Obviousness-Type Double Patenting Archives

Eye-Catching: Biosimilars Injunction Prevails

by Courtney Seams | Feb 6, 2025 | Patents

Addressing a preliminary injunction in patent litigation related to the Biologics Price Competition and Innovation Act (BPCIA), the US Court of Appeals for the Federal Circuit upheld the district court’s grant of a preliminary injunction, finding that there was a proper exercise of personal jurisdiction and that no substantial question of invalidity had been raised for the patents at issue that would prevent the injunction from issuing. Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., Case No. 24-1965 (Fed. Cir. Jan. 29, 2025) (Moore, C.J.; Reyna, Taranto, JJ.)

Regeneron holds a Biologics License Application for Eylea®, a therapeutic product containing aflibercept (a VEGF antagonist used in various treatments for eye diseases). Regeneron owns multiple patents related to its Eylea® product, including a patent directed to intravitreal injections using VEGF formulations. Mylan, Samsung Bioepis (SB), and other companies filed abbreviated Biologics License Applications (aBLAs) with the US Food and Drug Administration (FDA) seeking approval to market Eylea® biosimilars. Regeneron brought suit against these parties asserting infringement of its patent and filed a motion for a preliminary injunction.

The district court granted the preliminary injunction against SB, enjoining it from offering for sale or selling the subject of its aBLA without a license from Regeneron. SB appealed, arguing that:

The exercise of personal jurisdiction over it was improper.
There was a substantial question of invalidity of the patent under either obviousness-type double patenting or lack of adequate written description.
There was no causal nexus established.

The Federal Circuit upheld the exercise of personal jurisdiction on SB, finding that SB had minimum contacts with the state of West Virginia. SB is headquartered in South Korea and entered into a development and commercialization agreement with Biogen for a biosimilar to Eylea®, SB15, that gives SB continuing rights and responsibilities as the agreement is implemented. The Court found that SB did not have to distribute the product itself under the agreement for it to be subject to personal jurisdiction. Further, the Court found that SB’s aBLA and internal documentation indicated an intent to distribute SB15 US-wide, which was sufficient to establish intent to distribute the product in West Virginia.

The Federal Circuit also upheld the district court’s grant of the preliminary injunction. SB invoked another patent in the same family as the asserted patent that was directed to an intravitreal injection containing a VEGF trap as the reference patent for an obviousness-type double patenting theory. The Federal Circuit upheld the district court’s findings that the stability requirement, the “glycosylated” requirement, and the “vial” limitations in the claims of the asserted patent were all patentably distinct from the reference patent. The Court found that the stability requirement recited in the asserted patent was more specific than, and not inherent within, the reference patent. The Court further agreed that the reference patent embraced both non-glycosylated and glycosylated aflibercept, not only the glycosylated aflibercept contained in the asserted patent claims.

The Federal Circuit then addressed SB’s arguments that the specification lacked sufficient written description for the claimed [...]

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Same Applicant, Similar Claims Support Obviousness-Type Double Patenting Rejection

by Jake B. Vallen | Jan 4, 2024 | Patents

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board obviousness-type double patenting rejection, finding that an unexpected mechanism of action does not render the known use of a known compound nonobvious. In re: Institut Pasteur, Case No. 22-1896 (Fed. Cir. Dec. 13, 2023) (Taranto, Clevenger, Stoll, JJ.) (nonprecedential).

Institut Pasteur filed a patent application directed to peptides derived from human basic proline-rich lacrimal protein and claimed, among other things, a method for treating pain comprising of administering 10 to 300 mg/day of the peptide for seven days. The examiner rejected the claims for obviousness-type double patenting over another patent application filed by Pasteur, which was directed to diagnostic and therapeutic uses of human basic proline-rich lacrimal protein and peptides derived therefrom.

Pasteur appealed to the Board, which affirmed the examiner’s rejection. Rather than appeal the Board’s decision to the Federal Circuit, Pasteur sought continued examination of the application and modified the claims to specify that the method of treatment was for human patients, was in a dose of 1 mg/kg to 2 mg/kg at 10 to 300 mg/day, and should not induce pharmacodependence or tolerance in the patient. The examiner rejected the amended claims for obviousness-type double patenting over the same application. On appeal, the Board issued another decision agreeing with the examiner. Pasteur appealed this decision.

