On June 7, 2019, Amgen filed a petition for rehearing en banc of the Federal Circuit’s recent affirmance of summary judgment of non-infringement in favor of Sandoz in the BPCIA litigation regarding Sandoz’s ZARXIO (filgrastim-sndz) biosimilar and pegfilgrastim biosimilar candidate. As we previously reported, on May 8, 2019, a Federal Circuit panel concluded, among other things, that the district court did not err in ruling that Sandoz’s products did not infringe (literally or under the doctrine of equivalents) Amgen’s U.S. Patent No. 8,940,878 (“the ‘878 patent”). The ‘878 patent is directed to a protein purification method. The asserted claims, as construed, required three separate, sequential steps utilizing three solutions. Sandoz utilized a one-step, one-solution method, which the court held did not function in the same way as the claimed method. The panel reasoned that the doctrine of equivalents was inapplicable in this situation because its “precedent prohibit[ed] [them] from overriding the natural language of claim 7 to extend these limitations to cover nearly any type of adsorbent chromatographic separation.” The panel further noted: “The doctrine of equivalents applies only in exceptional cases and is not ‘simply the second prong of every infringement charge, regularly available to extend protection beyond the scope of the claims.’” (citation omitted).
In its rehearing petition, Amgen challenges the panel’s reasoning that the doctrine of equivalents applies only in “exceptional cases,” asserting that this reasoning runs contrary to Supreme Court precedent. Amgen argues that the Supreme Court does not limit the doctrine of equivalents only to cases where certain benefits and equities can be found for certain patents. Amgen also argues that infringement under the doctrine of equivalents is a settled patent right, and that the panel’s narrow application of the doctrine of equivalents runs contrary to the Supreme Court’s admonition against adopting rules that retroactively diminish the value of existing patent claims and disrupts settled expectations of patent holders.
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