Case Studies

Recent work at Mark Hooper Consulting has included:

Technical support on chemistry and other science issues.
Literature and precedent searches, to establish the common general knowledge and prior art.
Writing experimental protocols.
Practical work in organic synthesis, product characterisation, analysis (NMR, HPLC, mass spec, physical form, XRPD), formulation, stability testing, food science.

Here are a couple of opinion pieces on the need for scientific input alongside legal expertise.

Some examples of projects managed by Dr Hooper are given below (cases now finished).

1) Resolution Chemicals vs Lundbeck (Escitalopram)

Dr Hooper led the team at Pharmaterials in support of the legal team representing Resolution Chemicals against Lundbeck, in a patent revocation claim. He consulted on case strategy and choice of expert witness. He then managed and personally carried out a full practical programme involving organic synthesis and chiral resolution. This involved an initial run through of the practical project, a second repeat (recorded on video for use in the case) and then a final repeat monitored in person and recorded by both sides (including representatives from the opposing legal team). Dr Hooper then carried out full preparation for High Court proceedings.

2) Inhalation drug delivery

Various projects involving reviewing literature and related patents, designing practical programmes to defend a patent, discussing strategies to invalidate patents, carrying out experimental work to support those strategies. Also attended EPO hearings as an ‘on-hand’ scientific expert in support of patent invalidation case.

3) Physical form and chirality for Esomeprazole

Once the state-of-matter patent on Omeprazole (Nexium) had run out, it was extended by secondary patents on chirality (enantiomeric excess of S-form) and crystalline form. Dr Hooper worked on a case of potential infringement where he devised and carried out a practical programme to show non-infringement for crystal form of the API (in the supplied drug and final tableted formulation) and for enantiomeric excess of the API (again in the supplied drug and final tableted formulation).