T. JOHN WARD, District Judge.
Before the Court is Defendants Johnson & Johnson's ("J & J") and Cordis Corporation's ("Cordis") (collectively "Defendants") claim of inequitable conduct. The plaintiff and defendants each filed proposed findings of fact and conclusions of law. (Dkt. Nos. 314 and 315.) The Court also conducted a bench trial on March 2, 2011 on Defendants' counterclaim of inequitable conduct and the parties submitted their post-trial briefing on the issue after the bench trial. (See Dkt. Nos. 318, 320, and 323.) For the following reasons, the Court concludes that Defendants have not proven by clear and convincing evidence that Plaintiff Dr. Saffran committed inequitable conduct against the PTO.
Plaintiff Dr. Saffran resides at 107 Arch Street, Philadelphia, Pennsylvania 19106. (Joint Final Pre-Trial Order, Dkt. No. 278, at 11.) Defendant J & J is a corporation organized and existing under the laws of the State of New Jersey, and has a place of business at One Johnson & Johnson Plaza, New Brunswick, New Jersey 08933. (Defendants' Second Amended Answer, Dkt. No. 65, at ¶ 7.) Defendant Cordis is a corporation organized and existing under the laws of the State of Florida, and has a place of business in Warren, New Jersey. (Dkt. No. 65, at ¶ 8.)
Dr. Saffran is the owner of U.S. Patent No. 5,653,760 ("the '760 patent"). On October 9, 2007, Dr. Saffran filed suit against Defendants and alleged that Defendants infringe the '760 patent. (Dkt. No. 1.) From January 24-28, 2011, a jury trial was held on the issues of infringement and validity of the '760 Patent, willfulness, and damages. On January 28, 2011, the jury returned a verdict finding that Defendants infringe claims 1-3, 6, 8, 9, 11, 13, 15, 17 and 18 of the '760 Patent, that the '760 Patent is not invalid based on obviousness, that Defendants' infringement was willful, and that Dr. Saffran is entitled to damages in the amount of $482 million as a reasonable royalty. (Verdict Form, Dkt. No. 288.)
On March 2, 2011, the Court conducted a bench trial to consider Defendants' claim of inequitable conduct. Defendants claim Saffran committed inequitable conduct in two ways: (1) Saffran had knowledge and withheld, with intent to deceive the PTO, the Langer references that would have been material to the prosecution of the '760 Patent application; and (2) Saffran made material misrepresentations to the PTO, with an intent to deceive, by making statements in the '760 Patent such as "I have found" and "surprisingly." The Court has considered the evidence from both the jury trial and bench trial, including
"A patent may be rendered unenforceable for inequitable conduct if an applicant, with intent to mislead or deceive the examiner, fails to disclose material information or submits materially false information to the PTO during prosecution." Digital Control, Inc. v. Charles Mach. Works, 437 F.3d 1309, 1313 (Fed.Cir.2006); see also 37 C.F.R. § 1.56(a) ("Each individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability as defined in this section."). "The party asserting inequitable conduct must prove a threshold level of materiality and intent by clear and convincing evidence." Id. "The court must then determine whether the questioned conduct amounts to inequitable conduct by balancing the levels of materiality and intent, `with a greater showing of one factor allowing a lesser showing of the other.'" Id. (quoting Union Pac. Res. Co. v. Chesapeake Energy Corp., 236 F.3d 684, 693 (Fed.Cir.2001)).
"[T]he facts in inequitable conduct cases rarely, if ever, include direct evidence of admitted deceitful conduct." Akron Polymer Container Corp. v. Exxel Container, Inc., 148 F.3d 1380, 1384 (Fed. Cir.1998). "The intent element of the offense is thus in the main proven by inferences drawn from facts, with the collection of inferences permitting a confident judgment that deceit has occurred." Id. "However, inequitable conduct requires not intent to withhold, but rather intent to deceive. Intent to deceive cannot be inferred simply from the decision to withhold the reference where the reasons given for the withholding are plausible." Dayco Products, Inc. v. Total Containment, Inc., 329 F.3d 1358, 1367 (Fed.Cir. 2003). In addition, "a finding that particular conduct amounts to `gross negligence' does not of itself justify an inference of intent to deceive; the involved conduct, viewed in light of all the evidence, including evidence indicative of good faith, must indicate sufficient culpability to require a finding of intent to deceive." Kingsdown Med. Consultants, Ltd. v. Hollister Inc., 863 F.2d 867, 876 (Fed.Cir.1988) (en banc in relevant part); see also Larson Mfg. Co. of S.D. v. Aluminart Prod. Ltd., 559 F.3d 1317, 1340 (Fed.Cir.2009).
