What is a drug Patent?
According to the United States Patent and Trademark Office (USPTO) "A patent for an invention is the grant of a property right to the inventor, issued by the United States Patent and Trademark Office".
Why are Patents Important?
A patent is vital because it can help secure your invention. It can protect any product, design or process that meets the specifications according to its originality, practicality, suitability, and utility. In most cases, a patent can protect an invention for up to 20 years.
For example, when a pharmaceutical company first discovers a new drug for the disease, it should patent to sold under a specific brand name till the end of granted patent period by which the physicians can prescribe the drug for use by patients.
The discovered drugs are covered under patent protection, which means that only the pharmaceutical company that holds rights to manufacture, market the drug. It will be the most significant advantage for the company to get investment returns and profits over the period. Once the patent has expired, it can be manufactured and market by other companies. At this point, the drug called as a generic drug.
This article is an attempt to overview the various types of patents that are granting in the field of the pharmaceutical industry. Types of Pharmaceutical Patents are as follows
Formulation patent is a patent that seeks to cover the protection for pharmaceutical dosage forms includes a capsule, tablet, spray, lotion, gel, foam etc. The novel dosage forms like an immediate-release or extended-release profile also can be covered. It can specifically cover a particular drug or a class of drug or can cover a specific formulation technology or technique that applies to many drugs. The formulation patents are not intended to protect the active ingredient of the dosage form.
Patents on Manufacturing Processes
The patent has claims on the chemicals or drug manufacturing processes utilized to synthesize the drug. Typically, generic pharma companies will employ a different manufacturing process compared to the innovator when producing drugs with the same active ingredient.
Patenting of Polymorphs
Polymorphs are patentable subject matter in the U.S., Canada and many other countries. Polymorphism comes from the Greek word 'polus' meaning many and morph meaning different shapes. It can also be taken as an ability of any molecule to rearrange itself into different shapes. This different arrangement of atoms in a molecule can have a profound effect on its pharmaceutical properties like solubility, dissolution, among others. However, the safety and efficacy profile of the drug will remain the same, even though the crystal form is altered.
Patents on Combination Products
Pharmaceutical combination products are therapeutic and diagnostic products that combine drugs, devices and biological products, helps to produce safer and more effective treatments. The combination products are patentable, and the most potent drug combination patent requires inclusive coverage of each component of the product, as well as the complete product. Patent claims should focus on compounds, diagnostics, therapeutics, use, manufacture, and methods of treatment