Sun Pharma Global Fze v. Lupin Ltd.

SUN PHARMA GLOBAL FZE andSUN PHARMACEUTICAL INDUSTRIES, INC. Plaintiffs, v. LUPIN LTD. and LUPIN PHARMACEUTICALS, INC., Defendants.

Civil Action No. 3:18-cv-02213-FLW-TJB

UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY

March 8, 2021

*NOT FOR PUBLICATION*

OPINION

WOLFSON, Chief Judge:

This matter arises out of a patent dispute. Sun Pharma Global Fze and Sun Pharmaceutical Industries, Inc. ("Plaintiffs"), have filed an infringement suit, see 35 U.S.C. § 271, et seq., to protect the market for their drug BromSite after Lupin Ltd. and Lupin Pharmaceuticals, Inc. ("Defendants"), sought approval to sell a bio-equivalent generic version. Before the Court are three pretrial motions: Plaintiffs' Motion to Strike the expert report of James T. Carmichael, see ECF No. 121, Defendants' Cross-Motion to Preclude "any evidence at trial regarding prior art searches conducted by the [Patent & Trademark Office]," see ECF No. 129, and Defendant's Motion to Exclude certain opinions of Dr. Orest Olejnik. See ECF No. 165. For the following reasons, Plaintiffs' Motion to Strike is GRANTED, Defendants' Cross-Motion to Preclude is GRANTED in part, and Defendants' Motion to Exclude is DENIED in part.

I. FACTUAL BACKGROUND AND PROCEDURAL HISTORY

Plaintiffs manufacture BromSite, a patented drug used to treat and prevent ocular pain associated with cataract surgery. See U.S. Patent No. 8,778,999; Compl., Ex. A. Defendants, seeking to launch a bio-equivalent generic version, filed an Abbreviated New Drug Application ("ANDA") with the Food and Drug Administration ("FDA") before Plaintiffs' patent expired. Plaintiffs sued Defendants for infringement, claiming that Defendants' generic contains a chemically identical bromfenac ophthalmic solution in the same proportion, 0.075%, with the same viscosity. See Compl., at 2, 7-8. In defense, Defendants (1) assert that their generic has a different viscosity, (2) challenge the validity of the BromSite patent on the grounds that it is anticipated and obvious, and (3) claim that Dr. Lyle Bowman, who helped prosecute BromSite, committed inequitable conduct by failing to submit certain prior art he invented ("Bowman I") to the Patent & Trademark Office ("PTO"). See Answer, at 10-11; ECF No. 165, at 2-3.

The parties attempted to settle in 2020, see ECF No. 145, but were unable to do so. See ECF No. 155. This matter is now scheduled for trial beginning on March 22, 2021. See ECF Nos. 179-80. To that end, both parties have submitted pretrial motions to exclude or preclude expert testimony and reports. See ECF Nos. 121, 129, 165. On October 25, 2019, Plaintiffs moved to strike James T. Carmichael's Report. They contend that Carmichael offers improper opinion evidence on substantive patent law, see ECF No. 121, at 11-12, defects, errors, and omissions in the patent application process, id. at 6-8, the motivations of the patent examiner, id. at 8-9, whether the patent examiner reviewed Bowman I, id. at 10, and the examiner's mental state during patent prosecution. Id. at 10-11. Plaintiffs contend that Carmichael's Report should be stricken in its entirety because, absent the above-referenced evidence, it contains nothing more than "undisclosed third party statistical studies" and "rote recitation of facts that are readily obtainable from the [] patent file history," "not in dispute," and "not helpful within the meaning of [Fed. R. Evid.] 702." Id. at 13.

On November 18, 2019, Defendants filed a cross-motion to preclude all testimony on the PTO examiner's search history. Defendants insist that Plaintiffs "injected" this issue into the case by submitting that "the [PTO] examiner likely reviewed Bowman I regardless of whether [Plaintiffs] disclosed or did not disclose [it]," and that it would be unfair to exclude the Carmichael Report, which merely responds to that submission. See ECF no. 129, at 4. In any event, they argue, any testimony as to the PTO examiner's search history is inadmissible. Id. at 7-10.

Finally, on January 8, 2021, Defendants filed a motion to exclude certain expert testimony by Dr. Olejnik. See ECF No. 165. Defendants seek to exclude Dr. Olejnik's opinions on "'gelation' of ophthalmic compositions," id. at 5-9, whether prior art "anticipated" Plaintiffs' patent, id. at 13-16, and whether Plaintiffs' patent is "obvious" in light of prior art, id. at 14-19, on the grounds that Dr. Olejnik is unqualified and unreliable.

