Sun Pharmaceuticals v. Eli Lilly: obviousness-type double patenting in the pharmaceutical context

Sun Pharmaceutical Industries, Ltd. v. Eli Lilly and Company (Fed. Cir. July 28, 2010)

By Jason Rantanen

Double-patenting issues arise when two commonly owned applications cover the same or similar inventions.  The issues in this appeal revolved around an earlier patent claiming a composition of matter and describing a method for using that composition, and a later patent claiming that method of use. 

Both of the patents in this case, Patent No. 4,808,614 (the '614 patent) and Patent No. 5,464,826 (the '826 patent) relate to gemcitabine, the active ingredient of Lilly's Gemzar® product.  The '614 patent claims both gemcitabine itself, as well as a method of using it to treat viral infections.  In addition, the '614 patent's specification discloses using gemcitabine to treat cancer.  The '826 patent claims a method of treating cancer comprising administering a therapeutically effective amount of gemcitabine.  The difference was important: the '614 patent expired on May 15, 2010, while the '826 patent does not expire until November 7, 2012.

Note: The applications leading to both the '614 and '826 patents were filed on the same day, December 4, 1984.  The '614 was a continuation-in-part of application No. 473,883 ("the '883 application"), which did not disclose using gemcitabine to treat cancer.  That information was added as part of the continuation-in-part. 

After filing an Abbreviated New Drug Application ("ANDA") for a generic version of Gemzar®, Sun Pharmaceuticals, sought a declaratory ruling that the '826 patent was invalid and not infringed.  Lilly counterclaimed for infringement of the '826 and '614 patents.  The '614 patent was not at issue in this appeal.

Obviousness-type double patenting applies
Applicants are barred from obtaining multiple patents covering the same invention by the doctrine of double patenting.  There are two types of double patenting: statutory double patenting, which prohibits a later patent from covering the identical invention, and obviousness-type double patenting, which prevents a later patent from covering a slight variation of an earlier patented invention.

On appeal, the panel agreed with the district court and Sun that the latter type of double patenting occurred here, thus invalidating the asserted claims of the '826.  The basis for the court's decision were two prior opinions, Geneva v. GlaxoSmithKline, 349 F.3d 1373, and Pfizer v. Teva, 518 F.3d 1353.  In Geneva, the earlier patent claimed a compound and the specification disclosed its effectiveness for inhibiting beta-lactamase.  The later patent claimed a method of using the compound to affect beta-lactamase inhibition.  Similarly, in Pfizer, the earlier patent claimed several compounds and the specification disclosed their use in treating inflamation; the later patent claimed a method of using these compounds for treating inflammation.  In both cases, the court ruled that the claims were not "patentably distinct," and thus the latter claims were invalid for obviousness-type double patenting.  

While Lilly argued that Geneva and Pfizer did not apply because "the specification of the earlier patent disclosed a single use for the claimed compound, which was an essential part of the patented invention and thus necessary to patentability," Slip Op. at 8, the court rejected that argument for two reasons.  First, the court disagreed that the specification in Pfizer disclosed more than one utility for the claimed compound.  In addition, the court read the rule of Pfizer as simply that "obviousness-type double patenting encompasses any use for a compound that is disclosed in the specification of an earlier patent claiming the compound and is later claimed as a method of using that compound.  Pfizer never implies that its reasoning depends in any way on the number of uses disclosed in the specification of the earlier patent."  Slip Op. at 10. 

The court also rejected Lilly's argument that the specification of an earlier application should have been consulted, as opposed to the specification of the '614 patent.  Drawing upon its claim construction precedent, the court noted that the specification is relevant to determining the coverage of the claims, which is at the heart of the obviousness-type double patenting analysis.  The court further noted that "consulting the specification of the issued patent, as opposed to an earlier version, is consistent with the policy behind double patenting," which rests "on the fact that a patent has been issued and later issuances of a second patent will continue protection, beyond the date of expiration of the first patent of the same invention or an obvious variation thereof."  Slip Op. at 14-15.

12 thoughts on “Sun Pharmaceuticals v. Eli Lilly: obviousness-type double patenting in the pharmaceutical context

  1. David French writes:

    It seems to me that obviousness-type double patenting could be classified in two categories.

