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Novartis Pharmaceuticals Corporation v. Roxane Laboratories

March 31, 2011

NOVARTIS PHARMACEUTICALS CORPORATION, NOVARTIS PHARMA AG, AND NOVARTIS INTERNATIONAL PHARMACEUTICAL LTD., PLAINTIFFS,
v.
ROXANE LABORATORIES, INC. DEFENDANT.



The opinion of the court was delivered by: Hon. Dennis M. Cavanaugh

FOR PUBLICATION

AMENDED OPINION

DENNIS M. CAVANAUGH, U.S.D.J.:

This matter comes before the Court upon three motions for summary judgment by Novartis International Pharmaceutical Ltd. ("NIP"), Novartis Pharmaceutical Corporation ("NPC") and Novartis Pharma, AG ("NPAG") (collectively "Plaintiffs") and two motions for summary judgment by Defendant, Roxane Laboratories, Inc. ("Roxane") pursuant to Fed. R. Civ. P. 56. Plaintiffs also filed a cross motion to preclude Roxane's inequitable conduct contention and evidence, or alternatively, to strike those portions of Roxane's motion for summary judgment. Pursuant to Fed. R. Civ. P. 78, no oral argument was heard. After considering the submissions of the parties, the decision of this Court is set forth for the reasons expressed below.

I. BACKGROUND*fn1

Plaintiffs market and sell the drug Famvire in the United States for the treatment of various herpes-related infections. The active antiviral agent in Famvire is the chemical compound famciclovir. Plaintiffs' patent in suit, U.S. Patent No. 5,246,937 (the "'937 patent"), claims the compound famciclovir and its use for treating viral infections.

The '937 patent, entitled "Purine Derivatives," was issued on September 21, 1993 to Michael R. Harnden and Richard L. Jaevest, with Beecham Group PLC as the assignee.*fn2 The '937 patent claims priority to three British patent applications including GB 8423833 filed on September 20, 1984, GB 8510331 filed April 23, 1985 and GB 8520618 filed August 16, 1985. The priority date for claims 9 and 14-19 of the '937 patent is April 23, 1985. Claim 9 of the '937 patent presents the compound famciclovir, identified as 2-amino-9-(4-acetoxy-3-acetoxymethylbut-1-yl)purine. Claim 14 of the '937 patent presents a method of treating viral infections in a human or non-human animal using an effective, non-toxic amount of famciclovir. Claim 15 of the '937 patent presents a method of treating herpes virus infections in a human or non-human animal using an effective, non-toxic amount of famciclovir. Claim 16 of the '937 patent presents a method of treating herpes simplex type 1 (HSV-1) in a human or non-human animal using an effective, non-toxic amount of famciclovir. Claim 17 of the '937 patent presents a method of treating herpes simplex type 2 (HSV-2) in a human or non-human animal using an effective, non-toxic amount of famciclovir. Claim 18 of the '937 patent presents a method of treating varicella zoster in a human or non-human animal using an effective, non-toxic amount of famciclovir. Claim 19 of the '937 patent presents a pharmaceutical composition for treating viral infections which comprises famciclovir in combination with a pharmaceutically acceptable carrier.

The claimed compound famciclovir is a member of a class of compounds known as acyclic nucleosides. In 1977, a group from Burroughs Wellcome demonstrated that acyclovir (known by the chemical name 9-(2-hydroxyethoxymethyl)guanine), could selectively inhibit the herpes virus. Acyclovir is an acyclic nucleoside. Penciclovir is also an acyclic nucleoside. Acyclic nucleosides were known to have low bioavailability. Famciclovir is a prodrug-- a pharmaceutical compound that does not have the desired activity (i.e., antiviral effects), but is converted in the human body into the active compound, in this case, penciclovir. The purpose of a prodrug is toincrease the amount of active compound in the bloodstream after oral administration; that is, to increase the "bioavailability" of the active compound.

