Janssen Pharm. v. Teva Pharm. U.S.
| Decision Date | 08 October 2021 |
| Docket Number | Civil Action 18-734 |
| Parties | JANSSEN PHARMACEUTICALS, INC. and JANSSEN PHARMACEUTICA NV, Plaintiffs, v. TEVA PHARMACEUTICALS USA, INC., Defendant. |
| Court | U.S. District Court — District of New Jersey |
This patent case was brought by Plaintiffs Janssen Pharmaceuticals, Inc. and Janssen Pharmaceutica NV (collectively, “Plaintiffs” or “Janssen”) against Defendant Teva Pharmaceuticals USA, Inc. (“Defendant” or “Teva”). This action specifically concerns the validity of Claims 1-21 of U.S. Patent No. 9, 439, 906 (the “'906 Patent” or the “Patent-in-Suit”). ECF No 133 (“Final Pretrial Order”) at 2. The '906 Patent covers “a dosing regimen for administering paliperidone palmitate to a psychiatric patient in need of treatment for schizophrenia, schizoaffective disorder schizophreniform disorder, or other psychotic disorders.” Id.
The Court held a two-week bench trial in this matter that began on October 13, 2020, and concluded on October 30, 2020. ECF Nos. 135-37, 140-41, 145-49, 151. The parties submitted post-trial briefing and proposed findings of fact and conclusions of law in December 2020. ECF Nos. 164 ( ), 165 (“PFOF”), 167 (“Def. Br.”), 167-1 (corrected at 168-1 (“DFOF”)). On January 8, 2021, the parties submitted responsive briefs. ECF Nos. 188 ( ), 189 (“Def. Reply Br.”). Closing arguments were held on March 5, 2021. ECF No. 199.
In a letter dated December 5, 2017, Teva notified Janssen that it had submitted Abbreviated New Drug Application (“ANDA”) No. 211149 to the United States Food and Drug Administration (“FDA”) “seeking FDA approval to engage in the commercial manufacture, use, sale, offer for sale in and/or importation into the United States of generic paliperidone palmitate extended-release injectable suspension products . . . prior to the expiration of the 906 Patent.” Final Pretrial Order at 2. Defendant does not contest infringement of the '906 Patent. Id. Therefore, the only the issue for this Court to decide is whether the Patent-in-Suit is invalid based on the following legal principles: (1) obviousness; (2) lack of written description; and (3) indefiniteness.[1] Id. at 2-3.
This Opinion constitutes the Court's findings of fact and conclusions of law pursuant to Federal Rule of Civil Procedure 52(a). The findings of fact are based on the Court's observations and credibility determinations of the witnesses who testified at trial, and a thorough review of all the evidence admitted at trial. While the Court has reviewed all of the evidence presented, given the length of the trial record, the Court includes references only to the evidence most pertinent to its analysis.[2] For the reasons set forth below, the Court finds that the Patent-in-Suit is not invalid.
Plaintiff Janssen Pharmaceuticals, Inc. is a corporation organized and existing under the laws of the Commonwealth of Pennsylvania, and has its principal place of business at 1125 Trenton-Harbourton Road, Titusville, New Jersey 08560. Id. at 4. Plaintiff Janssen Pharmaceutica NV is a corporation organized and existing under the laws of Belgium, and has its principal place of business at Turnhoutseweg, 30, B-2340 Beerse, Belgium. Id. Janssen Pharmaceutica NV “is the owner of the entire right, title, and interest in and to the '906 Patent.” Id. at 5. Defendant Teva is a corporation organized and existing under the laws of Delaware, and has its principal place of business at 1090 Horsham Road, North Wales, Pennsylvania 19454. Id. at 4.
The dosing regimens at issue in this case provide detailed information concerning the use of paliperidone palmitate to treat schizophrenia and other psychotic disorders. To this end, the '906 Patent discloses unique combinations of dose amounts, dosing schedules, injection sites, and formulation properties. PFOF ¶ 7.[3] The main dosing regimen contained in Claim 2 consists of a 150 mg-eq.[4] first loading dose of paliperidone palmitate in the deltoid muscle on the first day of treatment, a second loading dose of 100 mg-eq. in the deltoid muscle during the sixth to tenth day of treatment, and successive monthly (± 7 days) maintenance doses of 25 mg-eq. to about 150 mg-eq. in either the deltoid or gluteal muscle. '906 Patent (DTX-1/PTX-1) col. 32:11-36. The main dosing regimen for patients with renal impairment contained in Claim 10 consists of a loading dose from about 75 mg-eq. in the deltoid muscle on the first day of treatment, a second loading dose from about 75 mg-eq. in the deltoid muscle on the sixth to tenth day of treatment, and successive monthly (± 7 days) maintenance doses of 25 mg-eq. to about 75 mg-eq. in either the deltoid or gluteal muscle. Id. col. 33:3-27.
