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« Biotech/Pharma Docket | Main | Summit on Biosimilars and Follow-on Biologics »

July 29, 2010



In view of the cited precedent, an unremarkable decision.

Let me get this straight.

They filed an early application, '883, that said nothing about cancer. On 12/4/84 the filed a CIP, '614, that mentioned cancer but did not claim the method. On the same day they filed '826 claiming the cancer methods. There was no terminal disclaimer for this second application.

So if they had ommitted the cancer disclosure from the '614 application they would have been in the clear? I don't see a reason why it had to be in the CIP at all.

Dear Student,

I hadn't actually gone back to check when all of the applications were filed, I was relying on the decision for this information. Your message prompted me to double-check the dates. The Federal Circuit opinion correctly identified filing dates, but did not mention that there were intervening application in between the December 4, 1984 applications and those that ultimately issued. Therefore, to set the record straight, the relevant family history (at least according to the Public Pair website) of the '614 patent is that it was filed on 6/4/1987 as a divisional application of App. No. 06/677,146 (which issued as U.S. Patent 4,692,434), which was filed on 12/4/1984 as a CIP of the '883 application. In addition, the '826 patent was filed on 7/26/1994 as a divisional application of 08/099,268, which was filed on 7/29/93 as a continuation application of 07/746,441, which was filed on 8/16/1991 as a divisional application of 07/163,571 (which issued as U.S. Patent 5,061,793), which was filed on 3/3/1988 as a continuation application of 06/786,419, which was filed on 10/10/1985 as a CIP of 06/677,783, which was filed on 12/4/1984 (and was the first application in that chain). I also didn't check what the various applications disclosed, but the Federal Circuit opinion provides the quote from the '614 patent specification.

In any event, yes, I believe you are correct that if they had left out the disclosure regarding the anti-cancer properties of gemcitabine, the '826 patent would not have had a double-patenting problem. And, yes, they did not claim the anti-cancer properties in the '826 patent, or any patent that issued from that family. However, there is a requirement that an applicant disclose the best mode, and the patent drafter may have had that in mind when they included the anti-cancer disclsoure in the specification. It is often difficult using hind-sight reconstruction to second guess why a disclosure was included, or not included, in an application.

Thanks for the comment.

EG - I agree that the case appears unremarkable, but I don't think Geneva and Pfizer were as clear-cut as the Court suggests. However, the decision in consistent with the stated policy concerns. Thanks for reading the post anyway.

Would it have been possible for Lilly to statutorily disclaim claims 2, 6 and 7 during litigation or as soon as they received the notice letter?

Gaby L.

You can file a terminal disclaimer in an issued patent as long as the patent to which you are tying the disclaimer has not already expired. Therefore, Lilly could have filed a disclaimer up until May of this year. However, Lilly would be in the same position as they are now - no current patent protection for the '826 claims. And, as this is an ANDA case, there is no past infringement damages to worry about. So, yes, they could have, but it would not have had much of a practical impact. Thanks for the question.

Of course, presumably, Eli Lilly could not have claimed priority back to the original '833 application for the cancer claims, but yet that disclosure was used against them in the obviousness analysis as if the cancer material had been filed with the original '833 disclosure. There is a discussion towards the end of the opinion to the effect that it is the spec in the "issued patent" that counts, and not in the original application which was only "an early draft" of the issued patent. Well that "early draft" was an original spec-as filed! Unremarkable. (Assuming you are not Eli Lilly).

"It would shock one's sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . . and then prevent the public from making any beneficial use of such product by securing patent upon each of the uses to which it may be adapted."

Try telling that to software patent advocates...

Actually, that quote needs to be qualified by the statement "relating to the uses disclosed in the application." It has long been the case that a new use for an old compound can be patented; while the old compound is not itself patented "again," the new use is.

So if the use was new and not disclosed in the earlier application, there may have been (or should have been) a different result.

In addition, the distinction between inflammation and inflammatory disorders is pretty weak - not that I think Lilly's argument was persuasive, but this is the kind of semantic pin-dancing that can only be done by judges with no understanding of the underlying science.


I was not referring to a terminal disclaimer. Instead, I was asking about a statutory disclaimer. See 35 U.S.C. 253 for a discussion on statutory vs terminal disclaimers.

Under 37 CFR 1.321(a) the owner of a patent may disclaim a complete claim or claims of his or her patent. This may result from a lawsuit or because he or she has reason to believe that the claim or claims are too broad or otherwise invalid. If the patent is involved in an interference, see 37 CFR 41.121(a).

As noted above, a statutory disclaimer is a statement in which a patent owner relinquishes legal rights to one or more claims of a patent.

Am I the only one who's bothered by this line of cases? How is it that a non-use-limited composition of matter claim can be patentably indistinct from a novel method of treatment claim for the purposes of obvious-type double patenting? Straight obviousness possibly (depending on the gap in time between the reference patent application/patent and the follow-on application), but double patenting???

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