The case Alcon v. Barr
was a Hatch-Waxman matter, with Alcon losing on infringement, but surviving as to validity. The discussion of enablement and written description is of interest.
Critically, however, the district court found, and the parties do not dispute on appeal, that the composition of the generic product proposed in Barr’s ANDA is significantly different from the compositions tested in Alcon’s study. Alcon, 837 F. Supp. 2d at 376; J.A. 6984, 6991. 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. Id. at 376–77; Appellant Br. 39; J.A. 5539–40, 5985. (...)
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. See Lucent Tech., Inc. v. Gateway, Inc., 543 F.3d 710, 722–24 (Fed. Cir. 2008) (recognizing that overly speculative circumstantial evidence will not suffice to prove infringement).
As to section 112
Section 112 of the patent statute describes what must be contained in a patent specification. Among other requirements, it must contain “a written description of the invention, and of the manner and process of making and using it . . . [such] as to enable any person skilled in the art to which it pertains, . . . to make and use the same . . . .” 35 U.S.C. § 112, ¶ 1 (2006). Thus, this statutory language mandates satisfaction of two separate and independent requirements: an applicant must both de- scribe the claimed invention adequately and enable its production and use. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1344 (Fed. Cir. 2010) (en banc); Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1562–63 (Fed. Cir. 1991).
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. Alcon contends that Barr presented no evidence that any experimentation would be required for a person of ordi- nary skill in the art to practice the invention as claimed.
Barr responds that the patents provide very little guidance to one skilled in the art in the form of only three working examples and do not disclose any data for chemi- cal stability. Barr contends that the reported data relate only to physical stability, not prostaglandin degradation, and that the patents do not disclose how PECOs work to chemically stabilize prostaglandins. Barr further asserts that the technology at issue is highly unpredictable, particularly with regard to choice of pH, buffer, buffer concentration, preservatives, chelating agents, and other excipients.
We agree with Alcon that the district court erred in its enablement analysis. To 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.” In re Wands, 858 F.2d 731, 736–37 (Fed. Cir. 1988); see also Johns Hopkins Univ. v. CellPro, Inc., 152 F.3d 1342, 1360 (Fed. Cir. 1998) (“[I]t is imperative when attempting to prove lack of enablement to show that one of ordinary skill in the art would be unable to [practice] the claimed invention with- out undue experimentation.”) (emphasis omitted). After the challenger has put forward evidence that some exper- imentation is needed to practice the patented claim, the factors set forth in Wands then provide the factual con- siderations 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. Wands, 858 F.2d at 737.
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. Alcon, 837 F. Supp. 2d at 370, 380–83.
Practising vs. optimizing:
Indeed, Barr’s expert observed that “when ‘you have a lot of variables on top of one another, the experimentation gets out of control quickly.’” Id. at 383 (citing J.A. 6009). But such an unsubstantiated conclusory statement is not sufficient. Cephalon, Inc. v. Watson Pharm., Inc., 707 F.3d 1330, 1339 (Fed. Cir. 2013). Barr adduced no evidence at trial that changing any of the “variables” or “[v]arious parameters” identified by the district court 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.
An inventor need not know why an invention works:
Furthermore, a patent does not need to guarantee that the invention works for a claim to be enabled. It is well settled that an invention may be patented before it is actually reduced to practice. Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 61 (1998). Similarly, a patentee is not re- quired to provide actual working examples; we have rejected enablement challenges based on the theory that there can be no guarantee that prophetic examples actual- ly work, as “[t]he burden is on one challenging validity to show by clear and convincing evidence that the prophetic examples together with other parts of the specification are not enabling.” Atlas Powder Co. v. E.I. du Pont de Nemours & Co., 750 F.2d 1569, 1577 (Fed. Cir. 1984). Nor is it “a requirement of patentability that an inventor correctly set forth, or even know, how or why the invention works.” Newman v. Quigg, 877 F.2d 1575, 1581–82 (Fed. Cir. 1989) (citing Diamond Rubber Co. v. Consol. Rubber Tire Co., 220 U.S. 428, 435–36 (1911)). Thus, it is likewise irrelevant here, as a legal matter, whether the ’287 and ’062 patents contain data proving that PECOs enhance the chemical stability of prostaglandins.
Flunking the written description test?
Barr responds 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 therefore are not precise and “overreach” the scope of the patent disclosures. Appellant Br. 49–50. Barr contends that the specifications only disclose physical data from one compound to support the proposition that PECO enhances the chemical stability of all prostaglandins, but that they do not disclose any data on chemical stability, prostaglandin degradation products, or prostaglandin degradation pathways.
We agree with Alcon that the specifications provide an adequate written description of the claimed invention. “[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.”
Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 968 (Fed. Cir. 2002). 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. Ariad, 598 F.3d at 1350, 1352; Koito Mfg. Co. v. Turn-Key-Tech., LLC, 381 F.3d 1142, 1154 (Fed. Cir. 2004). That assess- ment “requires an objective inquiry into the four corners of the specification.” Ariad, 598 F.3d at 1351.
Written description vs. enablement:
Despite these disclosures, the district court concluded that the asserted claims were invalid for lack of an ade- quate written description “for essentially the same rea- sons that they fail the enablement requirement . . . .” Alcon, 837 F. Supp. 2d at 384. But written description is about whether the skilled reader of the patent disclosure can recognize that what was claimed corresponds to what was described; it is not about whether the patentee has proven to the skilled reader that the invention works, or how to make it work, which is an enablement issue. See Ariad, 598 F.3d at 1352. Barr’s argument regarding the difference between physical and chemical stability, even if correct, is thus not relevant to the inquiry. Critically, Barr adduced no evidence, let alone clear and convincing evidence, that was probative of whether an ordinarily skilled artisan would not have understood from the disclosures of Alcon’s ’287 and ’062 patents that the patent- ees invented, or possessed, the methods of the asserted claims. Without that evidence, there was no basis on which to find a lack of adequate written description.
Accordingly, we conclude that the district court erred in failing to apply the proper test for determining whether the patents recited an adequate written description and Barr again did not meet its burden of proving invalidity by clear and convincing evidence. We therefore reverse the district court’s judgment that claim 12 of the ’287 patent and claim 19 of the ’062 patent are invalid for lack of an adequate written description.
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. Finally, because we conclude that the district court did not abuse its discre- tion in denying Barr’s Rule 59(e) motion to amend for JMOL of noninfringement as to Alcon’s ’383 and ’052 patents, we affirm that decision.
Here's what PatentHawk had to say about the decision
In Alcon v. Barr (2012-1340), a CAFC panel reminds that the U.S. patent regime is rotten to the core. Applicants may get patents for so-called "inventions" that don't work: "a patent does not need to guarantee that the invention works for a claim to be enabled. It is well settled that an invention may be patented before it is actually reduced to practice."