Millennium Pharms., Inc. v. Sandoz Inc.
| Decision Date | 20 August 2015 |
| Docket Number | C.A. No. 12-1011-GMS |
| Parties | MILLENNIUM PHARMACEUTICALS, INC., Plaintiff, v. SANDOZ INC., et al., Defendants. |
| Court | U.S. District Court — District of Delaware |
In this patent infringement action, the plaintiff Millennium Pharmaceuticals, Inc. ("Millennium") alleges that Abbreviated New Drug Applications ("ANDAs") filed by the defendants Sandoz Inc. ("Sandoz"), Accord Healthcare, Inc. ("Accord"), and Actavis LLC ("Actavis") (collectively, "the defendants") infringe claims 20, 31, 49, and 53 of U.S. Patent No. 6,713,446 ("the '446 patent").1 (D.I. 1.2) The court held a four-day bench trial in this matter on November 4 through November 7, 2014. (D.I. 139-42.) Presently before the court are the parties' post-trial proposed findings of fact and conclusions of law concerning the validity of the '446 patent, specifically whether the asserted claims of the '446 are invalid as obvious under 35 U.S.C. § 103. (D.I. 132, 133.)
4. Actavis is a limited liability company organized and existing under the laws of the State of Delaware, with its principal place of business at Morris Corporate Center III, 400 Interpace Parkway, Parsippany, New Jersey.
5. VELCADE® (bortezomib) for Injection is a proteasome inhibitor used in the treatment of patients with multiple myeloma and patients with mantle cell lymphoma who have received at least one prior therapy.
6. In 2003, the Food and Drug Administration ("FDA") granted "accelerated approval" to New Drug Application No. 21-602 for VELCADE® for Injection, for the treatment by intravenous administration of patients with multiple myeloma who have received at least two prior therapies and have demonstrated disease progression on the last therapy.
7. VELCADE® for Injection was subsequently approved in 2005 for treatment by intravenous administration of patients with multiple myeloma who had received at least one prior therapy; in 2006 for treatment by intravenous administration of patients with mantle cell lymphoma who had failed at least one prior therapy; in 2008 for frontline treatment by intravenous administration of patients with multiple myeloma; in 2012 for subcutaneous administration; and in 2014 for treatment of adult patients with multiple myeloma who had previously responded to VELCADE® for Injection therapy and relapsed at least six months following completion of prior VELCADE® for Injection treatment.
8. The '446 patent has been listed in connection with VELCADE® for Injection in the FDA's publication, Approved Drug Products with Therapeutic Equivalence Evaluations, referred to as the "Orange Book."
9. U.S. Patent No. 5,780,454 ("the '454 patent"), among others, is also listed in the Orange Book in connection with VELCADE® for Injection. The '454 patent, entitled "Boronic Ester and Acid Compounds," issued on July 14, 1998, is assigned to Millennium, and will expire on May 3, 2017. The '454 patent is prior art to the '446 patent and is of record in the prosecution of the '446 patent.4
10. Millennium sells VELCADE® for Injection in the United States.
11. The '446 patent, entitled "Formulation of Boronic Acid Compounds," issued on March 30, 2004, naming Shanker Lai Gupta as the inventor. The '446 patent claims priority to Provisional Application No. 60/264,160, filed on January 25, 2001 ("the '160 provisional").
12. A Certificate of Correction issued for the '446 patent on September 6, 2005.
13. The '446 patent is assigned to the United States of America as Represented by the Secretary of Health and Human Services.
14. Millennium holds an exclusive worldwide license to the '446 patent for the research, development, and manufacture of Bortezomib for distribution, sale and use in oncology disease states. Pursuant to its license, Millennium has the right to bring suit for infringement and defend invalidity counterclaims in its own name and own behalf.
15. Millennium asserts claims 20, 31, 49, and 53 ("Asserted Claims") of the '446 patent.
16. Claim 20 of the '446 patent is directed to directed to lyophilized mannitol boronate ester compounds, including the lyophilized mannitol ester of bortezomib.
17. Claim 31 of the '446 patent is directed to preparing the lyophilized mannitol ester of bortezomib by lyophilizing a mixture of water, bortezomib and mannitol.
18. Claim 49 of the '446 patent is directed to a lyophilized cake comprising the lyophilized mannitol ester of bortezomib.
