Braintree Laboratories Inc. v. Breckenridge Pharmaceutical, Inc.

Citations: 170 F. Supp. 3d 555; 2016 WL 1070844; 2016 U.S. Dist. LEXIS 33336Docket: 12-CV-6851 (AJN)

Court: District Court, S.D. New York; March 15, 2016; Federal District Court

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Braintree Laboratories, Inc. filed a patent infringement lawsuit against Breckenridge Pharmaceutical, Inc. on September 11, 2012, concerning Breckenridge's attempt to obtain FDA approval for a generic version of Braintree's colon cleansing solution, SUPREP. Breckenridge filed a motion for summary judgment of non-infringement on July 6, 2015, which was granted by the court.

The case centers on U.S. Patent No. 6,946,149 (the ’149 Patent), issued in September 2005, which covers a composition and methods for colonic lavage. Claim 15 of the patent outlines a composition for inducing purgation that includes specific amounts of sodium, magnesium, and potassium sulfate, while ensuring no clinically significant electrolyte shifts occur and excluding phosphate. Claim 23 describes a method for administering this composition in multiple doses.

Braintree's patent was justified by highlighting issues with existing colonic lavage methods: traditional methods required large volumes of solution that patients found intolerable, while newer methods, though requiring smaller volumes, led to significant bodily chemistry disturbances. Braintree's SUPREP is an osmotic laxative approved for colon cleansing before a colonoscopy, sold as a kit consisting of two 6-ounce bottles of solution, each to be diluted to 473 mL. 

Breckenridge’s Generic Product aims to replicate SUPREP’s formulation and administration method through the Abbreviated New Drug Application (ANDA) process, ensuring identical ingredients and dosage instructions if approved.

Drinking a diluted bottle of the Generic Product, similar to SUPREP, results in 'copious, watery diarrhea.' In 2011, Braintree filed a lawsuit against Novel Laboratories in the District of New Jersey over a generic version of SUPREP. The court ruled that Novel's product, identical to SUPREP, infringed Braintree's patent, leading to a summary judgment in Braintree's favor, which Novel appealed. The Federal Circuit affirmed some aspects of the district court's decision, while remanding others. In 2012, Braintree initiated a suit against Breckenridge, claiming its Generic Product infringed the ’149 Patent. Breckenridge accepted the district court's interpretation of 'purgation' from the Novel case, defined as a significant evacuation of stool following oral administration of the solution. Breckenridge agreed to limit its arguments regarding the ’149 Patent and filed a motion for summary judgment of non-infringement in July 2013, which was administratively denied pending the Novel case's appeal. After the stay was lifted in June 2015, Breckenridge refilled its motion in July 2015. The legal standard for infringement, under 35 U.S.C. 271(e)(2)(A), indicates that submitting an ANDA for a patented drug constitutes infringement, focusing on what the applicant intends to market. Additionally, Section 271(b) states that inducing infringement, such as encouraging prescriptions of a product, also results in liability. The infringement analysis involves construing patent claims and comparing them with the accused product.

To prove patent infringement, a plaintiff must show, by a preponderance of the evidence, that the accused device meets all limitations of the asserted patent claims. Literal infringement occurs only when each limitation is present; absence of any limitation means there is no infringement. In summary judgment motions, the court must view evidence favorably for the non-moving party, and the moving party must establish that no genuine dispute exists over any material fact. Breckenridge claims that its Generic Product does not infringe the '149 Patent because it exceeds the specified volume limitation of 'from about 100 mL to about 500 mL' by containing 946 mL of solution. Breckenridge also argues that the Generic Product does not violate 271(e)(2) as the patent does not cover its FDA-approved use. Braintree counters that Breckenridge's arguments are barred by the Federal Circuit's Novel II decision and involve claim construction, which the parties agreed not to address. Braintree contends that the Generic Product does satisfy the volume limitation and violates 271(e)(2). The court will explore these arguments, noting that the '149 Patent has four limitations, one of which is the volume requirement. In the Novel litigation, Braintree proposed a 'one bottle' theory, asserting that each diluted bottle of the Generic Product independently infringes the patent, necessitating proof that each bottle meets all claim limitations. The district court previously found that one bottle of the Generic Product did infringe all limitations.

