Pharmaceutical Inventions 1 Flashcards
what is a patent?
patent = a form of intellectual property which gives its owner the right to exclude others from making using selling importing an invention for a limited period of years - in exchange for publishing an enabling public disclosure of the invention - proving a description of the invention in sufficient detail that others can work on it once the monopoly is over.
Patents protect inventions - gives the owner the right to sue for infringement any person using making selling importing an article which makes use of the protected invention - gives the owner a legal monopoly to use the invention in the patent
UK patent lasts 20 years from the time patent application is filled
- provides protection throughout UK provided renewal fees are paid every year
USA utility patent - 20 years
USA design patent 15 years
- A patent only gives owner rights within the country it was granted in
How to gain patent protection in other countries?
by filling application in the patent offices of the individual countries
or by applying to the international patent co-operation treaty (PCT)
or for protection in most European countries applying to the European patent convention (EPC)
list some patented devices
Allen and hanbury (GSK) - Ventolin rotahaler - salbutamol sulphate/asthma 1975
Respimat - soft mist inhaler - tiotropium bromide/COPD - 2003
Novartis - transdermal patch - scopolamine/motion sickness - 1979
Zosano Pharma - micro-needle array patch - vaccines/biologics - 2006
example of a patented API
Novartis - siponomid (brand name Mayzent) for Multiple sclerosis
siponomid is a sphingosine phosphate 1 recptor modulator for subtypes 1 and 5
- 1st ever OD oral medication for treatment of relapsing-remitting and active secondary progressive MS
how to know if an invention is patentable?
invention:
- has to be patentable subject matter
- has to be useful (functional/operative)
- has to be novel/original
- has to not be obvious to a person skilled in the art
what are things you can’t patent in the UK?
discovery
scientific theory
mathematical model
artistic/musical/dramatic creation
computer programme
scheme/rule or method for performing a mental act
describe the UK patent application process
any person may apply for a patent
- but only the inventor is granted it
an applicant for a UK patent has a choice b/w national patent or european patent
for UK patent - application consists of:
- description of invention
- the claims
- summary + abstract of invention
- drawings illustrating invention
UK application filed at UKIPO -
intellectual property office
In USA - US patent & trademark office (USPTO)
1) search request is filed within next 6 months and patent examiner will determine if invention is new and inventive
2) within 12 months - application is formalised - applicant must file a set of claims that define the claimed/patented invention
3) within 18 months - the UKIPO will publish the application
4) applicant then has a further 6 months (within 24 months) to request UKIPO examination + pay relevant fees
5) approximately 12 months later - UKIPO will issue an examination report and patent is either granted or applicant must respond to concerns examiner has - may involve changing claims
6) following applicants response - further examination report issued - examination continues until final refusal or grant which is at 4.5 years
describe the european patent office (EPO) application process
for application to the EPO:
1) application (consisting of the same thing as UKIPO) - published within 6 months of application date without search report
2) search report issued and published within 6 months of application
3) within a further 6 months - applicant must file request for examination
4) following examination, examination report then issued and for UK patents further examination continues until refusal or grant
5) for european patents drafted in english - further step involves translating claims into french and german
when can the period of protection of 20 years be extended?
In certain cases - period of protection can be extended by SPCs - supplementary protection certificates
allows an extension for upto 5 years for pharmaceutical/medicinal products and plant production products
This period is to compensate for time taken to gain regulatory approval e.g. marketing authroisation from the MHRA or EMA
- this usually causes delays
- SPC accounts for delays
SPC for an API can also be extended a further 6 months on top of the 5 extra years if it has undergone pediatric testing
SPCs only valid for products marketed in UK and only issued to patent holder
give 2 examples of patent controversy
1) Harvard college vs Canada
- supreme court case regarding patentability of a Harvard oncomouse - a mouse that had its genome GM by a cancer-promoting (onco)gene
in 1985 - Harvard college filed a process patent - for method by which mice were modified and patent for end product - the GM mice
the process patent was granted but product patent was refused based on the grounds that higher life forms were outside definition of inventions so were not patentable
- the question for the court was would it fall under manufactured/composing matter
- the court ruled NO
2) The european patent organisation + individual european states have laws which allow patents on inventions of cells inc. stem cells - provided they are novel, inventive and capable of use in industry
the same laws prohibit patents of inventions which are immoral
in a landmark decision - the highest legislative body of EPO ruled that inventions which involve destroying human embyos are immoral cant be patented
the highest EU court also considered this issue and rendered most human embryonic stem cell inventions not patentable in europe
what is skinny labelling?
practice of follow-on drug manufacturers seeking approval for some but not all of the indications for which the branded drug was approved
- its a successful strategy for generic drug makers to get around the brands follow-on new use patents - keeps the brand from falling off the “patent cliff”
- long after expiration of the original patents
what is a trademark and what is the difference b/w a registered and unregistered trademark?
Trademark - type of intellectual property - that consists of recognisable sign, design, expression that identifies products/services of a particular source from those of others
- important in defining a BRAND
what is copyright?
- exclusive right given to the creator of a creative work to reproduce the work - usually for a limited time
- creative work may be literary, artistic, musical, educational
