1199seiu Nat'l Benefit Fund v. Allergan, Inc. (In re Restasis (Cyclosporine Ophthalmic Emulsion) Antitrust Litig.)
1199seiu Nat'l Benefit Fund v. Allergan, Inc. (In re Restasis (Cyclosporine Ophthalmic Emulsion) Antitrust Litig.)
Opinion of the Court
TABLE OF CONTENTS
I. INTRODUCTION...140
II. PLAINTIFFS' ALLEGATIONS...141
A. Allergan's Development of Restasis®...141
B. Allergan's Unsuccessful Attempts to Obtain a Second-Wave Patent on Restasis®...142
C. Applications for FDA approval of Generic Versions of Restasis®...143
D. Allergan's Alleged Improper Efforts to Delay Generic Versions of Restasis®...144
1. Submitting Sham Citizen Petitions to the FDA...144
2. Defrauding the USPTO into Issuing Second-Wave Patents...147
3. Wrongfully Listing the Second-Wave Patents in the Orange Book...149
4. Filing a Series of Sham Patent Infringement Lawsuits...150
5. Attempting to Avoid Invalidation of the Second-Wave Patents via Sale to the Saint Regis Mohawk Tribe...151
III. LEGAL STANDARDS...152
IV. ANALYSIS...153
A. Are the Citizen Petitions Protected by Noerr -Pennington ?...153
B. Is it Plausible that Allergan's Alleged Anticompetitive Actions Caused a Delay in the FDA Approval Process?...158
V. CONCLUSION...160
I. INTRODUCTION
This multi-district litigation arises out of defendant Allergan's alleged actions to improperly delay the Food and Drug Administration ("FDA") in approving generic competitors to its dry-eye medication Restasis ®. The plaintiffs purchased Restasis ® after the date that Allergan's original, lawfully obtained patent had expired. They contend that the price they paid for Restasis ® would have been lower if Allergan had been required to face competition from generic manufacturers. Plaintiffs bring claims under the Clayton Act,
There are two separate groups of plaintiffs, Direct Purchaser Plaintiffs ("DPPs") and End-Payor Plaintiffs ("EPPs"). The DPPs purchased Restasis ® directly from *141Allergan, and the EPPs purchased Restasis ® at another point in the chain of sale. Plaintiffs originally filed 13 separate cases in various courts around the country, and the Judicial Panel on Multi-District Litigation transferred all of the matters to the Eastern District of New York, where they were consolidated before me.
The complaints are substantially identical with respect to what Allergan is alleged to have done. Plaintiffs allege that Allergan engaged in a number of unlawful, anticompetitive measures to delay generic drug manufacturers from entering the market and to allow Allergan to continue charging inflated monopoly prices for Restasis ®. These measures include: (1) filing frivolous citizen petitions with the FDA to delay its approval of generics; (2) defrauding the U.S. Patent and Trademark Office ("USPTO") into issuing second-wave patents on Restasis ® by submitting a false and misleading affidavit; (3) wrongfully listing those patents in the FDA's Orange Book, which delayed the generic approval process; (4) suing generic manufacturers for infringing on those fraudulently obtained patents without a good-faith belief that its suits could succeed; and (5) transferring the patents to the Saint Regis Mohawk Tribe (and then leasing them back) in order to avoid their invalidation by "renting" the Tribe's sovereign immunity.
Defendant now moves to dismiss the Consolidated Complaints for failure to adequately allege causation. For the reasons set forth below, Allergan's motion is denied.
II. PLAINTIFFS' ALLEGATIONS
A. Allergan's Development of Restasis ®
The allegations of the Consolidated Complaints, taken as true for purposes of this decision, are as follows. In 1993, Allergan bought a license from another pharmaceutical company for a patent that covered the use of the drug cyclosporine to treat dry eyes. Cyclosporine is insoluble in water, and therefore difficult to deliver in an aqueous solution, such as an eye drop. While the idea of using cyclosporine to treat dry eyes was covered by the existing patent, nobody had yet developed a method to get cyclosporine into a person's eyes. Allergan solved this problem by using an oil-in-water emulsion that contained a small amount of castor oil, which would dissolve the cyclosporine, together with glycerin, an emulsifier, and an emulsion stabilizer, in water. Allergan obtained a patent-referred to by the parties as the "Ding I" patent-covering the cyclosporine/castor oil emulsion on December 12, 1995.
The Ding I patent covered a range of ratios between cyclosporine, castor oil, glycerin, the emulsifier, the emulsion stabilizer, *142and water. In relevant part, the patent covered any solution containing: between .05% and .4% cyclosporine and between .625% and 5.0% castor oil. It also listed four examples (labeled 1A-1E) as potential formulations. Two such examples relevant to this case were: .1% cyclosporine to 1.25% castor oil and .05% cyclosporine to .625% castor oil.
After obtaining the Ding I patent, Allergan began clinical trials of several combinations of cyclosporine and castor oil. In the first clinical trial, known as the "Phase 2" study, Allergan tested all four of the combinations listed as examples in the Ding I patent-plus a control group using no cyclosporine and, instead, just castor oil, glycerin, and the emulsifiers-on a total of 88 patients with moderate-to-severe dry-eye disease. The goal of Phase 2 was to determine the safety and efficacy of particular doses of the drug in order to settle on an appropriate dosage level for large-scale clinical trials ("Phase 3"). The results of the Phase 2 study were published in May 2000. All tested combinations, including the castor-oil-only solution, improved the symptoms of dry-eye disease, and all the cyclosporine solutions outperformed the castor-oil-only group. Importantly, the Phase 2 study concluded that the drug's efficacy did not increase when more than .05% cyclosporine was present. The .1% cyclosporine formulation "did not perform better" than the .05% formulation. (DPP Compl. ¶ 107.) That said, there were differences in how the .05% and .1% cyclosporine formulations performed. The .1% formulation "produced the most consistent improvement in objective and subjective endpoints (such as superficial punctate keratitis and rose bengal staining)," while the .05% formulation "produced the most consistent improvements in patient symptoms (such as sandy/gritty feeling and ocular dryness)." (DPP Compl. ¶ 108.) Therefore, the authors of the Phase 2 study recommended that subsequent clinical studies should focus on those two formulations.
