Case: Purdue Pharma L.P. v. Endo Pharmaceuticals, Inc., No. 04-1189, -1347, -1357 (Fed. Cir. 2/1/06)The Two Sentence Summary: After a rehearing, the panel vacated its earlier decision (see blog posting
here), and held that Purdue withheld material information from the PTO by implying the existence of clinical data supporting its claim, but that the intent to deceive prong of the inequitable conduct analysis should be reconsidered by the trial court because the failure to disclose was not highly material. The panel also found that the trial court erred in limiting the claims by importing a dosage limitation from the prosecution history.
What They Were Fighting About: After a bench trial, the trial court invalidated Purdue's patent for Oxycontin, finding that Purdue committed inequitable conduct by implying that it had clinical data supporting its discovery of a four-fold dosage range for oxycodone. The trial court also held that if the claims were valid, the generic product manufactured by defendant Endo infringed. In a June 2005 decision, the panel had affirmed the trial court's finding of invalidity due to inequitable conduct.
Federal Circuit Holdings:
- The panel summarized the law regarding inequitable conduct as follows: "Applicants for patents have a duty to prosecute patents in the PTO with candor and good faith, including a duty to disclose information known to the applicants to be material to patentability. 37 C.F.R. § 1.56(a) (2004); see also Molins PLC v. Textron, Inc., 48 F.3d 1172, 1178 (Fed. Cir. 1995). A breach of this duty may constitute inequitable conduct, which can arise from an affirmative misrepresentation of a material fact, failure to disclose material information, or submission of false material information, coupled with an intent to deceive or mislead the PTO. Molins, 48 F.3d at 1178. A party asserting that a patent is unenforceable due to inequitable conduct must prove materiality and intent by clear and convincing evidence. Kingsdown Med. Consultants, Ltd. v. Hollister, Inc., 863 F.2d 867, 872 (Fed. Cir. 1988). Once threshold findings of materiality and intent are established, the trial court must weigh them to determine whether the equities warrant a conclusion that inequitable conduct occurred. Molins, 48 F.3d at 1178. This requires a careful balancing: when the misrepresentation or withheld information is highly material, a lesser quantum of proof is needed to establish the requisite intent. See N.V. Akzo v. E.I. DuPont de Nemours, 810 F.2d 1148, 1153 (Fed. Cir. 1987). In contrast, the less material the information, the greater the proof must be. See id."
- The trial court's factual findings regarding inequitable conduct are reviewed with deference.
- Because the patents at issue were pending on or filed after the March 16, 1992 amendment of PTO Rule 56 regarding materiality, the post-amendment version of the rule governs (although the amendment did not constitute a significant substantive change to the pre-1992 standard). Under Rule 56, information is material to patentability if: [I]t is not cumulative to information already of record or being made of record in the application, and (1) It establishes, by itself or in combination with other information, a prima facie case of unpatentability of a claim; or (2) It refutes, or is inconsistent with, a position the applicant takes in: (i) Opposing an argument of unpatentability relied on by the Office, or (ii) Asserting an argument of patentability. 37 C.F.R. § 1.56(b) (2004).
- The trial court's finding that Purdue failed to disclose material information was not clearly erroneous. Purdue's representations to the PTO allowed a clear inference that it had clinical proof of an improved dosage range when in fact Purdue did not have supporting clinical data but only an inventor's "insight." An express misrepresentation by Purdue was not necessary to a finding of failure to disclose.
- It was not necessary to show that the examiner relied upon Purdue's claims of an improved dosage range. Purdue's claim of a discovery of an improved dosage range was central to its claims of patentability and to oppose the examiner's arguments of unpatentability.
- Even if the dosage range was not a limitation of the patent claims, the information would be material because the trial court made an express finding, and materiality is not limited to matters reflected in the claims of a patent.
- The dosage range information withheld by Purdue was not mere advocacy of advantages of the invention. Rather, Purdue consistently and repeatedly used the dosage range to distinguish prior art.
