Court Opinion

ID: 8410501
Source: CourtListenerOpinion
Date Created: 2022-11-02 18:05:18.185291+00
Date Added: 2024-06-11T16:47:46.763016
License: Public Domain

PAULINE NEWMAN, Circuit Judge,
concurring in part, dissenting in part.
I concur in the court’s ruling that the claims are infringed if valid, as well as the rulings on the issues of inequitable conduct, fraud, unclean hands, and attorney fees. However, I cannot agree that the claims of the '281 patent are invalid, for the findings of “inherent anticipation” and obviousness are based on incorrect premises of law.
Applying a novel theory of “inherent anticipation,” the court invalidates Astra’s patent on a newly discovered chemical process: a process involving known ingredients but different and previously unknown reaction conditions and achieving a different result. Based on a flawed analysis of the law of “inherent anticipation,” the court invalidates the patent on Astra’s previously unknown process for producing an in situ polymeric sublayer for omeprazole. *1377The court apparently reasons that because the ingredients were known, it is irrelevant that a significant change in conditions produces a result that is different from that achieved under the conditions of the prior art. Such a view of “inherency” is contrary to legal as well as scientific principles.
The court’s explanation and citation of authority suggest that my colleagues have confused the law governing patentability of a newly discovered use of a known composition, which is achieved by “process” claim,1 with the unpatentability of the known composition itself. The claims at issue are not directed to a composition; they are directed to a process for forming a sublayer from known ingredients:
Claim 1. A process for preparing an oral pharmaceutical formulation comprising the steps of:
forming a core material comprising a proton pump inhibitor and at least one alkaline reacting compound, wherein the concentration of the alkaline reacting compound is about 0.1 mmol/g dry ingredients in the alkaline containing part of the core material, and
applying an enteric coating polymer layer so as to surround the core material thereby forming in situ a separating layer as a water soluble salt product between the alkaline compound and the enteric coating polymer.
The Astra process is not described in the prior art, although Astra admitted that it believed that the Korean company Chong Kun Dan Corporation (CKD) had made such a product. It is not disputed that such a sublayer does not form under the conditions in the CKD patent application. No such reaction is described in CKD’s Korean patent application, nor the conditions that could have produced such a product. Nonetheless, my colleagues rule that the process discovered by Astra is “inherently anticipated” by the CKD application. That is not the law of either anticipation or inherency. I must, respectfully, dissent.

“Anticipation” Means Lack of Novelty

Novelty is fundamental to patentability. Lack of novelty, or “anticipation” in patent-ese, means that the subject matter was previously known in terms of 35 U.S.C. § 102.2 While some properties and uses of known compositions may indeed be “inherently anticipated” in that their existence would have been known to persons in the field of the invention, even if unpublished, that is not this situation. No prior art describes the Astra process, and there is no evidence that a person of ordinary skill would have known of its existence. What is unknown cannot “anticipate.”
Anticipation requires that “each element of the claim at issue is found, either expressly described or under the principles of inherency, in a single prior art reference or that the claimed invention was previously known or embodied in a single prior art device or practice.” Kalman v. Kimberly-Clark Corp., 713 F.2d 760, 771 (Fed.Cir.1983). See MEHL/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed.Cir.1999) (to anticipate, a single reference must teach every limitation of the claimed invention; any limitation not explicitly *1378taught must be inherently taught and would be so understood by a person experienced in the field); In re Baxter Travenol Labs., 952 F.2d 388, 390 (Fed.Cir.1991) (the dispositive question is “whether one skilled in the art would reasonably understand or infer” that a reference teaches or discloses all of the elements of the claimed invention); Continental Can Co. v. Monsanto Co., 948 F.2d 1264, 1268-69 (Fed.Cir.1991) (to anticipate, every element of the claims must appear in a single prior art reference, or if not expressly shown, then demonstrated to be known to persons experienced in the field of technology); In re Samour, 571 F.2d 559, 562 (CCPA 1978) (the key question is whether a single prior art reference “publicly discloses every material element of the claimed subject matter”).
The principle of “inherency,” in the law of anticipation, requires that any information missing from the reference would nonetheless be known to be present in the subject matter of the reference, when viewed by persons experienced in the field of the invention. However, “anticipation by inherent disclosure is appropriate only when the reference discloses prior art that must necessarily include the unstated limitation, [or the reference] cannot inherently anticipate the claims.” Transclean Corp. v. Bridgewood Servs., Inc., 290 F.3d 1364, 1373 (Fed.Cir.2002) (emphasis in original); Hitzeman v. Rutter, 243 F.3d 1345, 1355 (Fed.Cir.2001) (“consistent with the law of anticipation, an inherent property must necessarily be present in the invention described by the count, and it must be so recognized by persons of ordinary skill in the art”); In re Robertson, 169 F.3d 743, 745 (Fed.Cir.1999) (that a feature in the prior art reference “could” operate as claimed does not establish inherency).
Thus when a claim limitation is not explicitly set forth in a reference, evidence “must make clear that the missing descriptive matter is necessarily present in the thing described in the reference, and that it would be so recognized by persons of ordinary skill.” Continental Can Co., 948 F.2d at 1268. It is not sufficient if a material element or limitation is “merely probably or possibly present” in the prior art. Trintec Indus., Inc. v. Top-U.S.A. Corp., 295 F.3d 1292, 1295 (Fed.Cir.2002). See W.L. Gore v. Garlock, Inc., 721 F.2d at 1554 (Fed.Cir.1983) (anticipation “cannot be predicated on mere conjecture respecting the characteristics of products that might result from the practice of processes disclosed in references”); In re Oelrich, 666 F.2d 578, 581 (CCPA 1981) (to anticipate, the asserted inherent function must be present in the prior art).
Applying these principles, it is incorrect to hold that the CKD application “inherently anticipates” the '281 invention. The panel majority contravenes this vast body of precedent, for it is not disputed that no reference explicitly or inherently teaches the process that Astra found to produce an in situ polymeric sublayer. The requirements of inherent anticipation were not met.

