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Janssen Pharmaceutica N.V. v. Mylan Pharmaceuticals.

October 13, 2006

JANSSEN PHARMACEUTICA N.V., AND JANSSEN PHARMACEUTICA PRODUCTS, L.P. PLAINTIFFS,
v.
MYLAN PHARMACEUTICALS., INC. DEFENDANTS.
JANSSEN PHARMACEUTICA N.V., AND JANSSEN PHARMACEUTICA PRODUCTS, L.P. PLAINTIFFS,
v.
DR. REDDY'S LABORATORIES, LTD., AND DR. REDDY'S LABORATORIES, INC. DEFENDANTS.



The opinion of the court was delivered by: Lifland, District Judge

OPINION

I. Introduction

Plaintiffs, Janssen Pharmaceutica, N.V., a Belgian corporation, and its New Jersey-based subsidiary, Janssen Pharmaceutica, L.P. (collectively "Janssen"), are the inventors and producers of risperidone, the active ingredient in Janssen's successful drug for the treatment of schizophrenia, Risperdal. It is perhaps an understatement to describe Risperdal as merely "successful." The drug has been described by the American Chemical Society as "a standard in the treatment of psychosis, revolutionizing anti-psychotic treatments." Pl.'s Ex. ("PX") 309. In 2005 alone, Risperdal accounted for over $3 billion in worldwide sales for Janssen's parent company, Johnson & Johnson. Vergis Tr. 78:9-16.

Defendants, Mylan Pharmaceuticals, Inc. ("Mylan"), a West Virginia corporation, Dr. Reddy's Laboratories, Ltd., an Indian corporation, and its New Jersey-based subsidiary, Dr. Reddy's Laboratories, Inc. (collectively, "DRL"), are drug manufacturers seeking to market a generic version of risperidone. Janssen filed this suit claiming infringement of its U.S. Patent No. 4,804,663 ("the '663 patent"), which claims risperidone, among other chemical compounds. Mylan and DRL concede they have infringed the '663 patent; they counter, however, that the '663 patent is invalid due to obviousness, and alternatively, Mylan argues that the '663 patent is unenforceable due to Janssen's alleged inequitable conduct.

The parties tried the case before the Court from June 28, 2006 through June 30, 2006 and on July 5, 2006. Thereafter, they submitted proposed findings of fact and conclusions of law. The parties' submissions and the record evidence have been carefully considered. For the reasons set forth below,*fn1 the Court finds that Mylan and DRL have failed to prove by clear and convincing evidence that the '663 patent is obvious under 35 U.S.C. § 103(a), and that Mylan has failed to prove by clear and convincing evidence that Janssen engaged in inequitable conduct. Thus, the '663 patent is neither invalid nor unenforceable, and as a result, Mylan and DRL have infringed that patent under 35 U.S.C. § 271(e)(2).

II. Background

A. The '663 Patent

On February 14, 1989, the United States Patent and Trademark Office ("PTO") issued the '663 patent to its inventors Ludo E.J. Kennis and Jan Vandenberk and assignee, Janssen. PX 1. The '663 patent originated from a patent application filed with the PTO on March 27, 1985. Stipulations of Fact ("SF") 14-15; PX 1.

The '663 patent's 18 claims encompass compounds "having useful antipsychotic properties and being useful in the treatment of a variety of complaints in which serotonin release is of predominant importance." PX 1.

Among those compounds are risperidone and compound 11, which are included in each of the patent's 18 claims.*fn2 SF-17. There is no claim in the '663 patent in which risperidone is the only compound. PX 1; Wolff Tr. 546:1-10.

The compounds claimed in the '663 patent were the result of Janssen's efforts to invent an effective antipsychotic drug, with few side effects, for the treatment of Schizophrenia. Tamminga Tr. 53:4-22.

B. Schizophrenia

Schizophrenia is a debilitating disease of the brain characterized by hallucinations, delusions and other symptoms that impair a person's capacity for thought, attention, memory, emotion and social functioning. Tamminga Tr. 46:19-47:1. Despite much research, the cause, mechanism, and etiology of the disease remain unknown. Tamminga Tr. 47:2-3.

