PATENT

27th March, 2023 Economy

Disclaimer: Copyright infringement not intended.

Context

The Indian Patents Office rejected an application of Johnson and Johnson (J&J) seeking an extension of its patent on anti-Tuberculosis (TB) drug Bedaquiline beyond July 2023, when it is set to expire.

What Is a Patent?

A patent is an exclusive right granted by the Government to the inventor to exclude others to use, make and sell an invention is a specific period of time.
A patent is also available for improvement in their previous Invention.
The main motto to enact patent law is to encourage inventors to contribute more in their field by awarding them exclusive rights for their inventions. They are a form of incorporeal right. [Incorporeal rights are rights to property that can't be seen or touched but are still enforceable by law. Generally, incorporeal rights pertain to intangible property such as copyrights, licenses, rights-of-way, and easements.]

Basic tests for any invention to be patentable:

Firstly, the creation must be novel, which does not already exist.
Second, the creation must be non-obvious; it should be a considerable advance over the prior one; a slight modification in technique will not issue the product the right to a patent.
Third, the innovation must be beneficial in a legitimate manner, which means that it must not be exclusively employed in any unlawful work and must be valuable to the world in an honest way.

Key Pointers

An invention considered as new if, on the date of filing the application, any such invention is not known to the public in any form, i.e. oral, writing, or any other form.
The patent has a limited term of 20 years, which is counted from the date of filing of the patent application.
A patent is a territorial right. Thus it can only be applied in the country where it has been granted. Therefore, any legal action against infringement or infringement of patent rights can only be taken in that country. To obtain patent protection in different countries, each country must apply for a patent.
The Patent Cooperation Treaty (PCT) provides a way to file an international patent application in which a patent can be filed through a single patent application in a large number of countries. However, the PCT of a patent remains discretionary of the individual patent office only after the application is filed.
Patent ownership is transferable. A patent owner has the right to grant a license for use or even sell the ownership of a patent.

History of Patents in India

The first step of the patent in India was Act VI of 1856
The Act was repealed by Act IX of 1857 as it had been enacted without the approval of the British Crown. Fresh legislation was enacted for granting ‘exclusive privileges’ was introduced in 1859 as Act XV of 1859. The Act excluded importers from the definition of an inventor. The Act was then amended in 1872, 1883 and 1888.
The Indian Patent and Design Act, 1911 repealed all previous acts. The Patents Act 1970, along with the Patent Rules 1972, came into force on 20 April 1972, replacing the Indian Patent and Design Act 1911. The Patent Act is basically based on the recommendations of the report Justice Ann. The Ayyangar Committee headed by Rajagopala Iyengar.
Again, The Patents Act, 1970 was amended by the Patents (Amendment) Act, 2005 regarding extending product patents in all areas of technology including food, medicine, chemicals and microorganisms.

What cannot be patented?

Frivolous Inventions: These are contrary to natural laws. E.g. If any invention runs from the blood of a human and nothing else. This would be contrary to the natural laws and will come under the frivolous inventions. Something always against the establishment of natural laws.
Inventions against public order or morality or which causes harm to the environment.
Mere discovery of scientific principles or any discovery. E.G Newton’s theories and other principles etc. If these theories will be patentable, how wills students study them if they are not given freely in the public domain.
Mere discovery of a known substance is not patentable.

Compulsory License

Compulsory Licensing is one of the most important aspects of the Indian Patents Act 1970, subject to certain conditions being fulfilled.
At any period after the expiry of three years from the date of the sealing of a patent, any interested party may, subject to the following conditions, apply to the Patent Controller for the issuance of a compulsory patent license.
If a person grants permission to use any product, then it would be called a voluntary license. Any person can ask for a compulsory license. Be it a natural person, artificial person, or a company.

Grounds for granting of compulsory license

The reasonable demand shall be there.
The product shall not be reasonably in public domain.
The patented invention is not worked in the territory of India.

