Biosimilar Makers Must Plan for Originator Firms Gaming the Patent System, Panel Says

A company developing an original biologic may have a very short window to recoup costs of development and achieve the kind of revenues possible from product exclusivity before competitor biosimilars may appear on the market, according to Kevin McCabe, chief exclusivity officer at TherapeuticsMD.

The 20-year exclusivity clock starts to tick from the filing of an initial patent application, long before the product is approved and hits the market. However, some companies become adept at patent filings that enable them to push out this window of opportunity by many years, he said in a panel presentation on biosimilar litigation and patent issues at the Specialty Therapies and Biosimilars Congress in Miami Wednesday.

“You may have 5 years to recover the hundreds to billions of dollars that you spend developing that particular drug product. If you’ve ever been involved in a launch, you’re not making significant money off that product until the third, fourth, or fifth year, and that’s when you’re facing your patent expiration,” he said. Much of the patent window of exclusivity is eaten up by clinical trials and FDA review, he added.

It’s important to keep in mind the successive patents that can be filed to keep an original product in a position of market dominance, McCabe said. Drug descriptions in biologics license applications can be written cleverly to achieve this aim.

“Amgen’s really good at it. They can get basically 40 years’ term for a product. How they do that is they have dedicated teams of in-house counsel that study these things like nobody’s business to identify these little nuances that put the patent in exactly the right spot that’s going to be a problem for the company that’s developing the biosimilar application, and this is just part of the game, right?” McCabe said.

This leads to massive patent portfolios for single products, noted Alexandra Valenti, a partner with Goodwin Procter’s intellectual property litigation group. “AbbVie is probably the most infamous of these for its patent portfolio on Humira [adalimumab].” In the United States, AbbVie filed 247 patent applications for the rheumatoid arthritis medicine, 132 of which were granted, and 89% of those were filed after the company obtained marketing approval for the agent. Adalimumab had $20 billion of sales in 2018 and is the world’s best-selling drug.

Such tactics by original drug manufacturers call for careful planning and footwork by biosimilar manufacturers, McCabe said.

Inter partes reviews (IPRs) and post grant reviews (PGRs) have “completely changed the landscape of how patents are challenged,” according to Ha Kung Wong, an intellectual property law expert with Venable Fitzpatrick and an editorial booard member of The Center for Biosimilars^®. These became legal tools for challenging patent claims in 2011. Wong described IPRs and PGRs as “mini litigations with very limited discovery, limited causes of action, and a statutorily set time limit for completion, from filing of a petition through a final written decision.”

These petitions don’t necessarily have to be filed by a wronged party, which gives them extreme utility for intended biosimilar makers to block what they feel are insubstantial patent claims. What’s most important about these is that they allow rapid challenges on multiple grounds. “This is something you need to prepare for early on, whether you are the challenger or the patentee, because if you’re the patentee, you have to be aware that as soon as you get that patent grant, someone can challenge you immediately under this process. You may have a patent and then 18 months later you may not have one, so keep that in mind,” Wong said.

The FDA is becoming more comfortable with the process of reviewing biosimilar applications, and the standard review is taking 10 to 12 months currently, the panel said, with priority reviews averaging 6 to 8 months. Some applications have taken longer, although Valenti predicted that the FDA’s growing familiarity with the process is going to standardize the review length.

The development time for biosimilars under best-case scenario is between 1 and 5 years, and 9 years or more in the worst cases, the panel said.

The cost of a biologics license application for a biosimilar is averaging $100 million, Valenti said. “Over time, I think that companies will come up with more efficient ways to put these applications together. The FDA will not demand as much of the applicant in order to get approval.”