“Bayer loses Cancer Drug patent appeal : Natco an Indian Company to produce generic Nexavar at Rs 8880 against MNCs Rs.2.8lakh –for a month’s therapy’’ was one of the headlines in Times of India dated 4th March 2012.
This is a clear indication that “patents” is not a fancy legal term - which we thought the multinational drug companies use for making profits. “Patent” is going to affect our life in a substantial way.
An anticancer drug Sorafenib tosylate (NEXAVAR) patented by a multinational company Bayer, was costing Rs. 2.8 lakh for a month’s treatment. Using a rare & exceptional clause in the Indian Patent law, the Government of India has permitted an Indian Company to manufacture and market the same patented drug at a cost almost 30 times lower than that of the innovator. Result: Saving of Rs. two lakh seventy one thousand per month on cancer treatment per patient. I am sure many cancer patients in India suffering from advanced renal cancer or hepatocellular carcinoma can now afford therapy and will survive and enjoy an additional life span, thanks to a timely and clever decision of the Government of India.
What is a patent’? Who grants a patent? Why are patents becoming important day by day? It is high time that all of us make an attempt to understand at least the basics of patents as it has a tremendous impact on commerce, business and our health. As the saying goes, “What you are aware of you are in control of; what you are not aware of is in control of you”.
Let us try to understand the basics of patents.
1. What is a patent?
It is a Monopoly or a special right.
Granted to whom?
To an Inventor
What is the purpose?
For disclosing his invention
Granted by whom?
By the respective Governments
For how long?
For 20 years
What is the purpose of such a grant?
Encouraging the inventor & ensuring progress of science and technology
2. Can we get a patent for anything or is it restricted only to Medicines?
We can apply for and get patents for anything – from a safety pin to supersonic jet, from an anticancer drug to an automobile part.
In pharmaceuticals, patents are granted for drugs, devices, compositions, processes, manufacturing methods, drug formulations, and improvements of the existing technology etc.
3. What are the 3 basic criteria needed for making the invention patentable?
1. Novelty: The invention should be new, not known to the world. It should be first time in the world.
A safety pin was granted patent in 1899; (Inventor: William Middlebrook); now it looks so simple but no one knew till then that a safety pin could be made. (hence nothing should deter you from making an attempt for a new invention!)
2. Inventiveness: Your invention should not only be new but also should not be obvious to people. There has to be some feature which a man in the same field would not have easily thought of. It cannot be ‘workshop’ improvement. Invention cannot be patented if it consists of an obvious and minor change in existing technology.
For example: Imagine, someone had invented for the first time, a door knob made up of wood. You study the existing wooden door knob and try to make a door knob with copper. Your invention would be novel (assuming that you are the first person who made a door knob with copper) but will not have “inventiveness”. It is obvious that anyone would have thought of it after looking at the existing wooden door knob. Your invention is not patentable.
3. Utility. Every invention should have some utility to be patentable. Invention cannot be just for the sake of invention. There has to be a purpose.
4. Why are patent rights called territorial?
There is nothing called a “Universal Patent “or a “World patent”.
You get a patent when you apply for the same in a particular country and the patent will be valid only in that country. If you want your invention to be patented in many countries you will have to apply for patents in different countries. If you are granted a patent for your invention in India, it would be valid only in India. Anyone can copy your invention and market a product based on your invention in United States; you cannot prevent it, unless you have also applied for a patent for the same invention in United States.
Every country can decide (as per TRIPS –an International Agreement which most of the countries have signed) what can be patented and what cannot in that country. This is based on the national policy, economy and specific requirements of that country. For example the following things are not patentable in India:
6. How do we obtain an Indian Patent?
The process of obtaining an Indian patent consists of:
Application: An application has to be made to Indian patent office in a specified format giving details of the invention and the required fees*.
Publication: A summary of your patent application (i.e. summary /abstract of your invention) is published in the patent office journal within 18 months of your application
Request for Examination: A request for the Examination of the application has to be made along with additional Fees** by the inventor/patentee (owner of the Patent) to show his continued interest in pursuing his application.
Evaluation: Application would be evaluated by the Patent examiner on the basis of the 3 patentability criteria, i.e. Novelty, Inventiveness and Utility. He would ascertain that your invention is not covered under the list of non-patentable inventions. He may seek clarifications from the inventor /patentee and may sometimes allow minor modifications in the description of the invention.
Granting of the Patent : If the Patent Examiner and the Controller of patents are satisfied with your invention and if there are no objections from any one (related or unrelated to your field), Patent would be granted , which would be valid for 20 years from your first application date. There is a need to keep paying annual maintenance fees if you want to retain the validity of your patent for 20 years.
(*Rs 1000/= Patent office fees for an individual inventor)
(**Rs 2500/=Examination Fees for an individual inventor)
i) Data about the inventor : Address, nationality, contact details, email etc. and related information
ii) Specification: This will include:
CLAIM/S: It is the heart of a patent in which an inventor states exactly what his invention is and what it does. Claims define the legal scope (right) of a patent.
8. What are the rights of a patentee (owner of the patent)?
The patentee has the exclusive rights to make, use, sell, and distribute the product of his patented invention.
He can assign or license his rights to others.
The patentee has the right to file a case in a court if his rights have been infringed.
9. What is Patent Infringement?
Patent infringement is an unauthorized use, manufacture, and sale, distribution of any patented invention (product or process) within the country or import of any patented invention to the country during the 20 years of term of the patents – without the permission of the inventor/patentee.
If the patent is infringed the patentee can file a case in an appropriate court against the infringer. Patentee may ask the court for an injunction to prevent continuation of the infringement and for an award of damages because of the infringement. (You may be aware of a recent US case wherein Samsung was supposed to have copied the patents of Apple, in their cell phones and was ordered by the Court to pay damages of more than I billion US $ to Apple)
10. What is “compulsory License” (under Indian Patent Act)?
At any time after a period of 3 years from the date of the grant of a patent, any person interested can make an application to the Controller General of Patents for grant of Compulsory license on that patent. i.e. permission to manufacture and market the patented product, if he can show that:
1. Reasonable requirement of the public with respect to the patented product has not been satisfied, OR
2. Patented invention is not available at affordable price, OR
3. Patented invention is not worked in the territory of India (i.e. manufactured within India).
Compulsory license was granted to Natco, an Indian company to manufacture the patented product NEXAVAR (Sorafenib tosylate, patented and marketed in India by Bayer) as the patent office agreed that the patented product is not adequately supplied and the price is not “affordable”.
This decision was challenged by Bayer at Appellate Board (Patents) in Chennai. The Appellate board agreed with the decision of Indian Patent office and the Compulsory license granted was upheld.
“The purpose of this article is to give an overview of the subject and should not be construed as a professional advice”
|Dr Ravindra Shetty (March 2013)|