Chiesi U.S. Inc. v. Aurobindo Pharma U.S. Inc.
| Decision Date | 16 August 2022 |
| Docket Number | Civil Action 19-18756 (ZNQ) (LHG) |
| Parties | CHIESI USA, INC., et al., Plaintiffs, v. AUROBINDO PHARMA USA, INC., et al., Defendants. Chiesi USPTO Arguments Accused of Inequitable Conduct in this Litigation Arguments Aurobindo and Mr. Jay Akhave Made to Patent Office |
| Court | U.S. District Court — District of New Jersey |
NOT FOR PUBLICATION
(Under Temporary Seal)
This Opinion constitutes the Court's findings of fact and conclusions of law pursuant to Federal Rule of Civil Procedure 52.
Plaintiffs Chiesi USA, Inc. and Chiesi Farmaceutici S.P.A. (“Plaintiffs” or “Chiesi”) bring this suit for patent infringement against Defendants Aurobindo Pharma USA, Inc. and Aurobindo Pharma Ltd. (“Defendants” or “Aurobindo”). Plaintiffs own United States Patent No. 8,658,676 (“the ‘676 patent”), Patent No. 10,010,537 (“the ‘537 patent”), and Patent No. 11,103,490 (“the ‘490' patent,” collectively “the Patents in Suit”), which are listed in the Orange Book as covering Plaintiffs' clevidipine injectable emulsions, marketed under the brand name Cleviprex®. The Amended Complaint alleges that Defendants have infringed the Patents in Suit by filing Abbreviated New Drug Application (“ANDA”) No. 213280 with the United States Food and Drug Administration.
The Court held a bench trial for 7 days, beginning on January 10 2022, and concluding on January 20, 2022. The parties presented closing arguments and submitted proposed findings of fact and conclusions of law in April 2022.
This Court has subject matter jurisdiction over this action, including all claims and counterclaims asserted herein, pursuant to 28 U.S.C. §§ 1331, 1338(a), 2201 and 2202. Venue is proper in this Judicial District pursuant to 28 U.S.C. §§ 1391 and 1400(b).
Plaintiff and Counterclaim Defendant Chiesi USA, Inc. (“Chiesi USA”) is a corporation organized and existing under the laws of the state of Delaware, having its principal place of business in Cary, North Carolina 27518. (Final Pretrial Order, “FPO” ¶ 1) (ECF No. 298). Plaintiff Chiesi Farmaceutici S.p.A. (“Chiesi S.p.A.”) (together with Chiesi USA, “Chiesi” or “Plaintiffs”) is a corporation organized and existing under the laws of Italy, having its principal place of business in Parma, Italy. (FPO ¶ 2). Plaintiff Chiesi USA is a wholly owned subsidiary of Plaintiff Chiesi S.p.A. (FPO ¶ 3).
Defendant and Counterclaim Plaintiff Aurobindo Pharma USA, Inc. (“Aurobindo USA”) is a corporation organized and existing under the laws of Delaware, having a principal place of business in East Windsor, New Jersey. (FPO ¶ 4). Defendant Aurobindo Pharma Ltd. (“Aurobindo Ltd.”) (together with Aurobindo USA, “Aurobindo” or “Defendants”) is an Indian corporation having a principal place of business in Andhra Pradesh, India. (FPO ¶ 7). Defendant Aurobindo USA is a wholly owned subsidiary of Defendant Aurobindo Ltd. (FPO ¶ 8).
1. Have Plaintiffs proven by a preponderance of the evidence that Defendants have infringed claims 1 and/or 8 of the ‘676 patent, claim 7 of the ‘537 patent, and/or claim 6 the ‘490 patent?
2. Have Defendants proven by clear and convincing evidence that claims 1-8 of the ‘676 patent, claims 1, 2, 7 and 8 of the ‘537 patent, and/or claim 6 the ‘490 patent are invalid as obvious pursuant to 35 U.S.C. § 103?
3. Have Defendants proven by clear and convincing evidence that the ‘676 patent, the ‘537 patent, and the ‘490' patent are unenforceable?
The findings of fact herein are based on the Court's observations and credibility determinations of the witnesses who testified at trial and a thorough review of the evidence admitted at trial. While the Court has reviewed all of the evidence presented, given the length of the trial record, the Court includes references only to the evidence most pertinent to its analysis. For the reasons set forth below, the Court finds that (1) Defendants' ANDA literally infringes the claims of the Patents in Suit asserted at trial, (2) the Patents in Suit are not invalid, and (3) the Patents in Suit are not unenforceable.
The present action is for patent infringement under 35 U.S.C. §§ 271(e)(2) and 271(a) and under the Hatch-Waxman Act, codified in part at 21 U.S.C. § 355(j). (FPO ¶ 80). Plaintiff Chiesi Farmaceutici S.p.A. is the current owner and assignee of the Patents in Suit. (FPO ¶¶ 12-13). Pursuant to 21 U.S.C. § 355(b)(1), the Patents in Suit are listed in the United States Food and Drug Administration (“FDA”) publication titled Approved Drug Products with Therapeutic Equivalence Evaluations (“the Orange Book”) as covering Cleviprex® (clevidipine) injectable emulsions (25 mg/50 mL and 50 mg/100 mL). (FPO ¶ 15).