Novel did not appeal the district court’s findings on each limitation of the patent but focused on the construction of the terms 'purgation' and 'clinically significant electrolyte shifts.' On the purgation issue, Novel contended that 'purgation' equated to 'cleansing,' asserting that a single bottle of the Generic Product was inadequate to meet the purgation limitation, which necessitated two bottles. However, the Federal Circuit upheld the district court’s interpretation of purgation as 'an evacuation of a copious amount of stool,' rather than full cleansing. The majority did not consider whether one bottle of SUPREP met the patent's volume limitation, as Novel did not appeal that decision.

Braintree noted that arguments from Breckenridge were not raised by Novel on appeal and were therefore waived. Novel also did not appeal the district court's dismissal of the 100 mL to 500 mL noninfringement argument, instead contesting the infringement finding on other grounds. Although Novel attempted to introduce an 'unapproved use' argument, it was not included in its briefs, leading to its waiver.

Braintree highlighted that some arguments advanced by Breckenridge were raised by Judge Dyk in a dissenting opinion, but the majority did not address these, suggesting that they were implicitly rejected. The Federal Circuit can choose to consider unraised arguments but is not obligated to do so. Braintree asserts that the majority's inaction does not equate to a substantive rejection of Breckenridge’s arguments.

Additionally, Breckenridge’s non-infringement argument is not barred by its stipulation, which limited defenses to the 'from about 100 mL to about 500 mL' limitation and accepted the claim construction of 'purgation' from the Novel case. Braintree contends that Breckenridge's motion improperly reargues claim construction, despite the stipulation that no claim construction was necessary.

Braintree misrepresents Breckenridge's statements made during the pre-motion conference, where Breckenridge suggested that if the term "purgation" required construction, they would likely lose the case. The Court will adopt the Novel I interpretation of "purgation," which was later confirmed in Novel II, negating the need for Braintree's motion to be resolved in its favor on this basis. Additionally, the stipulation does not state that "no claim construction is required." Instead, it specifies that Breckenridge will only contest non-infringement based on the volume limitation of "from about 100 mL to about 500 mL." Breckenridge's defense hinges on the argument that the Generic Product exceeds this volume limit, specifically citing that their product contains 946 milliliters. Braintree's objections focus on Breckenridge's interpretation of the volume limit, which they fear indirectly challenges the construction of "purgation." The Court recognizes that both parties intended to address the volume limitation in their arguments.

Breckenridge asserts that the Generic Product does not infringe the ’149 Patent due to its volume exceeding the specified range. The Court will evaluate Breckenridge's non-infringement claims, which will be addressed in two parts: first, the composition claims, where Breckenridge argues that the Generic Product does not meet the volume limitation; and second, the method claims, where they contend that the method of use for the Generic Product differs from that claimed in the patent, thus falling outside of infringement under 271(e)(2). Braintree claims that the Generic Product does infringe the composition claims 15 and 18 of the ’149 Patent, arguing that a single diluted bottle of the Generic Solution, which is 473 mL, falls within the specified volume range.

Braintree contends that the phrase 'from about 100 mL to about 500 mL' modifies the purgation limitation, indicating it pertains to the amount of solution needed to induce purgation. In contrast, Breckenridge asserts that this limitation refers to the total volume of solution administered during the treatment period, which totals 946 mL. The district court in Novel I sided with Braintree's interpretation without extensive justification. However, the current Court favors Breckenridge’s interpretation. The construction of patent claims is a legal question, evaluated through the perspective of a person skilled in the field, utilizing the patent specification and prosecution history. The specification of the ’149 Patent indicates that the 'from about 100 mL to about 500 mL' limitation corresponds to the entire volume administered rather than a single bottle or half-dose, supported by experimental data showing total volume measurements. Additionally, Braintree’s prosecution history reinforces this view, as it contrasts the claimed volume with larger volumes from other colonic lavage products, indicating that 'from about 100 mL to about 500 mL' refers to the cumulative solution given to a patient across the treatment period.

The Generic Product, with a volume of 946 mL, does not meet the volume requirement and therefore does not infringe the composition claims of the ’149 Patent. The parties concur that the independent claims of the T49 Patent are claims 1, 2, 15, and 18, which are all composition claims, thereby establishing that method claims 19, 20, and 23 are dependent on these composition claims. Since the Generic Product does not infringe the independent composition claims of the ’149 Patent, it cannot infringe the dependent method claims of the T49 Patent, as established in prior case law.

