The opinion of the court was delivered by: Katharine S. Hayden, U.S.D.J.
This patent infringement suit arises under the Federal Food, Drug, and Cosmetic Act (―FD&C Act), and, more specifically, the Hatch-Waxman Amendments to that body of law. Plaintiff PDL Biopharma, Inc. (―PDL‖), now substituted by EKR Therapeutics, Inc. (―EKR‖),*fn1 brought suit against defendant Sun Pharmaceutical Industries, Ltd. (―Sun‖) for infringement of patent 5,164,405 (―the ‗405 patent‖), of which the commercial embodiment is the branded product marketed as ―Cardene(r) I.V.‖ (―Cardene‖). The ‗405 patent, issued on November 17, 1992, is entitled ―Nicardipine Pharmaceutical Composition for Parenteral Administration,‖ and will expire on November 17, 2009. Cardene is currently the only FDA-approved intravenous calcium channel blocker indicated for the treatment of hypertension where oral ingestion is not feasible or desirable.
This action relates to Sun's filing of an Abbreviated New Drug Application (―ANDA‖) under Section 505(j) of the FD&C Act, 21 U.S.C. § 355(j) seeking U.S. Food and Drug Administration (―FDA‖) approval to market Sun's proposed ANDA product, ―Injectable Nicardipine Hydrochloride‖ (―Sun's ANDA product‖). On March 5, 2007, Sun wrote EKR a letter, purporting to serve as Notice of Certification for ANDA No. 78-405, as required under Sections 505(j)(2)(B)(i) and (ii) of the FD&C Act, codified at 21 U.S.C. § 355(j)(2)(B)(i) and (ii), and 21 C.F.R. § 314.95(c). In accordance with the FD&C Act, Sun made a certified statement pursuant to Section 505(j)(2)(A)(vii)(IV), 21 U.S.C. § 355(A)(vii)(IV) (―Paragraph IV‖), that the manufacture, use, or sale of the product outlined in Sun's ANDA No. 78-405 would not infringe the ‗405 patent. Soon afterwards, on April 16, 2007, EKR filed this lawsuit against Sun, asserting one claim for patent infringement.
After EKR filed an amended complaint (D.E. 8), and the parties had embarked upon discovery (D.E. 16, 18, 40, 42), Sun moved for summary judgment of non-infringement on November 20, 2007 without first seeking leave of Magistrate Judge Shwartz. (D.E. 62.) The motion was denied without prejudice on November 26, 2007 for failure to obtain leave, and Sun was directed to submit a letter explaining why it moved for summary judgment before discovery was completed. (D.E. 64.) Sun's letter followed on November 30, 2007, setting forth that its chief reason for moving for summary judgment was that ―time is of the essence‖ in this litigation due to the ―unique‖ situation that ―Sun expect[ed] to be awarded 180 days of marketing exclusivity‖ if Sun's ANDA was deemed non-infringing or if the ‗405 patent was ruled invalid. (D.E. 65.) Sun stated that because ―any marketing exclusivity is lost after the patent expires, Sun must obtain a decision on the merits no later than May 17, 2009 to enjoy the full benefit of its marketing exclusivity.‖ (Id.) Dating back to a July 2007 Rule 16 conference, Sun has contended that EKR's ―sole goal‖ is ―delay [of] a final decision on the merits at all costs‖ in order to harm Sun's chances of any success on its ANDA product. (D.E. 183.) As late as the February 17, 2009 oral argument, Sun has consistently argued that its potential exclusive generic marketing period represents a ―wasting asset‖ if a decision on the merits cannot be obtained in a timely fashion.
Based upon Sun's letter of December 3, 2007, Magistrate Judge Shwartz denied leave to file summary judgment motions but provided the requests could be renewed after resolution of outstanding discovery issues pending at that time. (D.E. 66.) On March 24, 2008, Magistrate Judge Shwartz ruled that despite the ongoing nature of discovery, ―combined motion practice addressing the construction of the single claim and defendant's non-infringement motion‖ could go forward. (D.E. 79.) Thereafter, Sun moved for summary judgment of non-infringement of the ‗405 patent (D.E. 121), and EKR responded with its opposition papers and cross-motion for summary judgment of infringement. (D.E. 135.)