Allergan's Phase 3 trials did just that. Those trials compared each of the formulations to the castor-oil-only control group, but not directly to each other. Three solutions were tested-.05% cyclosporine to 1.25% castor oil, .1% cyclosporine to 1.25% castor oil, and the control group of no cyclosporine and just castor oil. The Phase 3 results, which were also published in 2000, showed that both cyclosporine formulations outperformed the castor-oil-only control group, but that neither outperformed the other.
In February of 1999, following the Phase 3 trials, but before the results were published, Allergan filed a New Drug Application ("NDA") with the FDA seeking to market the .05% cyclosporine to 1.25% castor oil formulation tested in the Phase 3 trials. This formulation, which would become the Restasis ® formulation, falls within the ratios covered by the Ding I patent, though it is not one of the specific examples listed. The FDA approved that application in December 2002, and Allergan launched Restasis ® in 2003. Since then, Restasis ® has been the only FDA approved therapeutic treatment for dry eyes available on the U.S. market. Restasis ® owns 100% of the market share and has annual sales of approximately $1 billion. According to plaintiffs, every month that Allergan maintains its monopoly results in another $125 million in revenue.
B. Allergan's Unsuccessful Attempts to Obtain a Second-Wave Patent on Restasis ®
Anticipating that the Ding I patent would expire on May 17, 2014, Allergan made several attempts between 2004 and 2009 to obtain a "second-wave" patent that would continue to cover Restasis ® after *143the Ding I patent expired. Because all of these attempts were unsuccessful, they are not the basis for any of plaintiffs' claims. Nevertheless, they provide important context for Allergan's later, successful effort.
In August of 2004, Allergan attempted to obtain a patent on dry-eye medication with less than .1% cyclosporine and greater than .625% castor oil. This application was rejected, because it was obvious in light of the Ding I patent, which covered those ratios. In response, Allergan amended the application to include only the exact formula of Restasis ®: .05% cyclosporine and 1.25% castor oil, which was again rejected as obvious in light of Ding I. Allergan both appealed this rejection and filed a new application that was similar but added claims regarding new conditions that the method was asserted to treat, such as corneal graft rejection.
In June of 2009, however, Allergan withdrew its appeal and conceded that the claims for which it sought a more specific patent covering the Restasis ® formulation were obvious in light of Ding I. Specifically, Allergan wrote to the USPTO that "[t]he applicants concede that it would have been obvious to modify examples 1A-1E of the Ding reference to arrive at [the Restasis ® formula]. The differences are insignificant." Allergan also wrote that the claimed formulas for which it sought second-wave patents were "squarely within the teaching of the Ding reference, and the Office should disregard any statements by the applicants suggesting otherwise." Allergan did add a new claim, however, for a patent on a composition of less than .05% cyclosporine combined with no more than 1.25% castor oil. On September 1, 2009, this new claim was also rejected as obvious in light of Ding I. After that, Allergan stopped pursuing second-wave patents for several years.
C. Applications for FDA approval of Generic Versions of Restasis ®
Normally, drug companies that wish to sell a new drug must file an NDA with the FDA that includes certain specific data on the safety and effectiveness of the drug. However, the Drug Price Competition and Patent Term Restoration Act of 1984 (the "Hatch-Waxman Act") allows manufacturers to file Abbreviated New Drug Applications ("ANDAs") with the FDA for generic versions of already approved drugs. The generic manufacturers are not required to prove the drugs' safety and efficacy, as that has already been done by the brands. All these manufacturers need to show is that their generic copies share the same active ingredients and are bioequivalent to the brand name drug. The premise is that two drug products containing the same active pharmaceutical ingredient, in the same dose, and delivered in the same way, are equally safe and effective.
Plaintiffs identify five generic manufacturers who submitted ANDAs for generic Restasis ® by January of 2014. The earliest known ANDA was filed on November 14, 2011 by Watson Pharmaceuticals, followed by Teva Pharmaceuticals, Akorn Pharmaceutials, Mylan Pharmaceuticals, and finally InnoPharma on January 13, 2014. Plaintiffs allege that, by the summer of 2015, the FDA had concluded that at least some of those ANDAs were substantially complete at the time they were first filed. For example, InnoPharma has stated that, in mid-2015, the FDA deemed its ANDA to be substantially complete as of the January 2014 filing date. The Food, Drug, and Cosmetic Act ("FDCA") defines a "substantially *144complete" application as one that "on its face is sufficiently complete to permit a substantive review and contains all the information required."
The FDA, therefore, could have performed a substantive review as soon as January of 2014, and possibly even earlier for the other ANDAs. The substantive review could have allowed it to approve (or reject) the proposed generic. Plaintiffs allege that it is likely the FDA would have approved one or more of the ANDAs for several reasons: (1) they were submitted by "[s]ome of the largest and most sophisticated drug companies;" (2) the ingredients "are commonly known, easily available, and unprotected by patents;" and (3) the actual production of cyclosporine ophthalmic emulsion poses "little manufacturing or formulation obstacles." (DPP Compl. ¶ 283.)
D. Allergan's Alleged Improper Efforts to Delay Generic Versions of Restasis ®
1. Submitting Sham Citizen Petitions to the FDA
A generic drug is deemed bioequivalent to an already approved drug if any differences in formulation, i.e. , differences in preservatives or other inactive ingredients, do not impact the rate and extent to which the active ingredient (here, cyclosporine ) becomes available at the site of action (here, the eye).