This section will first provide the scientific background of the claimed invention. Next, the Court will provide the relevant research and patent history for the Patent-in-Suit.
Schizophrenia is a chronic psychotic disorder that affects approximately one percent of the world's population. DFOF ¶ 52; PFOF ¶ 11. The disorder is most commonly characterized by “disorganized behavior and speech, delusions, and hallucinations.” PFOF ¶ 11. Schizophrenia often manifests “in young people between the ages of 15 and 30, ” and is typically diagnosed after an individual suffers an acute psychotic episode. Id. ¶ 12; Trial Tr. (Kohler) at 1883:4-12. Antipsychotic medication is the main form of treatment for schizophrenia, and its aim is to achieve remission such that a person with schizophrenia can manage their symptoms and function independently. DFOF ¶¶ 53, 55; PFOF ¶ 12. There is currently no cure for schizophrenia, and each psychotic episode inflicts permanent damage upon the brain and reduces the chances of achieving remission. PFOF ¶¶ 12-13.
Schizophrenia is generally treated with antipsychotic drugs which have been available since the 1950s. DFOF ¶ 54; PFOF ¶ 15. These drugs are typically administered orally or as long-acting injectable formulations (“LAI”), sometimes referred to as a “depot.” DFOF ¶¶ 56-57; PFOF ¶¶ 14-15. Schizophrenia is challenging to treat because the symptoms of the disease make it difficult for patients to comply with their prescribed treatment, particularly when it comes to daily oral antipsychotics. DFOF ¶ 57; PFOF ¶ 14. When patients stop taking their medicine or miss a dose, they often have a relapse in the form of an acute psychotic episode, which can set off a cycle of worsening symptoms, additional missed treatment, and possibly institutionalization. Id.
“First-Generation” LAIs developed in the 1950s include “Prolixin (fluphenazine) decanoate, Prolixin (fluphenazine) enanthate, and Haldol (haloperidol) decanoate.” PFOF ¶ 15. These LAIs were accompanied by serious mental side effects such as dullness and cognitive impairment. Id. ¶ 16; see also DFOF ¶ 497. They were also associated with extrapyramidal symptoms (“EPS”) consisting of serious motor impairments, painful muscle contractions, tremors, and stiffness. PFOF ¶ 16; see also DFOF ¶¶ 497-498. Due to the severe mental and physical side effects associated with First-Generation LAIs, they were generally restricted to institutionalized patients who could not function in society. PFOF ¶ 17.
“Second-Generation” antipsychotics, developed in the 1980s and 1990s, were viewed as a major improvement from First-Generation antipsychotics because they had less frequent and less severe side effects (including EPS). Id. ¶ 19. Most of the Second-Generation antipsychotic drugs were administered orally, with Janssen's Risperdal Consta serving as the only Second-Generation LAI on the market for some period of time. Id. Risperdal Consta, however, requires oral supplementation for the first three weeks of treatment and provides only two weeks of therapeutic benefits, making biweekly injections necessary. Id. ¶ 20.
Janssen sought to improve upon these limitations, and eventually received FDA approval for Invega Sustenna in 2009. Id. ¶ 60. Invega Sustenna is seen as a vastly superior product to Risperdal Consta due to its unique dosing regimen consisting of high loading dose injections to initiate treatment and monthly maintenance injections thereafter. Id. ¶ 175-76. The dosing regimen does not require oral supplementation, is initiated in a uniform manner, and has led to important benefits such as improved treatment adherence and reduced risk of relapse. Id. ¶¶ 176, 190. Invega Sustenna is a “blockbuster” drug, and since 2013, it has accounted for the largest revenue share in the LAI antipsychotic market, with net sales of $1.7 billion in 2019 alone. Id. ¶¶ 187-88. When dosed according to its label, Invega Sustenna practices the claims of the '906 Patent. Id. ¶ 171.
Invega Sustenna was developed over the course of more than a decade in a process involving multiple stages of research, numerous clinical trials, and various unexpected setbacks. Id. ¶¶ 26, 36. The initial preclinical stage of the process consisted of formulation development and animal research. Id. Following the preclinical stage, Janssen began Phase I clinical trials. During Phase I, Janssen studied the formulation of paliperidone palmitate to be used in the drug, eventually choosing formulation F13. Id. ¶ 27. Janssen also studied single versus multiple-dose regimens, and deltoid versus gluteal injection sites in Phase I. Id. ¶¶ 27-29. In the BEL-7 Phase I clinical trial, [5] Janssen observed better results with a loading dose regimen of double doses on day 1 followed by monthly maintenance doses, and chose this regimen for further development. Id. ¶ 28. In the USA-3 Phase I clinical trial, Janssen observed that injections in the...
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