Can Janssen Revive Its Key Remicade Patent? Federal Circuit Hears Pitch

Oral arguments suggest Janssen may have difficulty getting reversal of district court and patent office rulings that its composition patent is invalid.

A three-judge panel of the US Court of Appeals for the Federal Circuit did not seem eager to overturn decisions invalidating Janssen Biotech Inc.'s Remicade (infliximab) composition patent but their questions during oral arguments left the outcome of the case uncertain.

The panel, which convened Oct. 3 at the US Court of International Trade in New York City, heard two cases concerning patent No. 6,284,471, which covers the infliximab anti-TNF antibody: Janssen's appeal of a district court ruling in its infringement suit against Celltrion Inc. and Pfizer Inc. subsidiary Hospira Inc. over their Remicade biosimilar Inflectra (infliximab-dyyb), and the US Patent and Trademark Office's decision in a reexamination proceeding. Both found that the patent is invalid for obviousness-type double patenting, which occurs when the claims in a second patent are not patentably distinct from those in the first patent.

The parties agreed that if the court affirms the PTO's decision then the appeal of the district court decision will be moot.

The district court concluded that the patent is invalid for obviousness-type double patenting in view of a later-filed but earlier-expired reference patent, No. 6,790,444. The '444 patent expires in 2011 and the '471 patent expires in September 2018. (Also see "Pfizer Eliminates Roadblock To Remicade Biosimilar Launch" - Pink Sheet, 17 Aug, 2016.)

The appeals court decision on the '471 patent is significant for Janssen, as reinstatement of the patent could enable it to seek damages for Pfizer's US launch of Inflectra in November 2016. Remicade generated $6.97bn in sales in 2016. It took a hit in the second quarter in part because of Inflectra competition and pricing pressure. US sales declined 13.9% to $1.06bn while worldwide sales declined 14% to $1.53bn. (Also see "Remicade: Biosimilars And Pricing Pressure Wear On J&J's Blockbuster Brand" - Scrip, 18 Jul, 2017.)

Janssen Wants Exception From Double Patenting Rule

Arguing for reversal of the district court decision, Janssen attorney Gregory Diskant, a partner at Patterson Belknap Webb & Tyler, distinguished Janssen's case from Gilead Sciences Inc. v. Natco Pharma Ltd., in which the Federal Circuit ruled in 2014 that a patent that issues after but expires before another patent can qualify as a double patenting reference for that other patent.

Diskant argued that Janssen did nothing to extend the '471 patent and that the '471 expired later than the '444 patent because of an act of Congress, referring to the Uruguay Round Agreements Act of 1994 (URAA). The statute changed the term for a US patent from 17 years from the patent issue date to 20 years from the earliest effective filing date. He also cited a footnote in the Gilead decision which says there are exceptions to the rule, such as patents that qualify for term extensions.

"We ask the court to grapple with those exceptions and find we are entitled to one as well," Diskant said.

Judge Jimmie Reyna questioned Diskant's analysis. "Say your argument makes a lot of sense," he said. "You have to deal with the URAA" and that changes your argument. Under the URAA, he said, the focus is on the expiration date.

"If we go by the numbers, you get a free ride," Reyna stated. He later said that it seems Janssen made a calculated risk when it filed the application that led to the '444 patent.

Reyna also questioned Celltrion's position, asking Celltrion attorney James Hurst, a partner at Kirkland & Ellis, why Congress did not refer to obviousness-type double patenting in the URAA. And when Hurst stated that Janssen deliberately obtained the '444 patent knowing it would expire in 2011, Reyes replied that the statute gave Janssen ground to do so and that it doesn't guarantee patent terms.

Chief Judge Sharon Prost asked Hurst about the footnote in the Gilead decision, saying it recognized there are exceptions to the rule. Hurst replied that there is nothing like patent term extension at issue in the present case and that Congress specified that the statute was subject to terminal disclaimers.