People who suffer from schizophrenia exhibit a wide array of symptoms that can be classified into three major categories: positive symptoms, negative symptoms, and cognitive symptoms. Tamminga Tr. 47:4-7.

Positive symptoms include extreme hallucinations and paranoid delusions. Hallucinations are auditory, visual or both. Schizophrenics do not just hear voices in their mind, "they believe that there are people actually talking to them." Tamminga Tr. 47:8-16. In addition, schizophrenics believe in the false realities created by their delusions, sometimes causing the delusions to take over their lives. Id. at 47:17-18.

Negative symptoms include the complete loss of all emotion and lack of spontaneous thought, both of which "result in a loss of social skills and really an entire loss of social functioning." Tamminga Tr. 47:19-24.

Cognitive symptoms include the impairment of memory and attention. These cognitive deficits cause schizophrenics to become unable to use information and to have great difficulty making decisions. Tamminga Tr. 47:25-48:4.

These symptoms can entirely take over the lives of persons with schizophrenia, preventing them from working or developing social networks. Less than 20 percent of schizophrenics have jobs, less than 15 percent ever marry, and approximately 10 percent eventually commit suicide. Tamminga Tr. 48:5-15.

C. Early Treatments

Schizophrenia is a disease as old as mankind. For most of that time, there were no effective medical treatments. The only option was compassionate care, placing schizophrenics into protected environments such as government hospitals that quickly became overcrowded. But compassionate care did nothing to treat the symptoms and the patients did not get better. Tamminga Tr. 48:18-49:2.

Beginning in the 1930s, doctors attempted medical treatments. These treatments included induced fever, electroconvulsive shock therapy and frontal lobotomy. None of these attempts to treat the disease was effective. To the contrary, these treatments could even worsen the symptoms of schizophrenia. Tamminga Tr. 49:3-12.

D. First Generation, "Typical" Antipsychotic Drugs

The lack of effective treatment options continued into the 1950s. Then, for the first time, doctors developed an antipsychotic drug to treat schizophrenia, called chlorpromazine. Tamminga Tr. 49:13-18. The discovery that chlorpromazine could treat some symptoms of schizophrenia was accidental. Physicians were testing chlorpromazine as a sedative when they noticed that chlorpromazine significantly reduced the hallucinations and delusions of their schizophrenic patients. Tamminga Tr. 49:19-25.

As the first pharmaceutical treatment for schizophrenia, chlorpromazine was rapidly adopted for use throughout the medical community. Pharmaceutical companies quickly began searching for similar drugs. This led to the development of new antipsychotics such as Janssen's haloperidol, marketed under the trade name, Haldol. Chlorpromazine, haloperidol, and other similar drugs became known as first generation, or typical, antipsychotics. Tamminga Tr. 50:12-16, 21-25.

While chlorpromazine and the other typical antipsychotics were an improvement over compassionate care and the early ineffective treatments, they were not perfect. A typical antipsychotic improved the positive symptoms of schizophrenia, but it had no effect on the negative or cognitive symptoms that severely impaired the emotions, thoughts, and social functioning of schizophrenics. In fact, in some cases a typical antipsychotic could even worsen these symptoms. Tamminga Tr. 50:1-3.

More significantly, even when typical antipsychotics were successful at treating the positive symptoms of schizophrenia, they had many unwanted and serious side effects, including sedation, cardiac side effects, and motor side effects. The motor-related side effects were the largest drawback. Tamminga Tr. 51:1-5.

For example, typical antipsychotics caused extrapyramidal symptoms ("EPS") that caused patients to experience rigidity and tremors similar to those of Parkinson's disease. The rigidity and tremors brought on by EPS were always uncomfortable and often painful. EPS symptoms tended to cease when a patient stopped taking the medication. Tamminga Tr. 51:6-52:2.

