Patent decision

BL number
O/320/20
Concerning rights in
GB 1600631.4
Hearing Officer
Mrs C L Davies
Decision date
11 June 2020
Person(s) or Company(s) involved
Sun Pharmaceutical Industries Australia PTY Limited
Provisions discussed
PA 1977 Section 1(1)(b)
Keywords
Inventive step
Related Decisions
None

Summary

The invention is concerned with Papaver somniferum (opium poppy) plants which have been modified to produce higher levels of codeine. P. somniferum plants typically produce a number of clinically useful opiates through a biosynthetic pathway, culminating in the production of morphine. Codeine is converted to morphine through this pathway by the codeine 3-O-demethylase (CODM) enzyme, and therefore the natural levels of codeine in the plants are low. As a result of these naturally low levels, codeine is mostly obtained from morphine by a semi-synthetic process in order to meet demand. By deleting the expression of three linked CODM genes in P. somniferum, the invention provides plants that do not convert codeine to morphine (or thebaine to oripavine), and therefore contain increased levels of codeine and no detectable morphine (or oripavine) in the total alkaloid content of their latex or dried straw. The plants are also able to produce noscapine, which is another common pharmaceutical obtained from P. somniferum.

Following the Windsurfing/Pozzoli approach, the Hearing Officer found that the claimed invention did not involve an inventive step. The application was refused under section 18(3).

Full decision O/320/20 PDF document459Kb