07/31/2014

Braintree Lab. v. Novel Lab.: Federal Circuit Reverses District Court's Summary Judgment Ruling on Infringement of Colonscopy Drug


 
 
 
 By: Roy Rabindranath, Contributor
 
TitleBraintree Lab., Inc. v. Novel Lab., Inc. (Fed. Circ. April 22, 2014).
Issues
[1] [Whether the district court erred in construing the limitations of U.S. Patent 6,946,149 (a)] "purgation" to mean "an evacuation of a copious amount of stool from the bowels after oral administration of the solution [....and (b)] "clinically significant electrolyte shifts" to require "alterations in blood chemistry that are outside the normal upper or lower limits of their normal range and other untoward effects.
Braintree Lab., at *5, 8 (text added, internal citations omitted).
[2] [Whether] the district court's grant of summary judgment of infringement [, based on the above claim construction, in favor of Braintree was erroneous].
Id. at *12 (text added).
[3] [Whether] the district court [erred in finding] that [the] Hechtor [reference] does not anticipate the asserted claims of the '149 patent....[and] in finding that Novel failed to demonstrate that the asserted claims of the '149 patent would have been obvious at the time of the invention.
Id. at *14, 16 (text added).
Holdings
[1(a)] In construing claim terms, the analytical focus must begin and remain centered on the language of the claims themselves, for it is that language that the patentee chose to use to "particularly point out and distinctly claim the subject matter which the patentee regards as his invention." The asserted claims here only require that the compositions "induce" (i.e., bring about or start) diarrhea. The claims do not contain language that requires achieving a fully cleansed colon for a colonoscopy. Thus, while cleansing the goal specifically articulated in the composition, it is not a claim requirement.
Braintree Lab., at *6-7 (text added, internal citations omitted).
[1(b)] Under our precedent, the patentee's lexicography must govern the claim construction analysis. We reverse the district court's claim construction and construe "clinically significant electrolyte shifts" to be "alterations in blood chemistry that are outside the normal upper or lower limits of their normal range or other untoward effects.
Id. at *9 (text added, internal citations omitted).
[2] [We] conclude that there remains a genuine dispute as to whether SUPREP avoids producing any clinically signficant electrolyte shifts in a patient populuation. We vacate the district court's grant of summary judgment of infringement, and we remand this matter to the district court for further factual findings concerning whether such alterations qualify as "clinically significant electrolyte shifts" in accordance with the proper claim construciton articulated here within.
Id. at *12 (text added).
[3] "Novel 'did not show proof that met the clear and convincing standard' that the asserted claims were ancticipated by the Hechter [reference]." Id. at *13 (text added, internal citations omitted). "[Moreover, as] the district court correctly noted, Novel did not prove that one of skill in the art would have been motiviated to combine [16] references. In other words, it failed to prove a 'plausible rationale as to why the prior art references would have worked together.'" Id. at *15-16 (text added).   

 

Procedural HistoryThis is a patent infringement case under the Hatch-Waxman Act. Defendant Appellant Novel Laboratories, Inc. ("Novel") appeals the grant of summary judgment by the United States District Court for the District of New Jersey that U.S. Patent No. 6,946,149 ("149 patent") held by Braintree Laboratories, Inc. ("Braintree") is infringed by the composition covered by Novel's abbreviated new drug application ("ANDA"). The district court entered summary judgment of infringement based on its construction of four disputed claim terms. Novel challenges the district court's claim construction for two of those terms. Following a six-day bench trial on Novel's invalidty defenses, the district [court] found that Novel failed to prove that the asserted claims were invalid. Novel also appeals those findings.
Braintree Lab., at *2 (text added, internal citations omitted). 
 
 
Legal Reasoning (Prost)
Background
Representative ClaimClaim 15 which the parties agree is representative, recites:

A composition for inducing purgation of the colon of a patient, the composition comprising from about 100 mL to about 500 mL of an aqueous hypertonic solution comprising an effective amount of Na2SO4, an effective amount of MgSO4, and an effective amout of K2SO4, wherein the composition does not produce any clinically significant electrolyte shifts and does not include phosphate.