Plaintiff Chiesi USA, Inc. is the owner of FDA-approved New Drug Application (“NDA”) No. 022156 for clevidipine injectable emulsions (25 mg/50 mL and 50 mg/100 mL), which are prescribed and sold under the trademark Cleviprex®. (FPO ¶ 53). Cleviprex is approved by the FDA for the reduction of blood pressure when oral therapy is either not feasible or not desirable. (FPO ¶ 57).
The present action arises from the submission of ANDA No. 213280 by Defendants Aurobindo Pharma USA, Inc. and Aurobindo Pharma Ltd.'s (together, “Aurobindo”) seeking approval from the FDA to commercially manufacture and market generic versions of Cleviprex (clevidipine) injectable emulsions (25 mg/50 mL and 50 mg/100 mL) (the “proposed products”) before the expiration of the Patents-in-Suit. (FPO ¶ 78, 81). The proposed products contain clevidipine butyrate, EDTA, oleic acid, soybean oil, glycerin, egg phospholipids, and sodium hydroxide, which is used to adjust the formulation's pH in the range of 6-8.8. (FPO ¶ 78).
Defendants counterclaim for a declaratory judgment that the Patents in Suit are not infringed (Counterclaim Count I), that they are invalid as obvious (Counterclaim Count II), are unenforceable based on inequitable conduct before the United States Patent and Trademark Office (Counterclaim Count III), and that they are unenforceable based on unclean hands (Counterclaim Count IV).[1] At trial, Plaintiffs asserted claims 1 and 8 of the '676 Patent, claim 7 of the '537 Patent, and claim 6 of the '490 Patent against Aurobindo. (Trial Tr. at 345:17-24 (Little); Trial Tr. at 1228:5-19). Each of the Patents in Suit is presently scheduled to expire on October 10, 2031. (FPO ¶ 16). The patents are each titled “Clevidipine Emulsion Formulations Containing Antimicrobial Agents” and their specifications are substantially identical. (FPO ¶¶ 17,19). Rajeshwar Motheram and Gregory Charles Williams are listed as the named inventors on all three patents. (FPO ¶ 18).
The pharmaceutical formulations claimed in the Patents in Suit cover Plaintiffs' Improved Cleviprex product,[2] which contains clevidipine along with EDTA as an active antimicrobial agent and oleic acid as a stabilizing co-emulsifier. (Tr. at 107:7-22 (Motheram)); see also, e.g., PTX-003 at claims; PTX-048.8). Clevidipine is a calcium channel blocker that is administered intravenously to treat high blood pressure. (Trial Tr. at 109:3-8 (Motheram)). Intravenous administration rather than oral therapy is preferred for the treatment of high blood pressure when oral delivery is not feasible or desirable, for example, in critically ill patients who are in an intensive care unit or undergoing surgery, such as a cardiac surgery where the patient may need blood pressure reduction or control. (Trial Tr. at 74:22-75:6 (Zwinski)). Improved Cleviprex has a longer period over which its vials may be used, i.e., “hang time” (12 hours) compared to the previous version, Original Cleviprex (4 hours). (Trial Tr. at 84:3-85:12 (Zwinski); PTX-048.3; PTX.053.3). Improved Cleviprex was approved by the FDA in 2011. (Trial Tr. at 107:23-108:1 (Motheram)).
Plaintiffs' expert, Dr. Little, opined that a POSA for the claimed inventions “is someone who has at least the equivalent of a Bachelor of Science degree in pharmaceutical sciences or chemical engineering, or an equivalent level of education or training, and several years of experience in the field of drug delivery technology or a similar field.” (Trial Tr. at 342:15-25 (Little)). Aurobindo's infringement expert, Dr. Tarantino, offered a slightly different definition of the POSA, asserting that one skilled in the art has “[a] college degree in an appropriate field such as pharmacy, pharmaceutical science or chemistry, and at least four years of work experience in the field of drug formulations, including experience with emulsion and sterile formulation.” (Trial Tr. 596:3-13 (Tarantino)). Aurobindo's validity expert, Dr. Crowley, offered the same definition as Dr. Tarantino. (Trial Tr. 1236:11-1237:1 (Crowley)). Dr. Tarantino opined that he disagreed with Dr. Little's definition of the POSA because “chemical engineering,” in his opinion, does not “cover pharmaceutical sciences.” (Trial Tr. 597:11-599:7 (Tarantino)). Dr. Tarantino did not, however, offer any support for his opinion that chemical engineers cannot or do not work in pharmaceutical sciences. (Trial Tr. at 597:11-599:7 (Tarantino)). Dr. Little asserted that chemical engineers routinely work in the pharmaceutical sciences, including his own students and his own Ph.D. advisor. (Trial Tr. at 344:4-19 (Little)). Dr. Crowley did not offer any similar criticism or discuss chemical engineering at all, nor did he testify that he disagreed with Dr. Little's proposed definition of a POSA.
The parties' proposed POSA definitions are therefore largely in agreement. The Court resolves the parties' dispute as to whether a POSA's degree could include one for chemical engineering in favor of Chiesi's position. In reaching its conclusion, the Court...
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