Medicine & Biotechnology

Biological Exclusions

Patents are not allowed in respect of plant or animal varieties or essentially biological processes for the production of plants and animals other than microbiological processes. More generally, an invention whose commercial exploitation would be contrary to public order or morality is prohibited. This latter prohibition is narrower than that which is prohibited by law.

Methods of medical treatment of humans and animals by surgery, diagnostic methods or therapy are excluded from patent protection. This exclusion does not apply to medicinal products compounds, or substances which are very commonly patented.

Products used in any such method are specifically patentable. The patent claims must of necessity, be framed in such a way as to be outside the scope of the exclusions.

Medical Treatment

Medical treatment refers to curative processes. Processes which do not have this objective may be patented. These include health, cosmetic and beauty methods and processes as well as hearing aids and contraceptive methods.However, if there is physical interaction that is part of the methodology for treatment of an animal or human, the exclusion is likely to apply.

The boundaries are difficult to draw. Courts and patent offices have taken different approaches. Many forms of non-curative surgery have developed.

The exclusion is not limited to processes and methods that require a surgeon or veterinary surgeon. Medical treatment of animals which can be administered by non-qualified persons is covered.

Diagnosis

The European Patent legislation has similar exclusions for diagnostic processes. The exclusion applies to a diagnostic method involving an intellectual aspect of the medical or veterinary decision, examination and fact-finding steps together with interactions with humans or animals for carrying out these steps of a technical nature

This leaves significant scope for elements of the diagnostic process to be patentable. The purely intellectual aspect by itself would be excluded on general principles. However, devices and such like, for use in medical examination, are potentially patentable. Technical steps and processes that do not involve interaction with the body are not caught by the exclusion and are potentially patentable.

Products, in particular substances or compositions not previously so used, may be patented for use for medical purposes. A patent may be available for the new use of an existing substance, whether already recognised as a medicine or not.

After some initial reluctance, It appears that a dosage regime in itself is potentially patentable. If it meets the key requirements of novelty and inventive step it may potentially be protected by patent.

Biotechnical Inventions

There is an EU Directive on the protection of biotechnological inventions. Inventions concerning plants or animals may be patented if the technical feasibility of the invention is not limited to a particular plant or animal variety. Certain biotechnological inventions are excluded from patentability on the grounds of public order on morality.

The directive covers material containing genetic information, which allows its propagation. The production of such propagation is protected. Farmers are permitted to use seeds obtained from harvest on their own farms.

There is equivalent protection for patented livestock reproduction material. The sale of breeding stock or animal reproductive material to a farmer, by or on behalf of a patent holder or with his consent, allows the farmer to use the livestock for agricultural purposes, including making the animal or reproductive material available for the purpose of the agricultural activity, but not for commercial reproduction.

The restriction on the patentability of things that are against public order or morality may cover offensive things and that which is illegal or against public policy. Even if something is illegal in Ireland, it does not follow that it is against public order or morality so as not to be patentable.

Genetic Engineering

Restrictions on patentability in relation to biotechnology raise the sensitive question of genetic engineering. Issues of morality and ethics arise as well as the suffering of animals and wider risks to the environment.

Processes for modifying genetic identity that are likely to cause suffering without substantial medical or veterinary benefit are specifically prohibited from patent protection.

The EU directive on biotechnological inventions provides that the following are contrary to public order and not patentable
• cloning human beings;
• processes which modify the germline or genetic identity of human beings;
• use of human embryos for industrial and commercial purposes;
• modifying the genetic identity of animals likely to cause them suffering without any substantial medical benefit to man or animal and animals resulting from the process

The European Patent Office has decided that inventions relating to products which necessarily involve the destruction of human embryos may not be patented. It does not rule out the possibility of patentability of inventions relating to human stem cells.

EU SPC

EU Council Regulation allows for supplementary protection certificates for human medicinal and veterinary products. A supplementary protection certificate extends the period of protection. The purpose of a supplementary protection certificate is to compensate for the period during which the invention is not available due to the EU’s regulatory approval procedure.

The certificate must be filed within six months of the date of authorisation or the grant of the patent, whichever is later. It takes effect on the expiration of the patent and is equal to the period between the application and the date of first authorisation in the EU.

The maximum duration is five years.  Renewal fees must be paid.  The certificate is granted to the patent holder.

The supplementary certificate is analogous to a patent but is not, strictly speaking, a patent. It applies to the product covered by the authorisation only.

The application is made to the Patents Office and must include details of the relevant authorisation.  Details of the application are published. An application may be made by a third party for a declaration that the certificate is invalid to the court or Controller.

It may be invalidated on the basis that the requisite conditions have not been satisfied, and that the patent has lapsed or been revoked.

A similar provision exists in for plant protection products procedures. The criteria are similar to that for medicinal supplementary protection certificates.

SPC Extension Effect

A supplementary protection certificate extends the duration of protection in relation to medical products to compensate for the delay in the authorisation.It takes effect after the patent has expired for a term equal to that between the date of application for the patent and the date of authorisation to place the product in the market.

The maximum duration is usually five years. Annual renewal fees are paid.

A supplementary protection certificate may be obtained in relation to individual medical and plant protection products disclosed in the patent. It extends the protection conferred by the patent for up to 5 years.

SPC Requirements

The medicinal or plant protection product must be covered by an Irish patent. The certificate does not extend the patent but only the current protection of the specific product covered by the marketing authorisation.

A medicinal or plant protection product must be protected by an Irish patent in force (the “basic patent”).

An SPC may be based on any “basic patent” which protects:

• the active ingredient(s) of the authorised medicinal or plant protection product;
• a method of producing the active ingredient(s);
• an application of the active ingredient(s); or
• a preparation containing the active ingredient(s) (at least in the case of plant protection products).

SPCs & Marketing Authorisaitons

Medicinal products for the treatment of humans and animals, and many agricultural chemicals, require market authorisation before they can be sold commercially. Though this process is independent of the patent granting procedure, the owner of such inventions may find that though they have a patent for their product, they may still have to wait for a number of years before they obtain the necessary authorisation to market it. SPCs compensate the patentee for this loss of time by extending the patent protection for specific products by up to five years.

An SPC does not extend the duration of the patent itself but only the protection for the specific product covered by the marketing authorisation to place the corresponding medicinal or plant protection product on the market.

An SPC for a medicinal active ingredient may also be extended for a further six months if it has undergone the appropriate paediatric testing.

The SPC is granted to the holder of the basic patent protecting the active ingredient, not to a licensee or a manufacturer.