Omeprazole Manufacturing Patent: 2-1 Inherent Anticipation

Omeprazole is the best-selling proton pump inhibitor sold under brand name Prilosec®. The drug operates by inhibiting the production of gastric acid, but only operates properly when administered within an enteric coating and an additional separating layer. AstraZeneca’s Patent No. 6,013,281 relates to the process of forming the coated pill. In a 2-1 decision, the Court of Appeals for the Federal Circuit (CAFC) found the ‘281 patent invalid as inherently anticipated.

A prior Korean patent application recites all but one claim limitation of the asserted ‘281 patent.*  That limitation requires that the separating layer be formed “in situ.” The trial court found, and CAFC affirmed that the in situ separation necessarily formed when practicing 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 [prior art] ingredients and protocols … necessarily resulted in in situ formation of a separating layer. Thus, the trial court correctly found inherent anticipation.

Concluding for the 2-1 majority, Judge Rader affirmed the finding of invalidy.

In dissent, Judge Pauline Newman took issue with the majority’s legal analysis.

Applying a novel theory of “inherent anticipation,” the court invalidates Astra’s patent on a newly discovered chemical process. . . . 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.

Judge Newman insisted that inherency requires that the ‘inherent information” still “be known to be present in the subject matter of the reference, when viewed by persons experienced in the field of the invention.”  In addition, any secret tests using the Korean method cannot serve as prior art because they are not public.

  • * One of the asserted claims (Claim 9) was not inherently anticipated, but was found obvious.

20 thoughts on “Omeprazole Manufacturing Patent: 2-1 Inherent Anticipation

  1. 20

    “And, I don’t mean to be a pill but their are a lot of posts here that begin with “I haven’t read the case, but . . .” Seems odd on this site.”

    Hey, I was really busy today. ;)

  2. 19

    Two points. First, the “each and every time” assertion was (according to Judge Newman) unsupported expert opinion – i.e., on cross-examination the expert admitted he had no experimental evidence to back up his testimony. Second, the AZ scientists did not argue in Korea that there was a separating layer produced in situ, but rather than the Korean patent applicant produced a separating layer and did not disclose it in the application, pursuant to the provisions of Korean patent law that permit certain information can be kept as a trade secret (which should give pause to those advocating abolishing the best mode requirement in the US).

    AZ’s real mistake was not having at least one dependent claim reciting the inlet air temperature limitation, since it was undisputed that the art did not contain this limitation.

    And, I don’t mean to be a pill but their are a lot of posts here that begin with “I haven’t read the case, but . . .” Seems odd on this site.

  3. 18

    Maxdrei – I believe that the test you described is exactly what is supposed to be the law in the US. And, you are correct that Newman and Rader appear to simply view the factual evidence differently. Sure, the CAFC is not supposed to get involved with fact finding – but that has never stopped them in the past.

    As for the patent owner being estopped because of arguments they made in Korea, I do not believe that would be the case. For starters, the Korean court apparently disagreed with the patent owner’s arguments in Korea. Perhaps more importantly, the defendant in this case apparently argued in the Korean court that the sublayer was NOT formed. So, who are you going to estop?

  4. 17

    What’s wrong with the English test for novelty: it exists unless a) the art contains CLEAR AND UNMISTAKEABLE DIRECTIONS to do something within the scope of the claim or b) something within the scope of the claim is the INEVITABLE RESULT of following the prior published directions. Simple test. Outcome hangs on the EVIDENCE. Newman and Rader just seem to interpret the available evidence differently. Puzzling to me. What’s the appeal court doing, involving itself in fact-finding? Isn’t that the job of the first instance, on the basis of the Court’s own intimate and direct observation of the cross-examination of the opposed party experts?

  5. 16

    I don’t see how Newman can argue that there is insufficient evidence that the Korean process produced the sublayer. First of all, the evidentiary standards are already part of the law, they can’t be made up to be different for different doctrines. Secondly, Astra specifically argued that the sublayer was formed by the Korean process in the Korean courts, which means they are judicially estopped from arguing differently in the US Courts. It shouldn’t be this hard.

