Thanks for drawing attention to the USPTO documentation, Mike senior.
Re your question, I would think that the examiner’s response does have bearing on the arbitration, although it’s difficult to say anything with certainty because we are not privy to the specifics of POH’s assertions against Mylan.
We have speculated that “fraudulent or negligent misrepresentations” and “unjust enrichment in relation to intellectual property and commercial licensing terms” likely relate to the Agila Improved Daptomycin Formulation patent. We have further speculated that the Agila patent was filed without POH’s knowledge or consent and was in breach of R&D and Licensing agreements signed between the two companies. We thought it possible that Agila, and in turn Mylan, planned to exploit TPM in its daptomycin formulation by claiming sole invention of the product and bypassing/breaching the licensing agreement it had signed with POH.
I think that this USPTO documentation lends weight to that speculation. It certainly makes it clear that Mylan has continued to claim use of TPM in a daptomycin formulation as its own invention, without acknowledging POH’s previous claims. The records show that the daptomycin patent application was filed in March 2015, after Mylan had assumed control of Agila, and that, despite the first rejection of all claims by the Examiner in August 2016 and a further final rejection of all claims in April 2017, Mylan has continued to argue, amongst other things, that POH’s patent doesn’t cover the use of TPM in injectable formulations and therefore that its patent should be allowed.
I read the Patent Examiner’s rejection letter in the same way as Jev. The Examiner is having none of Mylan’s arguments and delivers somewhat of a slapdown in the process.
A couple of further thoughts.
If we have ready access to this information, so too does the Arbitrator. If the daptomycin patent is a focal point of his/her deliberation, I would think that the Patent Examiner’s views and reasons for those views would hold considerable weight.
Secondly, even if POH were to lose this arbitration, without a patent, Mylan wouldn’t be able to proceed with bypassing POH and taking this formulation to market.
Thirdly, as Jev has noted, the USPTO decision states that a patent previously issued to POH discloses the use of TPM in formulations suitable for multiple routes of administration, including injection. POH has since further strengthened its patent portfolio with respect to injectables. In November it was stated that the TPM/propofol collaboration with Terumo had generated two separate patent applications, which will be progressed in all key territories. As well as a joint POH-Terumo patent specifically for the TPM/Propofol formulation, there was also a POH patent intended to further protect the use of TPM in a range of injectable formulations.
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