On June 20, 2008, Defendant sent Plaintiffs a Notice Letter informing them that it had filed Abbreviated New Drug Application ("ANDA") No. 78-679, including a Paragraph IV certification, seeking to market generic famciclovir tablets prior to the expiration of the '937 patent. Plaintiffs then filed a Complaint in this Court on July 31, 2008 alleging infringement of the '937 patent. Defendant has asserted numerous defenses, including invalidity of the patent due to obviousness and obviousness-type double patenting, and uneforceability of the patent due to inequitable conduct committed before the Patent & Trademark Office ("PTO").

II. STANDARD OF REVIEW

Summary judgment is granted only if all probative materials of record, viewed with all inferences in favor of the non-moving party, demonstrate that there is no genuine issue of material fact and that the movant is entitled to judgment as a matter of law. See FED. R. CIV. P. 56(c); Celotex Corp. v. Catrett, 477 U.S. 317, 330 (1986). "A party seeking summary judgment always bears the initial responsibility of informing the district court of the basis for its motion."

See Celotex Corp., 477 U.S. at 323. "This burden has two distinct components: an initial burden of production, which shifts to the nonmoving party if satisfied by the moving party; and an ultimate burden of persuasion, which always remains on the moving party." Id. at 330.

"In determining whether there are any issues of material fact, the Court must resolve all doubts as to the existence of a material fact against the moving party and draw all reasonable inferences - including issues of credibility - in favor of the nonmoving party." Newsome v. Admin. Office of the Courts of the State of N.J., 103 F. Supp.2d 807, 815 (D.N.J. 2000), aff'd, 51 Fed. Appx. 76 (3d Cir. 2002) (citing Watts v. Univ. of Del., 622 F.2d 47, 50 (D.N.J. 1980)). While a court must draw reasonable inferences, the non-moving party "may not rest upon

the mere allegations or denials of his pleading" to satisfy this burden, but must produce sufficient evidence to support a jury verdict in his favor. See FED. R. CIV. P. 56(e); see also Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586 (1986). "[U]nsupported allegations in memorandum and pleadings are insufficient to repel summary judgment." Schoch v. First Fid. Bancorporation, 912 F.2d 654, 657 (3d Cir. 1990). In addition, conclusory allegations are insufficient to establish genuine issues of fact. Lujan v. Nat'l Wildlife Fed'n, 497 U.S. 871, 902 (1990). The non-moving party "must do more than simply show that there is some metaphysical doubt as to the material facts." Matsushita Elec. Indus. Co., 475 U.S. at 586.

III. DISCUSSION

A. Infringement

Novartis has the burden of proving patent infringement by clear and convincing evidence. A determination of patent infringement involves two steps. "The first step is determining the meaning and scope of the patent claims asserted to be infringed. The second step is comparing the properly construed claims to the device accused of infringing." Markman v. Westview Instruments, Inc., 52 F.3d 967, 976 (Fed. Cir. 1995) (en banc) (internal citations omitted), aff'd, 517 U.S. 370 (1996).

Here, there are disputes regarding the scope of the asserted patent claims, and Roxane does not contest that its generic famciclovir products are covered by Claims 9 and 14 through 19 of the '937 patent. However, Roxane has challenged the validity of the '937 Patent, and genuine issues of material fact as to the validity of the patent are in dispute. A party cannot infringe an invalid claim or the claims of an unenforceable patent. Since genuine issues of material fact exist as to the validity of the patent, Novartis' motion for summary judgment of infringement must be denied.

B. Obviousness

Roxane has challenged the validity of the '937 patent on the grounds that the famciclovir invention was obvious. Plaintiffs have moved for summary judgment that the '937 patent was non-obvious, and to dismiss this defense.*fn3

To prevail on a defense of invalidity for obviousness, Defendant must demonstrate by clear and convincing evidence that:

the differences between the subject matter sought to be patented 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 ...


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