Greenblum & Bernstein, P.L.C.
Recent News in Intellectual Property
In This Issue:
· Amgen v. Sandoz: Federal Circuit’s December Ruling is Second Big Win for Biosimilar Applicants
· Merck’s Invanz® Patent Claims Held Obvious Despite Commercial Success, Copying
· New USPTO Director Nomination Approved by Senate Judiciary Committee
Walter Schlapkohl, Ph.D., Esq.
On December 14, 2017, the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) ruled in Amgen Inc. v. Sandoz Inc. (2015-1499) that the Biologics Price Competition and Innovation Act (BPCIA), which provides a regulatory and legal framework for the approval of biosimilars, supersedes state law claims. The ruling was the second victory for Sandoz in this case and a big win for biosimilar applicants in general who may now proceed to opt out of the BPCIA’s “patent dance” without fear of facing state law claims.
As we previously reported, Amgen sued Sandoz for patent infringement after Sandoz refused to provide Amgen with information regarding the manufacturing information for its biosimilar Zarxio® (filgrastim-sndz). As part of this suit, Amgen also claimed that Sandoz’s refusal to provide information regarding its biosimilar and participate in the patent dance constituted “unlawful” conduct that violated California’s unfair competition law.
In the first big win for biosimilar applicants, the Supreme Court held in June 2016 that courts could not require a biosimilar applicant to engage in the “patent dance.” The Supreme Court also held that biosimilar applicants may provide notice of commercial marketing to a reference product sponsor at any time before FDA’s decision to license the biosimilar. However, with regard to the state law claims, the Supreme Court remanded the case to the Federal Circuit with instructions to determine whether California law would treat non-compliance with the BPCIA as unlawful. If so, the Supreme Court further instructed the Federal Circuit to address whether the BPCIA preempts any additional remedy under state law.
The Federal Circuit chose to address the preemption question first finding that Amgen’s state law claims were preempted, i.e., the BPCIA’s complexity and carefully calibrated scheme for preparing to adjudicate and then adjudicating biosimilar patent infringement claims left no room for state-law claims to exist in this “field.” The Federal Circuit also held that the state law claims conflicted with the BPCIA such that these claims could not proceed.
The December ruling regarding state law claims bolsters what the Supreme Court held earlier this year: i.e., that biosimilar applicants may opt out of the “patent dance” without facing legal liability other than those expressly set forth in the BPCIA itself.
Merck’s Invanz® Patent Invalid As Obvious Despite Evidence of Commercial Success and Copying
In a split ruling on October 26, 2017, the Federal Circuit held that claims 21-34 of Merck Sharp & Dohme Corp.’s U.S. Patent No. 6,486,150, which covers a process for preparing a stable formulation of ertapenem (Invanz®), are invalid as obvious over the prior art.
In May 2014, Hospira informed Merck that it had filed an abbreviated new drug application (ANDA) seeking approval of a generic version of Merck’s Invanz® antibiotic. Merck then sued Hospira for infringement of two patents, the first directed to the antibiotic and the second directed to a process of preparing a stable formulation of the antibiotic. However, only the ‘150 patent, i.e., the process patent, was at-issue in the appeal.
At trial, the U.S. District Court for the District of Delaware agreed with Hospira that the contested claims of the ‘150 patent were obvious. As part of its analysis, the District Court reviewed objective evidence of commercial success and copying proffered by Merck, and found that while evidence of both commercial success and copying had been proffered, the evidence did not overcome the “strong prima facie case of obviousness” made by Hospira.
On appeal, the Federal Circuit affirmed in a split decision. Although the Federal Circuit believed that more weight should have been given to the evidence of commercial success, the majority found that the District Court did not err in concluding that the evidence of commercial success did not overcome the evidence of obviousness. With regard to copying, the Federal Circuit was also not persuaded that Hospira’s attempts at five alternative formulations to avoid the patented process were sufficient to overcome “the weight of the competing evidence of obviousness of the claimed process.”
In this regard, the majority (Judges Lourie and Hughes) affirmed the two-step approach of first deciding whether a prima facie case of obviousness has been made and then deciding whether the objective considerations are sufficient to rebut the prima facie case.
Judge Newman dissented, noting the need to remedy the court’s “inconsistent treatment of the procedures and burdens in applying the evidentiary factors of obviousness” and bring them in line with the precedent established in Graham v. John Deere Co., 383 U.S. 1 (1966). According to the dissent, the four Graham factors, i.e., (1) the scope and content of the prior art; (2) the differences between the claimed invention and the prior art; (3) the level of ordinary skill in the field of the invention; and (4) objective (“secondary”) considerations such as commercial success, failure of others, and long-felt need, are all to be considered as part of the obviousness analysis. Judge Newman opined that the both the District Court and majority improperly consigned the fourth factor regarding objective considerations to “rebuttal against the other three factors.”
Patent Office Director Approved by Senate Judiciary Committee
In a unanimous voice vote, Andrei Iancu’s nomination to lead the USPTO was approved by the Senate Judiciary Committee on December 14, 2017.
Mr. Iancu, an intellectual property litigation attorney, is the managing partner at Irrell & Manella LLP.
The Judiciary Committee’s approval is an important step and sets the stage for Mr. Iancu’s likely confirmation by the full Senate in early 2018.
Mr. Iancu told the Senate Judiciary Committee that looking at inter partes review (IPR) and post-grant review (PGR) proceedings would be among his top priorities if confirmed. Mr. Inancu also indicated that he would, if confirmed, make it a priority to issue further guidance on Section 101 patent eligibility if such guidance seemed proper.
Currently, Joseph Matal is performing the functions and duties of the Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office.