Example:

If any country makes the vaccine for the COVID 19, the other countries shall be given the vaccine for the same. Public health is the agenda for the WHO and the TRIPS. The Government has released a norm that the process of the vaccine shall be granted as a compulsory license for the other countries. PPP is the triangle of public health, patent, and pandemic and it is a relative issue in this crisis.

Penalties Regarding Patent Infringement

The Patents Act 1970 provides Chapter XX regarding the penalties for patent infringement.

Section 120– if any person falsely represents that any article sold by him is patented in India or is subject to an application for patent in India then he shall be liable for a fine which may extend to Rs 1 Lakhs.
Section 121– if any person falsely uses the word ‘patent office’ for his place of business or in any document issued by himself which mislead the belief of others then he shall be liable for imprisonment which is extended to six months or fine or both.
Section 122-if the person fails or refuses or falsely furnishes the following:

Any false information is given to the Central government under section 100 sub-section (5)
Any false information is given to Controller under section 146

He shall be liable for the fine which may extend to Rs 10 Lakhs.

Patent infringement suit

The Patents Act, 1970empowers the patentee to file a suit in case there is an infringement of his exclusive patent rights.
In order to file a suit, the limitation period as specified under the Limitation Act, 1963is three years from the date of the infringement of the patent rights.
The burden of proof usually lies on the plaintiff to prove that there was patent infringement by the defendant, but in certain cases, it is at the discretion of the court to decide the burden of proof.
In India, both district courts and the High Courts have the power to hear cases related to patent infringement.
However, in case there is a counterclaim for revocation of the patent filed by the defendant, then only the High Court has the right to hear the case. The patentee can file the case in the place of his residence or the place where he carries out his business, or where the cause of action arises.
Section 48 of the Indian Patents Act contains the rights of the patentees. It lists the following activities as the infringement of the patentee’s rights:

1. Using,
2. Making,
3. Importing,
4. Offering for sale patented products,
5. Selling the patented products or products directly obtained from the patented process.

If the defendant is involved in any of the above-mentioned acts, then he will be considered liable for infringement of the rights of the patentee.

What does not amount to infringement?

Section 107A of the Patents Act incorporates bolar provision and provision for parallel imports:

Bolar provision:It gives rights to the manufacturers of pharmaceutical products to conduct research on various patented products so that the products can be brought to market for the welfare of the general public. But this research can only come into effect after the expiry of the patented product.
Parallel import provisions:This gives the right to import the product from the person authorized by the patentee. This importation will not be considered an infringement of the patent rights of the patentee. This meant any person could import patented products from the person who is in possession of the due authorization or licence without seeking permission from the patentee, and this would not be considered an infringement.

Patent Evergreening

As per the Indian Patents Act, 1970 a patent is granted on a product, a process, or an invention for a limited period of 20 years.
After its lifespan expires, an invention no longer enjoys patent protection and the invention becomes a part of the public domain. This means anyone can make, use, or sell the invention without the threat of an infringement suit.
To avoid these companies, go for patent evergreening.
Ever-greening of patent, as the name suggests, is a corporate, legal, business, and technological strategy for extending / elongating the term of a granted patent in a jurisdiction that is about to expire, in order to retain royalties from them, by taking out new patents.
When the term of the patent is about to end, companies make trivial /insignificant variations to the existing patented invention and file for a new patent, thus extending their monopoly right beyond the limited period of 20 years. This is known as the Ever-greening of a patent.
Patents that are evergreened are typical in pharmaceutical patents. The evergreening of patents means securing wealth from high sales volume for a long time.