In June of 2013, with less than a year left on the Ding I patent, the FDA issued a draft guidance, on which it sought public comment, containing recommendations to applicants seeking to gain approval for generic versions of Restasis ®. Such guidance is not required, and plaintiffs allege that the FDA often approves generic versions of drugs without issuing any guidance. However, according to plaintiffs, by posting a draft guidance, and seeking comment on it, the FDA showed that it was well underway in evaluating the circumstances under which it would approve a generic version of Restasis.®
The draft guidance for generic versions of Restasis ® recommended the use of in vitro testing where: (1) the quality and quantity of the proposed ingredients, both active and inactive, of the generic were the same as that used for Restasis ;® (2) a comparative physiochemical characterization between Restasis ® and the generic was performed on six separate specified dimensions; and (3) the drug-release-rate tests were compared based on in vitro tests. Unless all those criteria were met, the proponent of the generic drug would be required to use in vivo testing.
On August 17, 2013, Allergan submitted a comment to the FDA asserting that the FDA should not approve any generic version *145of Restasis ® relying on in vitro testing. It told the FDA that it should "replace the Draft Guidance with a revised guidance document that explains in vivo comparative clinical studies are required to demonstrate that a proposed generic product is bioequivalent to" Restasis ®. Allergan also caused its position to be echoed in comments submitted by several doctors who, unbeknownst to the FDA, had received payments from Allergan for "consulting" services and "travel and lodging," some of which specifically related to Restasis.® For example, three doctors who submitted comments critical of an in vitro bioequivalence option received over $125,000 combined from Allergan.
Plaintiffs allege that Allergan knew that these comments to the draft guidance would not necessarily delay generic entry. This is because the FDA is required only to consider these comments; it is not required to respond to them. Therefore, starting in January of 2014, Allergan began to file with the FDA a series of "citizen petitions" attacking the FDA's draft guidance, which do require a response.
Before addressing the specifics of Allergan's citizen petitions, it is helpful to review what a citizen petition is. The FDCA allows any person to file a "citizen petition" requesting that the FDA take, or refrain from taking, administrative action.
According to plaintiffs, brand companies frequently use the citizen petition process to delay FDA approval of a competing generic. In addition to requiring the FDA to prepare a response, the filing of these petitions by brand companies signals to the FDA that the company is likely to file litigation against the FDA if it approves an ANDA and denies the petition. These petitions, therefore, can result in a considerable delay in the ANDA approval process while the FDA ensures that it is adequately prepared for potential litigation. Plaintiffs allege that the FDA thus has a well-known, longstanding practice of withholding ANDA approval until after the agency has authorized a response to a citizen petition that bears on the subject of the pending ANDA, even where the petition may lack merit. Indeed, the FDA has long acknowledged the problem of citizen petition abuse, stating in 2005 that it had "seen several examples of citizen petitions that appear designed not to raise timely concerns with respect to the legality or scientific soundness of approving an [ANDA], but rather to delay approval ...." 153 Cong. Rec. 127 (Jan. 4, 2007) (statement of FDA Chief Counsel Sheldon Bradshaw in 2005). Plaintiffs allege that these concerns continue despite a recent amendment to the FDCA,
Allergan's first citizen petition was filed on January 15, 2014, and it filed another petition on February 28, 2014, which added to and repeated the requests and arguments of the January petition. Allergan eventually withdrew the January petition, allowing the February petition to replace it. The petition largely reiterated Allergan's August 2013 comments to the FDA's June 2013 guidance, and made six requests of the FDA, including that it: (1) withdraw the draft guidance for generic approval *146and make clear that bioequivalence for a proposed generic version of Restasis ® can be demonstrated only through in vivo clinical studies; (2) reject as incomplete any ANDA referencing Restasis ® that does not include data from at least one in vivo study; and (3) make clear that it will not approve any ANDA based exclusively on in vitro data until clinical studies have been performed to validate that the in vitro studies correlate to relevant in vivo bioavailability. In support of the petition, Allergan cited to the public comments submitted by the doctors who had been paid by Allergan, again without disclosing that it had paid those doctors. Allergan supplemented this petition on May 29, 2014 and on October 31, 2014.
The FDA rejected every substantive request made in the citizen petition on November 20, 2014. The agency provided a thorough explanation of the scientific basis for the draft guidance. In sum: (1) for drugs like Restasis ® that have a modest clinical benefit, in vitro studies are likely to be more sensitive, accurate, and reproducible than comparative clinical studies; (2) in vivo studies could require more than 2,000 subjects with dry-eye disease to pass the statistical tests; and (3) a proposed generic that contains the same ingredients, in the same proportions, and shows the same release rate in in vitro tests should be sufficiently bioequivalent. The FDA also stated that the guidance was consistent with its policies to protect the public health, including refraining from unnecessary human research when other methods of demonstrating bioequivalence meet the regulatory standards for approval. Additionally, although it did not waver from its positions, the FDA noted on a few occasions in its response that it was considering revising its draft guidance to clarify certain topics addressed by Allergan in its petition. The FDA granted only Allergan's requests for: (1) an opportunity to comment on the guidance (which Allergan had already been given); and (2) an articulation of the basis of the FDA's guidance decision (which the FDA's response to the petition accomplished and which the FDA was required to do in response to any petition on the subject).
Allergan did not appeal the November 2014 rejection to a federal court, as it could have done. See
Instead, Allergan filed another citizen petition on December 23, 2014. This second petition largely repeated the positions and requests in the initial petition. Allergan supplemented the second petition four times, including on August 26, 2015, when it requested that the FDA convene a committee of outside experts to evaluate the use of in vitro methods, and refuse to receive, review, or approve any generic Restasis ® ANDAs until the outside committee's evaluation was complete. Plaintiffs contend that, given the FDA's rejection of Allergan's first petition, there was no realistic expectation that the second petition or its supplements would succeed, because they did not provide new, clinically relevant information.