Even worse, EPS symptoms could also gradually develop into a more serious motor syndrome called "tardive dyskinesia" ("TD"), characterized by motor difficulties such as, repetitive, involuntary, and purposeless movements. Unlike EPS, tardive dyskinesia was frequently irreversible even after the medication was discontinued. Tamminga Tr. 51:13-23.

These side effects had significant repercussions in the treatment of schizophrenia. Not surprisingly, patients disliked these motor side effects so much that they sometimes stopped taking their medication altogether. Tamminga Tr. 52:3-5.

E. Second Generation, "Atypical" Antipsychotic Drugs

In the 1960s, scientists' search for an improved antipsychotic resulted in the development of the first second generation or "atypical" antipsychotic, clozapine. Clozapine was introduced in the 1960s in Europe. Unlike the typical antipsychotics, clozapine had reduced motor side effects. Tamminga Tr. 52:6-9, 52:25-53:1.

Soon after clozapine was introduced, however, researchers discovered that while it had reduced motor side effects, it had a significant toxicity issue. It was found that clozapine could cause agranulocytosis, a sometimes deadly blood disorder. Due to its toxicity, the Food and Drug Administration ("FDA") did not approve clozapine in the United States until 1990. And even then, it was not approved for general use; its approval was limited to use only with treatment-resistant patients. Tamminga Tr. 52:10-24.

Despite this drawback, the discovery of clozapine demonstrated that it was possible to treat the positive symptoms of schizophrenia without serious motor side effects. It gave the medical community renewed hope for developing improved antipsychotic drugs. Tamminga Tr. 53:2-8. For that reason, clozapine became the focus of researchers looking for new drugs that would incorporate clozapine's improvements without its toxicity. Strupczewski Dep. (11/16/2004) Tr. 82:4-12. For example, both Eli Lilly and Sandoz spent years on research programs to modify clozapine to create a drug that would retain clozapine's benefits and eliminate its toxic effect. Meltzer Tr. 250:3-17; Tamminga Tr. 53:2-8.

F. Risperidone

Janssen was one of the companies attempting to develop a safe atypical antipsychotic. Following years of research and the testing of many potential compounds, two Janssen scientists, Kennis and Vandenberk, discovered risperidone. When approved by the FDA, risperidone became the first atypical antipsychotic available for general use that effectively treated symptoms with reduced side effects. Risperidone, sold by Janssen under the trademark Risperdal, was approved by the FDA in late 1993 and was first sold in the United States in 1994. Tamminga Tr. 53:9-13; Vergis Tr. 76:6-7, 13-15, 76:24-77:5.

Risperidone was a major advance over the typical antipsychotic drugs. Tamminga Tr. 55:19-56:5. Like the typical antipsychotics, risperidone has a potent effect in treating the positive symptoms of schizophrenia. However, unlike the typical antipsychotics, risperidone also improves the negative and cognitive symptoms of schizophrenia. Moreover, risperidone also has an extremely low side effect profile, with reduced EPS and almost no TD. Tamminga Tr. 53:14-22, 55:19-56:5.

Risperdal had a revolutionary impact on the treatment of schizophrenia. Once risperidone entered the market, the medical community "set aside" the typical antipsychotics. Tamminga Tr. 55:19-25.

G. Mylan & DRL's Abbreviated New Drug Applications

Following Janssen's success with Risperdal, generic manufacturers began filing Abbreviated New Drug Applications ("ANDA") with the FDA under the Hatch-Waxman Act, 28 U.S.C. § 355(j)(1), seeking approval to sell generic risperidone products. Most of those companies chose not to challenge Janssen's '663 patent and included a "paragraph III" certification under 28 U.S.C. § 355(j)(2)(A)(vii)(III), indicating that the FDA should not approve their applications until after the expiration of the '663 patent. Vergis Tr. 82:9-13; PX 75, PX 76, PX 77, PX 78, PX 85; PX 396.

On November 29, 2001, Mylan submitted an ANDA (No. 76-288) to the FDA seeking approval to market a generic risperidone tablet in various doses. Initially, Mylan also chose not to challenge the '663 patent by including a paragraph III certification with its ANDA. SF 21.

