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April 23, 2007

Bloated Anticipation

Case law broadening of prior art anticipation is bloating, and badly needs gas pills in the form of statutory guidance. But Congress, drafting patent reform in secret thrall to select corporate interests, is all deaf ears.

In a radical new precedent, prior art can anticipate a process even though unrecognized at the time. In a bitter 2-1 split decision, the appeals court (CAFC 04-1562) affirms a district court ruling of "inherent anticipation."

Astra sued several drug companies for seeking permission from the FDA to market generic versions of Prilosec®, Astra's tummy de-gasser. The four-phase district court trial ended with Andrx as infringing a couple of patents.

6,013,281 is a process patent for making omeprazole, the generic name for Prilosec®.

The ’281 patent issued in the United States on January 11, 2000, with priority back to the February 9, 1995, Swedish application. However, in 1993, before Astra’s Swedish filing, a Korean company, the Chong Kun Dan Corporation (CKD), began selling a form of omeprazole under the name “OMP” in Korea. CKD had filed an application (CKD Patent Application) with the Korean Intellectual Property Office (KIPO) for its OMP formulation. The CKD Patent Application became public at KIPO on April 20, 1993. Omeprazole III, slip op. at 2. As a result, Astra questioned CKD about infringement of its Korean process patent for manufacturing omeprazole, a foreign sister to portions of Astra’s ’505 (Astra’s Korean Patent), which issued on November 22, 1988. CKD denied infringement in reliance on its own “unique know-how and . . . patents.”

Astra sued CKD in Korea, and CKD initiated a proceeding with the Korean Patent Office (KIPO) for a finding of non-infringement.

Astra '281 inventors Dr. Kurt Lövgren and Johan Lundberg knew of the CKD process prior to filing, and, in a somewhat convoluted prosecution, got allowance for '281, with the examiner noting the claims patentable over the Korean prior art.

But the CKD prior art was killer at trial.

The district court found that the CKD patent application anticipated claims 1, 2, 3, 7, 16, and 20-21 of the ’281 patent. Omeprazole III, slip op. at 2. The CKD patent application became public on April 20, 1993, id., slip op. at 20, and contained all of the elements claimed in the anticipated claims. That application also disclosed the exact proportions of the principal ingredients in the ’281 patent’s example 1. Omeprazole III, slip op. at 7. The only ’281 “limitation” missing from the Korean application is the language “thereby forming in situ a separating layer.”

The CAFC boxing ring ropes for this slugfest -

Anticipation requires disclosure of each and every claim limitation in a single prior art reference, either explicitly or inherently. MEHL/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999). An anticipation analysis requires a comparison of the construed claim to the prior art. Helifix, Ltd. v. Blok-Lok, Ltd., 208 F.3d 1339, 1346 (Fed. Cir. 2000).

The CKD prior art did not explicitly disclose “in situ formation of a separating layer.” But Astra had intimated such, and were hung on its admission of invalidity by inherency.

 Therefore, anticipation turns on whether the CKD application inherently disclosed “in situ” formation. The CKD application disavowed a subcoating and disclosed no process conditions to form a separating layer in situ.

Nonetheless, in finding inherent anticipation, the district court relied on and set out in its opinion the assertions Astra made during the Korean Litigation and KIPO proceedings:

▪ that the CKD process (Method A) claimed in the CKD Patent Application resulted in the in situ formation of a separating layer in CKD’s OMP tablet, Omeprazole III, slip op. at 29;

Astra does not deny these statements. Furthermore, as noted by the district court: “If Astra had scientific proof with which to rebut or refute its prior admissions of inherency, it surely would have put on such proof. Astra did not.”

The district court acting as factfinder found credible that evidence of inherent in situ formation, and we find no clear error in that determination. The district court did not settle for proof that in situ formation could result from the CKD process, as is suggested in the dissent; rather, the district court credited evidence that in situ formation does result from the CKD process.

Inherency within the prior art is an invisible python of non-recognition that can strangle a patent nonetheless -

[A] prior art reference without express reference to a claim limitation may nonetheless anticipate by inherency. See In re Cruciferous Sprout Litig., 301 F.3d 1343, 1349 (Fed. Cir. 2002). Moreover, “[i]nherency is not necessarily coterminous with knowledge of those of ordinary skill in the art. Artisans of ordinary skill may not recognize the inherent characteristics or functioning of the prior art.” Id.; Schering Corp. v. Geneva Pharms., 339 F.3d 1373, 1377 (Fed. Cir. 2003) (rejecting the contention that inherent anticipation requires recognition in the prior art).

The record shows formation of the in situ separating layer in the prior art even though that process was not recognized at the time. The new realization alone does not render that necessary prior art patentable. Id. (citing Atlas Powder, 190 F.3d at 1347) (“[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s function, does not render the old composition patentably new to the discoverer.”); Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1376 (Fed. Cir. 2001) (explaining that newly discovered results of known processes are not patentable because those results are inherent in the known processes); Verdegaal Bros., Inc. v. Union Oil & Co. of Cal., 814 F.2d 628, 633 (Fed. Cir. 1987) (holding that the recognition of a new aspect of a known process is not a patentable invention of a novel process).

Judges Radar and Bryson comprised the majority, with Newman breaking wind on "inherent anticipation."

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. The 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, 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...

"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 taught 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 1982) (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.

The CAFC had previously equivocated whether prior art needed to be enabling to be anticipatory. Judge Newman has no qualm with a clear position requiring objective evidence of enablement.

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, 78 U.S. 516 (1870), the Supreme Court explained:

Patented inventions cannot be superceded 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 invention 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).

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"

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 patentability).

Patentability of the '281 Process

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 (1884))); Ansonia Brass & Copper Co. v. Electrical Supply Co., 144 U.S. 11 (1892). No reference shows the process conditions by which Astra produced the sublayer.

Conclusion

It is apparent that the requirements of "inherent anticipation" are not met. A consistent law, and consistent application, are critical to technological innovation. 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.

Posted by Patent Hawk at April 23, 2007 8:48 PM | Prior Art

Comments

Of --In a radical new precedent, prior art can anticipate a process even though unrecognized at the time,-- this bridge had been crossed in Schering v. Geneva, cited by the majority. See for example
Inherent Anticipation and Law review articles on inherent anticipation on IPBiz.

Posted by: Lawrence B. Ebert at April 24, 2007 5:03 AM

Can this subject matter 'anticipate'?
Claims (comprised of language) of a patent application describe how to achieve an important property of a chemical composition, a property previously (for 91 years) thought to be impossible (even by the major producer of the composition). The claims were rejected by the patent examiner on the grounds that they were anticipated by prior art and were obvious to someone of ordinary skill in the art.

Posted by: Lawnie Taylor at July 31, 2008 7:53 PM