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35 U.S.C. § 121 Safe Harbor from Double Patenting Rejections Does Not Apply to Continuation Applications

09-1020
September 15, 2009

Decision icon Decision

Last Month at the Federal Circuit - October 2009

Judges: Mayer, Clevenger, Schall (author)

[Appealed from: D. Mass., Judge Young]

In Amgen Inc. v. F. Hoffman-La Roche Ltd., Nos. 09-1020, -1096 (Fed. Cir. Sept. 15, 2009), the Federal Circuit held that the safe harbor against double patenting rejections of divisional applications provided by 35 U.S.C. § 121 did not apply to continuation applications. The Court held that in limited circumstances, both the patentee and a patent challenger may rely on evidence produced after the effective priority date but before the actual filing date of a patent to support or rebut a finding of no obviousness-type double patenting (“OTDP”). Finally, the Court affirmed the majority of the district court’s holdings of infringement and no invalidity for indefiniteness or anticipation.

Amgen Inc. (“Amgen”) is the owner of a family of patents directed to recombinant erythropoietin (“EPO”), a protein useful in treating blood disorders such as anemia. F. Hoffman-La Roche Ltd., Roche Diagnostics GmbH, and Hoffman-La Roche Inc. (collectively “Roche”) makes MIRCERA®, a recombinant EPO polypeptide covalently linked to polyethylene glycol (“PEG”). Roche manufactures MIRCERA® overseas, but has sought to market it in the United States. In response, Amgen sought a DJ that, if imported into the United States, MIRCERA® would infringe the claims of at least five of Amgen’s patents: U.S. Patent Nos. 5,441,868 (“the ’868 patent”), 5,547,933 (“the ’933 patent”), 5,618,698 (“the ’698 patent”), 5,756,349 (“the ’349 patent”), and 5,955,422 (“the ’422 patent”). These patents all descend as continuations from a single parent application, which issued as U.S. Patent No. 4,703,008 (“the ’008 patent”).

The ’008 patent was subject to a six-way restriction requirement between the following groups of inventions: polypeptides, DNA, plasmids, cells, pharmaceutical compositions, and assays. Claims to DNA were elected and issued in the ’008 patent. During the pendency of the application that issued as the ’008 patent, two continuation applications were filed and led to additional continuation applications that issued as the five patents-in-suit. The patents-in-suit may be divided into two groups: the “product patents” (the ’933 and ’422 patents, containing product and product-by-process claims) and the “process patents” (the ’868, ’698, and ’349 patents, claiming methods of producing recombinant EPO). None of the patents claim the subject matter claimed in the ’008 patent—DNA and cells containing the DNA.

Amgen brought a DJ action against Roche in Massachusetts, alleging that MIRCERA® would infringe Amgen’s five EPO patents. The case was decided by a combination of SJ, jury trial, and JMOL, and the district court entered judgment that the ’349 patent was neither invalid nor infringed, and that the remaining four patents were valid and infringed. The district court granted Amgen declaratory relief and permanently enjoined Roche from marketing MIRCERA® in the United States.

Roche appealed the district court’s findings that none of the claims were invalid for OTDP and that claim 1 of the ’422 patent was neither anticipated nor indefinite and infringed. Roche also challenged the jury’s verdict that the ’933, ’868, and ’698 patents were literally infringed. Amgen cross-appealed from the district court’s holding and the jury’s verdict that some of the asserted claims were not infringed.

The Federal Circuit vacated the district court’s grant of SJ to Amgen of no invalidity for OTDP, vacated the district court’s grant of JMOL of no infringement of claim 7 of the ’349 patent, remanded these issues to the district court for a new trial, and affirmed all other judgments.

35 U.S.C. § 121 provides a safe harbor against double patenting rejections for divisional applications filed as a result of a restriction requirement. The Federal Circuit, citing their holding in Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008), held that § 121 does not apply to continuation applications. The Court held that “[t]he statute on its face applies only to divisional applications, and a continuation application, like a continuation-in-part application, is not a divisional application.” Slip op. at 15-16 (footnote omitted). The Court recognized that Amgen’s applications may have satisfied all the substantive requirements of a divisional application, but refused to grant the patents the benefits accorded to divisional applications. Id. at 16-17 (quoting Geneva Pharm., Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1382 (Fed. Cir. 2003) (“Given the potential windfall [a] patent term extension could provide to a patentee, this court applies a strict test for application of § 121.” (alteration in original))). The Court distinguished this case from situations where a divisional application is properly filed in response to a restriction requirement and continuation applications are filed off the divisional application. Those continuations of divisional applications will continue to receive the benefit of the § 121 safe harbor from double patenting rejections. Accordingly, the Court vacated the district court’s SJ holding of no OTDP of the ’933, ’422, and ’349 patents over the claims of the ’008, ’868, and ’698 patents, and remanded for a new trial on this issue.

