Issuance date or expiration date as the reference point for obviousness-type double patenting?
| January 11, 2019
Novartis Pharmaceutical Corp. v. Breckenridge Pharmaceutical Inc., et al
December 7, 2018
Before Prost, Wallach, and Chen. Opinion by Chen.
Summary
The Federal Circuit reversed the district court’s decision to invalidate U.S. Patent No. 5,665, 772 based on obviousness-type double patenting because a change in patent term law should not truncate the term statutorily as assigned to the pre-URAA ‘722 patent.
Details
Novartis owns U.S. Patent No. 5,665,772 (hereafter ‘722 patent), which claims the compound everolimus, and U.S. Patent No. 6,440,990 (hereafter ‘990 patent), which is directed to some methods of treatment using everolimus and some pharmaceutical compositions including everolimus. Everolimus is an active ingredient in Zortress® and Afinitor®, which are famous drugs for treating certain cancers and preventing rejection in kidney and liver transplantations. Plaintiff Novartis sues Defendants Breckenridge for infringing ‘772 patent after Defendants sought FDA approval to market generic versions of Zortress® and Afinitor®.
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 ‘772 patent was filed on April 7, 1995 and issued on September 9, 1997. Because it was filed before June 8, 1995, the URAA’s effective date, the patent term is 17 years from the issuance date. Furthermore, Novartis obtained a five-year patent term extension under 35 U.S.C. §156 of the Hatch-Waxman Act. So the actual expiration date for the ‘722 patent is September 9, 2019. The ‘990 patent was filed on May 23, 1997 and issued on August 27, 2002. Because it was filed after the URAA’s effective date and claimed the same priority as the ‘722 patent from a September 24, 1993 PCT filing date. So the expiration date for the ‘990 patent is September 24, 2013. The following diagram illustrates the dates for each patent:
That is, the ‘990 patent issues later, but expired earlier, than the ‘772 patent. There is a terminal disclaimer filed in ‘990 patent.
Defendants relied heavily on decision in a previous federal circuit case, Gilead Sciences, Inc., v. Natco Pharma Ltd. 753 F. 3d 1208 (Fed. Cir. 2014). The following diagram illustrates the relevant dates of two patents in dispute:
Gilead held that the proper reference point for an obviousness-type double patenting inquiry is the expiration dates, rather than the issuance dates, of the patents in question. Thus, a patent (‘375 patent) that issues after but expires before another patent (‘483 patent) can qualify as a double patenting reference against the earlier-issuing, but later-expiring patent (‘483 patent). However, the Federal Circuit distinguishes this case from Gilead because the two patents in Gilead were all filed post-URAA while, in the present case, one patent was filed pre-URAA and the other patent was filed post-URAA. The URAA transition statute 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 PCT application to which priority is claimed, excluding provisional applications.
Defendants also relied on another previous case, Abbvie, Inc. v. Mathilda & Terence Kennedy Institute of Rheumatology Trust, 764 F. 3d 1366 (Fed. Cir. 2014). The following diagram illustrates the relevant dates of two patents in dispute:
AbbVie also held 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. The court explained 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. However, the Federal Circuit distinguishes this case from Abbvie because the two patents in Abbvie were all filed post-URAA.
The Federal Circuit’s rationale seems to place a lot of weight on the fact that Novartis did not engage in any gamesmanship such as the structuring of priority claims among related patents to obtain the benefit of one patent gaining a later expiration date. Furthermore, the URAA transition statute expressly provides that the term of a patent issuing from an application filed before June 8, 1995 shall be the greater of the 20-year term from the earliest priority date or 17 years from grant, subject to any terminal disclaimers. Thus, the Federal Circuit applies traditional, pre-URAA obviousness-type double patenting practice to the pre-URAA patent. That is, the ‘772 patent’s issuance date is used as the reference point for the obviousness-type double patenting analysis. Since the ‘990 patent is issued later than the ‘772 patent, the ‘990 patent is not a proper obviousness-type double patenting reference for the ‘772 patent.
Furthermore, the Federal Circuit considers that the holding is consistent with the core principle underlying the double patenting doctrine: giving one invention and nonobvious variants of that invention the same patent term. Here, critically, Novartis did not seek to extend its patent rights over its invention beyond one patent term, 17 years from issuance of the ‘772 patent.
Take away
- Is issuance date or expiration date as the reference point for obviousness-type double patenting? It depends. If the challenged patent is filed before June 8, 1995, the reference point for obviousness-type double patenting is the issuance date. If the challenged patent is filed after June 8, 1995, the reference point for obviousness-type double patenting is the expiration date.
