WILLIAM H. YOHN, JR., District Judge.
Plaintiff, Teva Pharmaceutical Industries Ltd. ("Teva"), sues AstraZeneca Pharmaceuticals LP and IPR Pharmaceuticals, Inc. (collectively "AstraZeneca"), for patent infringement, alleging that AstraZeneca's CRESTOR® prescription drug products infringe one or more claims of Teva's U.S. Patent No. RE39,502 ("the '502 patent").
AstraZeneca has filed a motion for summary judgment of patent invalidity due to prior invention pursuant to 35 U.S.C. § 102(g)(2). Although AstraZeneca in fact disputes that its CRESTOR® products infringe the asserted claims of Teva's '502 patent, AstraZeneca concedes—for purposes of the instant motion only—that the accused CRESTOR® product formulations fall within the scope of those claims.
As set forth herein, the court concludes that AstraZeneca was not required to have such a particularized appreciation in order to prove prior conception and reduction to practice of the invention claimed by Teva. Accordingly, because it is undisputed that (1) AstraZeneca made the accused product formulations before Teva invented the subject matter of the asserted claims, (2) appreciated that the formulations were stable, and (3) did not abandon, suppress, or conceal the formulations, the court will grant AstraZeneca's motion for summary judgment.
CRESTOR® is a prescription medication belonging to a group of drugs called statins that are used to treat high cholesterol. (Compl. ¶ 14; AstraZeneca Ans. ¶ 14
Sales of CRESTOR® products began after the FDA approved the New Drug Application ("NDA") for CRESTOR® in August 2003. (AstraZeneca Statement ¶ 23; Teva Resp. ¶ 23.) The CRESTOR® NDA lists the ingredients and the amount of each ingredient for all dosage strengths of CRESTOR® tablets that AstraZeneca sells commercially today. (See AstraZeneca Statement ¶ 24; Teva Resp. ¶ 24; Declaration of J. Richard Creekmore, Ph.D. ["Creekmore Decl."] ¶¶ 8-9 & Ex. A at AZ-EDPA-0019433; Decl. of Alan E. Sloan ["Sloan Decl."] ¶¶ 7-9.)
AstraZeneca researchers in Wilmington, Delaware, arrived at the formulations for all dosage strengths of the CRESTOR® tablet cores in 1999. (See AstraZeneca Statement ¶¶ 26, 42-45; Teva Resp. ¶¶ 26, 42-45.) The researchers had used different formulations for earlier Phase III clinical studies, but they wanted to improve on these earlier formulations for the final commercial product. (AstraZeneca Statement ¶ 27; Teva Resp. ¶ 27.) In particular, because the researchers already knew from the Phase III studies that rosuvastatin calcium would be safe and effective, they focused on product stability and manufacturability issues when developing the improved commercial formulations. (AstraZeneca Statement ¶ 28; Teva Resp. ¶ 28.)
Led by Richard Creekmore, the researchers began development of the planned commercial CRESTOR® products, referred to internally as the rosuvastatin "sales formulations," in early 1999.
In mid 1999, AstraZeneca planned to make 10,000-unit batches of uncoated 2.5 mg rosuvastatin sales formulation tablets. (AstraZeneca Statement ¶ 34; Teva Resp. ¶ 34.) A week later, AstraZeneca manufactured a 10,000-unit batch of 2.5 mg rosuvastatin sales formulation tablets containing the same ingredients, in the same amounts, as the commercial 2.5 mg CRESTOR® tablet cores. (AstraZeneca Statement ¶¶ 35-36; Teva Resp. ¶¶ 35-36.) Approximately two months later, AstraZeneca manufactured a 20,000-unit batch of 5 mg rosuvastatin calcium tablets. (AstraZeneca Statement ¶ 38-39; Teva Resp. ¶ 38.) These tablets contained the same ingredients, in substantially identical amounts, as the commercial 5 mg CRESTOR® tablet cores. (AstraZeneca Statement ¶ 39.)
