Another big pharma patent battle is underway. Amgen plans to take on Johnson & Johnson’s top-selling drug with a copycat version, seeking U.S. approval for its biosimilar of the psoriasis drug Stelara, which has been marketed in the U.S. since 2009.
But it may be held up by patents that didn’t exist when the drug was approved and that J&J had no hand in inventing.
The patents, which protect ways of controlling chemical changes to biologic drugs, were awarded about a decade ago to Momenta Pharmaceuticals, which was then an aspiring biosimilar manufacturer before later changing course to develop new drugs. J&J bought Momenta in 2020, ostensibly for the company’s rare disease drug nipocalimab. A side benefit, though, was the manufacturing know-how and intellectual property that Momenta had amassed during its years working on biosimilars.
If J&J is successful in asserting those patents, it could hamper biosimilar developers like Amgen from entering the market. For example, J&J could use the Momenta patents as a bargaining chip to get Amgen to agree to a later market entry date than September 2023, when Stelara’s patent protection is currently expected to expire. Every extra day of U.S. market exclusivity for Stelara is worth nearly $18 million in revenue for J&J, which earned $6.4 billion from U.S. sales of the drug last year.
“It just goes to show the various different plays that are going on in order to delay Amgen coming in,” said Tahir Amin, co-founder of the non-profit Initiative for Medicines, Access, & Knowledge, and a critic of the U.S. patent system.
For its part, J&J executives have been preparing investors for Stelara to face biosimilar competition in 2023, but also have hinted at the possibility that it could last longer. “It's also important to remind folks that there is not yet a [Food and Drug Administration]-approved biosimilar that's ready to be marketed out there,” CFO Joe Wolk told investors attending the J.P. Morgan Healthcare Conference in January.
The case illustrates drugmakers’ liberal use of intellectual property to build so-called “patent thickets” around their top products. This practice is particularly common with biologic drugs, which, because of their complex structure and manufacturing processes, offer many more patentable opportunities than older chemical drugs.
In its most recent annual report, J&J disclosed that the last Stelara “composition of matter” patent — the type of intellectual property that protects the underlying drug and is generally regarded as the most impervious to legal challenge — is due to expire in September 2023.
Many analysts have therefore anticipated biosimilars to Stelara could gain approval and be launched this year or in 2024.
Litigation between J&J and Amgen was triggered by Amgen’s notice that it intends to market a Stelara biosimilar, one step in a legal process commonly referred to as the “patent dance.” This process, which was outlined in a 2009 law creating a regulatory pathway for biosimilars, allows the two sides to exchange confidential information and resolve any intellectual property disputes.
In a November 2022 court complaint filed in response to Amgen’s notice, J&J cited only two patents at issue, both of which it had originated. However, in an amended complaint filed earlier this month, J&J added four more patents, all of which were initially filed between 2012 and 2015 by Momenta. A request for a preliminary injunction filed later in March names two of those Momenta patents.
Those two patents center on processes for modifying the animal cell cultures used to manufacture monoclonal antibodies — the class of biologic drugs that includes Stelara — and control what carbohydrates and amino acids are attached to these large proteins. Momenta had developed this expertise as it worked on copies of Humira, Eylea and other antibody-based drugs, before it pivoted away from biosimilar drug development.
In producing its biosimilar, code-named ABP 654, Amgen is violating those patents, J&J now claims.
J&J’s assertion of manufacturing patents granted years after Stelara’s approval follows a common pattern in biosimilar litigation, and is one that drug industry critics claim chills competition and drives up healthcare spending.
Some of those innovations can improve a drug or streamline manufacturing, noted Kevin Noonan, a patent attorney with the law firm McDonnell Boehnen Hulbert & Berghoff.
Others may not, yet still have the effect of extending market exclusivity. “That may be manipulating the system but the fact is that there’s nothing illegal about it,” Noonan said.
In an emailed statement, a J&J spokesperson said the company “has long been supportive of a robust, competitive environment for biologics, including biosimilars.”
“We’re confident in the strength of our intellectual property for Stelara and related manufacturing patents,” the spokesperson added. “We intend to vigorously defend our intellectual property to the full extent of the law.”
Similar criticism was directed toward AbbVie in its defense of its blockbuster inflammatory disease drug Humira, which finally saw its first biosimilar competitor, from Amgen, launch in January. Humira’s primary patents ran out in 2016 but, because of secondary patents, AbbVie was able to forestall competition until 2023 as well as negotiate a phased market entry.
J&J’s endgame could be similar, although such negotiated entries can sometimes come under scrutiny from antitrust regulators like the Federal Trade Commission. “The moment you make a deal with the [biosimilar manufacturer] the FTC comes along and says, ‘That's restraint of trade,’” Noonan said.
Legislation that has been advanced through the Senate Judiciary Committee would restrict some of the legal maneuvers available to drugmakers. The bill would limit how many patents originator companies can claim that were applied for more than four years after approval of their branded product or that protect manufacturing processes that aren't actually used.
That committee approved similar legislation last year, but it never got a vote in either house of Congress.
Patent thickets are among the reasons why biosimilars have so far had a smaller impact in the U.S. than in Europe, which has different patent laws as well as different purchasing practices. Both give branded drugmakers less leverage.
“We’re seeing the biosimilar space squeezed even before it takes off,” I-MAK’s Amin said. “The more the thickets appear, the more they have to spend on legal challenges. Is it really worthwhile?