Patent pharmaceutical

Intellectual Property Rights | Patent pharmaceutical

An Intellectual Property Rights patent pharmaceutical or drug can be given for novelty, inventive step and for industrial application. It can be claimed as

·        A drug or pharmaceutical product,

·        Modified drug or pharmaceutical of a known compound, if proved to be more efficeous than the known compound, and

·        A process of making the product and formulation containing the drug.  

Generic drug is a drug which is produced and distributed without patent protection. The generic drug may still have a patent on the formulation but not on the active ingredient. Patent pharmaceutical drug includes all medicines for internal or external use of human beings or animals and all substance intended to be used or in the diagnostics, treatment, mitigation or prevention of diseases in human being and animals.

If genetically modified gene sequence or amino acid sequence is novel which involves an inventive step and has industrial application, for which;

1. Gene sequence /amino acid sequence,

2. A method of expressing above sequences,

3. An antibody against the protein / sequence and a kit made from the antibody/sequence can be claimed and applied for patent.

The human genome product resulted in the identification of large number of genes and gene fragments which resulted in a large number of patent applications on DNA sequences and part sequences.

In case of an herbal, chemical, pharmaceutical or a medicinal composition, the process can be claimed and applied for patent by the following processes:

(a) A novel product by itself,

 (b)A process of extraction and/or process of mixing the ingredients either pre-prepared or extracted.

(c) Apparatus, if novel, either for the process of extraction and/or for the process of preparation.

In case of non-drug or non-pharmaceutical chemical, the following can be claimed:

(a) product, if it is novel,

(b) Process of making the chemical

(c) Apparatus for the preparation of a chemical, if it is novel and applied for patent.

In case of national emergency or extreme emergency, then the compulsory license may be granted without any terms and conditions in respect to any patented invention. In that situation, the central government may take a declaration by notification in the official gazette. Then the controller may grant compulsory license to any interested person to work on the patented invention. It includes public health crisis like Acquired immuno deficiency syndrome, human immuno deficiency syndrome, tuberculosis, malaria and other epidemic diseases.

The pharmaceutical industry includes chemical industry which includes agricultural chemicals and biotechnology industry whose innovations are from engineered plant varieties to human pharmaceutical therapies. The patented products of pharmaceutical companies can be easily and cheaply replicated by copiers with little investment.  Patented pharmaceuticals will pass through rigorous testing and approval before they can be introduced in to the market.In many technology based industries, many inventions are kept secret until they marketed. This enables the inventors to delay in patent filing and to maximize the effect till twenty years. 

The patent pharmaceutical industry is heavily regulated by government agencies to assure the safety and efficacy products which will be sold to consumers. In 2001, the pharmaceutical industry develops 402 new cancer medicines, 123 new treatments for heart disease and stroke, 83 new AIDS treatment and 176 new medicines for neurological disease. If any country has no manufacturing capacity, then the license has been granted by such country to import the patented pharmaceutical products from India and the pharmaceutical business is based on formulations, bulk products etc.