Pfizer’s proposed biosimilar of Amgen’s Epogen® and Johnson & Johnson’s Procrit® (epoetin alfa) is poised to be the first erythropoietin (EPO) biosimilar in the U.S. FDA staff recommended approval of Pfizer’s product as a biosimilar for the four indications of Epogen/Procrit. On May 25, 2017, FDA’s advisory committee agreed with that assessment, but FDA did not approve Pfizer’s product following the meeting. Instead, in a first for biosimilar products, FDA issued a complete response letter in June rejecting Pfizer’s EPO biosimilar application for a second time. Pfizer revealed that FDA did not approve the application after the advisory committee meeting due to FDA’s concerns with a manufacturing site for the EPO biosimilar. Pfizer’s product may not be approved, much less launched, this year due to outstanding manufacturing issues.
Biologics BlogVisit the Full Blog
Biologics Blog is a source of insights, information and analysis related to biologics, including the legal developments, trends and changing regulation that impact the biotechnology industry. Patterson Belknap represents biotechnology, pharmaceutical and healthcare companies in a broad range of patent litigation matters, including patent infringement cases, PTO trial proceedings, patent licensing and other contractual disputes. Our team includes highly experienced trial attorneys with extensive technical knowledge, many of whom have advanced scientific degrees and industry experience in fields such as molecular biology, biochemistry, chemistry, statistics and nuclear engineering.
When a small pharmaceutical company discovers a new medicine, it’s not uncommon for the company – which may not itself have the resources or infrastructure to get that medicine to patients – to seek a distribution partner early in development. If the partners make a deal – say the distributor pays for the right to sell the drug (if it gets approved) – and the partners publicize the existence of the deal (but not the full details of the medicine), does the deal bar a patent filed more than one year later? In Helsinn Healthcare S.A v. Teva Pharms. USA, Inc. (May 1, 2017), a unanimous panel of the Federal Circuit ruled that the on-sale bar of the America Invents Act (AIA) precludes such a patent, just as the pre-AIA on-sale bar would. But, in a decision with the potential to chill deals between small bio/pharma companies and potential commercialization partners, the court left unresolved some important questions about the meaning of the AIA’s on-sale bar.
The Federal Circuit Will Hear Apotex’s Appeal from a Preliminary Injunction Under the BPCIA in Early 2016
In early 2016, the Federal Circuit will hear Apotex’s appeal from a preliminary injunction barring Apotex from selling its proposed Neulasta biosimilar for 180 days after FDA approval. Briefing will be complete on February 12, 2016, and the Federal Circuit agreed to place the case on the oral argument calendar soon thereafter. Apotex had asked for a more expedited schedule but was not able to provide any specific evidence of when its proposed biosimilar product will be approved.
After the FDA approved the first U.S. biosimilar, Sandoz’s Zarxio (filgrastim-sndz), earlier this year, many predicted that the floodgates would open for biosimilar products. That has not been the case. No other U.S. biosimilar product has been approved. And, as FDA’s recent rejection of Hospira’s EPO biosimilar application suggests, Zarxio’s approval may ultimately provide little guidance for more complex products.
In Ariosa Diagnostics Inc. v. Sequenom Inc., 788 F.3d 1371 (Fed. Cir. 2015), a Federal Circuit panel held that Sequenom Inc.’s noninvasive prenatal diagnosis patent claims patent ineligible subject matter under the two-step test of Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012). Sequenom petitioned the court for rehearing en banc, arguing that the panel failed to consider the claimed method as a whole and that its analysis was therefore contrary to Supreme Court precedent. Sequenom’s petition received strong support from amici from numerous organizations, companies and academic groups. There were 12 amicus briefs in total, raising a variety of additional arguments in support of en banc review. On September 3, 2015, the court invited appellees to file a response to the petition for rehearing en banc.
Today, in Amgen Inc. v. Sandoz Inc., No. 2015-1499 (Fed. Cir. July 23, 2015), an historic case of first impression, a divided panel of the Federal Circuit interpreted the BPCIA. The court (per Judges Lourie and Chen) held that a biosimilar applicant can opt out of the BPCIA’s patent dance provisions by withholding its aBLA and manufacturing information, and that the only consequence of doing so is being subject to a patent infringement action on any patent that could have been listed during the patent dance. The court (per Judges Lourie and Newman) also held that a biosimilar applicant is required to provide a notice of commercial marketing under the BPCIA, and that such a notice can only be provided after the FDA has approved the biosimilar product. In short, both reference product sponsors and biosimilar manufacturers will find good and bad news in today’s decision.
The BPCIA created an abbreviated pathway for FDA approval of biological medicinal products that are “biosimilar” to an already FDA-approved product. The FDA recently approved the first U.S. biosimilar – Sandoz’s biosimilar of Amgen’s Neupogen – and is currently reviewing at least four other proposed biosimilars. Many innovators and biosimilars manufacturers are responding to the changing landscape for biologics by developing “biobetters”: new and improved versions of biologic medicinal products. While biobetters require discovery and an original Biologics License Application (BLA) with a full complement of pre-clinical and clinical data for marketing approval, they also offer many advantages. By offering superior and longer-acting medicine, biobetters provide a competitive advantage over biosimilar products. In addition, unlike biosimilars, they generally would be entitled to patent protection and 12 years of non-patent exclusivity under the BPCIA.
The Federal Circuit recently handed down a long-awaited Section 101 decision, one with potentially far-reaching consequences for biotech diagnostic patents. In Ariosa Diagnostics Inc. v. Sequenom Inc., No. 14-1139 (Fed. Cir. June 12, 2015), the Federal Circuit, applying the U.S. Supreme Court’s test for patent eligibility set out in Mayo Collaborative Servs. v. Prometheus Labs. Inc., 132 S. Ct. 1289 (2012), invalidated Sequenom’s breakthrough patent on noninvasive prenatal diagnosis through the amplification and detection of paternally inherited cell-free fetal DNA (“cffDNA”) in the blood of pregnant women. According to the court, “even such valuable contributions can fall short of statutory subject matter” under the test set out in Mayo. In addition to its implications for other biotech patents and investment in diagnostics, the Federal Circuit’s decision illustrates the potentially unintended consequences of Mayo and the need for a legislative solution so that breakthrough manmade inventions remain patent-eligible.
Medicare Part B covers drugs prescribed and administered in an outpatient setting (e.g., a doctor’s office or outpatient clinic), including many biologic drugs (given that they are often injectable drugs that must be administered by a health practitioner). In the wake of the recent approval of Sandoz’s Zarxio (filgrastim-sndz), the first FDA-approved biosimilar, the practical impact of Medicare Part B’s reimbursement policy will soon be tested in the marketplace.
On March 25, 2015, FDA denied Amgen’s Citizen Petition asking the FDA to require biosimilar applicants to certify compliance with the information disclosure provisions of the BPCIA before the FDA formally accepts the biosimilar application for review. FDA did not decide whether the disclosure provisions were mandatory, deferring to ongoing litigation on that issue.
Today the FDA announced approval of the first ever biosimilar in the United States, Sandoz’s Zarxio, a biosimilar of Amgen’s Neupogen (filgrastim) product. Although Sandoz has cleared FDA obstacles, when Zarxio reaches the market depends on the outcome of Amgen’s lawsuit under the BPCIA.
Although the most recent challenge to the Affordable Care Act does not affect the Biologics Price Competition and Innovation Act (BPCIA), it calls to mind the first round of Obamacare litigation, in which the BPCIA, while not directly challenged, briefly became collateral damage.