Category Archives: Double Patenting

Normal Double Patenting Rules Don’t Apply When the Patents Straddle the URAA

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In Novaritis Pharmaceuticals Corporation v. Breckenridge Pharmaceutical Inc., [2017-2173, 2017-2175, 2017-2176, 2017-2178, 2017-2179, 2017-2180, 2017-2182, 2017-2183, 2017-2184] (December 7, 2018), the Federal Circuit reversed the district court, determining that the law of obviousness-type double patenting does not require a patent owner to cut down the earlier-filed, but later expiring, patent’s statutorily-granted 17-year term so that it expires at the same time as the later-filed, but earlier expiring patent, whose patent term is governed under an intervening statutory scheme of 20 years from that patent’s earliest effective filing date.

Applying  Gilead Sciences, Inc. v. Natco Pharma Ltd., which held that a later-filed but earlier-expiring patent can serve as a double patenting reference for an earlier-filed but later-expiring patent, the district court found U.S. Patent No. 6,440,990 to be a proper double patenting reference for the earlier filed U.S. Patent No. 5,665,772, which had a longer term because of a change in the statutory term.

The Federal Circuit said that Gilead addressed a question that was not applicable in the present case — in Gilead, the Federal Circuit concluded that, where both patents are post- URAA, a patent that issues after but expires before another patent can qualify as a double patenting reference
against the earlier-issuing, but later-expiring patent.  In contrast, in the present case Novartis owns one pre-URAA patent (the ’772 patent) and one post-URAA patent (the ’990 patent), and the 17-year term granted to the ’772 patent does not pose the unjustified time extension problem that was the case for the invalidated patent in Gilead.


[T]he present facts do not give rise to similar patent prosecution gamesmanship because the ’772 patent expires after the ’990 patent only due to happenstance of an intervening change in patent term law. Both the ’772 and the ’990 patents share the same effective filing date of
September 24, 1993. If they had been both pre-URAA patents, the ’990 patent would have expired on the same day as the ’772 patent by operation of the terminal disclaimer Novartis filed on the ’990 patent, tying its expiration date to that of the ’772 patent. And if they had been
both post-URAA patents, then they would have also both expired on the same day. Thus, the current situation does not raise any of the problems identified in our prior obviousness-type double patenting cases. At the time the ’772 patent issued, it cannot be said that Novartis improperly
captured unjustified patent term. The ’990 patent had not yet issued, and the ’772 patent, as a pre-URAA patent, was confined to a 17-year patent term.

The Federal Circuit concluded that in this particular situation where we have an earlier filed, earlier-issued, pre-URAA patent that expires after
the later-filed, later-issued, post-URAA patent due to a change in statutory patent term law, it would not invalidate the challenged pre-URAA patent by finding the post-URAA patent to be a proper obviousness-type double
patenting reference.

The Novelty of an Optical Isomer is not Negated by the Prior Art Disclosure of its Racemate

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In UCB, Inc. v. Accord Healthcare, Inc., [2016-2610, 2016-2683, 2016-2685, 2016-2698, 2016-2710, 2017-1001] (May 23 2018), the Federal Circuit affirmed the district court’s determination that UCB’s patents on lacosamide, an anti-epileptic drug, were not invalid for obviousness-type double patenting, obviousness, and anticipation.

On the issue of double patenting, the Federal Circuit noted that in chemical cases, the double patenting inquiry is not whether a person of ordinary skill in the art would select the earlier compound as a lead compound, but rather whether the later compound would have been
an obvious or anticipated modification of the earlier compound — the underlying patent in the double patenting analysis need not be prior art to the later claim.  The Federal Circuit found that the district court did not err by focusing its double patenting analysis on the claims’ differences, as well as the claims as a whole.  The Federal Circuit said that proving that a claim is invalid for obviousness-type double patenting “requires identifying some reason that would have led a chemist to modify the earlier compound to make the later compound with a reasonable expectation of success.  Acknowledging that it was a close case, because it discerned no clear error in the district court’s underlying fact finding that there would have been no reasonable expectation of success in making the modifications needed to make the claimed combination, the Federal Circuit agreed with the district court that the asserted claims of the ‘551 patent were patentably distinct from the ’301 patent.

With respect to obviousness, the Federal Circuit applied a lead compound analysis, rejecting the proposition that the test does not apply in purification cases.  The lead compound analysis first determines whether a chemist of ordinary skill would have selected the asserted prior art compounds as lead compounds, or starting points, for further development efforts, and then determines “whether the prior art would have supplied one of ordinary skill in the art with a reason or motivation to modify a lead compound to make the claimed compound with a reasonable expectation of success.  The Federal Circuit found substantial evidence supported the district court’s conclusion that a person of ordinary skill in the art would not have selected either of the proferred lead compounds.

On anticipation, appellants argued that because the prior art disclosed the chemical structure, it it necessarily disclosed the R-enantiomer (lacosamide) recited in claim 9 of the ’551 patent.  The district court concluded that the prior art disclosed neither the R-enantiomer, nor any of its characteristics.  The Federal Circuit noted that the novelty of an optical isomer is not negated by the prior art disclosure of its racemate, and that the references specifically stated that it prepared the racemic amino acid derivatives rather than the individual enantiomers.  Thus, the Federal Circuit found no clear error in the finding of no anticipation.

A C-I-P Application is not Entitled to the Section 121 Safe Harbor from Double Patenting; and Cannot Retroactively be Turned into a Divisional Application

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In In re: Janssen Biotech, Inc., [2017-1257] (January 23, 2018), the Federal Circuit affirmed the rejection during reexamination of claims 1-7 of U.S. Patent No. 6,284,471 for obviousness-type double patenting.

The doctrine of obviousness-type double patenting is intended to prevent the extension of the term of a patent by prohibiting the issuance of the claims of a second patent that are not patentably distinct from the claims of the first patent.  Janssen argued that obviousness-type double patenting is not applicable because the safe-harbor provision of 35 U.S.C. § 121 protects the ’471 patent claims, so double-patenting turned on whether §121 applied, which in turn depended upon an interpretation of the prosecution history of the ’471 patent and that patent’s relationship to application to its parent application.

In that prosecution history, Janssen filed an application and received a 5-way restriction requirement with Group I drawn to antibodies, pharmaceutical compositions, and assay methods, and Group IV drawn to methods for treating an animal.  Rather responding to the restriction, Janssen expressly abandoned that application and filed two continuation-in-part application, one of which resulted in the patent under reexamination.

During reexamination, the Board found no reason to permit Janssen by amendment, to acquire the benefit of the safe harbor when Janssen  voluntarily and deliberately filed a continuation-in-part application with claims directed to subject matter absent from the parent application and outside the scope of its restriction.  Applying the one-way test for double patenting because it found that there were at least four instances where Janssen’s actions constituted deliberate and unnecessary actions that lengthened the prosecution time of the application.

The Federal Circuit agreed that the §121 safe harbor, by its literal terms, protects only divisional applications (or the original application) and patents issued on such applications.  Accordingly, the Federal Circuit said that patents issued on CIP applications or continuation applications are not within the scope of §121. The Federal Circuit said that its precedent was clear: aside from the original application and the original patent, the protection afforded by §121 is limited to divisional applications and patents issued on divisional applications.

Further, the Federal Circuit said that a patent owner cannot retroactively bring its challenged patent within the scope of the safe-harbor provision by amendment in a reexamination proceeding.