  6. 15

    ” I believe she is simply taking the position that the Korean application did not disclose a process which necessarily produced the third layer in situ.”

    If there is any issue made for the jury, it’s the issue of whether a limitation was inherent in a prior art disclosure. Overturning a case on that issue would require a big glaring boo-boo in the lower court’s ability to weigh evidence.

    But if that’s the issue, then why is Newman barking about “novel theories of ‘inherent anticipation'”?

  7. 14

    Malcolm –

    I just reread the dissent, and I do not believe that Judge Newman was suggesting that inherency requires knowledge by those skilled in the art at the time of the invention (or at any particular time prior to trial). Rather, when she says things like the identical subject matter must be “previously known,” I believe she is simply taking the position that the Korean application did not disclose a process which necessarily produced the third layer in situ. It’s not that the in situ formation of a third layer must have been previously known – rather, a process which necessarily (but perhaps unknowingly) produced a third layer in situ must have been known. As for the recognition by those skilled in the art, I read her dissent as merely requiring a certain evidentiary burden when establishing inherency. In other words, there must be sufficient evidence to convince someone skilled in the art that, if you follow the exact process taught by the prior art, a third layer will be formed in situ. “Might be formed” is not enough. Likewise, if the formation of that third layer in situ requires the selection of a process condition not disclosed in the prior art reference, that is also not sufficient.

  8. 13

    Malcolm, I did not read Judge Newman’s dissent as necessarily requiring that such knowledge be found at the time of the invention. Perhaps I read her dissent too quickly. But, you are right that requiring knowledge at the time of invention would be a “novel” theory – and one that I also believe would be incorrect. While “practicing the prior art” is not a defense to infringement, I find that it is often enlightening when evaluating questions of inherency. You also have to be extremely careful in steadfastly following the teachings of the prior art reference when deciding questions of inherency.

    As for whether or not “in situ” is an actual step in the claim, it really isn’t – however, it still is a limitation that must be considered. Of course that also does not change the analysis of whether or not “in situ” was inherent in the prior art process.

  9. 12

    Both a sound grasp of English and technology (and of law, too) are essential in this field.

    Yes, I can read up a technical field that I am not overly familiar with, up to a point (that point being that it is not too far removed), but I have seen little to lead me to beleive that many English majors, or Psych or PoliSci majors can. Those that can are few and far between, and frankly there are some in that category that actually work in patents and probably shouldn’t, no doubt including one or two on the bench.

    OTOH, in a perfect world I would be happy if all the Examiners spoke good English, but it isn’t going to happen. Even then, it’s usually because it isn’t their first language, not because they aren’t an English major. Heaven help us if they start offering Examiner jobs to English majors. It might solve the Examiner shortage, but it would be a disaster. At least when a case reaches the bench the technical issues have been predigested by others, so that only narrow points remain to be argued, but in the ‘FOAM’ everything is up for grabs.

  10. 11

    “Judge Newman insisted that inherency requires that the ‘inherent information” still “be known to be present in the subject matter of the reference, when viewed by persons experienced in the field of the invention.”

    Friends, THIS is a novel inherency theory. Or, to be more accurate, it is an old inherency theory that the Federal Circuit put to bed the last time Newman tried to float it (Elan v. Mayo).

    There simply is no requirement that the missing limitation be “recognized” as present in the prior art UNTIL the moment at trial when the defense’s expert presents evidence which purports to prove that the missing limitation “naturally flows” from what is taught in the art. If the experts’ view is adopted by the court: case closed. It doesn’t matter how “shocking” or “unexpected” it would be to find the missing limitation when the prior art is “viewed”.

  11. 10

    “Newman J. is one of the few remaining “science” people on the Fed. Cir. panel. ”

    Maybe that’s why she has trouble understanding and articulating legal rules which actually make sense.

    I still haven’t read the case, but metoo’s analysis seems to hit upon the same issue that Dennis recognized: the limitation re “in situ” is not a STEP, it is a description of something that happens when performing the process.

