari seeking review of Schering-Plough the FTC argued that “the only circumstance in which [the Eleventh Circuit in Schering-Plough] indicated the parties would exceed the exclusionary potential of the patent was that of ‘sham’ infringement claims.”[9] The FTC also acknowledged that other courts interpret Schering-Plough as establishing a test requiring an inquiry only into the nominal reach of the patent, and not an assessment of the likelihood that the patent owner would prevail in the litigation.[10] The FTC is correct in this regard. For example, the district court Ciprofloxacin decision rejected an argument that in Schering-Plough and Valley Drug the Eleventh Circuit had mandated an inquiry into the potential invalidity of the patent, and found that Schering-Plough should instead be “more fairly read as requiring an evaluation of the scope of the patent’s claims, and not a post hoc analysis of the patent’s validity, an approach which . . . has not been endorsed by any court other than the Valley Drug district court on remand.”[11]

The FTC has made it clear on a number of occasions that, as a general policy, it does not consider it appropriate for the antitrust inquiry to delve into the merits of the underlying patent dispute.[12] For example, in the Commission’s decision in Schering-Plough, the FTC “question[ed] the utility of a rule that would give decisive weight to an after-the-fact inquiry into the merits of the patent issues in a settled case.”[13] The FTC went on to note that:

An after-the-fact inquiry by the Commission into the merits of the underlying litigation is not only unlikely to be particularly helpful, but also likely to be unreliable. As a general matter, tribunals decide patent issues in the context of a true adversary proceeding, and their opinions are informed by the arguments of opposing counsel. Once a case settles, however, the interests of the formerly contending parties are aligned. A generic competitor that has agreed to delay its entry no longer has an incentive to attack vigorously the validity of the patent in issue or a claim of infringement.[14]

The FTC concluded that determining antitrust liability based on the merits of the underlying patent case would not be “supported by law or logic.”[15]

The Second, Eleventh and Federal Circuits all concur that a reverse payment settlement of a sham patent litigation would violate the antitrust laws, as would an agreement that exceeds the exclusionary potential of the patent. These determinations would inherently involve some assessment of patent validity and/or claim scope. In order to determine the exclusionary potential of a patent, an assessment of claim scope is necessary. For example, in Cardizem the district court construed the potential scope of the claims and determined that the settlement agreement included products falling outside the scope of the patent claims. Likewise, the assertion of a clearly invalid patent would exceed the exclusionary potential of the patent, and also constitute sham patent litigation. But I think a careful reading of all these decisions makes it clear that none of the circuits are advocating any probing inquiry into patent validity or claim construction. In the words of Judge Posner, a highly regarded appellate judge and former law professor known for his application of economic reasoning in deciding legal issues, unless there is something suspicious about the circumstances of a reverse payment settlement, e.g., the patent was procured by fraud or “almost certainly invalid,” “then to prevent a cloud from being cast over the settlement process a third party should not be permitted to haul the parties to the settlement over the hot coals of antitrust litigation.”[16] On the other hand, if the patent is invalid on its face, or the claims clearly do not encompass subject matter covered by the agreement, all of the circuits would consider this relevant in assessing whether the patent litigation was a sham, or whether the agreement exceeds the exclusionary potential of the patent.

"[T]he Federal Trade Commission Considers [Reverse Payment Settlements] Presumptively Anticompetitive”[17]

The Professors’ Brief correctly notes that the FTC has argued that reverse payment settlements should be treated as presumptively anticompetitive. This position has generally been rejected by the courts, particularly at the appellate level, and by the Department of Justice (the other governmental agency charged with enforcing federal antitrust law), but has been embraced by many academics. Interestingly, the FTC has only come to this position fairly recently. Originally, the FTC only expressed concern with respect to Hatch-Waxman settlements that either blocked market entry by other generic competitors or exceeded the scope of the patent claims. For example, a report entitled Generic Drug Entry Prior to Patent Expiration: An FTC Study, published by the FTC in 2002, notes the existence of reverse payment settlements, but does not identify them as particularly problematic. Rather, the report concludes that settlements of Hatch Waxman patent challenges are generally not problematic, so long is there is no potential for creating a regulatory bottleneck blocking entry by other generic competitors.[18]

Early FTC enforcement actions focused on agreements that either exceeded the scope of the patent or had the potential to block other generic competitors. However, after failing in some of these actions, the FTC shifted its enforcement strategy and began focusing on reverse payments as an independent basis for illegality.[19] Since that time, as recently noted by one commentator, the FTC has adopted a "nearly visceral reaction to Hatch Waxman patent litigation settlements."[20]

The Federal Circuit “Ignor[es] the Question of Whether the Patent Was Valid in the First Place,” and “Let[s] Patent Owners Buy Immunity from Competition Even with ‘Fatally Weak’ Patents”[21]

The Professors’ Brief seems to suggest that Bayer’s Ciprofloxacin patent is "fatally weak,” and that the Federal Circuit improperly “conclusively presume[d]” the patent’s validity. In fact, the Federal Circuit merely affirmed the district court's determination that there was insufficient evidence of patent invalidity to find that the litigation was a sham. Moreover, there was a wealth of evidence indicating that the patent was valid and infringed, the antithesis of a sham litigation. In particular, after the settlement agreement, the validity of Bayer’s patent was affirmed in a PTO reexamination. Thereafter, four other generic companies challenged the patent’s validity under Hatch-Waxman. Bayer defeated two of those challenges on summary judgment, and this decision was affirmed by the Federal Circuit. A third challenge was defeated after a bench trial upheld the validity of the patent. The fourth case was dismissed after the generic company withdrew its patent challenge.

The Professors’ Brief also argues that "[a]ccording to the [Ciprofloxacin] opinion, [a reverse payment settlement is immune from antitrust scrutiny] even if the patent in question is "fatally weak." The term "fatally weak" is never defined, and in fact the only time the Federal Circuit's decision ever uses the term is when summarizing (and rejecting) arguments made by the plaintiff. But as explained above, the Federal Circuit's approach does not bar antitrust scrutiny in circumstances where the patent was clearly invalid or not infringed at the time of the settlement. In such a case the assertion of patent infringement would be objectively baseless, thereby constituting a sham litigation.

The Professors’ Brief seems to imply that the Federal Circuit erred by not considering the underlying validity of the patent, but the plaintiff's never raised any argument challenging the validity of the underlying patent. As noted above, the PTO and all the courts that have addressed the validity of the patent, including the Federal Circuit, have universally upheld the validity of the patent. The plaintiffs did argue that the patent was obtained by fraud, but this allegation was rejected by the district court, and that decision was affirmed by the Federal Circuit. Notably, the issue of it in equitable conduct was never adjudicated in any of the other challenges to the patent. Based on this, the Federal Circuit quite logically concluded that the district court had not erred in determining that plaintiffs had failed to prove the underlying patent litigation was a sham.

Conclusion

Although the Supreme Court will probably not grant certiorari in this case, the issue of reverse payment settlements will remain a hot topic. Other antitrust challenges to reverse payment settlements are currently pending in other circuits, and could ultimately result in the circuits split sought by the FTC and signatories of the Professors’ Brief. Legislation has been introduced in Congress that if enacted would ban reverse payment settlements. But for the time being, the clear consensus in the courts remains that a reverse payment does not render an otherwise legal patent litigation settlement in violative of the antitrust laws.