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MERCK & CO. v. MYLAN PHARMS.

August 24, 1998

MERCK & CO., INC., Plaintiff,
v.
MYLAN PHARMACEUTICALS, INC., Defendant.



The opinion of the court was delivered by: ROBRENO

MEMORANDUM

 EDUARDO C. ROBRENO, J.

 AUGUST 24th, 1998

 I. INTRODUCTION

 This is an action brought by plaintiff Merck Pharmaceuticals against defendant Mylan Pharmaceuticals for patent infringement of its SINEMET CR tablets, designed for use in the treatment of Parkinson's disease. Merck alleges that, under the well-established patent law doctrine of equivalents, Mylan's filing of an Abbreviated New Drug Application ("ANDA") with the Food and Drug Administration, setting forth a generic formulation of Merck's products infringed upon United States Patents No. 4,832,957 (the "'957 patent") and No. 4,900,755 (the "'755 patent"). Defendant Mylan has now moved for summary judgment on the grounds that the prior art doctrine and prosecution history estoppel limit the scope of Merck's patents and, as a result of these limitations, Merck is precluded from asserting infringement by Mylan's product under the doctrine of equivalents. For the reasons which follow, the Court will grant summary judgment in favor of Mylan and against Merck.

 II. BACKGROUND *fn1"

 In the 1980's, Merck began development of a product intended to provide a more effective treatment of Parkinson's disease. The proposed product involved the controlled release of the two active ingredients already in the market, levodopa and carbidopa. On June 16, 1986, Merck filed its original patent application for the proposed product which included, as its broadest claim, the following:

 
A controlled release oral dosage formulation comprising a uniform dispersion of 5-300 mg of carbidopa, 2-1200 mg of levodopa, 0-25 mg of a tablet lubricant and optionally a pharmaceutically acceptable dye, in a polymer vehicle comprising 0-120 mg of a water soluble polymer and 0-120 mg of a less water soluble polymer, with the proviso that both polymers are not 0 mg, whereby following administration the carbidopa and levodopa are released slowly and simultaneously from the formulation.

 DE at A106. *fn2" The Patent and Trademark Office ("PTO") rejected all of these claims, in part, as being obvious over the prior art. Specifically, the patent examiner referenced, inter alia, the Sheth patent (U.S. Patent No. 4,424,235), which discloses a hydrodynamically-balanced (i.e. floating) controlled release formulation of carbidopa and levodopa in a polymer vehicle *fn3" , and the Schor patent (U.S. Patent No. 4,389,393), which discloses a controlled release formulation of any medicament containing the combination of hydroxypropylmethylcellulose [HPMC] and another cellulose *fn4" Further, the patent examiner required Merck to "elect a single disclosed species." DE at A122. This election is permitted under 35 U.S.C. § 121, which provides that "if two or more independent and distinct inventions are claimed in one application, the Commissioner may require the application to be restricted to one of the inventions." 35 U.S.C. § 121. Merck failed to respond to the PTO's rejection. As a result, pursuant to the PTO's Notice of Abandonment, the application was deemed abandoned. DE at A126.

 On December 11, 1987, Merck filed a second application limiting the scope of its claims. DE at A151-168. Now, instead of seeking coverage of formulations containing any "water soluble" and "less water soluble" polymers, Merck's broadest claim was restricted to a controlled release oral dosage formulation of carbidopa and levodopa in a polymer vehicle comprised of a water soluble polymer selected from a named group and a less water soluble polymer also selected from a named group. Specifically, the claim read as follows:

 
A controlled release oral dosage formulation comprising a uniform dispersion of 5-300 mg of carbidopa, 20-1200 mg of levodopa, 0-25 mg of a tablet lubricant and optionally a pharmaceutically acceptable dye, in a polymer vehicle comprising 0-120 mg of a water-soluble polymer selected from hydroxypropyl cellulose, hydroxypropylmethylcellulose, polyvinyl pyrrolidone, polyethylene glycol, starch and methyl cellulose and 0-120 mg of a less water-soluble polymer selected from polyvinyl acetate-crotonic acid copolymer, polyvinyl chloride, polyethylene, cellulose acetate, polyvinyl alcohol, polymethyl methacrylate, and ethyl cellulose, with the proviso that both polymers are not 0 mg, whereby following administration the carbidopa and levodopa are released slowly and simultaneously from the formulation.

 DE at A167. Again, however, the PTO rejected Merck's claims citing, in part, obviousness over the prior art, including Sheth and Schor. DE at A184-85 The patent examiner also reiterated the requirement that Merck elect a single disclosed species under 35 U.S.C. § 121. DE at 186.

 On July 25, 1988, Merck abandoned its second application and filed yet a third application, seeking coverage identical to that in the second. DE at A210-228. Prior to the PTO's consideration of the third application, Merck filed a preliminary amendment to the third application restricting the amounts of carbidopa and levodopa and limiting the polymer vehicle to two specific polymers. The broadest claim then disclosed:

 
A controlled release oral dosage formulation comprising a uniform dispersion of 25-100 mg of carbidopa, 100-400 mg of levodopa, 1-10 mg of a tablet lubricant and mixture of those with a pharmaceutically acceptable dye, in a polymer vehicle comprising 5-25 mg of a water soluble hydroxypropyl cellulose polymer [HPC] and 2-50 mg of a less water-soluble polyvinyl acetate-crotonic acid copolymer [PVACA] whereby following administration the carbidopa and levodopa are released slowly and simultaneously from the formulation.