    The issue for inherent anticipation is whether that “something” is “something” that necessarily occurs, as a matter of scientific fact, when the method is practiced. Here, the weight of the evidence showed that the answer to this question is: yes. Case closed.

    It is interesting to me that Rader and Newman are battling it out here and I think the underlying dispute is not “inherent anticipation” (which is relatively well-settled) but with the inevitable death of product-by-process claims (which Newman wrongly thinks are appropriate for claiming novel products).

  12. 9

    I would encourage reading the decision, as there are some interesting aspects to the case.

    One of the things that is perplexing is Judge Newman’s statement that: “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.” She also stated: “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.”

    The majority, on the other hand, states the exact opposite: “Furthermore, Dr. Umesh Banakar, Andrx’s expert, testified that if a formulator followed the CKD process as described in the CKD Patent Application, the separating layer would form in situ ‘each and every time’.” They went on to state: 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.”

    In my view, if by following the EXACT procedure disclosed in the CKD Patent Application, a separating sublayer was formed in situ every time, then the majority is correct on the question of inherent anticipation. And I think that Judge Newman would agree.

    Look at it this way. Imagine that a company begins manufacturing the pharmaceutical product in question in the U.S. and at the same time publicly discloses the exact manufacturing process used to manufacture the product (right down to the exact amounts, temperatures, etc.). They have no clue that their process creates a sublayer in situ, or that this sublayer is of any significance. Six months later, a competitor’s researchers make the surprising discovery that they can form a sublayer in situ and that this sublayer provides some wonderful benefit that no one ever imagined. Should that competitor be entitled to a patent on that process, even though someone else already developed (and disclosed) that exact same process – albeit without recognizing one of the benefits of that process? I think not. On the other hand, if the competitor determines that you must use an operating temperature which is different than that disclosed and used by the first company, else you do not obtain the sublayer, then there is clearly no inherent anticipation (and most likely the claim would not be obvious).

  13. 8

    Has anyone seen the patent lawsuit filed by Robert Tendler of Tendler Cellular against OnStar involving patent # 7,050,818?

  14. 7

    Thanks for the “Poetry trumps science” comment.

    But the reality is that we don’t have ENOUGH people with a command of the English language in the patent field. I haven’t seen any U.S. patents — or, notably, patent claims — that were not written in English.

    But I’ve seen plenty of patents that had nothing to do with chemistry, biology or any other particular scientific specialty.

    An intelligent person can read up on a particular invention that’s out of his or her field. But even the brightest individuals are worthless in a language that they don’t speak.

    The patent system will improve when the first requirement of patent examiners is that of being proficient with the language, not the last, since this proficiency is the more important skill and the skill that’s commonly applicable to all patents.

  15. 6

    I’m talking through my hat here since I haven’t read the case either, nor the Korean reference. But if the Korean claim had everything except the phrase “in situ” why isn’t this classic inherency? In claim 1 you form a core material comprising a proton pump inhibitor and at least one alkaline reacting compound,.. and apply 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. Assuming this claim meets 112 requirements, then if you juxtapose the core material with the enteric coat, you will inherently form the separating layer. There is no isolated step that causes the layer to form. The layer forms as a result of juxtaposing the compenents. Looks inherent to me (but if Judge Newman didn’t see it that way…well, no question she’s smarter than I am).

  16. 5

    I’m surprised no one has yet brought up the doctrine of “accidental anticipation”.

    Newman J. is one of the few remaining “science” people on the Fed. Cir. panel. Her arguments are often founded on sound scientific principles rather than emotional wavings of the poetic quill. However, the propensity as of late has been to hire the smooth spoken English majors to the CAFC posts rather than the scribenly challenged physicists and chemists. Poetry trumps science.

    As ye sow, so shall ye reap.
    God help us all.

