CAFC holds all the claims of a patent have the same expiration date, whether the claims are drawn to the product subject to patent term extension or not
Lee Wright | April 11, 2012
Genetics Institute, LLC v. Novartis Vaccines and Diagnostics, Inc.
August 23, 2011
Panel: Lourie, Plager and Dyk. Opinion by Judge Lourie. Concurrence-in-part and dissent-in part by Dyk.
Today, we bring you the second in a series of three articles regarding an important case from last year. For part 1, click here. This article discusses the following question:
Question: Where a patent has been granted an extension of term due to regulatory review, is there a different expiration date for the claims that were the subject to the regulatory review and the claims that do not claim the approved product?
Answer: The expiration date is not determined on a claim by claim basis.
A patent, and therefore all of the claims in the patent, have the same expiration date, which is the expiration date as extended by patent term extension.
At issue in this appeal are claims 1, 5, 9, and 10 of U.S. Patent 4,868,112 (the “’112 patent”). These claim, respectively, a recombinant DNA whose expression results in a truncated Factor VIII protein; a host cell containing the recombinant DNA; method of producing the truncated Factor VIII protein by culturing the host cells; and a truncated human Factor VIII protein.
The ’112 patent, which issued on September 19, 1989, and was set to expire on September 19, 2006, at the end of its seventeen-year term. In 2000, Genetics obtained a patent term extension (PTE) under 35 U.S.C. §156 based on the time consumed by testing and FDA regulatory review of its commercial recombinant Factor VIII protein, ReFacto®. The USPTO extended the term of the ’112 patent to February 28, 2010.
In their petition for PTE filed in the USPTO, Genetics identified claims 9 and 10 of the ’112 patent as relating to its commercial product ReFacto®. Claim 9 depends from claim 5 and claim 5 depends from claim 1.
On May 16, 2008, Genetics sued Novartis in the United States District Court for the District of Delaware to determine priority of invention under 35 U.S.C. § 291.
Genetics alleged that an interference in fact existed between the claims 1, 5, 9 and 10 of the ’112 patent and claims from two Novartis patents.
The district court held that a patent term extension under §156 applies to the term of the patent as a whole, i.e., to all claims in the patent.
Novartis appealed, alleging that the district court lacked jurisdiction to decide whether claims 1 and 5 of the ’112 patent and the Novartis patents interfered. Novartis argues that claims 1 and 5 of the ’112 patent are not entitled to an extended term because Genetics, in its patent term extension application under §156(d)(1), identified only claims 9 and 10 of the ’112 patent as relating to its commercial product ReFacto®. Novartis argues that patent term extension applies on a claim-by-claim basis. Therefore, Novartis argues, claims 1 and 5 expired on September 19, 2006, following the original seventeen-year patent term. Novartis argues claims 1 and 5 cannot support an interfering patents action under §291.
The CAFC rejected Novartis’s assertion that a patent term extension under §156 applies on a claim-by-claim basis.
The court holds that the plain language of §156 refutes Novartis’s argument. The title of §156 is “Extension of patent term.” Subsection (a) dictates that the term of the patent, as opposed to specific claim(s), shall be extended:
The term of a patent which claims a product, a method of using a product, or a method of manufacturing a product shall be extended in accordance with this section from the original expiration date of the patent . . . .”
§ 156(a) (emphases added).
Novartis argued that the rights derived in 156(b) support a claim by claim analysis:
Except as provided in subsection (d)(5)(F), the rights derived from any patent the term of which is extended under this section shall during the period during which the term of the patent is extended –
(1) in the case of a patent which claims a product, be limited to any use approved for the product.
156(b) (emphases added):
The court discussed that §156(b), which sets forth “the rights derived from any patent the term of which is extended under this section,” § 156(b) (emphasis added), and concluded that it is equally clear that §156 applies to the term of the patent, not individual claim(s).
The court holds that subsection (b) was intended not to restrict the extension to particular claims, but rather to limit the effect of the extension. Id. (stating, for example, that for patents that claim a product, the rights in the extended term are “limited to any use approved for the product”).
Thus, the court concludes that neither § 156(a) nor § 156(b) supports Novartis’s position that § 156 applies only to particular claims. Rather, the court holds that a patent as a whole is extended even though its effect may be limited to certain of its claims.
Novartis further argues that §156(d) supports the claim by claim analysis.
(1) To obtain an extension of the term of a patent under this section, the owner of record of the patent or its agent shall submit an application to the Director … The application shall contain –
(A) the identity of the approved product and the Federal statute under which regulatory review occurred;
(B) the identity of the patent for which an extension is being sought and the identity of each claim of such patent which claims the approved product … .
§ 156(d) (emphasis added)
The court holds that subsection (d)(1) merely lists the required contents of an application for a patent term extension. Subsections (a) and (b), on the other hand, set forth the legal effect of the patent term extension itself.
In sum, in light of the plain language of §156, and absent any indication that Congress intended that the extension should apply only to particular claims, the court declined to adopt Novartis’s arguments.
The court also disagreed with Novartis’ contention that the restrictions under §156(b) on the rights derived from the extension of the ’112 patent prevented Genetics from asserting claims 1, 5, and 10 in this §291 action. Novartis concedes that claim 9 covers Refacto®, the approved product for which Genetics received the patent term extension. Because claim 9 depends from claims 1 and 5, those claims must also cover Refacto®. See 35 U.S.C. § 112 ¶4.
Finally, the court also rejected Novartis’s related argument that no patent extended under §156 can form the basis of a §291 interfering patents action. The statutory text does not suggest that rights afforded by §156 are so limited. And, as the district court correctly noted, Genetics, 687 F. Supp. 2d at 497, the legislative history advises against Novartis’s interpretation: the 1984 House Report discussing the Hatch-Waxman Act provides that “all provisions of the patent law apply to the patent during the period of extension.” H.R. Rep. No. 98-857, pt. 1, at 39 (emphasis added).
In a foot note, the court noted that in Boehringer Ingelheim International GMBH v. Barr Laboratories, Inc., 592 F.3d 1340, 1349 (Fed. Cir. 2010), a case involving obviousness-type double patenting, the court had suggested in passing that a patent term extension might apply only to specific claims. The court dismissed the statements in Boehringer as dictum and further noted that Boehringer was not cited in support of either party’s position in this case.
1. PTE may extend the term of a patent for up to 5 years. An expired patent may form the basis of an action for past damages past the expiration date of a patent, up to the six-year limitation under 35 U.S.C. § 286.
The claims not subject to PTE cannot be enforced beyond the unextended term of a patent. However, where a patent has been granted PTE, be aware that an action for past damages may be filed for any claim in such a patent up to 11 years after the unextended term of a patent.
2. Claims that read on the product subject to FDA review may obtain extension of enforcement rights, whether or not they were listed in the petition for PTE.