On February 10, 2016, the FDA issued a lengthy letter denying all the substantive requests made by Allergan in its second petition and its supplements. In addition to disagreeing with Allergan's assertion that it "cannot receive or approve any ANDA submitted to the FDA that contains only in vitro test results," the agency found characterizations in Allergan's petition to be "misleading," research data it cited to be "insufficient," and scientific methods on *147which Allergan relied to be invalid and unreliable. It also wrote that Allergan had "repeat[ed] many of the assertions" from the first petition, and it concluded that Allergan's arguments "lack legal support" and "rest on flawed logic." In the letter's final sentences, the FDA granted two of Allergan's requests-that the agency: (1) disclose the in vitro bioequivalence methods it intended to accept for ANDAs; and (2) respond specifically to Allergan's testing of nine experimental test emulsions. It then stated that the letter itself fulfilled these requests and specifically noted that it had found Allergan's experimental data to be deficient. Again, Allergan elected not to appeal the denial of its petition to the courts. On February 10, 2016, the same day that it issued its response to Allergan's petition, the FDA posted a revised version of its draft guidance. The FDA published a notice about its revised draft guidance in the Federal Register on February 16, 2016.
In August of 2017, Allergan filed a third citizen petition to the FDA.
To the extent this Petition requests actions different from those requested in Allergan's previous citizen petitions that might have implications regarding the nature of the data and information necessary to support approval of an ANDA for cyclosporine ophthalmic emulsion, we deny those requests without comment. We will consider any issues related to such requests in the context of our review of specific applications and the record for the Draft Cyclosporine [Bioequivalance] Guidance.
2. Defrauding the USPTO into Issuing Second-Wave Patents
Meanwhile, in August of 2013, Allergan had filed six additional applications for patents with the USPTO. The applications are substantially identical to Allergan's prior, failed applications to obtain a patent specifically covering the Restasis ® formulation, which Allergan had conceded was obvious in light of the Ding I patent.
Under patent law, "where there is a range disclosed in the prior art, and the claimed invention falls within that range, the burden of production falls upon the patentee to come forward with evidence that (1) the prior art taught away from the claimed invention; (2) there were new and unexpected results relative to the prior art; or (3) there are other pertinent secondary considerations." Galderma Labs., L.P. v. Tolmar, Inc. ,
Allergan purported to do just that. In its August 2013 filings, Allergan represented that, since its 2009 concession of obviousness, it had "collected evidence that supports the patentability of the pending claims." Specifically, Allergan told the USPTO that the Restasis ® formulation of .05% cyclosporine to 1.25% castor oil performed far better than would be expected as compared to the .1% cyclosporine to 1.25% castor oil formulation. Allergan claimed that the Phase 2 trial revealed that the .1% cyclosporine formulation outperformed the .05% cyclosporine formulation, while the Phase 3 study revealed that the .05% formulation outperformed the .1% formulation. Thus, according to Allergan, the results of the Phase 3 trial were unexpected in light of the Phase 2 results.
These representations were false. The Phase 2 and Phase 3 trials were published in 2000, not "since 2009." Additionally, as described above, in neither Phase 2 nor Phase 3 did either of the formulations outperform the other. On October 17, 2013, the patent examiner rejected the second-wave patent applications.
A week later, on October 23, 2013, Allergan submitted to the patent examiner a declaration from Dr. Rhett Schiffman in an effort to overcome the rejection. Dr. Schiffman claimed that the Phase 3 results for Restasis ® were surprising because it performed significantly better than the .05 cyclosporine/.625 castor oil formula, which was tested in Phase 2 and disclosed as an example in the Ding I patent. Dr. Schiffman said this result was unexpected because the Phase 2 trial had suggested that the .1% cyclosporine formulation was superior to the .05% formulation. Plaintiffs allege, relying on the decision in Allergan, Inc. v. Teva Pharmaceuticals USA, Inc. ,
1. It relied on statistically insignificant data, and concealed the fact that the data was statistically insignificant from the USPTO.
2. It did not compare like test results; it compared the Schirmer tear tests performed with anesthetic to Schirmer tear tests conducted without anesthetic. Such a comparison has no scientific value.8
3. It used data manipulation techniques to amplify small differences between test results, giving the false impression that Dr. Schiffman had actually obtained significant results, and
4. It did not mention that Dr. Schiffman lifted the data he presented from the Phase 3 paper, published in 2000, more than a decade earlier. Thus, the data was prior art to the second-wave patents, and it could not support Allergan's patent application.9
*149The Schiffman declaration led the USPTO to reverse course. On November 21, 2013, the USPTO authorized the second-wave patents for which Allergan had applied. The decision to issue the patents explicitly relied on the representations made in the Schiffman declaration. In fact, in the Eastern District of Texas trial, Dr. Schiffman conceded that his declaration was instrumental in persuading the USPTO to grant the applications. The patents were issued one at a time. Five issued between January and April of 2014, and the sixth issued in February of 2016. Plaintiffs allege that Allergan procured these patents through knowing and intentional fraud on the USPTO.
3. Wrongfully Listing the Second-Wave Patents in the Orange Book
Under the Hatch-Waxman Act, a new drug applicant must submit to the FDA information on each patent that covers the drug or methods-of-use described in the NDA for which "a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug."
Allergan listed each of the five second-wave Restasis ® patents that issued between January and April of 2014 in the Orange Book shortly after they were issued. Plaintiffs allege that these listings were improper because Allergan knew it had obtained the patents through fraud and that a claim of patent infringement could not reasonably be asserted based on them. Put another way, Allergan knew that it could not realistically expect to prevail on the merits of any patent infringement suit it brought, since it knew the claims in the second-wave patents were obvious in light of Ding I, and it was aware of the fraud it perpetrated through the Schiffman declaration.