In the late summer of 1999, Dr. Creekmore gave a presentation regarding AstraZeneca's rosuvastatin sales formulations, in which he described the proposed commercial formulations for "ZD4522" (i.e., rosuvastatin) tablet cores for each of the 2.5 mg, 5 mg, 10 mg, 20 mg, 40 mg, and 80 mg dosage strengths. (Creekmore Decl. ¶ 18 & Ex. E at AZ-EDPA-0041448;
In the fall of 1999, AstraZeneca made a 160,000-unit batch of coated 2.5 mg rosuvastatin tablets. (AstraZeneca Statement ¶ 47; Teva Resp. ¶ 47.) These tablets contained the same ingredients as commercial 2.5 mg CRESTOR® tablets in substantially identical amounts.
On January 26, 2000, Dr. Creekmore and Norman Wiggins filed a patent application in Great Britain on behalf of AstraZeneca AB covering their rosuvastatin formulation work. (Creekmore Decl. ¶ 22; Declaration of Rama G. Elluru ["Elluru Decl."], Ex. 6 (GB application no. 0001621.2).) According to Dr. Creekmore, Example 3 of that application contains a full description of the 2.5 mg rosuvastatin sales formulation tablets. (Creekmore Decl. ¶ 22.) Example 3 discloses the same ingredients and, apart from decimal point differences as to two ingredients, the same ingredient amounts as the 2.5 mg rosuvastatin sales formulation tablet cores that AstraZeneca made in May and October 1999, and as the 2.5 mg commercial CRESTOR® product tablet cores.
AstraZeneca thereafter filed a patent application in the United States on August 4, 2000, which issued as U.S. Patent No. 6,316,460 ("the '460 patent") on November 13, 2001.
According to Teva's expert, Harold B. Hopfenberg, Ph.D., the use of amido-group containing polymeric compounds to stabilize statin-containing pharmaceutical formulations is not disclosed in the patent application that AstraZeneca filed in Great Britain, the '460 patent, or the CRESTOR® NDA. (Decl. of Harold B. Hopfenberg ["Hopfenberg Decl."] ¶¶ 11, 14.) Although these documents do disclose certain amido-group containing polymeric compounds—including crospovidone—as excipients that can be used in the claimed formulations, such compounds are disclosed for use for purposes other than stabilization. (See id. ¶¶ 15, 17.) All three documents disclose the use of a separate set of compounds—namely "tribasic phosphate salts in which the cation is multivalent"
At some point prior to December 1, 1999, Teva researchers, led by Michael Fox, were working on the problem of stabilizing formulations containing pravastatin, a statin drug and a very unstable substance. (Declaration of Michael Fox ["Fox Decl."] ¶ 5.) The particular problem, according to Fox, was to prevent the transfer of hydrogen ions and resulting degradation of pravastatin. (Id.) In an effort to evaluate the stabilizing effect of amido-group containing polymeric compounds on formulations containing statin drugs, on approximately December 1, 1999,
Teva filed a provisional patent application with the United States Patent and Trademark Office ("PTO") disclosing this invention on April 10, 2000. (Waldrop Decl., Ex. 1 ('502 patent).) Teva thereafter
Teva filed its complaint in this action in October 2008, alleging that AstraZeneca's manufacture, use, sale, or offer for sale in the United States, or importation into the United States, of its CRESTOR® products infringes one or more claims of the '502 patent. (Compl. ¶ 18.) In its answer, AstraZeneca denied Teva's allegations of infringement and raised affirmative defenses of noninfringement and invalidity of Teva's '502 patent, among others. (AstraZeneca Ans. ¶¶ 18, 21, 23.)
On September 10, 2009, approximately three weeks before the original fact discovery cutoff, AstraZeneca filed the instant motion for summary judgment of patent invalidity due to prior invention. Teva thereafter sought to stay the litigation pending the outcome of reissue proceedings it had initiated by filing an application for reissue of the '502 patent with the PTO on September 18, 2009. AstraZeneca opposed the stay, and the court denied Teva's stay motion on January 14, 2010. The parties thereafter completed the briefing of AstraZeneca's motion for summary judgment, with Teva filing its opposition on February 12, 2010, and AstraZeneca filing a reply brief on March 2, 2010. The court held oral argument in the case on June 21, 2010, and September 27, 2010.
