In re Sebela Patent Litig.
| Decision Date | 09 June 2017 |
| Docket Number | Civil Action No.: 14-6414 (CCC) (MF) |
| Parties | IN RE SEBELA PATENT LITIGATION |
| Court | U.S. District Court — District of New Jersey |
This is a consolidated1 Hatch-Waxman patent infringement action brought by Plaintiff Sebela International Limited ("Sebela"). The Defendants in the consolidated action are Actavis Laboratories FL, Inc., Actavis Pharma, Inc., Andrx Corp., and Actavis, Inc.2 (collectively, "Actavis"), and Prinston Pharmaceutical Inc., Solco Healthcare U.S., LLC, and Huahai US Inc. (collectively, "Prinston").
Plaintiff has asserted three patents against Defendants: U.S. Patent Nos. 7,598,271 (the "'271 patent"), 8,658,663 (the "'663 patent") and 8,946,251 (the "'251 patent"). A fourth patent, U.S. Patent No. 5,874,447 (the "'447 patent") was also asserted in this litigation. Sebela agreed to withdraw the claims related to the '447 patent in exchange for Defendants' agreement not tolaunch their ANDA products until June 10, 2017, the expiration date of the '447 patent. ECF No. 175; SOF3 ¶ 25.
The '271 patent is directed to a composition relating to Sebela's BRISDELLE® paroxetine mesylate product,4 and the '663 and '251 patents (the "method of treatment patents") are directed to methods relating to the same. Noven Therapeutics, LLC ("Noven"), was the original holder of New Drug Application ("NDA") No. 204516 for paroxetine mesylate capsules, which are marketed and sold under the trademark BRISDELLE. SOF ¶ 8. On October 16, 2014, Noven sued Actavis for infringement of the '447, '271, and '663 patents. SOF ¶ 12. On August 14, 2015, Noven filed a second suit against Actavis for infringement of the '251 patent. SOF ¶ 13. On November 26, 2014, Noven sued Prinston for infringement of the '447, '271, and '663 patents. SOF ¶ 16. On July 7, 2015, Prinston sued Noven for declaratory judgment on the '251 patent. SOF ¶ 17. On July 25, 2016, Sebela purchased all benefits and interests in the '447, '271, '663, and '251 patents and NDA No. 204516 from Noven, and on September 20, 2016, Sebela was substituted as Plaintiff. SOF ¶¶ 21-24; ECF No. 155.
Defendants have sought approval from the United States Food and Drug Administration ("FDA") to market generic versions of paroxetine mesylate. SOF ¶¶ 71, 77. Plaintiff alleges that Defendants will infringe the patents in suit by marketing their generic products. Defendants have stipulated to infringement of the asserted claims of the '663 and '251 patents. SOF ¶¶ 49-50, 67-68.
The Court conducted a bench trial in this matter from December 8, 2016, to December 14, 2016. The Parties submitted post-trial briefing and proposed findings of fact and conclusions of law. Closing arguments were held on February 24, 2017, and March 13, 2017. This Opinion constitutes the Court's findings of fact and conclusions of law pursuant to Federal Rule of Civil Procedure 52(a). The findings of fact are based on the Court's observations and credibility determinations of the witnesses who testified ANDA thorough review of all the evidence admitted at trial. For the reasons stated herein, the Court finds as follows:
As to the '271 patent, Plaintiff has not met its burden of proving infringement by a preponderance of evidence, so judgment of non-infringement will be entered in favor of Defendants on the '271 patent.5
As to the '663 patent, Defendants have met their burden of proving by clear and convincing evidence that the '663 patent is invalid, so judgment of invalidity will be entered in favor of Defendants on the '663 patent.
As to the '251 patent, Defendants have met their burden of proving by clear and convincing evidence that the '251 patent is invalid, so judgment of invalidity will be entered in favor of Defendants on the '251 patent.
Plaintiff Sebela is a Bermuda company with offices located in Hamilton, Bermuda. SOF ¶ 1. Sebela is the legal owner of all rights, title and interests in the '271, '663, and '251 patents.SOF ¶¶ 31, 40, 54. Sebela Ireland Ltd., a wholly owned subsidiary of Sebela, holds NDA No. 204516. SOF ¶ 22.
Defendant Actavis Laboratories FL, Inc. is a Florida corporation with a place of business at Morris Corporate Center III, 400 Interpace Parkway, Parsippany, New Jersey 07054. SOF ¶ 2. Defendant Actavis Pharma, Inc. is a Delaware corporation with a place of business at Morris Corporate Center III, 400 Interpace Parkway, Parsippany, New Jersey 07054. SOF ¶ 3. Defendant Andrx Corp. is a Delaware corporation with a place of business at 4955 Orange Drive, Davie, Florida 33314. SOF ¶ 4. Defendant Actavis submitted Abbreviated New Drug Application ("ANDA") No. 207129 to the FDA, including a paragraph IV certification as to each of the patents in suit. SOF ¶ 11.