The Orange Book listing has regulatory consequences with the FDA, two of which are significant here. First, a generic drug manufacturer, when it submits an ANDA, must include in its application one of the following four certifications with respect to the patents covering the branded drug it seeks to produce:
1. That such patent information has been not filed [in the Orange Book] (a "Paragraph I certification");
2. That such patent has expired (a "Paragraph II certification");
3. The date on which such patent will expire (a "Paragraph III certification"); or
4. That such patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted (a "Paragraph IV certification").
By listing the second-wave patents in the Orange Book, Allergan required any potential generic Restasis ® manufacturer to submit a Paragraph IV certification with its ANDA. When an application containing a Paragraph IV certification is received by the FDA for substantive review, *150the ANDA must also provide the patent owner with notice of the Paragraph IV certification, which includes a description of the factual and legal basis for the ANDA's assertion that the patent is invalid.
Plaintiffs allege that the first generic manufacturer to file an ANDA with a Paragraph IV certification undertakes a substantial risk of patent infringement litigation. In order to incentivize generic manufacturers to file ANDAs with Paragraph IV certifications-as opposed to waiting to free-ride off of another generic manufacturer that assumes the risk of challenging the patent-the Hatch-Waxman Act provides that the first applicant to submit a substantially complete application containing a Paragraph IV certification will have a 180-day exclusivity period as the only generic on the market.
Allergan's listing of the second-wave Restasis ® patents, therefore, allowed it not only to trigger a 30-month stay of FDA approval for the first generic Restasis ® application; it also prevented all other generic applications from being approved for an additional six months after the first application would have been approved. In effect, it allowed Allergan to extend its monopoly for the duration of the stay and potentially to limit the competition to only one generic competitor for an additional six months.
4. Filing a Series of Sham Patent Infringement Lawsuits
In June of 2015, the FDA acknowledged the receipt of several ANDAs containing Paragraph IV certifications for generic Restasis ®. This triggered the ANDA applicants' obligation to serve notice of their Paragraph IV certifications on Allergan, which, starting in July of 2015, the generic manufacturers Apotex, Akorn, Mylan, and Teva did. Several more generic manufacturers would eventually do the same. On August 24, 2015, Allergan filed suit against Apotex, Akorn, Mylan, and Teva in the Eastern District of Texas, alleging infringement of the second-wave Restasis ® patents. Allergan brought four more suits-against InnoPharma, Famy Care Pharma, Twi Pharmaceuticals, and Deva Holdings-in 2015 and 2016, after Allergan received those Paragraph IV certifications.
According to plaintiffs, knowing, as Allergan did, that the patents were procured through fraud, Allergan could not have had a reasonable expectation of prevailing on the merits in any of these suits. Rather, the purpose of the suits was to trigger the 30-month stay of FDA approval of the generics. Plaintiffs rely on the opinion of Federal Circuit Judge William C. Bryson, sitting by designation in the Eastern District of Texas, rendered after a bench trial, which found that the Restasis ® formulation *151was obvious in light of the Ding I patent and that the subsequent patents issued only because Allergan had "painted a false picture" of the relevant data. Allergan, Inc. ,
5. Attempting to Avoid Invalidation of the Second-Wave Patents via Sale to the Saint Regis Mohawk Tribe
In June of 2015, generic manufacturer Apotex petitioned the USPTO to initiate an inter partes review of the second-wave patents. Inter partes review is a process by which private parties may challenge previously issued patent claims in an adversarial process before the USPTO. SAS Institute Inc. v. Iancu, 584 U.S. ----,
In December of 2015, with a Board ruling expected shortly, Allergan settled the Apotex inter partes proceeding on undisclosed terms. By that point, however, other ANDA applicants, including Mylan and Teva, had also petitioned the Board for inter partes review. Those petitions were granted in December of 2016, and the Board instituted inter partes review against all six second-wave patents.
In an effort to save the patents from invalidation, on September 8, 2017, Allergan conveyed ownership of the patents to the Saint Regis Mohawk Tribe, which in turn gave Allergan an exclusive license for all FDA approved uses of Restasis® in the United States. In addition to conveying the patents to them, Allergan paid the Mohawk Tribe $13.5 million, plus up to $15 million in annual royalties. In "consideration" for the patents, the initial payment, and the royalties, the Mohawk Tribe gave Allergan only one thing-a promise not to waive its sovereign immunity with respect to any inter partes review or other administrative action in the USPTO relating to the second-wave patents. After the transfer, on September 22, 2017, Allergan and the Mohawk Tribe petitioned the Board to dismiss the pending inter partes review proceeding based on tribal sovereign immunity. That motion was denied by the PTAB, whose decision was recently affirmed by the Federal Circuit. Saint Regis Mohawk Tribe v. Mytan Pharm. Inc. ,
Allergan's Chief Executive Officer, Brent Saunders, explicitly acknowledged *152that the purpose of the Mohawk transfer was to disrupt the ongoing proceedings that may invalidate the patents-the inter partes review proceedings and the federal patent infringement lawsuit that Allergan itself had initiated against the generic manufacturers. Plaintiffs allege that no reasonable litigant could expect these obstructionist tactics to succeed and that Allergan undertook this sham transfer only to further delay the inevitable invalidation of its patents.
