Definiteness Does Require the Ability to Determine Infringement in Advance; Merely the Ability to Determine What the Claim Means

Star Scientific, Inc., v. R.J. Reynolds Tobacco Company [2007-1448] (August 25, 2008) [MICHEL, Schall, Dyk] The Federal Circuit reversed judgment that Star's U.S. Patent Nos. 6,202,649 and 6,425,401 were unenforceable due to inequitable conduct; and granting summary judgment of invalidity of all asserted claims due to indefiniteness.
DISCUSSION: The Federal Circuit reviews the district court's inequitable conduct determination under a two-tier standard; the underlying factual determinations are reviewed for clear error, the ultimate decision as to inequitable conduct is reviewed for an abuse of discretion. With respect to the '649 patent the Federal Circuit held that the district court clearly erred in finding that plaintiff had an intent to deceive the PTO, and with respect to the '401 patent, the Federal Circuit held that the district court clearly erred in finding that the information contained in the Burton letter and Curran data was material. The Federal Circuit said that the need to strictly enforce the burden of proof and elevated standard of proof in the inequitable conduct context is paramount because the penalty for inequitable conduct is so severe, the loss of the entire patent even where every claim clearly meets every requirement of patentability. The Federal Circuit said that just as it is inequitable to permit a patentee who obtained his patent through deliberate misrepresentations or omissions of material information to enforce the patent against others, it is also inequitable to strike down an entire patent where the patentee only committed minor missteps or acted with minimal culpability or in good faith. As a result, courts must ensure that an accused infringer asserting inequitable conduct has met his burden on materiality and deceptive intent with clear and convincing evidence before exercising its discretion on whether to render a patent unenforceable.
With regard to the deceptive intent prong, the Federal Circuit has emphasized that "materiality does not presume intent, which is a separate and essential component of inequitable conduct." Because direct evidence of deceptive intent is rarely available, intent can be inferred from indirect and circumstantial evidence, but it must still be clear and convincing, and inferences drawn from lesser evidence cannot satisfy the deceptive intent requirement.
With regard to the materiality prong, the Federal Circuit has held that "information is material when a reasonable examiner would consider it important in deciding whether to allow the application to issue as a patent." But information is not material if it is cumulative of other information already disclosed to the PTO. If a threshold level of intent to deceive or materiality is not established by clear and convincing evidence, the district court does not have any discretion to exercise and cannot hold the patent unenforceable regardless of the relative equities or how it might balance them. The district court held that the term "anaerobic condition" is indefinite and thus, since it appears in every asserted independent claim, held that all asserted claims are invalid as indefinite. The Federal Circuit noted that "[o]nly claims not amenable to construction or insolubly ambiguous are indefinite." A claim term is not indefinite just because "it poses a difficult issue of claim construction" the standard is whether "the claims [are] amenable to construction, however difficult that task may be." The Federal Circuit said that by finding claims indefinite only if reasonable efforts at claim construction prove futile, we accord respect to the statutory presumption of patent validity . . . ." The Federal Circuit held that from the claim term "anaerobic condition" and the intrinsic record, a skilled artisan would discern what the term delineates, and further found that this is further supported by statements to that effect in the patents' specifications.
The Federal Circuit noted that when a word of degree is used the patent's specification must provide some standard for measuring that degree to be definite. The Federal Circuit said that "anaerobic condition" is in effect a term of degree because its bounds depend on the degree of oxygen deficiency, however the Federal Circuit found that the intrinsic record provides a standard for measuring that degree and assessing the bounds of "anaerobic condition." In fact, the Federal Circuited noted, some of the claims explicitly refer to the standard. According to the Federal Circuit, the error the district court made was its misunderstanding that claim definiteness required that a potential infringer be able to determine if a process infringes before practicing the claimed process. "The test for indefiniteness does not depend on a potential infringer's ability to ascertain the nature of its own accused product to determine infringement, but instead on whether the claim delineates to a skilled artisan the bounds of the invention."