Understanding of Biosimilars Law Expected to Be Slow, Gradual Process

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By John T. Aquino

Nov. 16 — The life sciences industry's understanding of the biosimilar statute will evolve gradually through a series of court decisions over time, panelist said Nov. 16 at a biotech intellectual property conference.

This will be frustrating to the makers of biosimilars and to patients, all of whom want similar and less expensive versions of biologics that treat cancers and other diseases quickly approved for market, as well as to the makers of the original biologics who want to protect their patent rights, the panelists said.

Panelists said that everyone is searching for certainty from a statute they described as “fractured.”

Shaping Biologic Litigation for Decades

The focus of the panel's discussion was on the decision by the U.S. Court of Appeals for the Federal Circuit in Amgen v. Sandoz (9 LSLR 828, 7/24/15). In that case, a three-judge panel offered a split decision, affirming in part and denying in part the district court's interpretation of the Biologics Price Competition and Innovation Act (BPCIA), which offers a streamlined approval process for biosimilars.

In Amgen, the Federal Circuit denied each parties' petition for a hearing of the full (en banc) court on Oct. 16 (9 LSLR 1199, 10/30/15), and a petition for Supreme Court review must be received by Jan. 14, 2016, the panelists said.

“The ultimate outcome—whether the parties appeal to the Supreme Court and the court grants certiorari [review] or the court or the parties decide to let the Federal Circuit's ruling stand—will determine how biosimilar litigation proceeds for decades to come,” said Lisa Barons Pensabene, head of life sciences litigation at O'Melveny & Myers, LLP.

For now, applicants for approval will pick pieces of the BPCIA that suit them in an effort to get the biosimilar approved and to market quickly, she said.

The session, titled the “Evolving Landscape of Biosimilars Litigation in the United States,” was held at the BIO IP Counsels Committee Conference in Cary, N.C.

The Food and Drug Administration defines a biosimilar as a biologic product that is approved based on a showing that it is highly similar to an already-approved biological product, known as a reference product. The applicant relies on the reference product sponsors' (RPS's) data as part of the BPCIA's abbreviated approval pathway. The FDA approved the first biosimilar, known as Zarxio and made by Sandoz, in March, as a biosimilar of Amgen's cancer treatment Neupogen (9 LSLR 328, 3/20/15).

BPCIA: Three Judges, Three Interpretations

Zarxio was the focus of Amgen's litigation against Sandoz, with Amgen arguing that the BPCIA requires Sandoz to give to Amgen Zarxio's abbreviated biologic application (aBLA), Amgen and Sandoz to agree on a list of patents owned or licensed by Amgen that might be infringed by Zarxio, and Sandoz to provide Amgen with 180 days' notice that it planned to market a biosimilar. Sandoz contended that the exchange of information was optional, not mandatory, and that the 180-day notice could start from the date Sandoz filed the aBLA rather than the date the FDA approved Zarxio for market.

The Federal Circuit agreed with Sandoz and the district court that the information exchange outlined in the BPCIA is optional and with Amgen that the 180-day notice can only begin once the FDA has approved the biosimilar. “The court said that you can only declare your intent to market what you have received approval to market,” Pensabene said.

“But it's important to know that three different judges presented three different interpretations of the BPCIA, with Judge Raymond T. Chen disagreeing with Judges Pauline Newman and Alan D. Lourie, arguing that the notice of commercial marketing is not a stand-alone,” she said.

Certainty From Supreme Court?

“What was Judge Lourie trying to do with majority opinion? He said the same thing as BIO's amicus brief, which was that the case was all about notice,” Pensabene indicated, referring to the brief filed by the Biotechnology Industry Organization, which sponsored the BIO IP conference. “Lourie's opinion says that providing the aBLA is optional, but that if you don't do that there is a stand-alone requirement of 180 days' notice so that the RPS has notice prior to the biosimilar's launch.”

Timothy Creagan, chief patent counsel for Sanofi's Genzyme, said, “If the Supreme Court views the exchange of information in the BPCIA as optional, like the Federal Circuit and district court did, that would be unfavorable to the life sciences industry. How can you decide whether a biosimilar infringes your patent if you don't have access to the aBLA and its manufacturing information and you don't have a patent discussion with the applicant? And the 180-day notice portion of the Federal Circuit's decision has been viewed as adding six months of exclusivity for the RPS, which some have described as a ‘windfall.' I hope the case doesn't go to the Supreme Court because the idea of a ‘windfall' for biopharmas would not be well received by the court.”

Immac J. Thampoe, managing IP counsel of biologics and vaccines for Merck & Co., disagreed. “There are policy reasons to make medicines accessible to patients, and many big pharmas have invested in biosimilars and are looking for certainty. It's important that we know the rules of the game, for the companies and for patients. Therefore, I think it will be a good thing for it to go to the Supreme Court because we will have some clarity.”

Creagan said, “I'm all for certainty if we get the right result.”

Picking Pieces From the BPCIA

Pensabene said, “People ask, why are we in this mess? It's because the drafters of the BPCIA were thinking of a world in which exclusivity remains for patents and there would be an orderly process performed by the parties of exchanging information against a backdrop of the very generous 12-year exclusivity which the BPCIA gives to the RPS. But this is not the case for many, many drugs. None of the drugs currently in litigation have any exclusivity left. Sandoz filed its application and was faced with a period of information exchange while it was chafing at the bit to get to market.”

There are more than 55 biologic products with a date of licensure of 2007 or earlier, which means that their exclusivity expires in 2019, Pensabene added. “This is a problem for now. The Supreme Court, if it takes the issue up, is going to have to make a decision based on a fact pattern that won't exist in 10 years.”

Pensabene described the near future as “a BPCIA-ish world, with applicants picking pieces of BPCIA to hand over, turning over lists of patents to the RPS and saying, ‘Go on and sue me for infringement based on the list if you can, but we have met most of the requirements of the BPCIA and therefore don't have to give you 180-days notice.' This has some appeal. An RPS will have a list of patents the biosimilar could infringe, and if a patent is not on list, the RPS can never assert infringement of that patent. The question is, if an applicant does this, does it have to provide the 180[-days'] notice? Judge Chen said the 180-days' notice isn't a stand-alone provision, and Lourie writing in the majority opinion said that in this case it was. More clarity is needed on this.”

Piecemeal, Very Slow Process

Filko Prugo of O'Melveny & Myers, LLP, gave an update of pending biosimilar litigation.

“Apotex is following the BPCIA's information exchange for its biosimilars of Amgen's Neulasta and Neupogen,” he said (9 LSLR 1143, 10/16/15). “It gave notice early and said we don't have to give notice at all because we followed the BPCIA and are stopping at the notice. The new strategy is trying to get around giving the six-month's notice,” Prugo said.

Pensabene said, “Each new case will give us a little bit more information about how to work this statute.”

Prugo said, “It's a piecemeal, very slow buildup about what the BPCIA requires.”

To contact the reporter on this story: John T. Aquino in Washington at jaquino@bna.com

To contact the editor responsible for this story: Nancy Simmons at nsimmons@bna.com