III. LEGAL STANDARDS
Defendant moves to dismiss the Consolidated Complaints pursuant to Federal Rule of Civil Procedure 12(b)(6). When considering such a motion, the court must accept as true all well-pleaded factual allegations and must draw all reasonable inferences in plaintiffs' favor. Swiatkowski v. Citibank,
When deciding a Rule 12(b)(6) motion, "courts must consider the complaint in its entirety, as well as ... documents incorporated into the complaint by reference, and matters of which a court may take judicial notice." Tellabs, Inc. v. Makor Issues & Rights, Ltd. ,
"Causation in fact is, of course, a necessary element of any claim for relief." In re Actos End-Payor Antitrust Litig. ,
*153IV. ANALYSIS
For purposes of this motion, Allergan does not challenge the allegations of its misconduct: that it defrauded the USPTO into issuing it second-wave patents, used those patents to effect a 30-month stay of FDA approval of competitors to Restasis ®, and filed a series of citizen petitions with the FDA attacking its guidelines for the approval of generic Restasis ®; and when it appeared as though its patents would be invalidated by a federal court and/or the USPTO, Allergan conveyed them to the Saint Regis Mohawk Tribe and spent millions of dollars in an attempt to frustrate those proceedings by "renting" the Tribe's sovereign immunity.
Allergan argues only that these actions were harmless and caused no injury. It relies on a series of inferences leading to the conclusion that, Allergan's behavior aside, the FDA was nevertheless not ready to approve any of the generics. Allergan asks me to find, as a matter of law, that this conclusion is the only plausible one and therefore none of its alleged actions-which were taken with the sole objective of delaying market entry of competitors to Restasis ®-could have been successful in causing any such delay.
A. Are the Citizen Petitions Protected by Noerr-Pennington ?
As an initial matter, I must determine whether Allergan's citizen petitions are protected by the First Amendment and therefore immune from antitrust liability pursuant to the Noerr - Pennington doctrine. See E. R.R. Presidents Conference v. Noerr Motor Freight, Inc. ,
In Prof'l Real Estate Investors, Inc. v. Columbia Pictures Indus., Inc. ("PRE "),
*154In its motion, Allergan does not address the second (subjective) prong of the PRE test. In view of plaintiffs' allegations in the complaints, it is easily established that Allergan's subjective intent in filing citizen petitions was to frustrate generic competition of Restasis ®. Plaintiffs allege that Allergan chose not to appeal any of the denials of its petitions to a federal court, knowing that it was unlikely to win an appeal and preferring instead to file successive petitions because that would be more disruptive to the FDA approval process. No other inference is offered by defendant as to why it did not appeal the denials. Plaintiffs also allege that Allergan made scientific misrepresentations to the USPTO to obtain the patents, filed frivolous litigation to delay the generics, and engaged in bad-faith dealings with the Mohawk Tribe to circumvent the invalidation of their patents. It is highly plausible that a company willing to engage in such conduct was intending to delay the entry of generics into the market, rather than seeking to protect the public health, when it filed its citizen petitions.
Allergan does, on the other hand, contend that plaintiffs' allegations do not satisfy the first prong of the PRE test-that the citizen petitions were objectively baseless. Allergan exclusively relies on the FDA's responses to its petitions to argue that they were not shams.
Objective baselessness is assessed at the time of filing. See, e.g., In re Wellbutrin XL ,
Several cases illustrate the heavy burden placed on a defendant, like Allergan, seeking Noerr - Pennington immunity at this stage of the litigation. In In re Lipitor, the district court had concluded, on a motion to dismiss, that the defendant's citizen petition was entitled to Noerr - Pennington protection. 868 F.3d at 273. The court had reasoned that the petition was not objectively baseless because it was supported by science and because the FDA had observed that the petition raised "complex issues" and had taken several years to reach a decision before ultimately issuing a denial. Id. at 243, 273-74. The Third Circuit reversed. Id. at 274. It explained that by "[e]quating delay in consideration of a petition or its complexity with the petition's underlying merits," the district court had "fail[ed] to draw inferences in [ ] plaintiffs' favor." Id. The Third Circuit found that the plaintiffs' claim was entitled to proceed since plaintiffs had plausibly alleged that the citizen petition was not supported by science and one could reasonably infer that the FDA's actions in response to the petition "reflected little about its actual merits." Id. at 273-74.
Using like reasoning, the district court in In re Suboxone held, on a motion to dismiss, that defendant's citizen petition was not entitled to Noerr - Pennington immunity as a matter of law.
In this case, the FDA's responses fall far short of demonstrating that plaintiffs' allegations of objective baselessness are implausible. The FDA denied every substantive request made by Allergan in each of its three petitions. Allergan repeatedly requested that the FDA do away with in vitro testing for bioequivalency for Restasis ®, and the agency emphatically rejected this request each time it was made. Of course, that the petitions were denied in all substantive respects, standing alone, is not necessarily enough to plausibly allege that they were objectively baseless. Apotex ,
Moreover, Allergan's second and third citizen petitions largely rehash the claims of the first and were denied on the same grounds. The FDA, in denying the second petition, stated that Allergan had "repeat[ed] many of the assertions" from the first petition, that its data were "misleading" and "insufficient," and that its arguments "lack legal support" and "rest on flawed logic." In response to the third petition, the FDA stated that, because it had "addressed [Allergan's] assertions in its responses to the previous citizen petitions, it does not address them again here." It then denied any non-repetitive requests "without comment." The second petition was filed on December 23, 2014, and the third in August of 2017. The plausibility of objective baselessness grows with each filing. See California Motor Transp. Co. v. Trucking Unlimited,
That Allergan's first two petitions were "granted in part" also fails to establish that they were not baseless as a matter of law. See In re Suboxone,
Plaintiffs point out that the petitions were granted only to the extent that the FDA agreed to do that which it had already done or was otherwise required to do by law. In response to Allergan's first petition, the FDA granted only Allergan's requests for an opportunity to comment on its bioequivalence methodology for generic versions of Restasis ® and for an explanation of the scientific foundations for its decision to allow ANDA applicants to use in vitro testing to demonstrate bioequivalence, which the response itself provided. The FDA granted Allergan's second petition solely by agreeing to provide Allergan with "a more specific response" concerning the results of Allergan's testing of nine experimental test emulsions and by agreeing to share more information about the in vitro bioequivalence methods the FDA planned to recommend to ANDA applicants. The FDA then indicated that the information it provided in its response fulfilled Allergan's requests. Put simply, in response to the petitions, the FDA agreed to exchange information with Allergan about its scientific methodology, but the agency denied every one of Allergan's requests that it change that methodology. At a minimum, plaintiffs' reading of the FDA's partial grants of Allergan's first and second petitions is plausible.