A motion for summary judgment should be granted "if the pleadings, the discovery and disclosure materials on file, and any affidavits show that there is no genuine issue as to any material fact and that the movant is entitled to judgment as a matter of law." Fed. R. Civ. P. 56(c)(2). Material facts are facts that "might affect the outcome of the suit under the governing law." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). A factual issue is "genuine" if "the evidence is such that a reasonable jury could return a verdict for the non-moving party." Id.
In evaluating a motion for summary judgment, "[t]he evidence of the non-movant is to be believed, and all justifiable inferences are to be drawn in [the non-movant's] favor." Id. at 255, 106 S.Ct. 2505.
AstraZeneca asserts that independent claims 1, 26, 42, and 52 of Teva's '502 patent are invalid under 35 U.S.C. § 102(g)(2). (AstraZeneca Mem. 14-18.) Under that provision,
Id. § 102(g)(2). Priority of invention under § 102(g)(2) thus "depends upon conception and reduction to practice." Cooper v. Goldfarb, 154 F.3d 1321, 1327 (Fed. Cir.1998). A patent will be invalid for prior invention under § 102(g)(2) if another inventor either reduced the invention to practice first, or conceived of the invention first and then exercised reasonable diligence in reducing the invention to practice, provided that the prior inventor did not abandon, suppress, or conceal the invention. Mycogen Plant Science, Inc. v. Monsanto Co., 243 F.3d 1316, 1332 (Fed.Cir.2001); see also Rosco, Inc. v. Mirror Lite Co., 304 F.3d 1373, 1381 (Fed.Cir.2002). Where, as here, the priority of invention issue involves a comparison between an issued patent (Teva's '502 patent) and work performed by scientists (researchers at AstraZeneca), "it is... appropriate to place the focus of inquiry upon the specific claims of the [issued] patent[] as representing the invention at issue." Mycogen Plant Science, 243 F.3d at 1332.
AstraZeneca argues that summary judgment is warranted because the undisputed evidence shows that it invented first. In particular, AstraZeneca argues that there is no dispute (1) that it made the same CRESTOR® product formulations that Teva accuses of infringement well before December 1, 1999, the earliest date by which Teva claims to have conceived of and reduced to practice the subject matter of the '502 patent,
As an initial matter, the court agrees with AstraZeneca that, based on the record before it, there is no genuine factual issue that AstraZeneca arrived at its allegedly infringing CRESTOR® product formulations—and made multi-thousand-unit batches of those formulations—before Teva either conceived of or reduced to practice the subject matter of its '502 patent. Teva concedes that in mid 1999 AstraZeneca made a 10,000-unit batch of 2.5 mg rosuvastatin sales formulation tablets containing the same ingredients, in the same amounts, as the commercial 2.5 mg CRESTOR® tablet cores. (AstraZeneca Statement ¶¶ 35-36; Teva Resp. ¶¶ 35-36.) It is also undisputed that AstraZeneca made a 20,000-unit batch of 5 mg rosuvastatin sales formulation tablets in the summer of 1999, and a 160,000-unit batch of coated 2.5 mg rosuvastatin sales formulation tablets in the fall of 1999, both containing the same ingredients, in substantially identical amounts, as the corresponding commercial CRESTOR® products.
