Executive Summary
Following Sandoz’s Zarxio playbook, Pfizer plans to market Inflectra while patent litigation continues; February 2017 trial on cell culture media patent could answer question of potential damages.
Celltrion Inc. and partner Pfizer Inc. knocked out one of Janssen Biotech Inc.’s Remicade (infliximab) patents in district court and are betting they will win a ruling of non-infringement of a cell culture media patent. But even if they don’t prevail, they may rake in far more in revenues from an Inflectra biosimilar launch than would pay out in potential damages.
Pfizer announced on Oct. 17 that it would begin shipping Inflectra (infliximab-dyyb), its biosimilar to Janssen’s tumor necrosis factor inhibitor, in late November, nearly eight months after FDA’s April 5 approval. Janssen issued a release in response saying it considered this to be an “at-risk” launch. (Also see “Pfizer Sets Inflectra Launch Date; J&J Plans To Fight Back” – Scrip, 17 Oct, 2016.)
The risk centers around two of Janssen’s patents. Massachusetts District Court Judge Mark Wolf ruled in August that patent No. 6,284,471, which covers the infliximab anti-TNF antibody, is invalid for obviousness-type double patenting. (Also see “Pfizer Eliminates Roadblock To Remicade Biosimilar Launch” – Pink Sheet, 17 Aug, 2016.) Janssen said it is in the process of filing an appeal to the US Court of Appeals for the Federal Circuit.
The second patent, No. 7,598,083, covers particular compositions of cell culture media that are used to grow the living cells that produce biologics such as infliximab. That patent, issued in October 2009, expires on Feb. 7, 2027. A jury trial is scheduled to begin on Feb. 13, 2017 to determine if the patent is valid and, if so, whether Inflectra infringes it. Janssen said it would seek damages and royalties on future sales if the court finds that the ‘083 patent is valid and infringed.
The trial will also determine if Janssen is entitled to a permanent injunction and whether Celltrion and Pfizer followed the litigation provisions of the Biologics Price Competition and Innovation Act.
Treble Damages Seem Unlikely
Janssen filed two suits against Celltrion, which have been consolidated. The first complaint, filed in March 2015, claims Celltrion infringed several patents and failed to provide manufacturing process information for the Inflectra biosimilar in violation of the BPCIA. The second complaint, filed on June 14, alleges actual acts of infringement of the ‘083 patent based on new information about the cell culture media that was custom made for Celltrion by HyClone Laboratories Inc.
Janssen seeks a preliminary and/or permanent injunction prohibiting Celltrion and its partners from making, using or selling the cell culture media and/or a biosimilar product made with the media, as well as trebled damages.
In a Sept. 27 joint pretrial memorandum, Janssen said it would show that Celltrion and Pfizer infringed the patent claims either literally or under the doctrine of equivalents, whereby elements of the infringing product are not identical to the patented invention but equivalent to it. Janssen said it would also show that the formula for the defendants’ cell culture media contains every ingredient required by the patent claims. The patent calls for 52 required ingredients and nine optional ingredients.
For their part, Celltrion and Pfizer said they will show their product does not infringe literally or under the doctrine of equivalents. They stated that Janssen has not alleged literal infringement and has been proceeding under the doctrine of equivalents.
Shashank Upadhye, of Amin Talati Upadhye, said Pfizer has already won half the battle since the court found the ‘471 patent invalid. If the Federal Circuit were to reverse and the case went back to district court to determine liability, he said Janssen could not argue Pfizer had no good faith basis to launch and was liable for treble damages given Wolf’s ruling on the patent.
With regard to the ‘083 patent, Upadhye, a former attorney at Apotex Inc., said Pfizer may have good legal opinions to support its launch and thus would not be liable for willful infringement and treble damages. As for the size of an award, he said that would depend on what the patent covers and the relative contribution of the ‘083 patent.
Judge Wolf noted in an order finalizing his decision on the ‘471 patent that the court had offered Janssen several opportunities to seek a preliminary injunction to prohibit the sale of Inflectra in the US pending the outcome of litigation but the company declined to do so. Janssen said it could not comment on why it did not seek a preliminary injunction.
Pfizer had agreed not to launch Inflectra until at least Oct. 3, the end of the required 180-day notice of launch after licensure, but has taken extra time to prepare the launch. (Also see “Inflectra Launch Prep Continues Post-Deadline, Pfizer Says” – Pink Sheet, 6 Oct, 2016.)
Zarxio Infringement Suit Moves Forward
Pfizer’s decision to pursue an at-risk launch mirrors that of Sandoz Inc., which opted to launch Zarxio (filgrastim-sndz), its biosimilar to Amgen Inc.’s Neupogen (filgrastim), before the resolution of a patent infringement suit. Sandoz obtained FDA licensure on March 6, 2015 and launched Zarxio on Sept. 3, 2015. The marketing was delayed as the parties fought over provisions of the biosimilars statute. The dispute was resolved when the Federal Circuit ruled that biosimilar sponsors have to wait until FDA licensure to provide 180-day notice of commercial launch of their product.
In the ongoing patent litigation, Amgen claims infringement of patent Nos. 6,162,427 and 8,940,878. It is seeking a permanent injunction, damages, a declaration that Sandoz’s infringement is willful and deliberate and justifies an increase up to three times the amount of damages. Sandoz has counterclaimed for a declaratory judgement of non-infringement and invalidity of the patents.
Amgen filed a related infringement action against Sandoz in May in response to its submission of an application for a biosimilar version of Amgen’s Neulasta (pegfilgrastim). Amgen is asserting infringement of the ‘878 patent and patent No. 5,824,784. Sandoz asserted counterclaims seeking a declaratory judgment of invalidity and noninfringement of both patents. A trial is scheduled for the week of Dec. 11, 2017 or at the court’s convenience.
Biosimilar Pricing Is Next Frontier
As the court battles continue, there is increased focus on biosimilar pricing. Pfizer said Inflectra would be introduced at a 15% discount to the current wholesale acquisition cost of Remicade, before any discounts, which equates to $946.28 per 100mg vial.
At an Oct. 18 meeting on the future of the US biosimilars market held in Washington, DC, Lawrence LaMotte, of the Immune Deficiency Foundation, expressed concern that patients will be switched en masse to biosimilars for cost reasons rather than clinical reasons.
He alluded to CVS Health Corp.’s decision to remove Amgen’s Neupogen and Sanofi’s glargine insulin Lantis from coverage in its national formulary in 2017. (Also see “Rise Of The Biosimilar Formulary: CVS Excludes Lantus, Neupogen For 2017” – Pink Sheet, 2 Aug, 2016.)
“This is all about costs,” LaMotte said. “I find it interesting that with generics, the small molecules, we’ve been talking about these huge differences in costs” and yet Pfizer announced it is only giving a 15% discount off the reference product. He said patient organizations are very concerned that their physicians will have no control over prescribing because they will be overruled.
Jeff Eichholz, senior director of drug trend solutions at Express Scripts, also addressed Inflectra pricing at the event, which was co-sponsored by Friends of Cancer Research and the Duke-Robert J. Margolis Center for Health Policy.
He said the pharmacy benefit manager was looking for a 20% to 40% discount. “These are not going to be generic type discounts,” he said. “We’re really looking at these as competing brands, but overall when you get competition you do see the prices drop.”
https://pink.pharmamedtechbi.com/PS119342/How-Risky-Is-Pfizers-Launch-O…