Finally, in the absence of any actual substantive grants of its requests, defendant argues that its citizen petitions influenced FDA policy. It notes that, on a few occasions in its response to Allergan's first petition, the FDA stated that it was considering revising its draft guidance. Allergan claims that its petition prompted the FDA to engage in such reconsideration. Allergan further argues that the agency's revisions to its draft guidance in February of 2016 were largely the result of Allergan's comments in its second petition. Finally, Allergan points out that, in response to the third petition, the FDA agreed to "consider" Allergan's non-repetitive requests when reviewing specific ANDAs and the draft bioequivalence guidance. It also argues that the FDA denied this petition only because the 150-day statutory deadline for it to respond was imminent.
Plaintiffs dispute Allergan's characterization of the FDA's responses. They argue that Allergan seeks to take credit for changes in the draft guidance that it never sought or that simply clarified concepts that the FDA had accepted from the beginning. Plaintiffs further disagree with Allergan's claim that its second petition was the catalyst for the FDA's decision to revise its draft guidance in February of 2016. Plaintiffs do not specifically address Allergan's argument regarding the FDA's assertion in its response to the third petition that it will "consider" some of Allergan's requests. But they do allege that the brevity of the FDA's response, which denied every one of Allergan's requests "without comment," demonstrated that the petition was repetitive and unsupported. Because the significance of the FDA's actions is in dispute, and the inferences plaintiffs ask me to draw are plausible, defendant's petitions are not entitled to Noerr - Pennington immunity at this stage of the litigation. See In re Flonase , 795 F.Supp.2d at 315 n.16 (declining, on a summary judgment motion, to find that a petition was entitled to Noerr - Pennington immunity based on defendant's argument that its submission "contributed to the debate"
*158on bioequivalence compliance for the relevant drug category).
In sum, whether, on all of the evidence, a factfinder would find that the petitions were not baseless remains to be seen. Certainly, the inferences Allergan draws, considering the other possible inferences, are not sufficient to find as a matter of law that the First Amendment shields Allergan's citizen petitions from antitrust liability.
B. Is it Plausible that Allergan's Alleged Anticompetitive Actions Caused a Delay in the FDA Approval Process?
Allergan asserts that, even if the citizen petitions are not immune from antitrust liability, plaintiffs have failed to plausibly allege that the petitions delayed the FDA's approval of generic drugs. It points to
Allergan also argues that plaintiffs have not shown that the 30-month stay occasioned by the patent infringement lawsuits, and made possible through the fraudulently obtained patents and the wrongful Orange Book listing, delayed the market entry of generics. Allergan notes that the FDA did not grant tentative approval to ANDAs during this stay, even though it could have done so. See Actos ,
Allergan's arguments are not sufficient to overcome the plausibility of plaintiffs' claims. Plaintiffs allege that, despite the existence of
*159It is also reasonable to infer, as plaintiffs ask me to do, that the stay resulting from the patent infringement litigation led the FDA to divert its resources away from the ANDAs at issue. The FDA may have prioritized reviewing applications for other generic drugs, because, even if tentative approval were granted to the ANDAs, a drug subject to a stay would not be able to enter the market for some time (possibly over a decade if the patent infringement suit were successful and the ANDA applicant had to wait until the patent expired). See, e.g., In re Loestrin 24 Fe Antitrust Litig. ,
It also is plausible that Allergan's actions resulted in a delay in the approval process that continues to this day. The FDA may have slowed or halted its review of ANDAs to address the citizen petitions and to account for the stay so that, even if the review is now moving along unobstructed, the ANDAs would have been approved months or even years ago had the petitions not been filed. In re Flonase Antitrust Litig. ,
Allergan may be correct that its actions had no effect on the FDA's approval process. That process undoubtedly will be the subject of discovery and expert testimony. But it is also plausible that Allergan's efforts, which plaintiffs allege were intended solely to impede generic entry into the market, worked. "The choice between two plausible inferences that may be drawn from factual allegations is not a choice to be made by the court on a Rule 12(b)(6) motion." Anderson News, LLC v. Am. Media ,
Finally, the likelihood that Allergan's citizen petitions and its efforts to protect fraudulent patents resulted in plaintiffs' injury increases when these actions are viewed in the aggregate. Here, for example, the 30-month stay coincided with other events that plaintiffs allege caused delay-Allergan's filing of its fourth supplement to its second citizen petition, the FDA's response to the second citizen petition, and Allergan's filing of its third citizen petition. That the FDA was confronted with these events simultaneously makes it more plausible that the agency chose not to prioritize its review of the ANDAs during this time period. In re Skelaxin,
V. CONCLUSION
In sum, Allergan, admitting for purposes of the motion it brings, that it deliberately and repeatedly attempted to obstruct the entry of generics into the marketplace for Restasis ®, argues that plaintiffs have not plausibly alleged that Allergan's aggressive and persistent efforts had any effect on the timing of approval for its generic competitors to enter the market. Whether Allergan can convince a jury of this remains open. But its arguments that plaintiffs' allegations are implausible, and that the court should dismiss the case for failure to plead causation, are meritless. On the face of the Consolidated Complaints, the inferences plaintiffs draw-namely, that Allergan's efforts bore fruit in causing delay-are logical and amply support the plausibility requirement. Although defendant accuses plaintiffs of speculating, as the Second Circuit stated in Actos :
It is [defendant], however, that is here engaging in gross speculation. While it is possible that one or more of these factors may turn out to be barriers to plaintiffs' causation theory at later stages of the litigation, they do not mandate dismissing the complaint now. Indeed, even at summary judgment, an antitrust plaintiff may be entitled to a presumption of causation where the anticompetitive conduct is deemed wrongful because it is believed significantly to increase the risk of a particular injury and that injury occurred. If plaintiffs reach the summary judgment stage and make that showing, then it would be [defendant's] burden to show that some other factors, such as the ones identified above, are the "true" cause of the delay, and therefore the "true" cause of the artificially high drug prices plaintiffs paid. Dismissal at this early stage on the basis of speculation about possible and not inherently more plausible alternative causes would be premature.