In its appeal brief, Janssen said the Federal Circuit "has never relied on obviousness-type double-patenting based on a later-filed, earlier-expiring post-URAA patent to invalidate a pre-URAA patent with a 17-years-from issuance term based obvious-type double patenting."

Celltrion said in its response brief that Janssen is asking the court to carve out new exceptions to the doctrine of obviousness-type double patenting "that would require the court to repudiate the reasoning of prior decisions addressing the same issues raised here."

Can Safe Harbor Apply?

The oral arguments in the appeal of the PTO's reexamination decision, In re Janssen Biotech, focused on whether the '471 patent application is a continuation-in-part or a divisional application. The patent statue's safe harbor provision protecting patents from obviousness-type double patenting challenges applies only to divisional applications filed in response to a restriction requirement.

"We are leery now of bright line tests," Judge Reyna said.

Janssen filed an application in 1993 as a continuation-in-part (CIP) of two separate patent applications, and that application issued as the '471 patent in 2001.

The PTO's Patent Trial and Appeal Board instituted ex parte reexamination of the '471 patent in 2013. The PTO examiners found that the patent claims were obvious due to double-type patenting over two expired Janssen patents, Nos. 5,698,195 and 5,656,272, and the board affirmed the decision.

Judge Reyna asked PTO's attorney Frances Lynch, an associate solicitor in PTO's Office of the Solicitor, if the exclusion of the '471 patent from the safe harbor is a bright line test.

Lynch asserted that it is not office policy to turn a CIP application into a divisional application.

"The question is should we allow it?" Reyna said. "We are leery now of bright line tests."

Lynch said the Federal Circuit has ruled in previous cases that you can't go back and retroactively change a filing. "They unequivocally made the choice to file a CIP," she said. "That's the end of the story."

Janssen's attorney William Rooklidge, a partner at Gibson, Dunn & Crutcher, stated that there is no statute or regulation that says Janssen cannot change an application from a CIP to a divisional.

Janssen also argued in its brief that because the '471 patent was amended in reexamination, if the Federal Circuit finds for Janssen in its appeal of the PTO's decision, that would supersede the district court's ruling, which was based on the un-amended form of the '471 patent, and require reversal of the district court's ruling on invalidity for obviousness-type double patenting.

In addition to Reyna and Prost, the Federal Circuit panel included Judge Evan Wallach.

Battle Continues Over Remicade Cell Culture Media Patent

In separate litigation, Janssen has sued Celltrion and Hospira for infringement of patent No. 7,598,083, which covers particular compositions of cell culture media used to grow cells that produce biological medicines. That patent expires in February 2027.

Janssen filed an initial complaint against Celltrion in 2015 claiming Celltrion infringed several patents and failed to provide manufacturing process information for the Inflectra biosimilar in violation of the Biologics Price Competition and Innovation Act. In a June 2016 complaint, Janssen alleged actual acts of infringement of the '083 patent based on new information about the cell culture media patent that was custom made for Celltrion by HyClone Laboratories Inc.

In a ruling on the consolidated 2015 and 2016 actions, the court said that since Celltrion failed to participate in the patent information exchange process of the BPCIA, it would not limit damages to a reasonable royalty in the 2016 action or any future action if the '083 patent was found to be infringed. Janssen filed a new infringement suit in the US District Court for the District of Massachusetts on May 31.

There are now two biosimilars to Remicade on the market in the US. In July, Merck & Co. Inc. launched Samsung Bioepis Co. Ltd.'s biosimilar Renflexis (infliximab-abda). (Also see "Merck's Second-To-Market Renflexis Biosimilar Priced Below The First" - Scrip, 24 Jul, 2017.)

While Janssen is battling over its patents in court, it is also facing litigation over its Remicade contracts with payers. Pfizer recently filed suit against Janssen parent Johnson & Johnson alleging its exclusive contracts with payers have blocked patient access to Inflectra. (Also see "Pfizer v. J&J Sets Stage For Biosimilar Showdown Over Exclusive Contracts" - Pink Sheet, 20 Sep, 2017.)