II. LEGAL STANDARD

Fed. R. Evid. 602 provides that a witness may testify to facts as long as they are within the witness' personal knowledge. Id. Fed. R. Evid. 701 provides that a lay witness may offer opinion testimony if it is rationally based on the witness' perception, helpful, and does not require specialized knowledge. Id. Fed. R. Evid. 702 provides that "[a] witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if: (a) the expert's scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue; (b) the testimony is based on sufficient facts or data; (c) the testimony is the product of reliable principles and methods; and (d) the expert has reliably applied the principles and methods to the facts of the case." Id.; see also Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 589-92 (1993) (explaining these requirements); Kumho Tire Co. v. Carmichael, 526 U.S. 137, 160-52 (1999) (describing districtcourts' "gatekeeping obligation" with respect to expert testimony). In short, the Third Circuit has interpreted Rule 702 to impose a "trilogy of restrictions on expert testimony: qualification, reliability and fit." Calhoun v. Yamaha Motor Corp., U.S.A., 350 F.3d 316, 321 (3d Cir. 2003).

III. DISCUSSION

A. Plaintiffs' Motion to Strike the Carmichael Report

Mr. Carmichael is a former examiner in the PTO with no special training in pharmaceuticals, who did not work there at any time relevant to this litigation. See Green Decl., Ex. A, ¶ 7. Defendants have offered his Report—which touches on policies, procedures, defects, pressures, and incentives at the PTO—to rebut Plaintiffs' contention that the PTO examiner here "likely reviewed Bowman I regardless of whether [Plaintiffs] disclosed or did not disclose [it]." Id., Ex. D, at 101. Plaintiffs now "agree[] that such a statement if given in testimony may verge on speculative opinion testimony." Pl. Rep. Br., at 5-6. Similar testimony has been found inadmissible before. See, e.g., Comcast Cable Commc'ns, LLC v. Sprint Commc'ns Co., 203 F. Supp. 3d 499, 547 (E.D. Pa. 2016) ("[The expert] provides no basis for his opinion that the examiner must have considered [prior art] references other than generic PTO rules that require a thorough search of the prior art. Expert testimony about the subjective knowledge or state of mind of the examiner is not admissible in the absence of any support in the record.").

Plaintiffs have therefore withdrawn this portion of their argument, Pl. Rep. Br., at 6, and are no longer "attempting to proffer opinion testimony from any witness speculating as to what the [PTO] examiner personally considered, reviewed, thought, or believed," nor opinion testimony on the examiner's "search history" generally. Id. at 10 (emphasis added). Because the Carmichael Report "responds directly to an improper argument [Plaintiffs] injected into this case," Def. Br., at 2 (emphasis removed), and Plaintiffs have affirmatively represented to this Court that they will nolonger elicit opinion testimony on the PTO examiner's search history or infer from that history that the examiner likely reviewed Bowman I or other prior art, I GRANT Plaintiffs' Motion to Strike the Carmichael Report in its entirety.¹ See Def. Br., at 2 (stating that Defendants have "repeatedly offered to withdraw the Carmichael Report if [Plaintiffs] will withdraw [their] [] argument regarding the Examiner's search"); id. at 5 (describing Defendants' offer on September 20, 2019, to "withdraw Mr. Carmichael's . . . report . . . if [Plaintiffs] stipulate[] in writing that [they] will not raise [the argument at issue here] (or any other speculative argument about the Examiner's actions or views about [Bowman I])").²

B. Defendants' Cross-Motion to Preclude All Testimony on Search History

In their Cross-Motion, Defendants seek to preclude Plaintiffs from presenting not just opinion but fact testimony on the PTO examiner's search history.³ See, e.g., Def. Br., at 2, 7(arguing that Plaintiffs should be "precluded from adducing" or "proffering" "purported 'fact' testimony" on this issue). Specifically, Defendants seek to preclude testimony from Dr. Bowman that the PTO examiner conducted a search for "(LYLE) near2 (BOWMAN).INV" in United States and foreign databases before approving Plaintiffs' BromSite patent, initialed that search as "considered," which returned 69 hits in total, and included it in the prosecution file. See Pl. Br., at 4; ECF No. 121, Ex. 5 (summarizing examiner's "Search Strategy and Results," and "Search Info. Incl. Classification," as filed with Non-Final Rejection on October 25, 2012). Defendants argue that such testimony "would violate at least Federal Rules of Evidence 402, 403, 602, 701, and 702." Def. Br., at 7-8.

While Fed. R. Evid. 402 (relevance), 403 (prejudice), 701 (lay opinion), and 702 (expert opinion) do not govern the admissibility of Dr. Bowman's testimony here, Rule 602 does, and Dr. Bowman plainly lacks personal knowledge of the examiner's search history. He cannot therefore testify to the manner, substance, or results of the search. To the extent that Plaintiffs seek to admit the fact of the search into evidence (e.g., the terms used and the databases searched), and to demonstrate that the PTO examiner conducted the query "(LYLE) near2 (BOWMAN).INV," they may rely on the relevant files from the prosecution history. See Fed. R. Evid. 902(1) (providing that signed...