Alcon Research v. Barr: Generic Manufacturer Fails to Invalidate Patent under 112, 1st para., but Avoids Infringement

Category: Infringement   
By: Jesus Hernandez, Blog Editor/Contributor 
TitleAlcon Research Ltd. v. Barr Lab., Inc., No. 2012-1340, 1341 (Fed. Cir. March 18, 2014).
[1: infringement] Alcon argues that the district court erred in finding that Barr’s ANDA product did not infringe the asserted claims of Alcon’s ’287 and ’062 patents because its testing of travoprost formulations containing the same PECO [polyethoxylated castor oil] in the same concentration as Barr’s proposed generic product demonstrated that the PECO added to Barr’s composition enhances the stability of the prostaglandin.
Alcon Research at *7 (text added).
[2: enablement] Alcon argues that the district court erred in holding the asserted claims of the ’287 and ’062 patents invalid for lack of enablement because it only weighed the breadth of the claims against the detail of the patent disclosures […] that Barr presented no evidence that any experimentation would be required for a person of ordinary skill in the art to practice the invention as claimed.
Id. at *11.
[3: written description] Barr [argues] that the claims “flunk the written description requirement” because they encompass “a method for enhancing the chemical stability of innumerable prostaglandins by adding to them PECO in an endless number of combinations and concentrations” and there- fore are not precise and “overreach” the scope of the patent disclosures.
Id. at *15 (text added).
[1: infringement] We thus conclude that the district court did not clearly err in finding that the data in Alcon’s Table 7 had no bearing on whether Barr’s proposed generic product infringed Alcon’s patents. The formulations tested in Alcon’s stability study were meaningfully different from the product described in Barr’s ANDA and thus provided no basis from which to draw any reliable inferences regarding whether the PECO in Barr’s composition would chemically stabilize the prostaglandin.
Id. at *10.
[2: enablement] The district court erred here because its enablement analysis did not address that determinative question: Barr failed to make the threshold showing that any experimentation is necessary to practice the claimed methods, i.e., to use PECO to enhance the stability of a prostaglandin given the disclosures of Alcon’s ’287 and ’062 patents. Instead, the district court’s holding rested on its finding that the full scope of the claims was not enabled after applying the Wands factors as if they were a generalized test for deciding whether a patent disclosure is sufficiently detailed to support a broad claim.
Id. at *12.
[3: written description] [T]he ’287 and ’062 patent disclosures demonstrate that the inventors possessed the claimed invention: they conceived of and described their invention at the time the respective original patent applications were filed, including the idea that adding PECO would enhance the chemical stability of prostaglandins across a range of various formulation parameters as cited by the district court. […] That is all that the written description requirement demands.
Id. at *17 (internal citations omitted).
Procedural HistoryAlcon Research Ltd. (“Alcon”) appeals from the final judgments of the United States District Court for the District of Delaware finding that Barr Laboratories, Inc. (“Barr”) does not infringe claim 12 of Alcon’s U.S. Patent 5,631,287 (the “’287 patent”) and claim 19 of Alcon’s U.S. Patent 6,011,062 (the “’062 patent”) and holding those claims invalid for lack of enablement and lack of an adequate written description under 35 U.S.C. § 112, ¶ 1.1. […]
Alcon Research Ltd. at *2 (internal citations omitted).

Legal Reasoning (Newman, Lourie, Bryson)
Claim at Issue1. A method of enhancing the chemical stability of an aqueous composition comprising 

a therapeutically-effective amount of a prostaglandin, wherein the method comprises adding a chemically-stabilizing amount of a polyethoxylated castor oil [(“PECO”)] to the composition.

