Patent vs Product Licence

Patents

A patent is a set of exclusive rights granted for a specific period by a state to an inventor of a product or a process, in exchange for the inventor publicly disclosing a detailed description of the invention. A patent is therefore a form of intellectual property.

The most important right a patent gives the holder is the right to control who makes, or uses, the invention. So the person (or company) who holds the patent can either use the invention themselves, or give permission for others to use it.(1)

If another person uses the invention without permission, the patent-holder can sue them to:

  • Stop them doing it.
  • Get damages for lost profits.

Product Licences (Marketing Authorisation)

Product licences (now known as marketing authorisations) are for medicines.

A marketing authorisation is required in order to put a medicine on the market.(2) The product licence is obtained from the relevant licensing authority (either the Medicines and Healthcare Products Regulatory Agency [MHRA], for the UK, or the European Medicines Agency [EMA], for the European Union), upon production of satisfactory evidence of efficacy and safety.

A medicine cannot be marketed without a marketing authorised, and where a licensed (authorised) product exists, prescribers should prescribe that product unless it is unsuitable for a particular patient.(2,3)

The Difference

  • A patent protects an invention. It allows the inventor to prevent others using his invention without his permission.
  • A product licence (marketing authorisation) protects patients. It ensures that only medicines which have met certain standards of evidence with regards to safety and efficacy are allowed to be put on the market.

If a person has a patent over a drug, then he can prevent others from manufacturing it, but he cannot market it as a medicine himself unless he has a product licence.

References

  1. Patents Act 1977. Available from: http://www.legislation.gov.uk/ukpga/1977/37
  2. Human Medicines Regulations 2012 No. 1916. Available from: http://www.legislation.gov.uk/uksi/2012/1916/contents/made
  3. Prescribing guidance: Prescribing unlicensed medicines. Available from: http://www.gmc-uk.org/guidance/ethical_guidance/14327.asp
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