On January 15, 2009, the Court held a status conference, which yielded an agreement to hold oral argument on claim construction and each of the parties' summary judgment motions on February 17, 2009. The parties presented oral argument and chose not to call witnesses. The parties agree that a single claim term is at issue in the claim construction dispute: the meaning of ―isotonic‖ in claims 1-4 of the ‗405 patent. Another claim term, ―for parenteral administration,‖ had originally been in dispute but Sun stipulated to EKR's proposed meaning at the January 15, 2009 status conference, such that parenteral would take the meaning provided by the ‗405 patent, encompassing both direct injection and by infusion via intravenous drip. (See ‗405 patent, Col. 2, ll. 39-40.)
The type of patent infringement suit before the Court frequently surfaces when the underlying patent for a brand-name drug is approaching the expiration of its patent term. The Hatch-Waxman Amendments, as passed in the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. No. 98-417), amended the FD&C Act, creating § 505(j) of the FD&C Act, as codified in 21 U.S.C. § 355(j). Section 505(j) established the ANDA approval process, permitting lower-priced generic versions of FDA-approved innovator drugs to be approved and marketed to the public.
ANDA applicants must include in the ANDA a patent certification described in Section 505(j)(2)(A)(vii) of the FD&C Act. The ANDA certification must incorporate one of the following statements: (I) no patent information on the drug product that is the subject of the ANDA has been submitted to FDA; (II) that such patent has expired; (III) the date on which such patent expires; or (IV) that such patent is invalid or will not be infringed by the manufacture, use, or sale of the drug product for which the ANDA is submitted. EKR's lawsuit stems from Sun's certification under paragraph IV.
When making a paragraph IV certification, the ANDA applicant is required to provide notice of the paragraph IV certification to each patent owner listed in the certification and to the holder of the approved new drug application (―NDA‖) to which the ANDA related, in this case EKR. Submitting an ANDA for the same drug product claimed in a patent is an infringing act if the ANDA drug product-here Sun's product-is intended to be marketed before the expiration of the pertinent patent. Thus, the ANDA applicant may be sued for patent infringement once the patent holder is put on notice.
Critically, there is a 180-day marketing exclusivity incentive for generic manufacturers to be the first-in-time filers of ANDAs containing paragraph IV certifications challenging patents that are either: (1) invalid; (2) not infringed by the product that is the subject of the ANDA; or (3) are unenforceable. Not surprisingly, receipt of a paragraph IV certification will frequently precipitate a patent infringement suit against the ANDA filer by the patent owner.
The 180-day marketing exclusivity incentive springs from the Hatch-Waxman Amendments, and is currently housed in the FDA regulations. In the Federal Register of October 3, 1994 (59 F.R. 50338, 50367), FDA published the final rule implementing the patent and marketing exclusivity provisions of the Hatch-Waxman Amendments. The FDA regulation implementing section 505(j)(5)(B)(iv) of the Act provides:
If an abbreviated new drug application contains a certification that a relevant patent is invalid, unenforceable, or will not be infringed and the application is for a generic copy of the same listed drug for which one or more substantially complete abbreviated new drug applications were previously submitted containing a certification that the same patent was invalid, unenforceable, or would not be infringed, approval of the subsequent abbreviated new drug application will be made effective no sooner than 180 days from whichever of the following dates is earlier:
(i) The date the applicant submitting the first application first commences commercial marketing of its drug product; or
(ii) The date of a decision of the court holding the relevant patent invalid, unenforceable, or not infringed.
21 C.F.R. 314.107(c) (emphases added). In order to prove the first ANDA filer's entitlement to the 180-day exclusivity period, the FDA requires that the first ANDA applicant submitting a paragraph IV certification successfully defend a patent infringement suit or prove the patent invalid. In practice, this ensures that only ANDA applicants who are truly non-infringing can obtain the exclusivity period.
Thus, in general, an ANDA applicant whose ANDA contains a paragraph IV certification is protected from competition from subsequent generic versions of the same drug product for 180 days after either the first marketing of the first applicant's drug or a decision of a court holding the patent that is the subject of the paragraph IV certification to be invalid or not infringed.
The litigation prompted by ANDA filers' paragraph IV certifications is significant in its frequency and potential rewards for generic ANDA applicants. Determining infringement involves a two-step process whereby the Court must first construe the claims and next determine whether every claim limitation-or its equivalent-is found in the accused device. In re Gabapentin Patent Litig., 503 F.3d 1254, 1259 (Fed. Cir. 2007).
