Braintree Laboratories, Inc. v. Novel Laboratories, Inc.

Docket No. 2013-1438

April 22, 2014

Brief Summary: DC claim construction reversed and infringement finding remanded. Preamble term “a patient” considered limitation. Braintree’s patent found not anticipated, obvious or indefinite. Judge Dyk and Judge Moore separately dissented in part for different reasons.

Summary: Novel appealed grant of SJ to Braintree that its US 6,946,149 is infringed by Novel’s ANDA relating to the SUPREP® Bowel Prep Kit based on the construction of four claim terms and the patent is not invalid. Novel argued that the terms “purgation” (claims require “inducing purgation”) and “clinically significant electrolyte shifts” were incorrectly construed and the asserted claims were anticipated, obvious and indefinite. The DC disagreed with Novel that “purgation” means “cleansing” and, under that definition, SUPREP cannot infringe “because a full cleansing only occurs after ingesting 946 mL of solution (i.e., two doses)” (“inducing purgation” in the claims requires “about 100 ml to about 500 ml”). The FC panel concluded that “[t]he asserted claims here only require that the compositions ‘induce’ (i.e., bring about or start) diarrhea” and do not require “a fully cleansed colon” (“while cleansing is a goal specifically articulated in the specification, it is not a claim requirement”). The term “effective amount” was determined to “only require[] purgation and not a full cleansing” and specification to contemplate a fully cleansing “only in terms of a preferred embodiment” (Enzo, FC 2010 (“[I]t is improper to read limitations from a preferred embodiment described in the specification-even if it is the only embodiment-into the claim absent a clear indication in the intrinsic record that the patentee intended the claims to be so limited.”)). The DC’s construction of “clinically significant electrolyte shifts” was reversed because it was not supported by “the clear language found in the specification” (“[a] claim construction that excludes the preferred embodiment ‘is rarely, if even, correct and would require highly persuasive evidentiary support” (Adams Respiratory Therapeutics, FC 2010); “the patentee’s lexicography must govern the claim construction analysis” (Phillips, FC 2005)). The DC also found the preamble term “a patient” to mean “one or more patients” which Novel argued “limits the utility of the claimed compositions to administration in a single patient”. The FC noted this definition “would allow a composition to meet the claims even if 99 patients out of 100 experienced clinically significant electrolyte shifts, as long as one patient did not” and instead concluded “‘a patient’ to mean the general class of persons to whom the patented compositions are directed, i.e., a patient population”, “consistent with the ‘invention the patentee intended to define and protect” (Rowe, FC 1997). Because “there is evidence in the record that at least some patients experienced alterations in blood chemistry that are outside the normal upper or lower limits of their normal range”, the FC concluded “there remains a genuine dispute as to whether SUPREP avoids producing any clinically significant electrolyte shifts in a patient population” and vacated the DC finding of infringement. The FC disagreed that Novel’s alleged prior art anticipated the claims, in part because of a teaching away. Regarding obviousness, the FC panel agreed with the DC that “Novel did not prove that one of skill in the art would have been motivated to combine so many references” (“failed to prove a ‘plausible rational[e] as to why the prior art references would have worked together’” (Power-One, FC 2010)) and that Novel’s expert testimony was not credible. And the FC was not persuaded by Novel’s argument that the term “copious”, used in the DC construction of the “purgation” but not in the claims, is indefinite because “[d]escriptive words like ‘copious’ are commonly used in patent claims, to ‘avoid[] a strict numerical boundary to the specified parameter’” (Pall Corp., FC 1995). Judge Dyk’s dissent argued that Novel’s ANDA does not infringe because it does not meet the volume limitations of the claims (“about 100 ml to about 500 ml”) because Novel’s ANDA dose is 946 ml (citing Allergan, FC 2003) (“just because a patient could ingest only one bottle of Novel’s generic to achieve a purgation does not make Novel’s ANDA infringing”). Judge Moore’s dissent argued that the construction of the preamble term “a patient” was incorrect because “[w]e have repeatedly held that ‘a,’ when used in a ‘comprising’ claim, means one or more”, “[t]he exceptions to this rule [being] extremely limited” (“a patentee must evince a clear intent to limit ‘a’ or ‘an’ to ‘one’” (01 Communique Lab., FC 2012)). It pointed out that it may be difficult to determine “[w]hat percentage of people constitutes a patient population?…99.5%? A majority?” And, as this is an ANDA case, “the generic can’t launch without FDA approval” and “the statute creates a de facto injunction”. However, Jude Moore wrote that the claim language cannot be rewritten “to avoid this outcome” (citing Chef Am., FC 2004 (“[W]e construe the claim as written….”).

This entry was posted in Anticipation (35 USC 102), Claim Construction, Generics / ANDA, Infringement, Obviousness. Bookmark the permalink.

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