Braintree alleges that the Generic Product induces infringement of method claims 19, 20, and 23 of the ’149 Patent. Breckenridge counters that the Generic Product does not infringe these claims because it has FDA approval for a use not covered by the patent. The Federal Circuit has ruled that a method of use patent holder cannot sue an ANDA applicant for induced infringement if the applicant seeks FDA approval for a use not claimed in the patent. The FDA approval process confirms whether a drug is safe and effective for the use described in its labeling.

The ANDA indicates that the Generic Product is FDA-approved for colon cleansing in adults, which Breckenridge argues is not the same as the method claimed in the patent for inducing purgation. Braintree asserts that using the Generic Product for purgation is not an off-label use but a necessary mechanism for cleansing. The Court will analyze claims 19 and 20 separately from claim 23. Notably, the Federal Circuit has differentiated "purgation," defined as a substantial evacuation of stool, from "full cleansing" necessary for colonoscopy preparation, which is pivotal for Braintree's infringement claim regarding the purgation limitation of the ’149 Patent.

The one-bottle infringement theory hinges on the distinction between 'purgation' and 'cleansing.' Braintree asserts that 'purgation' serves merely as a means to achieve colon cleansing; however, the FDA-approved indication for the Generic Product is for 'cleansing of the colon as a preparation for colonoscopy in adults.' Claims 19 and 20 specifically describe a method for inducing colonic purgation, which Braintree argues is not an unapproved use. They attempt to draw an analogy to asthma medication, suggesting that reducing airway inflammation (the mechanism) is not an unapproved use if it results in improved breathing (the goal). However, this analogy fails due to the Federal Circuit’s definition of 'purgation' as the evacuation of a large volume of stool, contrasted with 'cleansing' as achieving full preparation for a colonoscopy. The Federal Circuit has clarified that purgation is quantitatively less than full cleansing, allowing for purgation to occur without achieving the complete cleansing required for medical procedures. Thus, purgation is positioned as a separate treatment goal, distinct from colon cleansing, undermining Braintree’s argument that purgation is simply a method to achieve cleansing.

Braintree has established a distinction between purgation and cleansing regarding its one-bottle infringement theory and cannot now equate purgation with cleansing in the context of the method claims of the ’149 Patent. The method of inducing purgation, which does not achieve a fully-cleansed colon for a colonoscopy, is not an FDA-approved use of the Generic Product, thus it does not induce infringement of claims 19 and 20 of the ’149 Patent. The FDA regulates not only the conditions treated by a drug but also the methods of use, including dosage and administration. The FDA-approved method for the Generic Product requires two bottles totaling 946 mL of solution, administered in a split-dose regimen.

Claim 23 of the ’149 Patent describes a method for inducing colonic purgation, specifying that the effective amount of the composition must be administered in two or more doses within a treatment period. The district court previously defined an "effective amount" as 473 mL, which means claim 23 covers administering this amount in two or more doses. Braintree contends that this implies administering at least 946 mL total, consistent with the Generic Product's method. However, the patent language specifies administering the effective dose "in two or more doses," not multiplying the effective amount. The specification indicates a preference for dividing the effective amount rather than multiplying it. Braintree's interpretation is further undermined by its own expert's acknowledgment that dividing doses improves patient compliance, reinforcing that claim 23 pertains to administering approximately 236 mL doses over a treatment period.

The analysis confirms that the dosage and administration method in claim 23 do not match the FDA-approved specifications for the Generic Product. The FDA-approved dosage is 946 mL given in two half-doses of 473 mL, while claim 23 specifies an 'effective dose' of 473 mL, divided into two half-doses of approximately 236 mL. As articulated by Judge Dyk, a generic product cannot infringe a patent if the FDA-approved dosage diverges from the patented claim. Consequently, the Generic Product does not infringe the '149 Patent, which requires a total volume of 100 mL to 500 mL administered in two half-doses for purgation. The Generic Product’s volume of 946 mL fails to meet this limitation, and its FDA-approved use is not covered by the patent. Thus, Breckenridge’s motion for summary judgment of non-infringement is granted, concluding the case. The court also notes that the parties intended to litigate the volume limitation issue, and the distinction between volume and purgation limitations is upheld. The doctrine of equivalents is not considered, as Braintree did not raise it as an alternative theory of infringement.