Monday, April 23, 2007

In re Omeprazole Litigation: inherent anticipation argued

Unresolved issues with inherent anticipation were apparent in the majority and dissenting opinions of In re Omeprazole Litigation. By a 2-1 vote, key claims of an Astra patent on omeprazole were invalidated.

The majority cited Mehl, 192 F.3d 1392. The majority also cited Schering v. Geneva, 339 F.3d 1373 for the proposition that inherent anticipation does NOT require recognition in the prior art.

The patent in question was US 6,013,281 [the '281 patent, to Astra], issued in 2000 but claiming priority back to 1995. This was a process patent for making the TABLET which is used to deliver omeprazole [Prilosec], which is an important part of the use of omeprazole, because omeprazole must reach the intestines WITHOUT being acidified in the stomach.

The odd twist in this case was that a Korean company, the Chong Kun Dan Corporation (CKD), began selling a form of omeprazole under the name “OMP” in Korea in 1993 and had a patent application filed in Korea in 1993. Astra sued CKD in Korea, and CKD initiated a proceeding with the Korean Patent Office (KIPO) for a finding of non-infringement. The only ’281 claim “limitation” missing from the Korean application is the language “thereby forming in situ a separating layer.”

Here's the rub: The CKD application disavowed a subcoating and disclosed no process conditions to form a separating layer in situ. BUT in the patent fight in Korea, Astra scientists argued 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 What one says in the context of a Korean patent litigation can return to haunt one in the United States, because both the US district court and 2 judges on the CAFC found that the testimony by Astra people in Korea overcame the disavowal by CKD about "forming in situ a separating layer." IPBiz thinks a key factor in this case is the quote from 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.” Although NOT explicitly presented by the CAFC, it looks like the lack of enablement of "forming in situ a separating layer" in the Korean patent application WAS TRUMPED by Astra's admission in court. Astra COULD HAVE presented evidence of lack of enablement in the US district court, but they didn't, and thus were hoisted on their own petard.

In dissent, Judge Newman (who authored the Continental Can opinion) wrote: the court invalidates the patent on Astra's previously unknown process for producing an in situ polymeric sublayer for omeprazole. The emphasis might be on the word unknown. This is further seen in the text: 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."

The problem with Continental Can was that it did NOT explicitly say "when" the thing had to be known: 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) These days, it is enough that the thing be known AT THE TIME OF LITIGATION, with of course a proof, at the time of litigation, that the thing was present at the time of the prior art (although not necessarily "known" at the time of the prior art.)

IPBiz has discussed this issue many times before -->

Law review articles on inherent anticipation

Todd Miller on inherent anticipation in AIPLA Q. J.

In fact, back in 1999 (before Schering v. Geneva, 339 F.3d 1373), LBE wrote in “Inherent difficulties,” Int. Prop. Today, Nov. 1999: To illustrate one issue in the interpretation of Continental Can, consider the discovery of buckyballs. In 1984, workers at Exxon disclosed the existence of C60, with the formula as determined by mass spectrometric measurement n6 and a way to make said C60. (J. Chem. Phys., 1984, 81, 3322). They did not disclose the correct structure of C60; Professors Smalley and Kroto proposed the structure of C60 to be that of a truncated icosahedron in 1985. This was not known to be correct until after the work of Huffman and Kratschmer in 1990. Now, assuming that the synthesis of Exxon always led to C60 with the icosahedral structure, would a patent claim to C60 in 1990 (with the truncated icosahedral structure) be inherently anticipated by the Exxon work in 1984, even though no one knew the structure in 1984, and in fact could not have proved the structure until 1990? Assuming that one of ordinary skill would recognize the inherent property, albeit at a later date, one might think there would be inherent anticipation. See Inherent Anticipation.

On inherent anticipation, see also:


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