Novartis Pharmaceuticals Corp v. Breckenridge Pharmaceutical
Opinion
This case involves the complicated, potential double-patenting situation in which the later-filed of two related patents, which share a common specification and effective filing date, expires before the term of the earlier-filed patent due to an intervening change in law by Congress defining a patent's term. When the patent owner filed for the first patent, the governing law defined the patent term as 17 years from the date the patent issued. When the patent owner filed for its second, related patent, the governing law was amended to define the patent term as expiring 20 years from the patent's earliest effective filing date. Because of the two patents' relatively early effective filing date, the change in patent term law caused the second patent to expire earlier than the first patent. The patent owner here concedes that the claimed inventions in the two related patents are obvious variants of each other. The legal question we confront in this appeal is whether the law of obviousness-type double patenting requires 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.
See
Novartis Pharmaceuticals Corporation and Novartis AG (collectively, Novartis) appeal the district court's decision to invalidate
Applying our decision in
Gilead Sciences, Inc. v. Natco Pharma Ltd.
,
The patents at issue in
Gilead
were both filed after the effective date of the URAA and claimed different priority dates.
BACKGROUND
Novartis owns the '772 patent, which claims the compound everolimus, and the '990 patent, which is directed to certain methods of treatment using everolimus and specific pharmaceutical compositions comprising everolimus. Everolimus is the active ingredient in Zortress® and Afinitor®, which can be used to treat certain cancers and prevent rejection in kidney and liver transplantations. Novartis sued Breckenridge Pharmaceutical Inc., Par Pharmaceutical, Inc., and West-ward Pharmaceuticals International Ltd. (collectively, Defendants/Appellees) for infringing claims 1-3, 7, and 10 of the '772 patent after Defendants sought FDA approval to *1359 market generic versions of Zortress® and Afinitor®.
In the district court, Defendants conceded that their proposed products infringe the '772 patent's asserted claims. The parties stipulated that the '772 patent and the '990 patent are assigned to the same entity, and both patents share the same named inventors. The parties further stipulated that if the district court found the '990 patent to be a proper double patenting reference to the '772 patent, then the claims of the '990 patent would render the asserted claims of the '772 patent invalid for obviousness-type double patenting. J.A. 135. Thus, the only question before the district court was whether the '990 patent could serve as an obviousness-type double patenting reference against the '772 patent.
The '990 patent issued later, but expired earlier, than the '772 patent due solely to a change in patent term law. On June 8, 1995, the passage of the URAA changed the term of a U.S. patent from 17 years from the issuance date to 20 years from the filing date of the earliest U.S. or Patent Cooperation Treaty (PCT) application to which priority is claimed, excluding provisional applications. Pub. L. No. 36-38,
The '772 patent was filed on April 7, 1995, and issued on September 9, 1997. Because it was filed before June 8, 1995, the expiration date of the '772 patent is September 9, 2014 (17 years from the September 9, 1997 issuance date). After the '772 patent issued, Novartis obtained a five-year patent term extension under
*1360
Relying on our decision in
Gilead
, which holds that a later-filed but earlier-expiring patent can serve as a double-patenting reference for an earlier-filed but later-expiring patent in the post-URAA context,
see
The district court also cited other post-
Gilead
district court decisions reaching the same conclusion in cases with similar fact patterns, including
Janssen Biotech Inc. v. Celltrion Healthcare Co.
,
First, the district court rejected Novartis's argument that there is no unjustified extension of patent rights or public harm because the '772 patent's expiration date is the same as it would have been had the '990 patent never issued. The district court emphasized that it was Novartis's choice to file the '990 patent, and the harm to the public lies in the inability to practice the invention claimed in the '990 patent once it expired.
Second, the district court dismissed Novartis's argument that, unlike the patent owners in
Gilead
and
AbbVie, Inc. v. Mathilda & Terence Kennedy Institute of Rheumatology Trust
,
Third, the district court was unpersuaded by Novartis's argument that allowing an earlier-expiring post-URAA patent to serve as a double patenting reference for a later-expiring, pre-URAA patent would effectively shorten the statutorily mandated 17-year term of the pre-URAA patent. The district court found that Novartis ran this risk by seeking a second patent on an obvious variant of its invention claimed in its first issued patent.
Finally, the district court addressed Novartis's argument that the § 156 patent term extension it received for its '772 patent is not an unjustified extension of patent rights and effectively immunized its patent from a double patenting challenge. While the district court acknowledged that this is true in the abstract, it noted that Novartis's § 156 patent term extension grant is not at issue here and that there is no case law supporting Novartis's proposition that a term extension immunizes a patent from a double patenting challenge. 2 Thus, the district court held that the '990 patent is a proper double patenting reference for the '772 patent and that the '990 patent renders the '772 patent invalid for obviousness-type double patenting.