The court also agrees with AstraZeneca that it may satisfy its burden to show that its earlier-made CRESTOR® products meet all the limitations of the asserted claims of Teva's '502 patent by conceding, for purposes of this summary judgment motion only, Teva's allegations of infringement. The Federal Circuit addressed a similar issue in Evans Cooling Systems, Inc. v. General Motors Corp., 125 F.3d 1448, 1450 (Fed.Cir.1997), a patent infringement action in which the defendant filed a motion for summary judgment asserting that the patent at issue was invalid for anticipation under 35 U.S.C. § 102(b)
Although both Evans Cooling Systems and Vanmoor involved motions for summary judgment of invalidity based on the "on sale" bar of § 102(b), the court agrees with AstraZeneca that the same reasoning applies in the § 102(g) context. Indeed, at least one district court has so held, concluding that a defendant in a patent infringement action had met its burden to show the identity of the patented invention and the accused product based on the plaintiffs' assertion that the accused product infringed, which assertion the defendant had accepted for purposes of its motion for summary judgment of invalidity pursuant to § 102(g). Benedict v. Gen. Motors Corp., 184 F.Supp.2d 1197, 1200 (N.D.Fla.2002), appeal dismissed, 42 Fed. Appx. 466 (Fed.Cir.2002); cf. Bennett Regulator Guards, Inc. v. Canadian Meter Co., Inc., 184 Fed.Appx. 977, 978 n. 1 (Fed.Cir.2006) (agreeing that "[w]hen the anticipatory reference is the accused product, the Defendant's burden [of showing that the anticipatory reference contains each and every claim element] is satisfied by the Plaintiff's infringement allegations in the Complaint that the accused product embodies the claimed invention" in a case in which the defendant raised a defense of
Teva objects that "[u]nlike § 102(g), which expressly requires consideration of the dates of conception and reduction to practice to show priority, § 102(b) provides for patentability unless `the invention was patented or described in a printed publication ... more than one year prior to the date of the application for patent in the United States.'" (Teva Opp'n 19 (quoting § 102(b)) (emphasis supplied by Teva).) Elsewhere in its opposition memorandum, Teva suggests because AstraZeneca has never appreciated that crospovidone contributes to the stability of its CRESTOR® product formulations, it cannot have "create[d] an embodiment that literally met all of the limitations of Teva's claims." (See Teva Opp'n 16 (stating that Dr. Creekmore believes that crospovidone hinders the stability of the formulation and suggesting that Creekmore "certainly did not create an embodiment that literally met all of the limitations of Teva's claims, or show that the invention would work for its intended purpose under the standard set forth by the Federal Circuit").) But whether AstraZeneca's CRESTOR® product formulations in fact meet all of the limitations of the asserted '502 patent claims and whether AstraZeneca appreciated this fact are separate inquiries. See Mycogen Plant Science, 243 F.3d at 1335-37 (concluding that "the portion of the reduction to practice test requiring that all limitations of the count be met ha[d] been satisfied" and addressing separately whether appellee appreciated the limitations of the allegedly infringed patent claims).
As in Evans Cooling Systems, Vanmoor, and Benedict, the entire basis of Teva's lawsuit is that AstraZeneca's CRESTOR® products infringe the asserted claims of the '502 patent. (Compl.¶¶ 16, 18.) Thus, by conceding, for purposes of the instant summary judgment motion, Teva's allegation that CRESTOR® infringes, there is no genuine issue of material fact that AstraZeneca has met its burden to show by clear and convincing evidence with which a reasonable jury could not disagree that CRESTOR® meets all limitations of the asserted patent claims.
As to Teva's argument that AstraZeneca has failed to prove prior conception or reduction to practice of the subject matter of the '502 patent because there is no evidence that its researchers appreciated the stabilizing effect of crospovidone on statin formulations, AstraZeneca agrees that its researchers lacked this specific appreciation. (See AstraZeneca Reply 2 (acknowledging that crospovidone "was included in the CRESTOR® formulations for its properties as a disintegrant").) Indeed, AstraZeneca notes in its reply brief that Dr. Creekmore "disputes Teva's contention about the stabilizing properties of povidone and [crospovidone]." (Id. (emphasis added).) AstraZeneca instead argues that even if Teva is correct about the stabilizing effect of crospovidone as a matter of science, it was not necessary for AstraZeneca to appreciate how, exactly, the allegedly infringing CRESTOR® product formulations achieved stability in order to establish priority of invention under § 102(g)(2). (See id. at 2-3.) Rather, it is enough that AstraZeneca appreciated that the CRESTOR® product formulations were in fact stable.