    The first is the case where something could have been claimed in the original filing because there was support for claims that could have been made but were not. This case is limited to where a subsequent application attempts to claim obvious variants on what was claimed previously. Additionally, external prior art does not render the coverage in the second patent obvious in view of the coverage of the first patent.

    And the second category is where there was no support for claiming the subject matter of the second patent in the specification of the first patent, but the coverage of the second patent is obvious over the coverage of the first patent in view of the external prior art.

    Is any distinction made on this basis?

  2. Agree with the posts above on In re Vogel. What bothers me the most about this decision is the reasoning that it is appropriate to look at the specification in this case to determine the scope of the claim. The “prior art” claim was to the compound itself. The potential uses of the compound do not relate to the scope of the claim.

  3. Thanks, Just, for reminding me of the correct cite – Vogel – about comparing claims to claims and not claims to spec in OTDP rejections.

  4. Just, it does appear the Feds have overruled a decision they cannot overrule except en banc.

    But, it happens all the time with this court. Respect for the law is not this court’s strong point.

  5. So just to be clear. Compositions and methods are always restricted vis-a-vis each other because they are patentably distinct, and yet we continue to find OTDP when compositions and methods are presented in separate applications. Of course, it is best to force a Restriction Requirement to avoid the whole issue, but that is merely form over function. If methods and compositions being patentably distinct from each other is basically black letter law at the PTO, the same should be true when OTDP is considered (although I am not the least bit surprised that it is not).

  6. Absent from this decision, and from the earlier decisions in Geneva and Pfizer, is a discussion of In re Vogel, which explicitly prohibited use of the specification for the purposes now apparently allowed by these cases. See In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970):

    “The second analysis question is: Does any claim in the application define merely an obvious variation of an invention disclosed and claimed in the patent? In considering the question, the patent disclosure may not be used as prior art.

    The Vogel court did not rule out all use of the specification, but it severely curtailed its use:

    “This does not mean that the disclosure may not be used at all. As pointed out above, in certain instances it may be used as a dictionary to learn the meaning of terms in a claim. It may also be used as required to answer the second analysis question above. We recognize that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim. A claim is a group of words defining only the boundary of the patent monopoly. It may not describe any physical thing and indeed may encompass physical things not yet dreamed of. How can it be obvious or not obvious to modify a legal boundary? The disclosure, however, sets forth at least one tangible embodiment within the claim, and it is less difficult and more meaningful to judge whether that thing has been modified in an obvious manner. It must be noted that this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. § 103, since only the disclosure of the invention claimed in the patent may be examined.

  7. Just checked, the later-issued patent, the ‘826, has an additional inventor. Presumably, absent common ownership, the two patent would remain perfectly valid, even if they were later united by common ownership.

    Now, if we constructed corporate assignment obligations such that common ownership would only date from a date sometime after grant, double patenting could not be used against the patents such as these. Perhaps these contracts could also be used to deflect 102(e) (f) and (g) as required and necessary by providing retroactive assignment to the date of invention.

    Probably overly sophisticated.

  8. Hopefully, strange alleged “douple-patenting” decisions like this one (comparing a claim of one patent to a specification [rather than a claim] of another patent) will largely disapear along with the last of the old patents issued under the old patent term statute?

  9. BTW, was there an issue about inventorship that may have prevented the claims from being included in the reference case?

  10. And, Phillies, had they claimed it in the same application, they probably would have received a restriction requirement, allowing them to do under Section 121 what they ended up doing voluntarily.

  11. Oh what a tangled web we weave. The use of the term “double patenting” in connection with this case, as well as the Geneva and Pfizer cases, is misleading, and I’m not convinced it’s in accord with earlier usage of that term. My recollection is that for OTDP to apply, the claims of the later patent must be obvious over the *claims* of the earlier patent. What’s bothersome here is not that Lilly received a later patent with claims that were obvious in view of the claims of the earlier patent, but that Lilly, like GSK and Pfizer, *could have claimed* the claimed invention in the earlier patent, and by not doing so, and not filing a terminal disclaimer, effectively received a longer patent term than it deserved.

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