Novartis appeals. We have jurisdiction under
DISCUSSION
"While the ultimate conclusion that a patent is invalid under the doctrine of obviousness-type double patenting is reviewed de novo, the underlying factual determinations-including the existence of secondary factors such as unexpected results-are reviewed for clear error."
AbbVie
,
A.
"Non-statutory, or obviousness-type, double patenting is a judicially created doctrine designed to foreclose 'claims in separate applications or patents that do not recite the 'same' invention, but nonetheless claim inventions so alike that granting both exclusive rights would effectively extend the life of patent protection.' "
Takeda Pharm. Co. v. Doll
,
Federal courts have applied the principles of obviousness-type double patenting for over a century to restrict a patent owner's patents on an invention and obvious variants to one 17-year patent term.
See, e.g.
,
Eli Lilly & Co. v. Barr Labs., Inc.
,
For example, for the traditional scenario of two pre-URAA patents, if a first patent issued in, say, 1990, then that first patent would expire 17 years later in 2007. If the patent owner secured a second, patentably indistinct patent in 1992, then the patent owner would be required to file a terminal disclaimer with the second patent so that it would expire at the same time as the first patent in 2007, rather than two years later in 2009. Without the terminal disclaimer, the second patent would be invalid for obviousness-type double patenting because otherwise the first and second patents collectively would give the patent owner a 19-year period of exclusivity.
In
Gilead
, we recognized that the change in patent term law under the URAA altered the analytical inquiry for double patenting; issuance dates of post-URAA patents did not serve as reliable stand-ins for the expiration date of the patent as is true for pre-URAA patents, and the proper reference point for an obviousness-type double patenting inquiry is
*1363
the expiration date of the patent in question.
Gilead involved U.S. Patent Nos. 5,763,483 and 5,952,375. Id . at 1209. When Gilead Sciences, Inc. (Gilead) sued Natco Pharma Limited (Natco) for infringement of its '483 patent, Natco asserted that the '483 patent was invalid for obviousness-type double patenting over Gilead's '375 patent. Id . The '375 and '483 patents were issued to the same inventors, commonly owned by Gilead, and contained very similar specification disclosures. Id . at 1210. The post-URAA '375 patent was filed on February 26, 1996, claimed priority from a patent application filed on February 27, 1995, and expired on February 27, 2015. Id . The post-URAA '483 patent was filed on December 27, 1996, claimed priority from a provisional application filed on December 29, 1995, and expired on December 27, 2016. Id . The following diagram illustrates the relevant dates for the two patents at issue in Gilead :
While we found that the '375 patent could serve as a double patenting reference against the '483 patent, even though the '483 patent issued first and expired 22 months after the '375 patent, our holding was limited to the post-URAA context.
Throughout Gilead , we repeatedly noted that our analysis was rooted in the consequences *1364 that flow from the implementation of the URAA's new patent term rule under which a patent expires 20 years from the effective filing date:
[F]or double patenting inquiries, looking to patent issue dates had previously served as a reliable stand-in for the date that really mattered-patent expiration. But as this case illustrates, that tool does not necessarily work properly for patents to which the URAA applies, because there are now instances, like here, in which a patent that issues first does not expire first.
Id . at 1215.
And we discussed several shortcomings of relying on issuance dates for patents in the post-URAA context where the patent term is 20 years from the earliest effective filing date, but none are applicable to this case. One such shortcoming is that patent terms could be subject to significant gamesmanship during prosecution. Id . If the double patenting inquiry post-URAA was limited to focusing on patent issuance dates, inventors could orchestrate patent term extensions by filing serial applications on obvious variants of the same invention, claiming priority from different applications in each, and arranging for the application with the latest filing date to issue first. Id . We noted in our opinion that Gilead had "crafted a separate 'chain' of applications, having a later priority date than the '375 patent family" such that the later-filed but earlier-issued '483 patent expired second. Id . at 1210.
Another shortcoming of using the issuance date for post-URAA patents is that a mere day's difference in the issuance of multiple patents could result in a significant difference in an inventor's period of exclusivity. Id . at 1215. To illustrate this, in Gilead we noted that if the '375 patent had issued the day before the '483 patent, the last 22 months of the term of the '483 patent would have been an improper extension of patent term. Id . at 1215-16.
Here, the 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. Moreover, unlike Gilead , Novartis here did not structure the priority claim of its '990 patent to capture additional patent term beyond the term it was granted for its '772 patent. In fact, the '990 patent's term expired before the '772 patent's original 17-year term. Given the different circumstances in this case, our holding in Gilead does not resolve the narrow question on appeal here.
B.
Following
Gilead
, we confirmed in
AbbVie
that obviousness-type double patenting continues to apply post-URAA.