In so doing, the Court discussed the holding in Takeda Pharmaceutical Co. v. Doll, 561 F.3d 1372 (Fed. Cir. 2009) (evidence generated up to the filing date of the later-filed application of alternative processes to make a product may be used to support a position that product and process claims are patentably distinct and therefore not subject to an OTDP rejection). The Court stated that a patent challenger may not use evidence produced after the filing date of the first-filed patent to support a prima facie case of OTDP (i.e., evidence that no alternative processes exist). However, should a patentee rely on post-filing date evidence to show the existence of alternative processes, the challenger may then also use post-filing date evidence to rebut the patentee’s assertions.

The Court then addressed the question of whether the process patent claims were invalid for OTDP over the ’008 patent. The Court agreed with the district court’s claim construction and held that the process claims required the step of producing and isolating a glycosylated EPO polypeptide with a specific biological activity. The Court held that a person of ordinary skill in the art would not have a reasonable expectation of success in producing this protein based on the claims of the ’008 patent. The Court relied on expert testimony that the ’008 patent claims did not teach which, if any, host cells would produce EPO with the carbohydrate structure necessary for its in vivo function and that no one had successfully produced a recombinant glycoprotein with in vivo biological activity where the carbohydrate structures were important for biological activity. Accordingly, the Federal Circuit affirmed the district court’s finding of no invalidity of claims 1 and 2 of the ’868 patent and claims 6-9 of the ’698 patent for OTDP.

The Federal Circuit affirmed the district court’s holding that the product patent claims were not invalid for anticipation by prior art teaching EPO protein purified from urine. The Court acknowledged that an old product is not patentable, even if made by a new process, but pointed out that a new product may be patented by reciting source or process limitations, so long as the product is new and unobvious. The district court construed the claims to include the source limitation “wherein said erythropoietin is purified from mammalian cells grown in culture,” and relied on expert testimony that demonstrated that EPO purified from mammalian cells could be distinguished from urinary EPO based on its carbohydrate content. The Court found that this distinction was sufficient to impart novelty on the claimed products.

The Federal Circuit affirmed the district court’s finding that the patents were not invalid for indefiniteness, holding that the definitions of EPO and the source limitations in the claims were definite because the product-by-process nature of the product claims allowed Amgen to define the claimed product by the source. The Court opined that “to call the process limitation indefinite in this situation would defeat one of the purposes of product-by-process claims, namely permitting product-by-process claims reciting new products lacking physical description.” Slip op. at 55-56.

The Court affirmed the district court’s findings of literal infringement of some of the asserted product and process claims, holding that the addition of PEG to recombinant EPO was simply the addition of an element, not a fundamental chemical transformation. Therefore, pegylation is not a transformation of the EPO polypeptide structure that would exclude it from the scope of the product claims. With regard to the process claims, the Court evaluated infringement under 35 U.S.C. § 271(g) (prohibiting the importation of a product made by a process patented in the United States). Specifically, the Court addressed whether MIRCERA® is materially changed by subsequent processes prior to importation. Stating that “[i]n the biotechnology context, a significant change in a protein’s structure and/or properties would constitute a material change,” id. at 65, the Court looked to Amgen’s specification and claims for a recitation of the protein’s structure and function. The Court found that the structure and functional differences between the product produced by Amgen’s claimed processes were not material because MIRCERA® still contains EPO, the structure of EPO remains intact, and MIRCERA® possesses the same functionality as the EPO product produced by the processes of Amgen’s claims. Accordingly, the Court affirmed the district court’s holding of infringement of both the product and process patents.

The Court also affirmed the district court’s JMOL overturning a jury’s verdict of infringement under the DOE for a subset of the asserted product claims, holding that Amgen had failed to identify limitation by limitation the equivalent functionway- result. In particular, the Court found that the record lacked particularized testimony and linking argument as to the insubstantiality of the differences between a therapeutic efficacy limitation in the claims and the actual therapeutic efficacy of MIRCERA®. Accordingly, the Court affirmed the district court’s holding of no infringement of claims 9, 11, 12, and 14 of the ’933 patent.

The Court vacated the district court’s JMOL holding of no infringement overturning a jury’s verdict of infringement of claim 7 of the ’349 patent, holding that a reasonable jury could have found this claim infringed because evidence was produced that Roche’s actual production process met the limitations of the claims. The Court remanded to the district court for a new trial.

On remand, the district court will reconsider the OTDP of the ’933, ’422, and ’349 patent claims over the ’008, ’868, and ’698 patent claims, and the infringement of claim 7 of the ’349 patent. Because the Court upheld the majority of the infringement rulings, the permanent injunction remains in place.

Summary authored by Elizabeth E. Mathiesen, Ph.D., Esq.