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The Biologics market has changed dramatically since the introduction of the Biologics Price Competition and Innovation Act (BPCIA) in 2014 in the US. The act provides a pathway for similar biologics to make it to market safely, cost-effectively, and legally.
However, the market has also become increasingly litigious.
LSIPR invited Urszula Wojtyra, IP lawyer and partner at Smart & Biggar, to chair an LSPN Connect panel on February 26 to discuss the early wave of biosimilar patent disputes and what they tell us about the future.
Wojityra was joined by Eva Kabir, professor of pharmacy at BRAC University, IP counsel at Aerie Pharmaceuticals William Coppola, and partner and head of life sciences at Kramer & Levin, Irena Royzman.
Choose your own adventure
A key aspect of biosimilar litigation is the patent dance, a series of back and forths between the biosimilar manufacturer and the innovator to decide what patents should make it through to the litigation process.
Explaining the process, Royzman said: “The patent dance is a ‘choose your own adventure’ of pre-litigation exchanges that should inform what patents should be litigated and when. The procedure takes around 6 months and kicks-off when the Food and Drug Administration accepts a biosimilar application to review.
“The biosimilar applicant should supply to the innovator its regulatory application and other manufacturing information. Within 60 days from receiving that information, the innovator provides a comprehensive patent list of patents that could be asserted in a dispute, the biosimilar responds with its contentions, then 60 days after that, the innovator provides its infringement and validity contentions. This is the path to litigation in the biologics market.”
When does a patent portfolio grow too large? This is where the term ‘patent thicket’ comes in.
The term grew in popularity with the AbbVie v Humira case last year. This arose when US pharma company AbbVie filed 200 patents, 100 of which covered a biologic called Humira, an active protein adalimumab. Humira purchasers claimed that the ‘thicket’ of patents was so large, that it would detract any biosimilar manufacturers from making a Humira similar.
“A patent thicket could decrease the level of competition in a market. Thickets have been accused of causing monopolies in a vertical and impeding innovation,” said Kabir.
Giving an alternative perspective, Coppola said: “It could just as well be called lifecycle management. If people want to design around the patents they can, but it's a fine line between negative cartels and an innovator protecting what they have created. If they lose the incentive to protect, then they lose the want to innovate.”
Giving their closing remarks, the panel discussed what we should expect to see in the biosimilars market going forward.
Kabir said: “I think you will see more ‘biobetters’ or ‘biosuperiors’. It is a marketing term that designates second generation products, with molecules a little altered to improve safety, efficiency etc. But as they have significant molecular differences, they are separate and follow their own regulatory pathway.”
Royzman added: “I think we will start to see litigation within the marketing exclusivity period for biosimilars. Litigation will begin earlier and that will have a number of consequences.”
LSPN Connect is the membership programme for the Life Sciences—to watch on this session and for more information on joining, visit www.lspnconnect.com
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Biosimilars, biologics, innovation, LSPN Connect, Smart & Biggar, Kramer & Levin, patent infringement, litigation