API and IP Newsletter
Contents
Leveraging Artificial Intelligence and Human Know-How to Accelerate Drug Discovery
PrecisionLife Enters Multi-Target R&D Partnership with Ono Pharmaceutical
Paragraph IV patent certifications in last two months
The Food and Drug Administration (FDA) regularly publishes information relevant to 180-day exclusivity for generic drug applicants provided under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Generally, this list describes drug products for which one or more substantially complete abbreviated new drug applications (ANDAs) containing a “paragraph IV” (PIV) patent certification have been submitted to FDA.
However, this list does not state names of ANDA filers with PIV certificate and one must rely on an educated guess based on the public domain information. If Brand sues the Gx, then of course it is known who has filed ANDA with P-IV certificate, but till then it will be a guess work.
https://www.fda.gov/media/133240/download
General information
Leveraging Artificial Intelligence and Human Know-How to Accelerate Drug Discovery
Through the integration of human expertise, artificial intelligence, and automation robotics, bio/pharma companies can more efficiently target drug discovery efforts with bigger payoff.
Astellas’ R&D is often focused on therapeutic drugs for rare diseases with small patient populations, presenting challenges to sample collection and limiting the potential for drug discovery through traditional approaches. Against this backdrop, a solution came to light with the advent of technology that utilizes induced pluripotent stem cells (iPSCs) to differentiate cells into target cells
News here.
PrecisionLife Enters Multi-Target R&D Partnership with Ono Pharmaceutical
PrecisionLife Limited, a global techbio company generating insights into disease biology to create novel precision medicines in chronic diseases, has entered into a multi-target discovery and validation partnership with Ono Pharmaceutical Co., Ltd., an R&D-orientated pharmaceutical company.
The R&D collaboration will leverage PrecisionLife’s combinatorial analytics-generated insights to identify novel therapeutic targets and patient stratification biomarkers in central nervous system (CNS) disorders for development by Ono.
News here.
Intellectual Property
Takeda Pharmaceutical Company Limited vs Generics (UK) Ltd (brigatinib)
The decision under appeal because the opposition division rejected the opposition filed against EP 2300013 by Generics UK.
Generics UK appealed.
This is composition of matter patent of brigatinib. Markush claim.
The patent was opposed on the grounds of Article 100(a), for lack of inventive step, 100(b) and 100(c) EPC.
In the appealed decision, the opposition division concluded that the patent as granted did not add subject-matter. Furthermore, the claimed subject-matter was sufficiently disclosed and involved an inventive step starting from document D8 (WO 2004/080980 A1) as the closest prior art.
Generics UK Limited’s arguments relevant to the present decision were as follows.
Document D8 is the closest prior art.
The application as filed did not credibly show that brigatinib was an ALK inhibitor; the test results on page 235 neither included brigatinib nor demonstrated a structure-activity relationship allowing the conclusion that brigatinib was an ALK inhibitor.
A structural modification of the compounds shown to be active would disrupt biological activity.
Therefore, no technical effect could be acknowledged for brigatinib and the objective technical problem had to be defined as the provision of further compounds. Brigatinib was merely an arbitrary compound.
Takeda’s arguments were as follows.
Starting from D8 as the closest prior art, the subject-matter of the main request differed in the structure of brigatinib.
The technical effect provided by this difference was the inhibition of ALK.
The effect had been credibly demonstrated by the structure-activity relationship derivable from the ALK inhibitors disclosed on page 235 of the application as filed.
Therefore, the objective technical problem was the provision of alternative kinase inhibitors, in particular ALK inhibitors, for the treatment of cancer. Generic UK had not disputed that brigatinib was a non-obvious solution to this problem.
Therefore, the results presented on page 235 provide (indirect) evidence that R2 4-(4-methylpiperazin-1-yl) piperidin-1-yl, which did not impair activity, will also be non-detrimental when structure would comprise dimethylphosphoryl, as in brigatinib.
The board therefore upheld that, contrary to the Generics UK’s view, the experimental results in the application as filed demonstrate a structure-activity relationship which allows the conclusion that brigatinib is an ALK inhibitor.
The problem can then be formulated as the provision of an alternative ALK inhibitor.
On the basis of the board's conclusion, Generics UK accepted that the experimental results in the application as filed made it credible that brigatinib is an ALK inhibitor, and that brigatinib was not an obvious solution to the technical problem of providing an alternative ALK inhibitor starting from the disclosure of document D8. It did not, therefore, raise any argument in this respect.
The board opined that brigatinib is a non-obvious solution to the skilled person seeking alternative ALK inhibitors, since there is no hint in D8 of the modifications required to arrive at brigatinib, a new ALK inhibitor.
Patent was upheld.
Decision here.
