[Ip-health] New Chair of BIO endorses (forced?) licensing of cell lines for biosimilars

James Love jamespackardlove at gmail.com
Wed Oct 16 09:07:02 PDT 2019


This is pretty significant.  The incoming chair of BIO, Jeremy Levin, 
has endorsed the open licensing of cell lines, after a period of 
exclusivity (a version of the one and done approach).

Among his quotes in the story:

"Further, you wouldn’t have biosimilar companies developing poor-quality 
products because they’d be using the exact same cell lines and 
processes, and the new biosimilar product would be identical to the 
originator. And that benefits the patients. Unless we resolve current 
practices with all parties at the table and understand the needs of all 
stakeholders — most importantly patients — it’s going to be very tough 
to implement. A company that is failing to innovate, but has a 
blockbuster that is bringing in billions in revenue, is going to fight 
to the death to protect what they have, despite what is important for 
patients and the economy."


https://www.lifescienceleader.com/doc/jeremy-levin-weighs-in-on-biosimilar-patent-thicket-0001

Jeremy Levin Weighs In On Biosimilar Patent Thicket
Source: Life Science Leader
By Rob Wright, Chief Editor, Life Science Leader
Follow Me On Twitter @RfwrightLSL

It’s 5:30 p.m. on Wednesday, June 5, 2019, at the BIO International 
Convention and Conference in Philadelphia. Up an escalator and down a 
side hall of the convention center, you’ll find a temporary office for 
BIO’s newly elected board-director chair, Jeremy Levin, DPhil, MB BChir, 
CEO of Ovid Therapeutics.


2. HOW CAN THE BIOSIMILAR PATENT-THICKET CONUNDRUM BE ADDRESSED?

We know one way to spur biopharmaceutical innovation is to guarantee the 
innovator gets a consistent revenue stream from a product it has 
developed which has been approved by the FDA. How do you assure a 
biologic drug development company that it’s not going to lose 
everything? This is a complex question, and no one has the answer. But 
at its core, companies need to decide that they want to do it and seek 
creative ideas and methodologies. For example, imagine if you offered a 
biologic developer, in exchange for guaranteed licensing of their cells 
and processes to any number of generic companies at the end of day “X” 
after some years of exclusivity, that they’d provide a perpetual license 
to all their processes and cell lines to those biosimilar manufacturers 
for a royalty stream in exchange. The original developer would be able 
to walk away from the original branded product that is now generic and 
still be guaranteed a royalty-based revenue stream.

To me, if regulators and industry were brave enough to work on 
constructs like this, it would help solve this patent-thicket problem. 
Further, you wouldn’t have biosimilar companies developing poor-quality 
products because they’d be using the exact same cell lines and 
processes, and the new biosimilar product would be identical to the 
originator. And that benefits the patients. Unless we resolve current 
practices with all parties at the table and understand the needs of all 
stakeholders — most importantly patients — it’s going to be very tough 
to implement. A company that is failing to innovate, but has a 
blockbuster that is bringing in billions in revenue, is going to fight 
to the death to protect what they have, despite what is important for 
patients and the economy.





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