Anticipation Also Requires Enablement

To “anticipate,” the identical subject matter must not only be previously known, but the knowledge must be sufficiently enabling to place the information in the possession of the public. In Seymour v. Osborne, 11 Wall. 516, 78 U.S. 516, 20 L.Ed. 33 (1870), the Supreme Court explained:
Patented inventions cannot be superced-ed by the mere introduction of a [prior art reference] unless the description and drawings contain and exhibit a substantial representation of the patented improvement, in such full, clear, and exact terms as to enable any person skilled in the art of science to which it appertains, to make, construct, and practice the in*1379vention to the same practical extent as they would be enabled to do if the information was derived from a prior patent. Mere vague and general representations will not support such a defense, as the knowledge supposed to be derived from the publication must be sufficient to enable those skilled in the art or science to understand the nature and operation of the invention, and carry it into practice use. Whatever may be the particular circumstances under which the publication takes place, the account published, to be of any effect to support such a defense, must be an account of complete and operative invention capable of being put into practical operation.
78 U.S. at 555 (emphases added). Precedent illustrates this principle in many areas of technology. See, e.g., Elan Pharmaceuticals, Inc. v. Mayo Foundation, 346 F.3d 1051, 1054-55 (Fed.Cir.2003) (anticipation requires enablement, whereby the reference “must teach one of ordinary skill in the art to make or carry out the claimed invention without undue experimentation”); Helifix Ltd. v. Blok-Lok, Ltd., 208 F.3d 1339 (Fed.Cir.2000) (a prior art reference that does not enable a person of ordinary skill in the art to practice the claimed invention does not anticipate the patent claims); Akzo N.V. v. United States Int’l Trade Comm’n, 808 F.2d 1471, 1480 (Fed.Cir.1986) (anticipation requires that the reference publicly discloses all elements of the claimed invention and enables its practice); Paperless Accounting, Inc. v. Bay Area Rapid Transit Sys., 804 F.2d 659, 665 (Fed.Cir.1986) (a non-enabling publication is insufficient to anticipate under § 102(b), although it may raise § 103 issues).
All parties agree that the closest prior art is the Korean CKD application. It was not disputed that the ingredients of the Astra and the CKD omeprazole formulations are the same standard enteric ingredients. Several references describe the use of microcrystalline cellulose plus an alkaline-reacting compound to formulate pharmaceuticals for drug delivery. However, no reference describes the conditions by which Astra produced an in situ interi- or sublayer. No reference suggests formulation temperatures at or below 42°C, or that such a sublayer might form at such low temperatures.
Andrx’s expert witness Dr. Banakar agreed that it was not possible to know, from the CKD Korean application, how or if the reaction conditions could be changed so as to produce an in situ sublayer. Although the panel majority states that Dr.Banakar testified that “if a formulator followed the CKD process as described in the CKD Pátent Application, the separating layer would form in situ ‘each and every time,’ ” on cross-examination Dr. Ba-naker admitted that he had conducted no experiments and his conclusion was without verification. He stated that his sole basis for “each and every time” was the Astra argument in the Korean proceedings, the argument that was negated by the evidence in the Korean court, including the testimony of Professor Chung, the Korean court-appointed expert. In all of the proceedings, in Korea and in the United States, it was never disputed that the CKD application does not disclose a separating sublayer, and that such a sublayer does not form in the conditions described for the CKD process. CKD testified in the Korean court that it consistently operated at or near the 70°C set forth in the CKD Korean application, and that no in situ sublayer was produced.
In the present litigation, the Andrx expert Dr. Banakar testified that specific process conditions are necessary to form an in situ separating layer, that such conditions are different from those set forth in the Korean application, and that his only basis for proposing that the Koreans formed an in situ sublayer was because *1380Astra had unsuccessfully so argued in Korea. Astra states that its argument was based not on information contained in the Korean patent application or gleaned in the Korean litigation, but on testing of a CKD product. It is not now disputed that the Korean process does not produce a separating sublayer.
By no stretch of fact or law can the Korean application inherently anticipate what it could not produce. A non-enabling reference cannot serve as an invalidating anticipation, either expressly or inherently. My colleagues on this panel, holding otherwise, do not explain how they plug this scientific and legal gap. Such an unexplained finding of inherent anticipation does not add clarity to this jurisprudence.