The materiality of information withheld during prosecution may be judged by the "reasonable examiner" standard. See Digital Control, 437 F.3d at 1316. That is, materiality embraces "any information that a reasonable examiner would substantially likely consider important in deciding whether to allow an application to issue as a patent." Akron Polymer, 148 F.3d at 1382 (emphasis in original) (internal quotations and citations omitted). Moreover, "[i]nformation concealed from the PTO may be material even though it would not invalidate the patent." Li Second Family Ltd. Partnership v. Toshiba Corp., 231 F.3d 1373, 1380 (Fed.Cir.2000).
"A party may show inequitable conduct by producing clear and convincing evidence of (1) material prior art, (2) knowledge chargeable to the patent applicant of prior art and its materiality, and (3) the applicant's failure to disclose the prior art to the PTO with intent to mislead." Avid Identification Systems, Inc. v. Crystal Import Corp., 603 F.3d 967, 972 (Fed.Cir.2010). In addition, inequitable conduct may be shown by clear and convincing evidence of the patent applicant's
At the outset, the Court observes that Defendants' claim of inequitable conduct essentially hinges on the Court finding that Dr. Saffran is a liar and that Dr. Saffran's testimony is not credible. Defendants' reliance on Dr. Saffran's alleged character for untruthfulness is clearly evidenced, for example, by their post-hearing briefing, which has the word "lied" or "liar" as a topic header for every subject in its brief but one. (See Table of Contents, Dkt. No. 318, at 2.) For the reasons discussed below, however, the does not find that Dr. Saffran's testimony was untruthful. Rather, at worst, Dr. Saffran's testimony in certain parts suffers from a lack of memory and/or lack of clarity, but the Court does not find that Dr. Saffran lacks any character for truthfulness or credibility in general. Therefore, after weighing all the evidence, including Dr. Saffran's testimony, the Court concludes that Defendants have not proven by clear and convincing evidence that Dr. Saffran committed inequitable conduct against the PTO for the '760 Patent. With this in mind, the Court proceeds into its factual findings and legal conclusions.
The Court issues the following findings of fact pursuant to Federal Rule of Civil Procedure 52.
Plaintiff Bruce N. Saffran ("Saffran") is the inventor of the '760 Patent. '760 Patent, Cover. Saffran received his Ph.D. in 1990 from the University of Utah and his M.D. from the University of Cincinnati Medical School in 1992. DTX-2371. Saffran currently practices diagnostic and interventional radiology. (1/25 AM Tr., 45:5-8 (Saffran).)
The '760 Patent was not the first patent for which Saffran applied. On August 30, 1993, Saffran filed United States Patent Application No. 08/114,745, entitled "Malleable Fracture Stabilization Device With Micropores For Directed Drug Delivery." That application issued on November 14, 1995 as United States Patent No. 5,466,262 (the '262 Patent). (DTX-2.) The application that issued as the '760 patent (No. 513,092) was filed on August 9, 1995, as a continuation-in-part of U.S. Patent Application No. 114,745, which as noted above, issued as the '262 Patent. (PTX-002; DTX-0002.)
The '760 patent was written and prosecuted by Dr. Saffran without an attorney prior to issuing on August 26, 1997. (1/25 AM Tr., 90:25-91:24; 117:23-118:2 (Saffran).)
A significant amount of Saffran's evidence regarding his conception and development of the ideas for the invention and also his dealings with the PTO is developed through Dr. Saffran's testimony. For some of Dr. Saffran's testimony, there is no other direct evidence to confirm or deny the testimony. For example, Dr. Saffran has no lab notebooks of experiments he performed or prototypes of any embodiments discussed in the '760 Patent. Saffran also has no witnesses that can directly testify to any experiments Saffran performed. The Patent it Yourself book has a chapter that discusses the need for documentation-including keeping records of ideas and experiments. DTX-2325 at CSF01740419. But the book also states that "[y]ou never have to furnish or demonstrate a working model of your invention." DTX-2325 at CSF01740529.
Due to Saffran's defense being significantly based on Dr. Saffran's testimony, Defendants' evidence and argument to support inequitable conduct largely consists of character attacks on Dr. Saffran and attempts to impeach Dr. Saffran. Defendants' proposed findings of fact spend twelve pages alleging that Dr. Saffran's testimony is not credible. (Dkt. No. 325, at 74-88.) The only live testimony Defendants offered at the inequitable conduct bench trial was a cross-examination of Dr. Saffran that lasted well over two hours, and much of this time was spent attempting to impeach Dr. Saffran. (See generally, 3/2 Tr. (Saffran).) Further, aside from the header that states "Materiality," the table of contents of Defendant's inequitable conduct post-trial brief shows that the header of every subject discussed in the brief mentions "Saffran's Lies" or "Saffran Intentionally Lied."