Braintree Lab., at *3.
[1] Claim Construction
Standard of ReviewClaim construction is a question of law, that we review de novo without deference.
Braintree Lab., at *5 (internal citations omitted).
"Purgation"
On appeal, the parties dispute the construction of the claim term "purgation" because the asserted claims cover compositions "comprising from about 100 mL to about 500 mL of an aqueous hypertonic solution." Braintree sells SUPREP in a kit containing two six-ounce bottles of concentrated solution, along with a dilution cup. A patient must dilute each of the two six-ounce bottles with ten ounces of water to form two sixteen-ounce solutions. Each of those half-those sixteen ounce solutions as a total volume of 473 mL, which is within the range found in the asserted claims of the '149 patent, but Braintree concedes that neither dose accomplishes a full cleansing. Thus, Braintree's "one bottle" infringement theory asserts that one (half-dose) bottle of SUPREP diluted with water to become a sixteen ounce solution, falls within the asserted claims. This infringement theory can prevail if purgation means the "evacuation of a copious amount of stool from the bowels after oral administration of the solution," which is something less than a full cleansing.
Id. at *5 (internal citations omitted).
Novel argues that SUPREP does not infringe the asserted claims if "purgation" means cleansing, because a full cleansing only occurs after ingesting 946 mL of solution (i.e., two doses). Pointing to the specification, Novel alleges that the physiological event that the inventor contemplated was cleansing the colon for a colonscopy. [...] Thus, Novel argues that an effective amount of solution must cleanse the colon.
Id. at *6 (text added, internal citations omitted).
The asserted claims here only require that the compositions "induce" (i.e., bring about or start) diarrhea. The claims do not contain language that requries achieving a fully cleansed colon for a colonoscopy. Thus, while cleansing is the goal specifically articulated in the specification, it is not a claim requirement.
Id. at *7 (internal citations omitted).
"Clinically Significant Electrolyte Shifts"On appeal, Novel argues that in requiring both alternations in blood chemistry and other untoward effects [in the claim construction of "clinically significant electrolyte shifts",] the district court ignored the inventor's clear definition of the term [...] in the specification. [...] Under our precedent, the patentee's lexicography must govern the claim construction analysis. Therefore, we disagree with the district court's modification of the clear language found in the specification.
Id. at *9 (text added, internal citations omitted).
[2] Infringement
Standard of ReviewWe review the grant of summary judgment under the law of the regional circuit. The Third Circuit reviews the grant of summary judgment de novo. Summary judgment is appropriate if the movant "shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law."
Braintree Lab., at *10 (internal citations omitted).
Analysis
Based on its construction of "purgation," which does not require a full cleanse, the district court found that one bottle of SUPREP meets the "purgation" claim limitation, as it will induce an evacuation of a copious amount of stool from the bowels and is a composition comprising 473 mL of an aqueous hypertonic solution. We affirm the district court's construction of this term, and we likewise affirm the district court's finding that one (half-dose) bottle of SUPREP practices this claim limitation.
Id. at *10 (internal citations omitted).
The district court also found that SUPREP practices the "wherein the composition does not produce any clinically significant electrolyte shifts" limitation. It based its conclusion not only on its erroneous construction of the term "clinically significant electrolyte shifts" but also on its importation of the claim terms "a patient" [from the preamble] into this limitation. [...] It defined "a patient" to mean "one or more patients." It then found that "at least one patient to whom SUPREP is administered will experience, or has experienced, no clinically significant electrolyte shifts." [...] We agree with Novel and conclude that, in this case, the district court's definition of "a patient" is incorrect. In view of the proper claim construction of "clinically significant electrolyte shifts," the district court's application of the claim terms "a patient" leads to the absurd result of infringement even if a composition causes clinically signficant electrolyte shifts in a large percentage of patients. Therefore, we instead interpret "a patient" to mean the general class of persons to whom the patented compositions are directed, i.e., a patient population.
Id. at *10, 13 (text added, internal citations omitted).
[3] Invalidity
Standard of ReviewInvalidity must be proven by clear and convincing evidence.
Braintree Lab. at *12.
Anticipation by HechterHechter teaches first mixing 60 grams of a dry powder composition with one-liter of water and then later adding three additional liters of water prior to administration. [...] After reviewing Hechter and the '149 patent's prosecution history, we conclude that Novel's argument is flawed for at least three reasons. First, Hechter does not disclose administrating this initial one-liter solution to a patient. [...] Second, although theoretically the initial one-liter solution described in Hechter could be hypertonic in a ptient, both parties' experts agreed that the only way to know whether Hechter's initial mixing solution was hypertonic would be to test it. But Novel has no evidence to suggest that the initial mixture in Hechter has been tested in a patient population, let alone that it was found to be hypertonic. [...] Third, Hechter actually teaches away from administering a hypertonic solution, stating that its solution needs to be isotonic in order to avoid clinically significant electrolyte shifts.
Id. at *13-14 (text added, internal citations omitted).
ObviousnessThe district court found that Novel, which relied on sixteen prior art references, failed to prove obviousness by clear and convincing evidence. [...] As the district court correctly noted, Novel did not prove that one of skill in the art would have been motivated to combine so many references.
Id. at *14-15 (text added, internal citation omitted).
Conclusion
Because we agree with Novel that the district court erred in its construction of the claim term "clinically significant electrolyte shifts," we reverse the district court's claim construction of the that term, vacate the district court's grant of summary judgment of infringement, and remand for further factual findings to determine whether the composition covered by Novel's ANDA product infringes under the new claim construction articulated herein. Further, we affirm the district court's findings that the asserted claims of the '149 patent are not invalid.
Braintree Lab., at *2-3. 
 
 
 
DYK, Circuit Judge, concurring in part, dissenting in part, and concurring in the result. Braintree Lab., J. Dyk Op., at *1.
I agree with Judge Prost that the district court erred in its construction of "clinically significant electrolyte shifts" and that the correct construction of that term is "alterations in blood chemistry that are outside the normal upper or lower limits of their normal range or other untoward effects." [...] However, I respectfully dissent from the majority's conclusion that Novel's [accused product] meets the volume limitation of the asserted claims. Under the proper interpretation of the volume limitation, Novel established non-infringement as a matter of law. In my view, the majority's contrary conclusion is inconsistent with established authority under the Hatch-Waxman Act.
Braintree Lab., J. Dyk Op., at *1-2.  
 
 
 
MOORE, Circuit Judge, dissenting. Braintree Lab., J. Moore Op., at *1 (text added).
[...] I disagree with the majority's construction of "a patient." I agree with the district court that "a patient" means "one or more patients" in accordance with the plain language of the asserted claims and with our precedent. I would affirm the district court's summary judgment of infringement because undisputed evidence shows that at least one patient who was treated with the accused composition has experienced "clinically significant electrolyte shifts" within the meaning of the claims. Therefore, I respectfully dissent.
Braintree Lab., J. Moore Op., at *1 (text added). 
 
 
 
© 2000-2019, Journal of the Patent & Trademark Office Society
Disclaimer & Privacy Policy