In support of its argument that appreciation of the stabilizing effect of crospovidone was not required, AstraZeneca relies on a series of cases in which the Federal Circuit has held that "`a reference may anticipate even when the relevant properties of the thing disclosed were not appreciated at the time.'" (See AstraZeneca Reply 2-3 (quoting Abbott Labs. v. Baxter Pharm. Prods., Inc., 471 F.3d 1363, 1367 (Fed.Cir.2006)).) Titanium Metals Corp. of America v. Banner, 778 F.2d 775 (Fed. Cir.1985), cited by AstraZeneca, has been described as the "classic case" on this point. See Abbott Labs., 471 F.3d at 1367. In that case, inventors sought to patent a titanium alloy consisting of certain specified ingredients in specified proportions and "characterized by good corrosion resistance in hot brine environments." 778 F.2d at 776. A prior art reference—an
In deciding whether the claimed alloys were patentable, the critical question was whether "what [was] sought to be patented, as determined by the claims, [was] new." Id. at 780. Because the Russian article disclosed a titanium base alloy falling squarely within the ranges of the patent claims, the court concluded that the claimed alloys were not new, finding it "immaterial, on the issue of their novelty, what inherent properties the alloys have or whether these applicants discovered certain inherent properties":
Id. at 781-82.
Applying this principle—that "the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer"
At oral argument, Teva argued that the cases on which AstraZeneca relies are inapposite because they involved allegations of invalidity under § 102(b), not § 102(g), and the Federal Circuit thus had no need to address the issues of conception, reduction to practice, and appreciation.
Even in the § 102(g) context, however, the Federal Circuit has recognized that a prior inventor need not always have appreciated every feature recited in a patent claim in order to have conceived of or reduced to practice the claimed invention. For example, in E.I. du Pont de Nemours & Co. v. Phillips Petroleum Co., 849 F.2d 1430, 1434-36 (Fed.Cir.1988), the Federal Circuit held that a defendant in an infringement action could meet its burden to show invalidity under § 102(g) by proving that its researchers' earlier-made products possessed certain property limitations of the asserted patent claims, without also showing that the researchers were aware that their products possessed the properties. The patent claims at issue in the case related to various copolymers, and as to four of the six claims at issue, the plaintiff had conceded that the defendant's researchers had made the claimed copolymers before the plaintiff had. Id. at 1434 & n. 3. The remaining two claims included certain property limitations not present in the other four, and as to those claims, the court remanded the case for a determination "whether the claimed copolymer, as defined in part by various property parameters, [was] new." Id. at 1434-36. The court observed that as the one challenging the validity, the defendant would have the burden on remand to prove that the property limitations were possessed by its researchers' products, but stated that in meeting that burden, the defendant "need not prove awareness by [its researchers] that their products possessed the properties." Id. at 1436 (emphasis added). Moreover, in the interference context, the Federal Circuit also has held that a prior inventor need not have appreciated those "inherent properties" of the count that "add nothing to the count beyond the other recited limitations and are not material to the patentability of the invention." Griffin v. Bertina, 285 F.3d 1029, 1034 (Fed.Cir.2002).
Dr. Creekmore's recognition that the rosuvastatin sales formulations were stable and sufficiently finalized to proceed commercially establishes that Dr. Creekmore appreciated "the fact of his invention" no later than late summer of 1999, months before Teva's alleged date of conception. See Dow Chem. Co., 267 F.3d at 1341. In Dow, also a § 102(g) case, the Federal Circuit reaffirmed its prior decisions that a prior inventor is not required to establish that he recognized the invention in the same terms as those recited in the count.
AstraZeneca has presented clear, convincing, and undisputed evidence on the basis of which a reasonable jury would be compelled to find that before December 1, 1999, AstraZeneca had arrived at its CRESTOR® product formulations for all dosage strengths, had made; i.e., conceived and reduced practice, multi-thousand-unit batches of the 2.5 mg and 5 mg tablets, and had concluded, based on stability studies, that the product formulations would have an acceptable shelf life and would therefore work for their intended purpose. On the basis of this clear, convincing, and undisputed evidence—and AstraZeneca's concession of infringement for purposes of this motion, by which AstraZeneca has satisfied its burden to show that the CRESTOR® product formulations meet all limitations of the asserted '502 patent claims—there is no genuine issue of material fact and the court concludes as a matter of law that AstraZeneca conceived of and reduced to practice the subject matter of those claims before Teva did.