12. The method of claim 1 wherein the composition is a topically administrable ophthalmic com- position.

Alcon Research Ltd. at *3.
Party Relationship
PatenteeAlcon owns the ’287 and ’062 patents, which are directed to methods for enhancing the stability of prostaglandin compositions, including Alcon’s glaucoma and ocular hypertension drug Travatan Z®, which contains travoprost, the synthetic prostaglandin fluprostenol isopropyl ester.
Id. at *3.
GenericBarr submitted Abbreviated New Drug Application (“ANDA”) […] to the U.S. Food and Drug Administration (the “FDA”), seeking approval to manufacture, use, and sell an ophthalmic travoprost solution as a generic version of Travatan Z®. Barr’s ANDA filing was second to that of Par Pharmaceuticals, Inc. […]
Id. at *3.
[1] Infringmement Analysis
Legal Standard - Infringement by ANDA PharmaceuticalUnlike a classic patent infringement case in which infringement exists if at least one claim of an asserted patent reads on a product or process that the accused infringer has introduced into the U.S. marketplace, an infringement inquiry provoked by an ANDA filing under the Hatch-Waxman system pursuant to 35 U.S.C. § 271(e)(2)(A) is focused on a comparison of the asserted patent against “the product that is likely to be sold following ANDA approval.” Abbott Labs. v. TorPharm, Inc., 300 F.3d 1367, 1373 (Fed. Cir. 2002). That determination is based on consideration of all of the relevant evidence and, “[b]ecause drug manufacturers are bound by strict statutory provisions to sell only those products that comport with the ANDA’s description of the drug, an ANDA specification defining a proposed generic drug in a manner that directly addresses the issue of infringement will control the infringement inquiry.”
Alcon Research Ltd. at *8.
Submitted Test Data not Enough to Prove Infringement
In its attempt to prove that the addition of PECO in Barr’s proposed generic product would chemically stabilize the prostaglandin travoprost and thus infringe the asserted claims of the ’287 and ’062 patents, Alcon relied solely on a theory that the data reported in Table 7 of a stability study that Alcon conducted during its development work could be extrapolated to infer that the addition of PECO would chemically stabilize travoprost in Barr’s ANDA composition. 
Id. at *8-9.
The test formulations used by Alcon to compile the data in Table 7 were maintained at pH 6.0–6.1 and contained, inter alia, 0.005% weight by volume of travoprost, varying concentrations of PECO, the antimicrobial preservative benzalkonium chloride, and a buffer solution comprising tromethamine, boric acid, and mannitol. Id. In contrast, the generic product proposed in Barr’s ANDA is main- tained at a different pH, is composed of 0.004% weight by volume of travoprost and a buffered preservative system comprising propylene glycol, sorbitol, and zinc chloride, but does not contain benzalkonium chloride or a tro- methamine/boric acid/mannitol buffer solution. Id. Alcon itself admitted that variation in parameters including pH, preservatives, and buffers can have a substantial impact on the chemical stability of a prostaglandin in an ophthalmic formulation. […] The data in Table 7 therefore were not evidence that Barr’s product, if and when approved, would infringe the asserted claims.
Id. at 9-10 (internal citations omitted).
[2] Enablement Analysis
Legal Standard: enablementTo prove that a claim is invalid for lack of enablement, a challenger must show by clear and convincing evidence that a person of ordinary skill in the art would not be able to practice the claimed invention without “undue experimentation.” […] After the challenger has put forward evidence that some experimentation is needed to practice the patented claim, the factors set forth in Wands then provide the factual considerations that a court may consider when determining whether the amount of that experimentation is either “undue” or sufficiently routine such that an ordinarily skilled artisan would reasonably be expected to carry it out. […]
Alcon Research Ltd. at *12 (internal citations omitted).
No Evidence of any undue experimentation profferedBarr adduced no evidence at trial that changing any of the “variables” or “[v]arious parameters” identified by the district court [e.g., the number of prostaglandins and the range of PECOs, various parameters including: pH, buffer, buffer concentration, preservatives, chelating agents, and other excipients] would render Alcon’s claimed invention inoperable, nor was there any evidence that experimenting with those variables was required for an ordinarily skilled artisan to be capable of increasing the chemical stability of a prostaglandin by adding PECO. Adjusting variables may be relevant to optimizing the stability of a given prostaglandin composition, but Barr proffered no evidence that any experimentation, let alone undue experimentation, with those variables would be necessary in order to practice the claimed invention. Without that evidence, there is no foundation for the district court’s nonenablement ruling.
Id. at *13 (text added).
[3] Written Description
legal standard: written description“[T]he hallmark of written description is disclosure.” Ariad, 598 F.3d at 1351. The standard for satisfying the written description requirement is whether the disclosure “allow[s] one skilled in the art to visualize or recognize the identity of the subject matter purportedly described.” […] There is no requirement that the disclo- sure contain “either examples or an actual reduction to practice”; rather, the critical inquiry is whether the pa- tentee has provided a description that “in a definite way identifies the claimed invention” in sufficient detail that a person of ordinary skill would understand that the inven- tor was in possession of it at the time of filing. […]
Alcon Research Ltd. at *15-16 (internal citations omitted).
Invention Adequately describedThe ’287 patent details the claimed invention and provides a step-by-step description of how a person of ordinary skill in the art may use it. It discloses the “unexpected[] discover[y] that the use of . . . polyethoxylated castor oils in [pharmaceutical] compositions,” especially those “topically applied to the eye,” “enhances the chemical stability of prostaglandins.” […] It provides exemplary formulations that embody the claimed invention, reciting concentrations of every ingredient. […] It also discloses data generated by the inventor from accelerated stability testing showing the effect of PECO and prostaglandin concentration on stability and comparing the effect of PECO to that of a more commonly used surfactant, polysorbate 80. […] The patent also describes various classes of prostaglandins to which the invention was understood to relate, which are covered by the term “prostaglandin” under the district court’s construction of that term, as well as preferred concentrations and thirty-two specifically preferred examples of those prostaglandins. […] It describes various types of PECOs that may be used in the invention, again with preferred types and concentrations. […] And the patent describes the various formulation parameters, including osmolality and pH, that may be selected when practicing the invention […]
Id. at *16-17 (internal citations omitted).
In view of the foregoing, we conclude that the district court’s assessment that Barr’s ANDA products would not infringe either claim 12 of Alcon’s ’287 patent or claim 19 of Alcon’s ’062 patent was correct and we therefore affirm that judgment. We further conclude that those claims are not invalid under § 112, ¶ 1 and accordingly we reverse the district court’s contrary holding.
Alcon Research Ltd. at *21-22.
Editor's Notes
This case also discusses the denial of a JMOL motion. For further reading, click here.
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