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07 January 2019
On 7 December 2018 a Federal Circuit panel in Novartis AG v Ezra Ventures LLC (2017-2284) held that a patent term extension (PTE) granted pursuant to 35 USC Section 156 was not invalid for obviousness-type double patenting. The Federal Circuit's decision in this case should provide pharmaceutical patentees with some assurance that their PTEs generally will not fall foul of the obviousness-type double patenting doctrine.
A PTE is intended to compensate a pharmaceutical patentee for the portion of the patent term it loses while commercial approval of its patented drug product is delayed because of the Food and Drug Administration's (FDA's) regulatory review process. The US Patent and Trademark Office (USPTO) may grant a PTE of up to five years, depending upon the length of the FDA's regulatory review.
If there are multiple patents that cover the drug product in question, the patentee may choose only one patent to which to attach a PTE.(1) The patentee in that situation will then be in possession of two (or more) patents that cover related subject matter, and that expire at different times. The doctrine of obviousness-type double patenting, however, under certain circumstances prohibits a patentee from owning two patents that claim non-patentably distinct subject matter, but that expire at different times. Under those circumstances, a patentee may be required to submit to the USPTO a 'terminal disclaimer' that disclaims any portion of the term of the later-expiring patent that extends beyond the term of the earlier-expiring patent. Pharmaceutical patentees have thus expressed concern over the possibility that their PTEs might be abrogated or cut short by the obviousness-type double patenting doctrine.
In this case, Novartis owned two patents, US Patents 5,604,229 (the '229 patent) and 6,004,565 (the '565 patent). The '229 patent claimed fingolimod, the active ingredient in Novartis's multiple sclerosis drug product Gilenya and the '565 patent claimed a method of administering fingolimod. The '229 patent was originally set to expire on 18 February 2014. However, the USPTO granted a five-year PTE for Gilenya, and Novartis chose to attach the PTE to the '229 patent, thereby extending the term of the '229 patent to 18 February 2019. The '565 patent expired on 23 September 2017.(2)
Novartis sued Ezra for infringement of the '229 patent in the District of Delaware. Ezra moved for judgment on the pleadings and argued that:
The district court denied Ezra's motion and entered final judgment in Novartis's favour on the Section 156(c)(4) and double patenting issues. Ezra appealed.
On 7 December 2018 the Federal Circuit, in a decision authored by Judge Chen, affirmed the district court.
The Federal Circuit rejected Ezra's argument that Novartis effectively extended the terms of two patents in violation of Section 156(c)(4). According to Ezra, Novartis's choice to attach a PTE to the '229 patent effectively extended the term of the '565 patent term, because the '229 patent covers the compound (fingolimod) required to practise the method of the '565 patent. The Federal Circuit, however, observed that the statutory language of Section 156 did not foreclose any such "effective" extension, noting "That the method of the '565 patent cannot be practiced during the '229 patent's extended term is a permissible consequence of the legal status conferred upon the '229 patent by § 156". The Federal Circuit also observed that nothing in the statute could be read to limit a patentee's choice as to which of its patents to extend.
Turning to the question of whether Novartis's PTE was invalid under the doctrine of obviousness-type double patenting, the Federal Circuit relied on its prior decision in Merck & Co v Hi-Tech Pharmacal Co(3) to hold that Novartis's PTE was not invalid. In Merck the Federal Circuit upheld the validity of a PTE that had been attached to a patent that previously had been terminally disclaimed to overcome an obviousness-type double patenting rejection by the USPTO. The Federal Circuit reasoned that its holding in Novartis was a "logical extension" of its holding in Merck:
We agree with the district court's observation that if a patent is terminally disclaimed to another patent to overcome an obviousness-type double patenting rejection and then term-extended under § 156 (as in Merck), it necessarily will expire after the patent to which it had been subject to an obviousness-type double patenting rejection. Such an extension would result in the situation, as here, where the term of patent protection afforded to the patentably indistinct patent to which the extended patent was terminally disclaimed is—in Ezra's words—"effectively" extended because of a PTE granted pursuant to § 156.
The Federal Circuit dismissed Ezra's policy-based arguments against Novartis's PTE. The Federal Circuit noted that Novartis had chosen to extend the earlier-filed '229 patent and, thus, Novartis "does not raise the traditional concern with obviousness-type double patenting of a patent owner 'extending his exclusive rights to an invention through claims in a later-filed patent that are not patentably distinct from claims in the earlier filed patent'". The Federal Circuit also noted that the facts of the case did not give rise to any "potential gamesmanship issue" and that, "[b]ut for the § 156 PTE, the '229 patent would have expired before the '565 patent". The Federal Circuit further noted that a "judge-made doctrine", such as obviousness-type double patenting, should not curtail a "statutorily authorized time extension", such as a PTE.
The Federal Circuit concluded, "we hold that a PTE pursuant to § 156 is valid so long as the extended patent is otherwise valid without the extension".
For further information on this topic please contact Christopher Loh at Venable LLP by telephone (+1 410 244 7400) or email (email@example.com). The Venable LLP website can be accessed at www.venable.com.
(2) The '229 patent is a pre-Uruguay Round Agreements Act (URAA) patent; its original term was set to expire 17 years after its 18 February 1997 issue date. The '565 patent is a post-URAA patent; it expired 20 years after its 23 September 1997 effective filing date.
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