Defendants have had ample opportunity to obtain testimony by Dr. Saffran and have plenty of evidence to attempt to prove that Dr. Saffran is a liar and is not credible. Dr. Saffran has taken multiple depositions in this case and additionally in Dr. Saffran's previous patent infringement lawsuit of Saffran v. Boston Scientific Corp., No. 2:05-CV-547 (TJW) (E.D.Tex.) ("the BSC Litigation").
The Court finds that Defendants have not proven that Dr. Saffran has a character of untruthfulness or that his testimony should be disregarded as untruthful. The Defendants have attempted to show the Court multiple instances in the record where Dr. Saffran has been untruthful or his testimony has been inconsistent or illogical. (See, e.g., Dkt. No. 315, 74-86; Dkt. No. 318.)
As noted above, Defendants have pointed to numerous instances in the record where Dr. Saffran has been allegedly untruthful or his testimony has been allegedly inconsistent or illogical. Similar to the one illustration above, the Court finds that, after reviewing and observing Dr. Saffran's testimony, Defendants have not proven that Dr. Saffran has a character of untruthfulness or that his testimony should be disregarded as untruthful, but instead, only that his testimony at times suffers from a lack of clarity and/or memory. Considering the voluminous testimony that Defendants' possess from Dr. Saffran from depositions and trials on multiple occasions over periods of years, it is not unusual that there are some inconsistencies due to failures of clarity and/or memory. The Court will consider Dr. Saffran's testimony in its legal conclusions and will consider any memory or clarity failures to merely affect the weight to be accorded to that particular testimony.
Dr. Saffran did not disclose the PTO the Langer references.
Dr. Saffran was unaware of the Langer references until 2004 when he learned
Although not required, Defendants have presented no direct evidence that Dr. Saffran knew of the Langer references before
By using phrases such as "I have found," Dr. Saffran used the past tense twelve times in the '760 Patent. See, e.g., '760 Patent, 5:19-23 ("Although this is true to some extent, I have found unexpectedly that if small molecules such as water, urea, bicarbonate, and hydrogen ions are permitted to pass though the device, healing occurs much more quickly.") (emphasis added). Dr. Saffran used the term "unexpected" twelve times in the '760 Patent. See, e.g., id. at 8:35-37 ("I have found unexpectedly that, if one affixes medicine directly to the minimally-porous layer, one can bypass the need for the microporous layer entirely!") (emphasis added). Dr. Saffran used the term "surprising" twelve times in the '760 Patent. See, e.g., id. at 8:15-17 ("Another surprising feature of this invention is that it can be manufactured to selectively restrain molecules of a particular ionic charge regardless of pore size.") (emphasis added). Dr. Saffran used the term "remarkable" four times in the '760 Patent. See, e.g., id. at 7:42-46 ("Although the macromolecular restrainment means of the Malleable Fracture Stabilization Device with Micropores is a feature of its minimally-porous layer, the present invention is remarkable in that it accomplishes this task using a single sheet, rather than a two layered sheet.") (emphasis added). Dr. Saffran described a feature as a major/significant advance (3 times) or significant improvement (6 times) over the prior art. See, e.g., id. at 7:50-52 ("Therefore, the elimination of an entire layer while maintaining function is a highly significant improvement in design.") (emphasis added). Dr. Saffran described features as entirely new or impossible using the prior art. See, e.g., id. at 15:13-18 ("Although I have disclosed the implantation of multiple medicines in my application for the Malleable Fracture Stabilization Device with Micropores, the surprising specificity of medicine release provided by the chemical bond is entirely new and unexpected.") (emphasis added). Defendants' allege that Dr. Saffran was making misrepresentations to the PTO that Dr. Saffran made actual discoveries or performed actual experiments. Additionally, Defendants' allege that these statements by Dr. Saffran were intended to mislead or exaggerate to the PTO regarding the importance of the invention.
Dr. Saffran filed for both the '262 Patent and the '760 Patent without the help of an attorney. Dr. Saffran did not use similar language, such as "surprising" or "unexpected" in the '262 Patent, and Dr. Saffran used the present tense in the '262 Patent. But when Dr. Saffran was drafting the '760 Patent, he was much more excited about it than the '262 Patent. (3/2 Tr., 92:18-20 (Saffran) ("It was certainly more exciting, and I have spent a lot more time working on the '760 than I did on the '262.").) Dr. Saffran even used an exclamation mark in the '760 Patent. '760 Patent, 8:35-37. Dr. Saffran did not think about which specific tense he was using when drafting the patent. (3/2 Tr., 93:4 (Saffran).)