Pasteur argued that the Board’s second decision was unsupported by substantial evidence because the Board applied a legally flawed prima facie obviousness analysis and disregarded the secondary indicia of nonobviousness presented in a declaration submitted by Catherine Rougeot, the named inventor of the application.

The Federal Circuit disagreed with Pasteur and affirmed the Board’s rejection. As for Pasteur’s argument that the Board disregarded the differences between the claims of the patent application and the claims of the other application, the Court noted that the Board “explained why each claim limitation was obvious in light of the [other application].” With respect to Pasteur’s argument that the Board improperly relied on inherency when finding one limitation of the filed application to be satisfied, the Court concluded that “[i]t is settled that inherency may supply a missing claim limitation in an obviousness analysis.”

As for Pasteur’s challenge to the Board’s consideration of the secondary indicia of nonobviousness presented in the Rougeot declaration, the Federal Circuit found that the Board’s analysis was supported by substantial evidence. The Court made clear that Pasteur failed to prove that the benefits claimed by the application were unexpected compared to the closest prior art since unexpected mechanisms of action do not ipso facto make the known use of known compounds nonobvious. The Court also noted that Federal Circuit precedent did not demand a finding of nonobviousness simply because one limitation was found to be satisfied through inherency. The Court was similarly unpersuaded by the long-felt need described in the Rougeot declaration because any need for the subject matter claimed by the patent application was already satisfied by the subject matter claimed by the other [...]

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“All Substantial Rights” Test Informative in Obviousness-Type Double Patenting Context

by Paul Devinsky | Jul 15, 2020 | Patents

The US Court of Appeals for the Federal Circuit endorsed for the first time the “all substantial rights” test to determine whether inventions are commonly owned for purposes of obviousness-type double patenting validity analysis of a later patent. Immunex Corp. v. Sandoz, Inc., Case No. 20-1037 (Fed. Cir. July 1, 2020) (O’Malley, J.) (Reyna, J., dissenting). The Court determined that patents were not commonly owned—and therefore a later patent was not invalid for obviousness-type double patenting—when the patentee retained a secondary right to sue for infringement and the right to “veto” further assignment of the patents by the grantee.

Roche licensed a family of patent applications to Immunex. Under the license agreement, Immunex agreed to pay a running royalty to Roche based on sales of products incorporating the patented technology. Non-party Amgen subsequently acquired Immunex. Amgen, Immunex and Roche entered into an agreement to eliminate the continuing royalties to Roche. The agreement granted to Immunex a paid-up, irrevocable, exclusive license to the US patent family for the patents-in-suit and gave Immunex the sole right to sublicense. It further granted Immunex the exclusive right to prosecute applications in the US patent family. Critically, Roche retained the secondary right to assert the patents if Immunex did not assert them in litigation after being informed of potential infringement, and the right to veto any downstream assignment by Immunex to a third party.

Immunex and Roche later sued Sandoz for infringing a patent included in the license agreement. At trial, Sandoz argued that the patents-in-suit were invalid for obviousness-type double patenting over several patents filed by Immunex.

The judicially created doctrine of obviousness-type double patenting prohibits claims in a second patent that, while not for the same invention, are so similar to the claims of a commonly owned earlier patent that granting both patents exclusive rights would “effectively extend the life of patent protection.” This doctrine rests primarily on two justifications: preventing unjustified extension of the time of the right to exclude, and preventing multiple infringement suits by different assignees. The doctrine applies to all commonly owned patents, including cases in which the obvious variant inventions have different inventors.

Urging a novel theory of common ownership, Sandoz argued that although the patents-in-suit were assigned to Roche, Immunex effectively owned both the Immunex patents and the patents-in-suit. Sandoz asserted that the agreement between Amgen, Immunex and Roche conveyed “all substantial rights” in the patents-in-suit, which was tantamount to an assignment of ownership. Thus, Sandoz argued that the “all substantial rights” test, which previously had only been used to determine who had standing to sue for infringement as a “patentee” under 35 USC § 281, should apply in the context of obviousness-type double patenting.

Immunex argued that the “common ownership” analysis should take into account ownership at the time of invention, such that common-ownership-based obviousness-type double patenting arises only where the relevant inventions were owned by the same entity.

The Federal Circuit agreed with Sandoz, endorsing for the first time the all substantial rights test to [...]

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