The case of Johnson and Johnson Patent Evergreening

J&J had filed a patent for Fumarate salt of bedaquiline in 2008.
Since 2008, J&J had indulged in ‘evergreening’ — a strategy to extend the life of patents about to expire in order to retain revenues from them — by making multiple claims in its applications for patent extensions.
J&J’s primary patents on Bedaquiline would expire in July 2023. After that generic drug manufacturers such as Lupin and Macleods, among others, could produce Bedaquiline, thus ensuring cheaper and wider access to the drug.
Also, recently it was challenged by two tuberculosis survivors in Mumbai in 2019 as part of a campaign to make the drug more affordable.
In response, Johnson and Johnson applied to extend its patent beyond 2023 and until 2027.
The application was under review by the patent office.
But it was found that J&J, filed for multiple patents on bedaquiline in India, not limiting itself to the basic compound patent but also filing secondary patents to stake claims on routine improvements. The strategy is called patent evergreening used by companies to keep the prices high as it would keep the affordably priced generic versions of the drug out of the market.
The Indian Patents Office rejected the application saying that stated that the invention claimed was obvious and does not involve any inventive step, and is therefore non-patentable.
- Section 3(d) of the Patents Act states that salt forms and derivatives of known substances are not patentable.
- J&J’s present application are liable to be rejected as the claimed compounds are mere admixtures, resulting in mere aggregation of properties and not a new invention under Section 3(e) of the Patents Act.

Significance

According to the latest available estimates, in 2019, over 55,000 patients who had developed multi-drug resistant TB could have benefited from access to Bedaquiline. As of March 2020, only a little over 10,000 of these patients had accessed the drug.
It is high time that alternate manufacturers start supplying Bedaquiline at lower prices, especially as TB programmes around the world plan to scale-up the all-oral, shorter, six-month drug-resistant TB regimen.
The rejection opens the door for drug manufacturers to produce generic versions of bedaquiline, which are expected to be more affordable and to contribute to India's goal of eliminating TB by 2025.
Concern: J&J continues to hold the patent on Bedaquiline in other major markets such as South Africa, meaning that Indian generic manufacturers will be unable to export the drug there.

Read all about TB: https://www.iasgyan.in/daily-current-affairs/tuberculosis

MDR TB, XDR TB AND Bedaquiline

TB is an infection of the bacterium Mycobacterium tuberculosis in the lungs, but often in other organs as well. It can be treated by strictly adhering to the doses and frequencies of drugs prescribed by a physician.

Deviations from this schedule can lead the bacteria to become drug-resistant. Yet they happen because the drugs often have side effects that diminish the quality of life and/or because patients haven’t been afforded access to the requisite drugs on time.

TB incidence in India has been on the decline, but Multidrug-Resistant Tuberculosis (MDR TB) and Extensively drug-resistant TB (XDR TB) endanger initiatives to locally eradicate the disease.

MDR TB resists treatment by at least isoniazid and rifampicin, the two frontline drugs in TB treatment. XDR TB resists these two drugs as well as fluoroquinolones and any second-line injectable drug. XDR TB is rarer than MDR TB.

Drug-resistant TB is harder to treat. One important option for those diagnosed with pulmonary MDR TB is bedaquiline.

Unlike second-line treatment options that are injected and can have severe side effects, like permanent hearing loss, bedaquiline is available as tablets and is less harmful.

India’s Health Ministry has guidelines for bedaquiline use as part of the Programmatic Management of MDR TB under the National TB Elimination Program.

PRELIMS PRACTICE QUESTION

Q. Which of the following statements are correct with reference to Patent Laws in India?

a) Bolar provision gives rights to the manufacturers of pharmaceutical products to conduct research on various patented products before the expiry of the patent so that the products can be brought to market for the welfare of the general public.

b) The Patents Act 1970, replacing the Indian Patent and Design Act 1911 is based on the recommendations of the Ayyangar Committee headed by Rajagopala Iyengar.

c) At any period after the expiry of three years from the date of the sealing of a patent, any interested party may, subject to the following conditions, apply to the Patent Controller for the issuance of a compulsory patent license.

d) In India, only the High Courts have the power to hear cases related to patent infringement.

1) a and c

2) b and d

3) b and c

4) a, b and c

Answer: 3