In another experiment, Dr. Saffran prepared a stent analog by manipulating paperclips into a scaffolding in the form of a rudimentary stent. (Id. at 74:13-75:2.) Dr. Saffran coated his paperclip stent analog with butter, but found this experiment somewhat difficult to achieve results. (Id. at 75:4-10.) In another experiment, Dr. Saffran coated his paperclip stent analog with PAM® cooking spray. (Id. at 75:4-10.) In this experiment, Dr. Saffran dipped his coated paperclip stent analog in chili oil and then repeated the dipping into water or vegetable oil as in the prior experiment with the pretzel sticks. (See id. at 74:23-75:10.)
Dr. Nahum Goldberg can corroborate that Dr. Saffran was performing experiments at his home during the time frame around which Dr. Saffran conceived of the invention, but Dr. Goldberg did not know the specifics of those experiments. (DTX-2382 at 41:3-11 (Dr. Goldberg deposition) ("Q. BY MR. HOWARD: Did you ever discuss with Dr. Saffran the experiments that—that he had been doing relating to his—his—his product? A. We never discussed a specific—any specific experiment, rather that experiments were being done in his basement. Q. Did you ever witness any of these experiments? A. I was never present for any of these experiments.").)
Through Dr. Saffran's home experiments, he "discovered" and "found" various concepts and principles that partially formed the basis for the '760 Patent. Dr. Saffran was doing a significant amount of reading from a variety of sources during the time period before applying for his patents, and Dr. Saffran may have put ideas together through his training, education, and residency activities. (3/2 Tr., 97:3-98:25; 140:1-146:3 (Saffran).) Dr. Saffran did not, in the '760 Patent, refer to any data or specific experiments he had performed. (Id. at 95:6-17.) Dr. Saffran
The Court makes the following conclusions of law based on the abovementioned findings of fact and the relevant caselaw, including the legal principles discussed in the "legal standards" section above.
This Court has original jurisdiction over the subject matter of this action under 28 U.S.C. §§ 1331 and 1338(a) and 2201-2202. This Court has personal jurisdiction over the Defendants because they do business and sell infringing products in this judicial district and within Texas. Venue is proper under 28 U.S.C. §§ 1391(b) and (c) and 1400(b).
Based on the abovementioned findings of facts and applicable caselaw discussed above, the Court concludes that Dr. Saffran did not commit inequitable conduct towards the PTO by not disclosing the Langer references. In order to conclude that Dr. Saffran committed inequitable conduct, the Court must conclude that Defendants have proven by clear and convincing evidence that the Langer references were material and that Dr. Saffran withheld them from the PTO with the intent to deceive the PTO. See Nilssen, 504 F.3d at 1229.
Based on the "reasonable examiner" standard for materiality, the Court concludes that the Langer references were material. See Digital Control, 437 F.3d at 1316. An examiner would substantially likely consider the Langer references important in deciding whether to issue the '760 Patent. As noted above, the specific Langer article relied on by Defendants' for their invalidity defense, for example, discloses a pendant chain system where a drug is chemically bound to a polymer backbone-chain and is released by hydrolytic or enzymatic cleavage. (DTX-21.) This is at least relevant to Dr. Saffran's discussion of hydrologic chemical bonds used for the medicine release kinetics in one embodiment discussed in the '760 Patent. '760 Patent, 14:53-15:20. Although the jury considered this Langer article in its determination of whether the '760 Patent is valid, the fact that the jury did not invalidate the patent based partially on this reference does not mean it is not material for purposes of inequitable conduct. Li Second Family Ltd. Partnership, 231 F.3d at 1380. Defendants have proven that the Langer references are material by clear and convincing evidence.
Although the Court concludes the Langer references are material, the Court concludes that Dr. Saffran did not withhold the Langer references with intent to deceive the PTO. Dr. Saffran could not have withheld the Langer references with intent to deceive because Dr. Saffran was not aware of those references until 2004, which was after the prosecution of the '760 Patent. Defendants have not proven by clear and convincing evidence that Dr. Saffran intended to deceive the PTO by withholding the Langer references. Therefore, the Court concludes that Dr. Saffran
The Court also concludes that Defendants have not proven by clear and convincing evidence that Dr. Saffran committed inequitable conduct towards the PTO by making statements in the '760 Patent such as "I have found." As noted above, inequitable conduct may be shown by clear and convincing evidence of the patent applicant's "affirmative misrepresentations of material facts, failure to disclose material information, or submission of false material information-coupled with an intent to deceive." Nilssen, 504 F.3d at 1229 (citations omitted).