 DE at A237-238. Based on this narrower claim, the PTO issued the '957 patent to Merck. DE at A242

 On February 24, 1989, after receipt of the '957 patent, Merck filed an application for what is now the '755 patent. DE at A261-280. The broadest claim asserted in this application was identical to the broadest claim described above for the second application in the '957 prosecution. *fn5" As it did previously, the PTO rejected Merck's claims as obvious over the prior art including, inter alia, Sheth and Schor. DE at A287-288. Again, the patent examiner also required an election under 35 U.S.C. § 121. DE at 289.

 Merck then narrowed its claims to mirror those of the '957 patent, absent the dye and lubricant. DE at A294-295. At that point, it also made the following statements to the PTO:

 
Applicants take issue with some of the Examiner's characterizations of the references.
 
Sheth et al (U.S. Patent 4,424,235) does describe a sustained-release combination of levodopa and carbidopa, but the design of the formulation and the components thereof differs from those of the present claims. A single polymer is used in the Sheth formulation selected from a natural gum, methyl cellulose, hydroxypropylmethylcellulose, hydroxypropylcellulose and sodium carboxymethylcellulose. The claimed formulation is a combination of hydroxypropylcellulose and polyvinylacetate-crotonic acid copolymer . . .
 
. . . The last secondary reference, Schor et al (U.S. 4,389,393), lists a number of medicinal agents deliverable by their claimed formulation, none of which is identified as an anti-Parkinson agent and none of which comprises two active ingredients. Furthermore, their formulation comprises hydroxypropylmethylcellulose primarily as the carrier or optionally
 
"with about 0 to 30% by weight of the mixture of . . . methylcellulose sodium carboxymethylcellulose or other cellulose either." (Column 4, lines 22-28).
 
Accordingly, Schor does not suggest the combination of the hydroxypropyl-cellulose and polyvinyl acetate-crotonic acid copolymer as presently claimed as a vehicle for any medicament.

 DE at A295-296. On the basis of the amendment, the '755 patent was issued.

 In February of 1996, Mylan filed an Abbreviated New Drug Application with the Food and Drug Administration, pursuant to the Hatch-Waxman Act *fn6" , disclosing a product containing: (a) 200 mg of levodopa and 50 mg of carbidopa; 29.3 mg of HPC polymer and; (c) 12.8 mg of hydroxypropyl methylcellulose (HPMC) polymer. DE at A13-16.

 On June 24, 1997, Merck filed a complaint in this Court alleging infringement of both its '755 patent and its '957 patent. The instant action ensued.

 III. STANDARD OF REVIEW *fn7"

 Federal Rule of Civil Procedure 56(c) states that summary judgment is proper "if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law." FED. R. CIV. P. 56(c); see also Celotex Corp. v. Catrett, 477 U.S. 317, 322, 91 L. Ed. 2d 265, 106 S. Ct. 2548 (1986); Williams v. Borough of West Chester, 891 F.2d 458, 463-64 (3d Cir. 1989). A factual dispute is "material" only if it might affect the outcome of the case. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 91 L. Ed. 2d 202, 106 S. Ct. 2505 (1986). For there to be a "genuine" issue, a reasonable fact finder must be able to return a verdict (or render a decision) in favor of the non-moving party. Id. On summary judgment, it is not the court's role to weigh the disputed evidence and decide which is more probative. Brewer v. Quaker State Oil Refining Co., 72 F.3d 326, 331 (3d Cir. 1995). Rather, the court must consider the evidence, and all reasonable inferences which may be drawn from it, in the light most favorable to the non-moving party. United States v. Diebold, Inc., 369 U.S. 654, 655, 8 L. Ed. 2d 176, 82 S. Ct. 993 (1962); Tigg Corp. v. Dow Corning Corp., 822 F.2d 358, 361 (3d Cir. 1987); Baker v. Lukens Steel Co., 793 F.2d 509, 511 (3d Cir. 1986). If a conflict arises between the evidence presented by both sides, the court must accept as true the allegations of the non-moving party. Anderson v. Liberty Lobby, Inc., 477 U.S. at 255.

 Once the movant has carried its initial burden, Rule 56(e) shifts the burden to the nonmoving party as follows:

 
When a motion for summary judgment is made and supported as provided in this rule, an adverse party may not rest upon the mere allegations or denials of the adverse party's pleading, but the adverse party's response, by affidavits or as otherwise provided in this rule must set forth specific facts showing that there is a genuine issue for trial. If the adverse party does not so respond, summary judgment, if appropriate, shall be entered against the adverse party.

 Fed.R.Civ.P. 56(e). With respect to an issue on which the non-moving party has the burden of proof, the burden on the moving party may be discharged by "showing"--that is, pointing out to the district court-- that there is an absence of evidence to support the nonmoving party's case. Celotex ...


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