Secret Information Cannot “Anticipate”

My colleagues speculate that CKD practiced a sublayer-producing process in secrecy, although the Korean inventors denied such practice in the proceedings in the Korean Patent Office and also in the Seoul District Court. Whatever may or may not have been done in secret in Korea does not convert a secret and still unknown process into prior art.
“Anticipating” subject matter must be known, and the knowledge must be sufficient to place enabling information in the possession of the public. See, e.g., Vulcan Eng’g Co. v. Fata Aluminium, Inc., 278 F.3d 1366, 1372-73 (Fed.Cir.2002) (a secret system that was not known or publicly used in the United States is not prior art and cannot “anticipate”); Woodland Trust v. Flowertree Nursery, Inc., 148 F.3d 1368, 1371 (Fed.Cir.1998) (secret prior use or knowledge by another is not a bar to pat-entability).
The Korean court found that an in situ sublayer was not produced by the process set forth in the CKD specification. I repeat, this finding is not challenged by any evidence presented in this case. Even if CKD indeed practiced a secret process in Korea, and made a sublayer while concealing the process, such an unknown process is not an inherent anticipation.

Patentability of the '281 Process

Astra informed the United States patent examiner that the Korean proceedings included CKD’s challenge to the validity of the Korean counterpart of Astra’s '281 patent. Astra submitted to the PTO, with English translations, CKD’s Korean patent application, Astra’s Opposition Statement, the Korean Patent Office’s Confirmation of Scope decision of September 25, 1994, As-tra’s evidence that the CKD product has a separating sublayer, and the Korean district court’s ruling that the CKD process does not produce an in situ separating sublayer.
On this background, the United States examiner found that the '281 process was patentable. My colleagues on this panel rely on cases which hold that a known composition cannot be re-patented as a composition when a new property is discovered, citing Atlas Powder, 190 F.3d at 1347, and Bristol-Myers Squibb, 246 F.3d at 1376. That is a correct statement of law, but irrelevant to this case. The '281 claims are not for a known composition; the claims are for a newly discovered process. See Loctite Corp. v. Ultraseal Ltd., 781 F.2d 861, 875 (Fed.Cir.1985) (a new process is patentable subject matter, whether or not the product is already known); Atlantic Thermoplastics Co., Inc. v. Faytex Corp., 970 F.2d 834, 841 (Fed.Cir.1992) (“In the words of the Supreme Court, ‘While a new process for producing [a known composition] was patentable, the product itself could not be patented ....’” (quoting Cochrane v. Badische Anilin & Soda Fabrik, 111 U.S. 293, 312, 4 S.Ct. 455, 28 L.Ed. 433 (1884))); Ansonia Brass & Copper Co. v. Electrical Supply Co., 144 U.S. 11, 12 S.Ct. 601, 36 L.Ed. 327 (1892). No reference shows the process conditions by which Astra produced the sublayer.

*1381
Obviousness of Claim 9

The invalidation of claim 9 is a misapplication of the law of obviousness, for there was no prior art or even general knowledge that suggested that a major lowering of the formulating temperature would cause a polymeric sublayer to form in situ. The court’s invalidation of claim 9 appears to be founded on the postulate that CKD had a secret process for making the disavowed sublayer. Accepting that Astra’s scientists, Dr. Lovgren and Dr. Lundberg, believed that CKD had made an in situ sublayer and thereby were spurred to experimental investigation, that did not render their success obvious. Obviousness cannot be based on secret or concealed information.
In addition, no references have been cited to suggest that the phosphoric acid, carbonic acid, or silicic acid of Astra’s claim 9 should replace the zwitterionic L-arginine in the Korean formulation. And no reference suggested that such a change, combined with a significant temperature reduction, would produce an in situ separating sublayer. Hindsight is not an available analytical mechanism to show obviousness. See Interconnect Planning Corp. v. Feil, 774 F.2d 1132, 1138 (Fed.Cir.1985) (“The invention must be viewed not with the blueprint drawn by the inventor, but in the state .of the art that existed at the time.”)

Conclusion

It is apparent that the requirements of “inherent anticipation” are not met. A consistent law, and consistent application, are critical to technological innovation.3 The panel majority’s divergence from precedent not only has led the court to invalidate a fully valid patent, but also brings further uncertainty to this important aspect of patent law.

. 35 U.S.C. § 100(b) defines "process” as follows: "The term 'process’ means process, art or method, and includes, a new use of a known process, machine, manufacture, composition of matter, or material.”

. 35 U.S.C. § 102 provides that novelty is negated if the invention was known or used by others in the United States, § 102(a); or if the invention was patented or described in a printed publication, § 102(b); or in public use or on sale, § 102(b); or derived from another, § 102(f); or the prior invention of another who did hot abandon, suppress, or conceal it, § 102(g).