formulation patent cases Flashcards
describe Teva v Leo
regarding psoriasis treatment
- calcipotriol + beclamethasone were well established APIs used in psoriasis cream/ointment
- often prescribed together - had diff benefits
- could not use together at same time due to pH instability - patient compliance issues
- due to presence of water
Leo came up with a solution - to use - arlamol E - non aqueous solvent
patent claimed:
- 2 APIs - calcipotriol + beclamethasone
- one base
- one solvent - Arlamol E
was Teva vs Leo invention obvious or inventive?
High court said yes obvious and disallowed the patent because:
- Arlamol E was disclosed in a non-aqueous composition with beclamethasone in a previous document called Turi
- a person skilled in the art would test Turi and see that the combination worked
Court of Appeal said NO not obvious and allowed the patent because:
- there was no sufficient expectation that Arlamol E would have worked
- there was nothing pointing to Arlamol E having a higher likelihood of success over other non-aqueous solvents
- to find out if it worked would require a research project
- long felt need for combination product and no explanation for why it had not been done before
describe Hospira vs Genentech
drug - HERCEPTIN - trastuzumab
Genentech had a patent concerning lyophilised formulations of trastuzumab with trehalose as the lyoprotectant, histidine as the buffer and polysorbate 20 as surfactant
Hospira argued patent was obvious as phase II clinical trials disclosed trastuzumab as a liquid formulation - so a skilled person would be motivated to develop a lyophile
high court held that the claims of the patent were obvious - as all aspects of the claims could be reached by routine approaches applied to excipients
- so they disallowed patent
court of appeal upheld the decision and disallowed the patent because:
- screening methods + excipients - part of the CGK
- tests were routine
- there was a degree of confidence that screening methods would produce a formulation that worked
describe Gedeon richter vs bayer schering
pharma - contraceptive
bayers formulation of contraceptive tablet Yasmin - contained 2 steroids - drospirenone and ethinylestradiol
problem was that drospirenone was sparingly soluble and with slow dissolution - would degrade
- needed to be in a rapid dissolution formulation to avoid degradation
High court said Bayer’s patent was not obvious
- although in vitro PF testing is obvious
- there was no expectation of outcome and success
court of appeal upheld finding:
- they said prior art to invention was a speculative jump in the dark
- no expectation of success and that formulation would work
Describe omnipharm vs merial
solutions of fiprinol
- anti-parasitic agent - for protecting animals against fleas
Merial had a patent concerning a ready to spot on solution comprising
- organic solvent
- organic co-solvent
- compound to inhibit crystallisation
omnipharm argued spot on application was obvious in light of a spray for all over use called frontline
court held that it was not obvious as there was no explanation that spot on application would be successful - allowed Merial’s patent
concluding remarks on formulation patents
on the whole - formulation patents struggle to survive challenges to validity unless they offer genuinely surprising benefits
formulation patents can be important IP factors to support life cycle of a drug - but a GOOD INVENTION is key to success
the limitation of “persons skilled in the art” must be understood
the prior art must be understood to present a convincing argument - expert witness must have full knowledge and experience of prior art - to advise the court with clarity
