Pharmaceutical industry after manufacturing a drug for a disease has to undergo a patent process. A patent process is like a protection given to the drug so as not to be copied by the other pharmaceutical companies. After getting a patent drug, the pharmaceutical company can manufacture the drug, market the drug, and sell it to earn profit from it.
In India, the Intellectual property act came into action by Patents Act, 1970. The patent act was amended in 2005, to include product patent in it. After this amendment, food, drugs, chemicals, and isolated MO’s (microorganisms) were included in it. For a drug to complete the patent registration process, a period of 1 to 2 years is required.
The concept of the patent drug was introduced to protect the drug from duplicity and safeguard the life of people as well as the pharmaceutical company.
Patent claims in Pharmaceutical Industry
Pharmaceutical companies have to follow a patent registration process for the same. There is the variant type of patent claims or claim that are practised in pharmaceuticals. The major ones are:
1. Product patent or claim
The claim is the active chemical substance as an entity. It’s a superior claim that suggests apart from the patent holder nobody can manufacture, sell, or import the chemical.
2. Product by process patent
The claim is on chemical or the processes used to produce the drug. It is the second-best claim as it delegates the protection against the import or export of a drug. Although, other companies can surge out with a viable process not covered in the pharmaceutical drug patents.
3. Process patent
The claim covers only the chemical process but not the chemical product. It was introduced as it was sometimes difficult to prove that another company is using the patented process.
4. Formulation patent
This claim is on the pharmaceutical dosage of the drug. It’s basically on the formulation of a drug or a class of drugs or for a range of drug with the variant mode of action like slow releases, the location of action etc. Thus, the pharmaceutical company patents on the range of drugs dosage only.
Drug patent Expiration
The pharmaceutical drug patent is given for a span of around 20 years. After the drug patent expiration, the drug becomes generic and is permitted to sold and manufactured by other pharmaceutical companies. The patent drug after 20 years is called the generic drug. However, as per the law, the generic drugs are to be similar to the branded drug by the same efficiency, usage, route of administration, pharma cokinetics and pharmacodynamics.
Once the patent holder is removed, the generic drug faces a huge completion upon marketing. Competition results in the price drop which results in a public profit. The public is benefited as the same life-saving drug can reach them at a comparatively low price.
The drug patent expiration can, however, be renewed by the patent holder. The renovation is based on the formation of a new version of the drug. It requires clinical trials and re-registration of the patent. Additionally, the new drug should capable enough to compete with the original generic drug.