Defendant's motion to dismiss the Consolidated Complaints for lack of causation is therefore denied. The court will address defendant's motion to dismiss various EPP state law claims for failure to state a claim by separate order.
SO ORDERED.
Three cases that were transferred to me have been voluntarily dismissed.
There are three additional complaints-one on behalf of Walgreen Co., The Kroger Co., Albertsons Companies, Inc., and HEB Grocery Company L.P.; one on behalf of CVS Pharmacy, Inc.; and one on behalf of Rite Aid Corporation and Rite Aid Hdqtrs. Corp.-that are not filed as class actions. Those actions, on behalf of direct purchasers of Restasis ®, are not subject to defendant's current motion.
A narrow patent was issued on December 21, 2013,
Allergan argues that this is untrue, and that Restasis ® is difficult to copy. The question of which party is correct is not suitable for resolution on a motion to dismiss.
In addition, in 2016, the FDA issued amendments to its draft guidance and Allergan submitted comments on those amendments.
Though this Opinion had yet to issue at the time of Allergan's applications to the USPTO, the principle that unexpected results can overcome a prima facie case of obviousness in light of prior art was already established. See, e.g., Iron Grip Barbell Co. v. USA Sports, Inc. ,
A Schirmer tear test is a commonly used device to diagnose and measure dry eyes. It involves placing a strip of filter paper under a patient's eyelid and recording how many millimeters of the paper are wetted by the patient's tears.
The Eastern District of Texas's decision is discussed in greater detail infra at pp. 150-51, in the section on Allergan's patent infringement lawsuits against the generic manufacturers.
The Second Circuit has adopted an alternative test that applies in a subset of cases in which the petitioning party has engaged in a pattern or practice of filing successive petitions. Primetime 24 Joint Venture v. Nat'l Broad. Co. ,
Defendant also suggests in its reply brief that its citizen petitions warrant First Amendment protection because the FDA solicited comments on the draft guidance and its petitions were responding to those requests. If I were to accept this argument, it would eliminate the sham exception to the Noerr - Pennington doctrine. In the face of overwhelming precedent, I decline to do so. See, e.g., PRE ,
The FDA draft guidance permitted the use of in vitro studies to prove bioequivalence only where the proposed generic: (1) included the same ingredients as Restasis ® in the same amounts; (2) had the same physiochemical properties as Restasis ® on at least six separate metrics; and (3) had an acceptable comparative release rate (meaning that the same amount of cyclosporine would be delivered to the eye for absorption).
In support of this allegation, plaintiffs cite to the FDA's Eighth Annual Report on Delays in Approvals of Applications Related to Citizen Petitions and Petitions for Stay of Agency Action for Fiscal Year 2015 at 8 (July 29, 2016), available at www.fda.gov/downloads/AboutFDA/CentersOffices/OfflceofMedicalProductsandTobacco/CDER/ReportsBudgets/UCM517279.pdf ("the FDA remains concerned about the resources required to respond to ... petitions ... at the expense of completing the other work of the agency").
In its reply brief and at oral argument, Allergan argued that plaintiffs did not allege that the 30-month stay caused the FDA to "backburner" its review of Restasis ® and thus urged the court not to consider this argument. Plaintiffs, however, need not plead in their complaints a response to every potential argument raised by defendant in its motion to dismiss. The crux of these lawsuits is plaintiffs' claim that Allergan's numerous actions, including obtaining the 30-month stay, delayed the FDA's, review of ANDAs. Thus, the complaints provided defendant with notice of this issue, and defendant's claim of surprise is unconvincing.
Reference
- Full Case Name
- IN RE RESTASIS (CYCLOSPORINE OPHTHALMIC EMULSION) ANTITRUST LITIGATION This Document Applies To: 1199SEIU National Benefit Fund v. Allergan, Inc., 17-cv-6755 American Federation of State, County & Municipal Employees District Council 37 Health & Security Plan v. Allergan, Inc., 17-cv-6684 Sergeants Benevolent Association Health & Welfare Fund v. Allergan, Inc., 17-cv-7300 Philadelphia Federation of Teachers Health & Welfare Fund v. Allergan, Inc., 17-cv-7377 St. Paul Electrical Workers' Health Plan v. Allergan, Inc., 18-cv-41 FWK Holdings, LLC v. Allergan, Inc., 18-cv-677 Rochester Drug Co-Operative, Inc. v. Allergan, Inc., 18-cv-970 KPH Healthcare Services, Inc., a/k/a Kinney Drugs, Inc. v. Allergan, Inc., 18-cv-974 International Union of Operating Engineers Local 501 Security Trust Fund v. Allergan, Inc., 18-cv-749 United Food & Commercial Workers Unions & Employers Midwest Health Benefits Fund v. Allergan, Inc., 18-cv-816 Self Insured Schools of California v. Allergan, Inc., 18-cv-968 Fraternal Order of Police, Miami Lodge 20, Insurance Trust Fund v. Allergan, Inc., 18-cv-969 and Plumbers & Pipefitters Local 178 Health & Welfare Trust Fund v. Allergan, Inc., 18-cv-972.
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