On October 24, 2003, DRL submitted an ANDA (No. 76-879) to the FDA also seeking to sell a generic version of risperidone. SF-27. DRL's ANDA, however, contained a "paragraph IV" certification pursuant to 28 U.S.C. § 355(j)(2)(A)(vii)(IV), challenging the validity of the '663 patent.*fn3 SF 29. On November 19, 2003, Mylan followed DRL's lead and amended its ANDA (No. 76-288) to include a paragraph IV certification. SF-23. Both Defendants informed Janssen of its paragraph IV certifications shortly thereafter. SF 24, 29.

H. The Current Litigation

On December 30, 2003, Janssen filed separate patent infringement actions against Mylan (Civil No. 03-6220) and DRL (Civil No. 03-6185) under 35 U.S.C. § 271(e)(2).*fn4 On March 8, 2004, the two actions were consolidated for discovery and pre-trial purposes. Two additional actions filed by Janssen against DRL (Civil Nos. 05-0884, 5326) based on the filing of additional paragraph IV certifications for different forms of risperidone were consolidated with No. 03-6185 on March 9, 2006.

In February 2004, Mylan and DRL filed separate answers. Both Defendants asserted an affirmative defense claiming that the '663 patent is invalid for obviousness under 35 U.S.C. § 103(a). Both Defendants also asserted a counterclaim seeking a declaration of invalidity.

On June 7, 2006, Mylan amended its answer to include the additional affirmative defense that the '663 patent is unenforceable due to Janssen's alleged inequitable conduct. Mylan also seeks a declaratory judgment to that effect. DRL did not join Mylan in asserting this defense and counterclaim.

I. Jurisdiction, Venue and Applicable Law

This Court has subject matter jurisdiction over Janssen's patent infringement claims and Mylan and DRL's counterclaims pursuant to 28 U.S.C. §§ 1331 and 1338(a). Defendants have waived any objections to this Court's exercise of personal jurisdiction, SF 11, and venue is proper under 28 U.S.C. §§ 1391(b)(1) and (c), and 1400(b).

Because this action arises under the patent laws of the United States, this Court must apply the precedents of the United States Court of Appeals for the Federal Circuit, which has jurisdiction over any appeal of this judgment. See 28 U.S.C. § 1295(a).

III. Analysis

A. Patent Infringement

One is liable for patent infringement if he or she,"without authority makes, uses, offers to sell, or sells any patented invention . . . during the term of the patent therefor . . . ." 35 U.S.C. § 271(a). Additionally, the filing of an application with the FDA under 21 U.S.C. § 355(j) "for a drug claimed in a patent" is an act of infringement "if the purpose of such submission"--as demonstrated in the applicant's paragraph IV certification--"is to obtain approval . . . to engage in the commercial manufacture, use, or sale of [that] drug . . . before the expiration of such patent." 35 U.S.C. § 271(e)(2)(A).

Defendants concede infringing the claims of the '663 patent with their proposed ANDA products. SF 47. Thus, the only issues before the Court are those raised in Defendants' affirmative defenses to infringement: (1) whether the '663 patent is invalid due to obviousness, as asserted by Mylan and DRL, and (2) whether the '663 patent is unenforceable due to inequitable conduct, as asserted only by Mylan.

"A patent shall be presumed valid." 35 U.S.C. § 282. The validity of each claim within a patent must be evaluated independently; the invalidity of one claim does not disturb the presumption of validity of another. Id. The party challenging the patent bears the burden of proving by clear and convincing evidence the invalidity or unenforceability of the claims of a patent. Id. "The 'clear and convincing' standard of proof of facts is an intermediate standard which lies somewhere between 'beyond a reasonable doubt' and a 'preponderance of the evidence'" and "has been described as evidence which produces in the mind of the trier of fact an abiding conviction that the truth of [the] factual contentions [is] 'highly probable.'" Buildex, Inc. v. Kason Indus., Inc., 849 F.2d 1461, 1463 (Fed. Cir. 1988) (internal quotation omitted).

