Holding: The minimum contacts requirement for personal jurisdiction may be met by an abbreviated Biologics License Application that declares an intent to market or distribute the biologic within a given state. For non-obviousness type double patenting, the fact that one patent has a broad claim that encompasses a narrower claim in a second patent does not automatically constitute double patenting. An obviousness inquiry still needs to be performed to determine if the claims are patentably distinct.
Regeneron owns the Biologics License Application for EYLEA®, a therapeutic product for treating angiogenic eye disease that includes aflibercept. Aflibercept is a vascular endothelial growth factor (VEGF) antagonist that can bind or trap VEGF proteins before they can bind to receptors in the body and stimulate blood-vessel growth. Regeneron owns a family of ten patents that are directed to VEGF antagonist formulations. Two of the patents in this family, US Pat. No. 11,084,865 and U.S. Pat. No. 9,340,594 are relevant in this case.
Several companies including Mylan, Samsung Bioepis (SB), Formycon AG, and others filed abbreviated Biologics License Applications (aBLA) with the FDA seeking approval to market EYLEA® biosimilars. Regeneron filed patent infringement suits against Mylan, SB, Formycon, and other applicants alleging infringement of the ‘865 Patent. The cases were consolidated in the Northern District of West Virginia. The present appeal involves two of Regeneron’s suits against SB. In these cases, the district court enjoined SB from offering for sale or selling its biosimilar product.
SB is a biosimilar products company headquartered in South Korea. SB signed an agreement with Biogen MA Inc. that gave Biogen the exclusive right to commercialize its EYLEA® biosimilar, known as SB15, in the United States. SB does not have any facilities or employees in the United States, and does not do business in West Virginia. SB moved to dismiss the infringement suit filed by Regeneron in the Northern District of West Virgina for lack of personal jurisdiction.
The Federal Circuit found that the district court had personal jurisdiction over SB. According to Federal Rule of Civil Procedure 4(k)(1)(A), a district court has personal jurisdiction over a defendant if that defendant would be “subject to the jurisdiction of a court of general jurisdiction in the state where the district court is located.” This requires that a state’s long-arm statute allows service of process and asks whether the assertion of jurisdiction would be inconsistent with due process.
The minimum contacts standard allows a court to satisfy due process and exercise specific personal jurisdiction when the defendant has certain minimum contacts with the forum such that the suit does not offend traditional notions of fair play and substantial justice. The Federal Circuit found that SB’s aBLA filing and agreement with Biogen provided these minimum contacts. The aBLA filing established that SB planned on marketing or distributing its proposed biosimilar upon approval, and there was no limitation on where Biogen could distribute SB15 and Biogen had plans to distribute across the United States. Further, SB’s distribution agreement with Biogen allowed SB to maintain a role in Biogen’s distribution through certain mechanisms established in their agreement. These factors provided sufficient minimum contacts for personal jurisdiction to lie against SB in West Virginia.
SB also appealed the district court’s grant of a preliminary injunction to Regeneron. SB argued that it had raised a substantial question as to invalidity of the ‘865 patent for obviousness-type double patenting in view of the ‘594 Patent. Both of these patents claim priority to a provisional application filed on June 16, 2006 and to a nonprovisional application filed on June 14, 2007. However, Regeneron filed a terminal disclaimer for the ‘594 Patent that produced an expiration date for this patent in 2021. There was no terminal disclaimer filed for the ‘865 Patent, so its expiration date is in 2027.
In finding no obviousness-type double patenting, the district court held that several limitations from claim 1 of the ‘865 Patent were patentably distinct from claim 5 of the ‘594 Patent. These limitations include: (1) at least 98% of the VEGF antagonist is present in native conformation following storage at 5°C for two months; and (2) the VEGF antagonist is glycosylated. The Federal Circuit affirmed the district court’s ruling.
As to the first limitation, the claims of the ‘594 Patent simply require that the VEGF antagonist is stable for at least 4 months rather than specific conditions provided in the ‘865 Patent. The Federal Circuit rejected SB’s argument that the 98% native conformation limitation in the ‘865 Patent was obvious because it was simply an “additional property” of the composition claimed in the ‘594 Patent. The fact that one patent has a broader claim that reads on another patent with a narrower claim does not, by itself, give rise to double patenting. The standard analysis to determine obviousness still needs to be applied.
SB made a similar argument as to the second limitation, alleging that glycosylation was just an additional property of the claimed product in the ‘594 Patent, which was construed to allow for either glycosylated or non-glycosylated aflibercept. The Federal Circuit applied the same reasoning as given for the first limitation by requiring that SB challenge the district court’s obviousness analysis rather than simply stating that the ‘895 Patent claims are just directed to an additional property of the claimed product in the ‘594 Patent.
SB also argued that the district court erred in finding Regeneron had established a nexus between SB’s infringement and irreparable harm that would occur without injunctive relief. SB pointed out that its aBLA only required 96% stability after two months of storage, so it could sell SB15 that was 96% stable without infringing the ‘865 Patent. However, SB’s approved aBLA was not limited to the non-infringing product. The Federal Circuit held that the fact that the scope of the aBLA is broader than the claims of the ‘865 Patent does not defeat causal nexus.
SB further alleged that the Regeneron must prove that the 98% stability feature drives demand to meet the causal nexus requirement since this the unique feature of the ‘865 Patent. However, in cases where the infringing product is the claimed invention without other significant features, the causal nexus analysis is less complicated, and it is sufficient to show that the infringing product itself will cause irreparable harm.
Federal Circuit Precedential 
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