It is also clear that AstraZeneca did not abandon, suppress, or conceal its earlier-developed CRESTOR® formulations. The requirement of § 102(g) that the prior inventor must not have "abandoned, suppressed, or concealed" his invention "encourages prompt public disclosure of an invention by penalizing the unexcused delay or failure of a first inventor to share the `benefit of the knowledge of [the] invention' with the public after the invention has been completed." Checkpoint Sys., Inc. v. U.S. Int'l Trade Comm'n, 54 F.3d 756, 761 (Fed.Cir.1995) (quoting Paulik v. Rizkalla, 760 F.2d 1270, 1280 (Fed.Cir. 1985) (Rich, J., concurring)) (alteration in original). "One way a prior inventor may avoid the disqualifying effect of § 102(g) is by promptly filing a patent application claiming the invention." Id. Another is by showing that the prior inventor "engaged in reasonable efforts to bring the invention to market." Id. at 762; see also Dow Chem. Co., 267 F.3d at 1343. Here, AstraZeneca has done both.
Following its manufacture of batches of 2.5 mg and 5 mg rosuvastatin sales formulation tablets from mid 1999 to the fall of 1999, AstraZeneca filed patent applications covering the CRESTOR® formulations in Great Britain in January of 2000 and in the United States on August 4, 2000. (Creekmore Decl. ¶¶ 22-23.) The Great Britain patent application was apparently terminated in January 2001 (Jones Decl. ¶ 6 & Ex. I), while the United States application was ultimately issued as the '460 patent in November 2001 (Creekmore Decl. ¶ 23; Elluru Decl., Ex. 2). In addition to filing these patent applications, AstraZeneca also filed an NDA for CRESTOR® in June 2001, and began marketing CRESTOR® commercially in the United States after receiving FDA approval in August 2003. (See id., Ex. 8; Sloan Decl. ¶ 6.) Teva has produced no evidence disputing these facts. These activities are sufficient to show by clear and convincing evidence that AstraZeneca did not abandon, suppress, or conceal its invention,
Teva argues that AstraZeneca's British patent application and '460 patent support, rather than negate, a finding of suppression or concealment here because those applications do not disclose any appreciation that crospovidone contributed to the stability of the formulation. (Teva Opp'n 21.) Agreed. As set forth above, however, the court has concluded that AstraZeneca was not required to have such an appreciation in order to establish priority of invention. Accordingly, AstraZeneca need not have disclosed such appreciation in its patent filings.
AstraZeneca has presented clear, convincing, and undisputed evidence with which a reasonable jury could not disagree that it conceived and reduced to practice an embodiment meeting the limitations of the asserted claims of Teva's '502 patent before Teva did, and that it did not abandon, suppress, or conceal its invention. There is no genuine issue of a material fact. Accordingly, the court will grant AstraZeneca's motion for summary judgment of invalidity under § 102(g)(2). An appropriate order accompanies this memorandum.
At oral argument, Teva suggested for the first time that there is a genuine factual issue as to whether the CRESTOR® product formulations were stable, as that term is used in the '502 patent. Teva asserts that while the patent defines the term "stabilized pharmaceutical composition" to mean that "after storage for six months at 40° C. and 75% relative humidity, no more than about 10%, preferably no more than about 5%, and more preferably, no more than about 1% by weight of the active component initially present in the composition degrades into the corresponding lactone" (Waldrop Decl., Ex. 1 ('502 patent) at col. 3 l. 65-col. 4 l. 3), AstraZeneca has not produced six-month stability data for its infringing CRESTOR® products. As set forth above, however, by conceding, for purposes of this motion, Teva's allegation that CRESTOR® infringes, AstraZeneca has met its burden to show that CRESTOR® meets all limitations of the asserted patent claims, including that CRESTOR® is a "stabilized" (or, for purposes of independent claims 42 and 52, "stable") pharmaceutical composition.