19. Claim 53 of the '446 patent adds to the method of claim 31 the further step of reconstituting the lyophilized mixture comprising the mannitol ester of bortezomib with a pharmaceutically-acceptable carrier.
i. ANDAs Filed by the Defendants
20. Millennium's VELCADE® for Injection is FDA-approved to treat multiple myeloma and mantle cell lymphoma. (D.I. 112-1, ¶¶ 11-13.)
21. Sandoz, Accord, and Actavis filed ANDA Nos. 203654, 204405, and 204332, respectively, seeking approval for the commercial manufacture, use, and sale of generic versions of VELCADE® for Injection. (Id., ¶¶ 16, 20, 25.)
22. The defendants dispute that any of the asserted claims are valid. (Id., ¶¶ 18, 23, 28.)
23. The defendants previously entered into stipulations regarding infringement of certain claims of the '446 patent including the Asserted Claims with the exception of Claim 53, which relies on induced infringement. (See D.I. 86, 92, 94.) The defendants challenge the alleged induced infringement of Claim 53. The primary issue presented at trial was obviousness.
24. In separately-captioned actions, Millennium filed complaints for patent infringement against Sandoz (C.A. 12-1011-GMS), Accord (12-490-GMS), and Actavis (12-1750-GMS) on August 2, 2012, November 19, 2012, and December 21, 2012, respectively.
25. Millennium's actions against Accord and Actavis were consolidated with the Sandoz action on April 23, 2013. (D.I. 21.)
The court has subject matter jurisdiction over this matter pursuant to 28 U.S.C. §§ 1331, 1338, and 2201. Venue is proper in this court under 28 U.S.C. §§ 1391 and 1400(b). The court has considered whether the asserted claims are invalid due to obviousness and, if so, whether the defendants induced infringement of Claim 53 of the post-trial submissions, and the applicable law, the court concludesthat the asserted claims of the 5 Rule 52(c) motion. The court's reasoning follows.
A. Obviousness
The defendants challenge the validity of each of the asserted claims as obvious in light of the prior art. The court finds, for the reasons that follow, that the defendants have established by clear and convincing evidence that the asserted claims of the '446 patent are obvious.
While worded differently, each claim has three central elements: (1) freeze-drying bortezomib, (2) using mannitol, (3) to form a bortezomib-mannitol ester.6 Tr. 122-25 (Repta). Millennium asserts an invention date of December 1997 based on the first time that Dr. Valentino Stella freeze-dried bortezomib with mannitol.7 Tr. 477 (Stella); PTX-32 at 13-17 (Waugh Notebook); Tr. 690-91 (Snow).
35 U.S.C. § 103(a) provides that a patent may not be obtained "if 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 to a person having ordinary skill in the art." 35 U.S.C. § 103(a). Obviousness is a question of law that is predicated on several factual inquires. See Richardson-Vicks v. Upjohn Co., 122 F.3d 1476, 1479 (Fed. Cir. 1997). Specifically, the trier of fact is directed to assess four considerations: (1) the scope and content of the prior art; (2) the level of ordinary skill in the art; (3) the differences between the claimed subject matter and the prior art; and (4) secondary considerations of non-obviousness, such as commercial success, long felt butunsolved need, failure of others, acquiescence of others in the industry that the patent is valid, and unexpected results. See Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966).
A patent and each of its claims are presumed to be valid. 35 U.S.C. § 282(a). A party seeking to challenge the validity of a patent based on obviousness must demonstrate by "clear and convincing evidence" that the invention described in the patent would have been obvious to a person of ordinary skill in the art at the time the invention was made. Kao Corp. v. Unilever U.S., Inc., 441 F3d 963, 968 (Fed. Cir. 2006) (citation omitted). "Clear and convincing evidence is evidence that places in the fact finder 'an abiding conviction that the truth of [the] factual contentions are 'highly probable.'" Alza Corp v. Andrx Pharms., LLC, 607 F. Supp. 2d 614, 631 (D. Del. 2009) (quoting Colorado v. New Mexico, 467 U.S. 310, 316 (1984)). This burden of proof remains constant, even when a patent invalidity attack relies on the same prior art previously considered by the PTO. See Sciele Pharma Inc. v. Lupin Ltd., 684 F.3d 1253, 1260 (Fed. Cir. 2012) (...
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