TEVA NEUROSCIENCE, INC., ET AL. Plaintiff,
WATSON PHARMA, INC., ET AL. Defendant.
CLAIRE C. CECCHI, District Judge.
This matter comes before the Court by complaint of Teva Neuroscience, Inc., Teva Pharmaceuticals USA, Inc. and Teva Pharmaceuticals Industries, Ltd. (collectively, "Teva") against Orchid,  Watson,  Mylan and Apotex (collectively, "Defendants"). This case concerns the validity, enforceability and alleged infringement of United States Patent No. 5, 453, 446 ("the 446 Patent"), which is alleged to cover Azilect§, Teva's rasagiline mesylate tablet product. Trial is scheduled to commence on May 15, 2013. Presently before the Court are Defendants' motions in limine to preclude the introduction of certain evidence at trial. Having considered all of the submissions filed in connection with the motions, the decision of this Court is set forth below.
I. Defendants' motion in limine to preclude Teva from presenting evidence on pharmaceutical development and difficulties
In their first motion in limine, Defendants seek to preclude Teva from presenting two categories of evidence. First, Defendants move to exclude Teva's proposed testimony regarding the difficulties a person of ordinary skill in the art ("POSA") would have encountered when separating the enantiomers of racemic PAI. According to Defendants, any such evidence would be inconsistent with Teva's position during the claim construction process. In response, Teva asserts that its position in this regard is not at odds with its presentation during claim construction, where the parties' disputed the purity level of R() PAI as described in the 446 patent. As such, Teva contends that it should be permitted to present limited evidence regarding the difficulties it had separating the enantiomers of racemic PAI, coupled with testimony regarding what a POSA would have known about such difficulties in January 1990.
Defendants' motion further seeks to preclude Teva from presenting evidence regarding the pharmaceutical development process in general or issues related to the development of Azilect§ which occurred after January 3, 1990, the earliest possible priority date of the 446 patent. Defendants argue that such evidence is irrelevant and prejudicial, and should be precluded pursuant to Federal Rules of Evidence 401, 402 and 403. In opposing Defendants' motion, Teva contends that evidence regarding uncertainties in the drug development process is relevant to the obviousness inquiry in that it goes to whether or not a POSA would have a reasonable expectation of success. Teva further asserts that brief testimony regarding the challenges it faced in developing Azilect§ as a commercial product is likewise relevant to provide context for the obviousness inquiry.
Having reviewed the parties' submissions, the Court does not find grounds to preclude either category of evidence. As to the difficulties a POSA may have experienced or understood regarding separating the enantiomers of racemic PAI, the Court does not find such testimony to be categorically inconsistent with Teva's position during claim construction, where the parties disputed the purity level such separation would produce. Further, the evidence Teva intends to offer regarding the difficulty, expense and unpredictability of enantiomer separation is relevant to the Court's obviousness analysis, including a POSA's motivations or reasonable expectation of success. Indeed, the unpredictability of enantiomer separation has been specifically acknowledged by district courts, see, e.g., Forest Labs, Inc. v. Ivax Pharm., Inc. , 438 F.Supp.2d 479, 493 (D. Del. 2006), aff'd 501 F.3d 1263 (Fed. Cir. 2007), and the Federal Circuit has stated that "predictability is a vital consideration in the obviousness analysis." Otsuka Pharm Co. v. Sandoz, Inc. , 678 F.3d 1280, 1298 (Fed. Cir. 2012) (citations omitted). Accordingly, Teva will be permitted to present such evidence.
As to the second prong of Defendants' motion, "[n]either the common practice of pharmaceutical companies, nor the procedure necessary for FDA approval can be considered irrelevant to the factual underpinnings required to demonstrate obviousness or non-obviousness." Novartis Pharms. Corp. v. Teva Pharms. USA, Inc., No. 05-1887 (DMC) , 2009 U.S. Dist. LEXIS 103104, at *41 (D.N.J. Nov. 5, 2009). Such evidence will assist the factfinder in understanding the relevant background and rendering a determination as to whether or not the 446 patent was obvious in light of the prior art. Similarly, Teva's proposed testimony on the challenges it faced in commercializing Azilect§ may provide context for the Court's obviousness analysis. See In re Gabapentin Patent Litig., No. 00-2931 (FSH), 2011 U.S. Dist. LEXIS 51130 at *43-44 (D.N.J. May 11, 2011) ("Evidence of the research and development efforts made in developing [a drug] are also relevant to the patent's validity."). Accordingly, Defendants' motion in limine No. 1 is denied.
II. Defendants' motion in limine to preclude Dr. Peter Jenner from offering testimony as to the state of the art
Defendants' second motion in limine requests an order precluding Teva's expert, Dr. Peter Jenner, from testifying as to the state of the art regarding Parkinson's disease in 1990 because he offered limited answers to six questions during his full-day of deposition testimony. In responding to those six background questions, Dr. Jenner cited confidentiality restrictions imposed by the pharmaceutical companies that sponsored his work developing new compounds to treat Parkinson's disease prior to 1990. Defendants assert that Dr. Jenner's invocation of confidentiality prevented them from fully exploring his experience with the prior art, rendering his testimony in that regard unfairly prejudicial pursuant to Federal Rule of Evidence 403.
In response, Teva counters that Defendants will not be prejudiced because they have full access to the published references Dr. Jenner utilized to reach his opinions and that he in no way relied on the confidential work cited during his deposition. Teva further contends that Defendants waived their right to object to Dr. Jenner's testimony because they delayed until the filing of the instant motion to raise it with the Court. Lastly, Teva points out that the complete exclusion of an expert is an extreme remedy that is not justified on the facts presented here.
The Court finds that exclusion of Dr. Jenner's testimony is not warranted. Contrary to Defendants' assertions, it appears that Dr. Jenner's opinion regarding the state of the art - more specifically, which chemical entity a POSA would have selected as a lead compound - is based on publicly available prior art, not unpublished research performed by Dr. Jenner. As noted by Teva, Dr. Jenner has identified numerous prior art references which form the basis for his opinion. Defendants have not pointed to any specific statement within Dr. Jenner's report which indicates that he relied on his confidential work in forming his opinions. Accordingly, Dr. Jenner has provided substantial information concerning the basis of his opinion, despite his inability to answer certain questions based on confidentiality.
Indeed, it does appear that Dr. Jenner provided information in response to most of the six questions at issue and that he satisfactorily answered hundreds of questions regarding his opinions during his deposition, which lasted for one full day. In light of the various prior art references cited in his expert report, coupled with his lengthy deposition testimony, Dr. Jenner has provided sufficient information for Defendants to determine how he arrived at his opinion. Fitz, Inc. v. Ralph Wilson ...