  17. 4

    I think since 2001 the law has sorted out pretty cleanly, that “inherency” requires recognition at the time of litigation, but not at the time of the prior art. Prima Tek II LLC v. Polypap S.A.R.L., 412 F.3d 1284, 75 USPQ2d 1219, 1223-24 (Fed. Cir. 2005) (“Inherent anticipation does not require an appreciation of the inherent limitation by those of skill in the art before the critical date of the patents at issue”); Schering Corp. v. Geneva Pharmaceuticals, Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664 (Fed. Cir. 2003), rehearing en banc denied 348 F.3d 992, 68 USPQ2d 1760 (Fed. Cir. 2003); Crown Operations Int’l v Solutia, Inc., 289 F.3d 1367, 62 USPQ2d 1917 (Fed. Cir. 2002) (“If [a claim] limitation is inherently disclosed …, it must necessarily be present and a person of ordinary skill in the art would recognize its presence.”). (This is back-of-the-envelope work, not legal advice. Look it up for sure before you rely on it.)

    Malcolm, I don’t understand your assertion that “‘in situ’ is not a claim step.” Sure, lots of examiners repeat old myths about “functional” language and “claim step”, but repetition of baloney doesn’t make it so. Suspicion of “functional” language in apparatus claims and structural language in method claims was abolished 40 years ago. In re Swinehart, 439 F.2d 210, 212, 169 USPQ 226, 228 (CCPA 1971) (“there is nothing intrinsically wrong with the use of [functional language] in drafting patent claims … Indeed we have even recognized in the past the practical necessity for the use of functional language”); In re Land, 368 F.2d 866, 882, 151 USPQ 621, 635 (CCPA 1966) (“It is true that the italicized portions are ‘functional’ but we do not regard that as good ground to give them ‘no weight’”).

    If you are letting examiners steal patent scope from your clients based on this kind of stuff, you’re not representing your client well. (This is definitive advice to a colleague. Fix your practice before your malpractice carrier knocks on your door.)

  18. 3

    Malcolm, there may be nothing novel about the majority’s theory of anticipation, but that doesn’t mean it’s right :-)

    As Newman herself notes, quoting Chisum, the CAFC has oscillated between whether inherency requires recognition or not.

    Inherency is a very important concept for those of us in the chemistry field, and it is high time it was cleared up, one way or the other, in an enbanc opinion.

    Regards, Luke

  19. 2

    It’s interesting to note that although the process temperature played a critical role in the in situ formation of the separating layer, none of the claims recite any temperature limitations. I wonder if a dependent claim that specified a process temperature of 42 degrees Celsius or lower would have been found to be inherently anticipated.

    On the litigation side, I don’t recall a previous Fed Circuit decision where so much reliance was placed on a party’s statements made during litigation in another country, and I can think of at least one case where the FedCir disregarded a patentee’s statements made during prosecution (not litigation) elsewhere. But I don’t read every FedCir decision – can any of the litigators out there comment on whether or not the majority’s reliance on the Korean litigation is unusual?

    I cringe whenever I see a dissent by Judge Newman, and this case was no different – the majority got it wrong (although, as usual, her dissent was a good read, but it’s the kind of reading I wish was unnecessary). Tellingly, Judge Rader wrote for the majority here: he also authored the 2005 SmithKline v Apotex decision, another “inherent anticipation” pharamceutical case (crystalline form of paroxetine HCl) which was wrongly decided through faulty analysis analogous to that on display here. There’s a certain symmetry between the two cases: in the SKB case, the claim was to a product, and although the defense couldn’t produce a sample of product produced before the 102(a) date, anticipation was found on the grounds that a prior art crystallization process would necessarily have resulted in at least a small amount of the claimed product, a conclusion unsupported by the evidence. In other words, the existence of a prior art process was used to invalidate a product claim, even though there was no evidence that that process would necessarily have led to that product. Here, the question was whether a claimed process was anticipated, and the majority in essence relied on the existence in the prior art of the product of the claimed process (the Korean omeprazole formulation) to invalidite the process claim – even though, as Judge Newman noted, all the evidence indicated that the process disclosed in the prior art (the Korean patent) did not lead to the prior art product, and therefore the existence per se of the product in the prior art did not constitute disclosure of the claimed process to make the product.

  20. 1

    Without reading the case, I’m guessing Judge Newman is wrong because “in situ” isn’t a step and therefore there is nothing novel whatsoever about the majority’s theory of inherent anticipation.

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