AbbVie is a prime example of the post-URAA scenario we contemplated in Gilead where an inventor, seeking to prolong his exclusivity rights over his invention, applies for a second patent on an obvious variant of his invention protected by a first patent but chooses a different, later priority date than the one relied on for the first patent so that the second patent expires later than the first patent. The following diagram illustrates the relevant dates for the two patents at issue in AbbVie , U.S. Patent Nos. 7,846,442 and 6,270,766. Id . at 1369-70.
The first-issued '766 patent was filed on August 1, 1996, claimed priority from October 8, 1992, and expired October 12, 2012. Id . at 1369. The second-issued '422 patent was filed on September 12, 2005, claimed priority from August 1, 1996 (rather than October 8, 1992), and expired on August 21, 2018. Id . at 1370. AbbVie sought a declaratory judgment that claims of the '422 patent (second-issued, second-expiring) were invalid over the '766 patent (first-issued, first-expiring) for obviousness-type double patenting. Id . at 1370. We agreed with the district court's double patenting invalidity ruling, explaining that the patent owner had impermissibly sought an undue patent term extension for its later-expiring, patentably indistinct claims by choosing to claim different priority dates for its patent applications, thereby *1366 ensuring that the resulting patents would have different expiration dates. AbbVie is distinguishable from the situation here because it not only involved two post-URAA patents, but also because the earlier-filed patent had an earlier issuance date and earlier expiration date.
C.
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, we decline to invalidate the challenged pre-URAA patent by finding the post-URAA patent to be a proper obviousness-type double patenting reference.
3
Instead, we apply our traditional, pre-URAA obviousness-type double patenting practice,
see supra
, to Novartis's challenged pre-URAA patent. That is, we use the '772 patent's issuance date as the reference point for our obviousness-type double patenting analysis. As we recognized in
Gilead
, looking to the patent issuance dates pre-URAA serves as a reliable guide for assessing whether a patent may serve as a double patenting reference against another patent.
See
This approach is most consistent with the URAA transition statute, which ensures that patent owners, like Novartis with its pre-URAA '772 patent, enjoy the greater of a 20-year from earliest effective filing date or 17-year from issuance patent term. The statute reads: "The term of a patent that is in force on or that results from an application filed before [June 8, 1995]
shall be the greater of
the 20-year term as provided in subsection (a), or 17 years from grant, subject to any terminal disclaimers."
*1367
Moreover, this approach is consistent with the core principle underlying the double patenting doctrine: giving one invention and nonobvious variants of that invention the same patent term.
See
infra
. The key purpose of obviousness-type double patenting is to prevent a patent owner from extending the exclusivity rights over his invention beyond a full patent term. We saw this impermissible practice in
Gilead
and in
AbbVie
, where the patent owners claimed different effective filing dates for different patents to extend the life of patent exclusivity.
Gilead
,
CONCLUSION
The district court erred in finding that the post-URAA '990 patent is a proper obviousness-type double patenting reference for the pre-URAA '772 patent. We have considered Appellees' other arguments and find them unpersuasive. Therefore, we reverse the district court's decision.
REVERSED
COSTS
No Costs.
This extension does not affect the obviousness-type double patenting analysis here because the '772 patent's original expiration date of September 9, 2014 (without its patent term extension under § 156 ) is still later than the '990 patent's expiration date of September 24, 2013. Thus, we need not address the interplay of § 156 PTEs and obviousness-type double patenting in this opinion. We address that issue in a concurrently issued opinion finding that obviousness-type double patenting does not invalidate an otherwise validly obtained PTE under § 156.
See
Novartis AG v. Ezra Ventures LLC
, No. 2017-2284,
We recognize that there are other fact patterns that could arise from hybrid situations in which one patent is pre-URAA and the other is post-URAA. We decline to address those other fact patterns in this opinion and limit our opinion to the specific facts of this case.
Appellees point to the "subject to any terminal disclaimers" language in the statute to argue that the '772 patent was subject to a terminal disclaimer once the '990 patent subsequently issued. But that argument lacks merit because it assumes this statutory language commands how to assess whether a given patent's term should be terminally disclaimed; we instead read "subject to any terminal disclaimers" in its ordinary sense that a patent's term provided for in this transition provision may be subject to a terminal disclaimer depending on the relevant facts, as is true for the term of any patent. But as explained supra , no terminal disclaimer was necessary for the '772 patent because the '990 patent is not a proper double patenting reference.
Reference
- Full Case Name
- NOVARTIS PHARMACEUTICALS CORPORATION, Novartis AG, Plaintiffs-Appellants v. BRECKENRIDGE PHARMACEUTICAL INC., Par Pharmaceutical, Inc., West-Ward Pharmaceuticals International Limited, Defendants-Appellees
- Cited By
- 13 cases
- Status
- Published