- A discovery can be based on insight rather than clinical evidence, but that did not excuse Purdue for implying, if not suggesting, that clinical evidence existed when it did not.
- Purdue's failure was not highly material. An affirmative misrepresentation would have been more material.
- The panel summarized the law regarding intent to deceive as follows: "Direct evidence of intent to deceive or mislead the PTO is “‘rarely available but may be inferred from clear and convincing evidence of the surrounding circumstances.’” Baxter Int’l, Inc. v. McGaw, Inc., 149 F.3d 1321, 1329 (Fed. Cir. 1998) (quoting LaBounty Mfg., Inc. v. USITC, 958 F.2d 1066, 1076 (Fed. Cir. 1992)). Intent to deceive, however, cannot be “inferred solely from the fact that information was not disclosed; there must be a factual basis for a finding of deceptive intent.” Hebert v. Lisle Corp, 99 F.3d 1109, 1116 (Fed. Cir. 1996). When determining whether intent has been shown, a court must weigh all evidence, including evidence of good faith. Baxter, 149 F.3d at 1330. This court has held that “a patentee facing a high level of materiality and clear proof that it knew or should have known of that materiality, can expect to find it difficult to establish ‘subjective good faith’ sufficient to prevent the drawing of an inference of intent to mislead.” Critikon, Inc. v. Becton Dickinson Vascular Access, Inc., 120 F.3d 1253, 1257 (Fed. Cir. 1997). Nevertheless, it is important to remember that “‘materiality does not presume intent, which is a separate and essential component of inequitable conduct.’” Allen Eng’g Corp. v. Bartell Indus., Inc., 299 F.3d 1336, 1352 (Fed. Cir. 2002) (quoting Allen Organ Co. v. Kimball Int’l, Inc., 839 F.2d 1556, 1567 (Fed. Cir. 1988))."
- The trial court erred in analyzing intent. First, it gave too much weight to internal Purdue documents regarding the difficulty of proving to the FDA that its dosage range was the most efficient. The FDA approval was subject to a different standard than the patentability issues, so the FDA documents were only marginally related.
- The trial court improperly found that Purdue failed to disclose highly material information. Thus, there was less basis for the trial court to infer intent to deceive because the information withheld was less material.
- The panel remanded for the trial court to reconsider its inequitable conduct finding in light of the decision.
- The panel upheld the trial court's finding of infringement by Endo's product.
- The trial court held that the claims required acceptable pain control for 90% of patients over a four-fold dosage range because the invention itself required this rather than any express claim limitation. This finding was in error.
- The panel considered whether the term "controlled release" was limited to a four-fold dosage range. The term was not limited by the claims or the specification. However, the panel noted that the claim could be limted by the prosecution history: "Next we look to the prosecution history to determine whether it contains statements that narrow the scope of the claims. Id. at 1317. Under the doctrine of prosecution disclaimer, a patentee may limit the meaning of a claim term by making a clear and unmistakable disavowal of scope during prosecution. See Seachange Int’l, Inc. v. C-COR Inc., 413 F.3d 1361, 1372-73 (Fed. Cir. 2005); Omega Eng’g, Inc. v. Raytek Corp., 334 F.3d 1314, 1323-26 (Fed. Cir. 2003). This may occur, for example, when the patentee explicitly characterizes an aspect of his invention in a specific manner to overcome prior art. See Microsoft Corp. v. Multi-Tech Sys., Inc., 357 F.3d 1340, 1349 (Fed. Cir. 2004) (interpreting “sending,” “transmitting,” and “receiving” limitations as requiring direct transmission over telephone line when patentee stated that invention transmits over a standard telephone line, thus disclaiming transmission over a packet-switched network)."
- The trial court erred in finding that "during prosecution Purdue deliberately and clearly relinquished, disclaimed and surrendered" scope of its claims. Although Purdue relied on the four-fold dosage range to distinguish its formulations from prior art, it did not describe the range as a necessary feature of the claimed formulations, but rather as a property of or result of administering the dosage. The claim language contained no limitations, and importing extraneous limitations from the prosecution history was improper.
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