Outrunning All Fields of Use

Section II.B. License Field of Use? ?When commercialization partners are interested in a biopharma project, they usually want it all.? Regional alliances happen when an originator withholds the home territory and aligns with regional partners (as will be discussed in II.C. Territory Splits), but most commercialization partners want access to any and all project expansions or windfalls.

As shown in the graphic below, “All Fields of Use” has been the dominant definition of alliance scope across all stages of development at signing for several decades.? For Pre-95 through 2009 datapoints, I’ve borrowed an analysis done by Recap which included all alliances commenced in the relevant period.? For the 2010-16 portion, however, I’ve included 170 global deals having total deal payments to the project originator of at least $50 million.

Approximately 70% of recent global biopharma alliances across all stages of development have entailed All Fields of Use.? So, what’s been happening in the other 30%?? About 25% of global alliances commenced since 2010 have defined the license field by disease or excluded specific diseases from the licensed field of use.? The remaining 5% of recent global alliances have defined the license field by type of product – typically the delivery setting or route of delivery.

With respect to recent alliances which defined the licensed field by diseases, however, most were discovery or preclinical stage deals in immunotherapy, and so had little relevance outside of cancer.? That implies that withholding diseases from the scope of a global non-oncology alliance is much rarer than one chance in four. One such exception was Proteostasis’ 2013 discovery collaboration with Biogen for proteosome inhibitors.? Here’s the alliance snapshot:

Biogen’s licensed field of use starts all-inclusive, but Proteostasis regains rights in cancer and infectious diseases to Compounds not in the clinic in the event Biogen hasn’t pursued such uses within five years of signing.? Here’s the contract language:

Technology to enhance drug efficacy is another exception, as seen in Halozyme’s 2011 alliance with Intrexon (later called Precigen).? Here’s the deal snapshot:

Intrexon has licensed exclusive rights to Halozyme’s PH20 Drug for treatment of genetic emphysema plus any additional fields except for use in treatment of angioedema and two additional diseases.? Here’s the contract language:

Finally, for compounds in Phase II or later stages of development at signing, occasionally there will be a global alliance that essentially divides the field of use by disease.? Such was the case in the 2010 Angioblast (later Mesoblast) Phase II alliance with Cephalon for stem cell therapy.? Here’s the deal snapshot:

As shown in the contract language below, Cephalon had rights for all cardiovascular, CNS and oncology diseases, while Angioblast retained rights for all other diseases, including the right to use any Cephalon IP associated with such ex-field diseases.

Despite commercialization partners’ strong preference, and convincing track record, for accessing all fields of use in biopharma alliances, there is precedence for successfully withholding such access by disease, formulation or type of product.? With so much else to resolve in an alliance negotiation, however, it’s no small task to outrun “all fields of use”.

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You can see the introduction to this ongoing series of articles about best practices in biopharma licensing, or go directly to links to previously posted articles of the series here.