B. Obviousness

"[A] claimed invention is unpatentable if the differences between it and the prior art are 'such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art.'" Alza Corp. v. Mylan Labs., Inc., ___ F.3d ___, No. 06-1019, 2006 U.S. App. LEXIS 22616, at *4 (Fed. Cir. Sept. 6, 2006) (quoting 35 U.S.C. § 103(a)). Obviousness is a question of law. Id. at *4-5. Its resolution depends on four underlying factual inquiries, the so-called Graham*fn5 factors: "'(1) the scope and content of the prior art; (2) the level of ordinary skill in the prior art; (3) the differences between the claimed invention and the prior art; and (4) objective evidence of nonobviousness.'" Id. at *5 (quoting In re Dembiczak, 175 F.3d 994, 998 (Fed. Cir. 1999)).

1. The Scope and Content of the Prior Art

The scope and content of the prior art is limited to art that is analogous to the claimed invention. See In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004). Analogous art is that which is from the same field of endeavor or, if not within the field of endeavor, is still reasonably pertinent to the particular problem with which the inventor is involved. Id.

The prior art includes (1) analogous patents or printed publications of a person besides the inventor in this or a foreign country before March 27, 1985, (2) analogous patents and printed publications of the inventor in this or a foreign country before March 27, 1984, and (3) analogous U.S. Patents (not invented by Kennis and Vandenberk) that issued after March 27, 1985 but were filed before -- or were entitled to rely on a U.S. filing date before -- March 27, 1985. 35 U.S.C. § 102(a), (b), and (e).

Defendants argue that the '663 patent is obvious in light of the drug pirenperone, which is covered by U.S. Patent No. 4,342,870 ("the '870 patent"). Pirenperone was also invented in part by Kennis. The '870 patent was assigned to Janssen, and issued more than one year prior to the filing date of the '663 patent. Thus, it is statutory prior art under 35 U.S.C. § 102(b).

Other patents and publications fall within the scope and content of the prior art, and will be discussed in more detail as necessary below.

2. The Level of Ordinary Skill in the Prior Art

The second Graham factor is the level of ordinary skill in the prior art. The obviousness analysis is conducted from the perspective of a person at that skill level. 35 U.S.C. § 103(a). This hypothetical person of ordinary skill is an objective legal construct who is presumed to be aware of all the relevant prior art. Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986).

While the person having ordinary skill knows all of the prior art, he or she is neither a genius nor an innovator. "A person of ordinary skill in the art is also presumed to be one who thinks along the line of conventional wisdom in the art and is not one who undertakes to innovate, whether by patient, and often expensive, systematic research or by extraordinary insights, it makes no difference which." Standard Oil Co. v. Am. Cyanamid Co., 774 F.2d 448, 454 (Fed. Cir. 1985); see also Life Techs., Inc. v. Clontech Labs., Inc., 224 F.3d 1320, 1326 (Fed. Cir. 2000).

The parties in this case dispute the appropriate educational background of the person having ordinary skill in the art. Janssen argues such a person would have a master's degree in chemistry, medicinal chemistry, or pharmacy, or a bachelor's degree in one of those fields "with at least two years of experience in research in antipsychotic drugs." Pl.'s FF&CL, at p.24. Mylan and DRL claim that the person of ordinary skill would have a "Ph.D with at least two years of experience and a record of research success, which is attested to by a small group of publications." Defs.' FF&CL, at p. 49. The dispute appears to be somewhat academic (so to speak).*fn6 Neither party contends that the educational background of the person of ordinary skill is determinative of whether the '663 patent is obvious or nonobvious. See, e.g., Meltzer Tr. 266:2-9, 19-24 (testifying that a person of ordinary skill with either educational background would find the '663 patent nonobvious); Wolff Tr. 530:19-25 (testifying that the person of ordinary skill would have possessed a doctorate, without stating that this ...


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