The Court concludes that Dr. Saffran did not commit inequitable conduct by the mere fact that Dr. Saffran used the past tense in the '760 Patent. The Federal Circuit in Hoffmann-La Roche, Inc. v. Promega Corp., 323 F.3d 1354, 1367 (Fed. Cir.2003) held that the district court did not clearly err in considering the applicant's use of the past tense. The applicant in Hoffmann-La Roche used the past tense in reference with data results and particular experimental methods. See id. at 1363 ("The inventors state, for example, that a certain quantity of cells `were resuspended in 75 ml of a buffer,' that the cells `were lysed in a French press.'"). Further, in Hoffmann-La Roche, "[e]ach step of the example, over more than two columns of the patent, [was] described in the same fashion, using the past tense." Id. at 1363-64. In that case, the district court had found that the use of the past tense was an intentional misrepresentation because it was knowingly false. Id. at 1366-67. The Federal Circuit in Novo Nordisk Pharm., Inc. v. Bio-Tech. General Corp., 424 F.3d 1347, 1357-1363 (Fed.Cir.2005) also considered the use of past tense, but like Hoffmann-La Roche, the applicant also mentioned specific data and detailed experimental steps. One example in the patent in that case stated "that `[t]he fusion product was purified from this extract,' 1983 PCT application at 10 (emphasis added), that `[t]he purified fusion protein was evaluated to be more than 98% pure,' id. (emphasis added), and that `[t]his ... product was then treated with leucine aminopeptidase.' id. (emphasis added)." Id. at 1357. Unlike these cases, however, Dr. Saffran never provided a detailed experimental procedure and never presented any detailed numerical results upon which the examiners could have possibly relied when determining the patentability of the '760 patent and believed that the past tense may have been used for experiments that had not been physically performed. Therefore, Defendants have not proven with clear and convincing evidence that these alleged misrepresentations were material. Furthermore, the Court has found that Dr. Saffran, when making these statements, did not intend to imply that he had actually performed laboratory experiments that he did not or that he had made actual discoveries he did not. Therefore, the Defendants have not shown by clear and convincing evidence that the use of the past tense was with an intent to deceive. Hence, Dr. Saffran did not commit inequitable conduct by using the past tense in the '760 Patent.
The Court also concludes that Dr. Saffran did not commit inequitable conduct by virtue of using language such as "surprising," "unexpected," "I have found," or "I have discovered." First, the Court concludes that Defendants have failed to provide clear and convincing evidence of any
Id. Dr. Saffran's representations or omissions, however, did not rise to the level of those in Purdue Pharma. Dr. Saffran did not come close to suggesting the existence of clinical studies, and the Court has already found that he did not suggest he had performed laboratory experiments that he did not. Indeed, even with the facts as they were in Purdue Pharma., the Federal Circuit observed that "[w]hile we affirm the trial court's finding that Purdue's actions met a threshold level of materiality, we stress that the level of materiality [in the case of Purdue Pharma.] is not especially high." Id. Therefore, for the abovementioned reasons, the Court concludes that Defendants have failed to provide clear and convincing evidence that the use of language such as "surprising" met the burden for materiality.
Second, the Court concludes that Defendants have failed to provide clear and convincing evidence that Dr. Saffran had the requisite intent to deceive the PTO when using language such as "surprising." As noted in the Court's factual findings above, Dr. Saffran was not intending to deceive the PTO into believing he had actually performed laboratory experiments or made actual discoveries that he did not. And Dr. Saffran was not intending to deceive the PTO by misleading the PTO regarding the importance of his invention. The most that may have been shown by the evidence is that Dr. Saffran was excited about the invention of the '760 Patent and consequently used language such as "surprisingly" or "remarkable" to emphasize his excitement to the PTO. In prosecuting his patent pro se, he even used exclamation marks. The Court concludes that such evidence is not clear and convincing evidence that Dr. Saffran had the requisite intent to deceive. Therefore, the Court concludes Dr. Saffran did not commit inequitable conduct by using language such as "surprising," "unexpected," or "I have found."
Having found that Defendants have not met their burden of proving inequitable conduct by clear and convincing evidence, the Court concludes that Dr. Saffran did not commit inequitable conduct toward the PTO. The Court therefore finds that the '760 patent is not unenforceable and DENIES
IT IS SO ORDERED.