Pursuant to Rule 56(c), summary judgment is appropriate when there is no genuine issue of material fact and the moving party is entitled to judgment as a matter of law. Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986). A dispute about a material fact is genuine ―if the evidence is such that a reasonable jury could return a verdict for the nonmoving party.‖ Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986).
The court must view the facts and reasonable inferences drawn therefrom ―in the light most favorable to the party opposing the motion.‖ Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986) (quoting United States v. Diebold, Inc., 369 U.S. 654, 655 (1962) (per curiam)). The opposing party, however, must produce evidence upon which a reasonable fact finder could rely, Celotex, 477 U.S. at 324, and ―do more than simply show that there is some metaphysical doubt as to material facts.‖ Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586 (1986). Thus, to survive summary judgment the nonmoving party must ―make a showing sufficient to establish the existence of [every] element essential to that party's case, and on which that party will bear the burden of proof at trial.‖ Celotex, 477 U.S. at 322.
The operative documents in this patent infringement action are the ‗405 patent itself and Sun's ANDA application. In support of their motions, the parties have submitted declarations appending excerpts of deposition testimony, correspondence, and other related documentary evidence. Because the patent claims alone vest the patent holder's right to exclude, they are set forth at the outset. See Halliburton Energy Servs. v. M-I LLC, 514 F.3d 1244, 1249 (Fed. Cir. 2008) (―Because claims delineate the patentee's right to exclude, the patent statute requires that the scope of the claims be sufficiently definite to inform the public of the bounds of the protected invention, i.e., what subject matter is covered by the exclusive rights of the patent. Otherwise, competitors cannot avoid infringement, defeating the public notice function of patent claims.‖).
A. The '405 Patent's Claims at Issue
The ‗405 patent contains nine claims. (Col. 10, l. 35-Col. 12, l. 29.) What is claimed is:
1. In a process for producing a stable pharmaceutical composition containing nicardipine hydrochloride suitable for parenteral administration and useful in the treatment of disease conditions which may be alleviated by the administration of calcium channel blocking agents, which process comprises admixing a therapeutically effective amount of nicardipine hydrochloride and a pharmaceutically acceptable aqueous vehicle comprising at least a major proportion of water, the improvement comprising:
(a) dissolving in an aqueous vehicle consisting essentially of water a physiologically and pharmaceutically acceptable buffer in an amount effective to maintain the pH of the pharmaceutical composition at about 3.0 to about 4.5, thereby forming a buffered solution; and
(b) adding to said buffered solution at least 1 mg/ml of said therapeutically effective amount of nicardipine hydrochloride, and a physiologically and pharmaceutically acceptable non-chloride compound selected from saccharides, including sorbitol, mannitol, dextrose and glucose, and non-saccharides, including polyethylene glycol and glycerol, in an amount effective to render the pharmaceutical composition isotonic.
2. The process of claim 1 further comprising the step of terminally sterilizing said pharmaceutical composition by autoclaving.
3. A pharmaceutical composition suitable for parenteral administration to mammals and useful in the treatment of disease conditions which may be alleviated by the administration of calcium channel blocking agents, which composition comprises:
(a) a physiologically and pharmaceutically acceptable non-chloride compound selected from saccharides, including sorbitol, mannitol, dextrose and glucose, and non-saccharides, including polyethylene glycol and glycerol, in an amount effective to render the pharmaceutical composition isotonic;
(b) a physiologically and pharmaceutically acceptable buffer, selected from citrate, acetate, phosphate, and lactate buffers, in an amount effective to maintain the pH of the composition at about 3.0 to about 4.5;
(c) a pharmaceutically acceptable aqueous vehicle consisting essentially of water; and
(d) at least about 1 mg/ml nicardipine hydrochloride in solution herein.
4. A composition according to claim 3 wherein the therapeutically effective amount of nicardipine hydrochloride is from about 0.5 mg/ml to about 10 mg/ml of aqueous vehicle and the aqueous vehicle is water (water for injection) alone.
5. A composition according to claim 3 wherein the buffer is selected from citrate and acetate buffers.
6. A composition according to claim 3 wherein:
(a) the therapeutically effective amount of nicardipine hydrochloride is from about 1 mg/ml to about 2.5 mg/ml of aqueous vehicle;
(b) the non-chloride compound is a saccharide selected from sorbitol and mannitol used in an amount of about 48.0 to about ...