Defendant Prinston Pharmaceutical Inc. is a corporation organized and existing under the laws of Delaware with a principal place of business at 2002 Eastpark Boulevard, Cranbury, New Jersey 08512. SOF ¶ 5. Defendant Solco Healthcare U.S., LLC is a Delaware corporation with a principal place of business at 2002 Eastpark Boulevard, Suite A, Cranbury, New Jersey 08512. SOF ¶ 6. Defendant Huahai US Inc., is a corporation organized and existing under the laws of New Jersey, with a place of business at 2001 Eastpark Boulevard, Cranbury, New Jersey 08512. SOF ¶ 7. Defendant Prinston filed ANDA No. 207188 with the FDA, identifying the BRISDELLE drug product, and seeking to market and sell within the United States a generic 7.5 mg paroxetine mesylate capsule product. SOF ¶ 14. ANDA No. 207188 contains a paragraph IV certification as to each of the patents in suit. SOF ¶ 15.
The '271 Patent, titled "Crystalline Paroxetine Methane Sulfonate," issued on October 6, 2009 (with certificates of correction issued on May 17, 2011, and December 22, 2015), from U.S.Application Serial No. 09/200,743 (the "'743 application"), which was filed on November 30, 1998. SOF ¶ 27. The '743 application was filed as a divisional of U.S. Application Serial No. 08/872,023 (the "'023 application"), which was filed on June 10, 1997, and issued as the '447 patent. SOF ¶ 27. The '743 application included a priority claim to the '023 application. SOF ¶ 27. The '271 patent relates generally to a crystalline form of paroxetine mesylate. SOF ¶ 35; JTX-2. The inventors listed on the '271 patent are Franciscus Bernardus Gemma Benneker, Frans Van Dalen, Jacobus Maria Lemmens, Theodorus Hendricus Antonium Peters, and Frantisek Picha. SOF ¶ 30; JTX-2.
On January 31, 2001, Synthon, which was the holder of the '743 application, filed a request for an interference between the '743 application and U.S. patent No. 6,063,927 (the "'927 patent"), which was owned by SmithKline Beecham and claimed a crystalline form of paroxetine mesylate described by reference to 8 infrared ("IR") peaks. PFOF7 ¶¶ 55, 62; DFOF8 ¶ 102. The patent examiner suspended prosecution of the '743 application on February 21, 2001, PFOF ¶ 64, and the Board of Patent Appeals and Interferences (the "BPAI") instituted an interference proceeding (the "Interference Proceeding") on October 1, 2002, PFOF ¶ 67. Despite the different peak listings, applying the broadest reasonable interpretation standard, the BPAI ultimately decided the interference in Synthon's favor. See PFOF ¶ 77.
The '663 patent, titled "Method of Treating Thermoregulatory Dysfunction with Paroxetine," issued on February 25, 2014 (with a certificate of correction issued on October 7, 2014), from U.S Application Serial No. 12/292,960 (the "'960 application"). The '960 applicationwas filed on December 1, 2008, as a continuation of the now abandoned U.S. Application Serial No. 11/499,586 (the "'586 application"), which was filed on August 4, 2006. SOF ¶ 36; JTX-3. The '633 patent relates generally to methods of using paroxetine to treat thermoregulatory dysfunction. See SOF ¶¶ 46-48; JTX-3. The sole inventor listed on the '663 patent is Patricia Allison Tewes Richards. SOF ¶ 39; JTX-3.
The '251 patent, also titled "Methods of Treating Thermoregulatory Dysfunction with Paroxetine," issued on February 3, 2015, from U.S. Application Serial No. 14/157,992 (the "'992 application"), which was filed on January 17, 2014. SOF ¶ 51. The '992 application was a continuation of the '960 application. SOF ¶ 51; JTX-4. The '251 patent relates generally to methods of using paroxetine to treat thermoregulatory dysfunction. See SOF ¶¶ 62-66; JTX-4. The sole inventor listed on the '251 patent is Patricia Allison Tewes Richards. SOF ¶ 53; JTX-4.
The specifications of the '663 patent and the '251 patent are substantively identical.9 PFOF ¶ 207; DFOF ¶ 26. The specifications disclose that paroxetine can be used to treat hot flashes at doses of 9.5 mg down to 0.1 mg. 12/12 Tr. a.m. (Locker) 91:5-11. The specifications contain two prophetic examples. 12/12 Tr. a.m. (Locker) 91:12-92:3. Example 1 describes administering paroxetine hydrochloride and paroxetine mesylate at doses of 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, and 9.5.10 DFOF ¶ 14; JTX-3 at 4:63-5:23. Example 2 describes administering paroxetine hydrochloride, in anhydrous form, hemihydrate form, and monohydrate form, at doses of 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, and 9.5. DFOF ¶ 15; JTX-3 at 5:25-6:23. In each example the patent concludes that "[a]fter a few days to weeks, the symptoms ameliorate." DFOF ¶ 15; JTX-3 at 5:23, 6:23.
The following witnesses appeared and provided live testimony during the bench trial:
i. Plaintiff's Fact Witness
The Court heard testimony from Mr. Scott Briggs, who is Chief Commercial Officer at Sebela Pharmaceutical, Inc., 12/13 Tr. (Briggs) 17:12, and who previously served as Vice President of Marketing and Sales at Noven, 12/13 Tr. (Briggs) 18:12-13. Mr. Briggs testified on issues related to the marketing and sales of Brisdelle.
ii. Plaintiff's Expert Witnesses
1. Allan Myerson
The...
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