PUBG – Patent Undiscovered BattleGround

INNOVATION VS COMMERCIAL GAIN VS EQUITABLE ACCESS

Are you stressed about working from home? Do you want to go out on vacation? Is going out to buy groceries more haunting than an actual haunted house? Yes, we agree and truly believe that one small virus has changed our whole lifestyle. From deodorants to disinfection spray, from wearing colorful lipsticks to wearing the self-designed mask, the definition of fashion has now changed. 

With rising total statistics of the patients contracting the coronavirus, the heat and pressure to discover treatment and vaccines are boiling. On one side, discovering medicine is a challenge for the medical sector; on the other hand, identifying rights and patent protection scope is challenging to IP Sector. 

Many renowned countries discovered several drugs, medicines, injections, and treatments in the last few months, but now the question triggers the patent protection or royalty? The conceptual understanding of the relationship between patent protection and the invention is clear-cut. Once you invent something novel, you confer rights to protect the work from the third party using it without your permission. 

Let us begin with the COVID-19 Discovery Channel- 

• On 9th November 2020- the collaboration company of PFIZER and BioNTech announced the discovery of a new drug named BNT162b2, which proves to be 90% effective in treating the virus. They promised to supply 50 million dosages of medicine by the end of 2020 at an exclusive price of $39 (nearly crossing 2800 INR).
• The second announcement was made by US pharma Company- MODERNA, claiming to discover a drug which shall be 95% effective in treating the virus priced at $25-$37 (nearly 2200 INR-3700 INR)
• One of the peculiar things about these drugs is that they require Cold Storage facilities. These medicines will require a temperature of around -70 degrees Celsius to survive. 
• The third medicine discovered by AstraZenecaOxford claims to be 75% effective and is priced at a minimal rate of $3-$5 (nearly about 250 INR) and does not require any temperature saturations to work with. This medicine is the most eye-catching of all three.

Having said all of these, let’s get into the IP issues concerning discovering the medicines. Easy said than done- the discovery of new technology, process, and inventive steps takes a large amount of time, money, R and D, and most importantly, the intellectual of a person. This is why royalty on these products is very high, making sense because of hard work repays. 

As mentioned earlier, patent protection restricts the third party from using the formula or process to recreate the same medicine. Now when the entire world is under life threat with death mortality reaching the sky, struggling to find their way out of this havoc, if these drugs are caught in the battle of patentability grants, where no manufacturer apart from the patentee can produce the medicine we fear that the drugs might get drained in the pipeline. 

In the hurry of getting incentives for innovation done, the common public who expects the medicines to reach them as soon as possible will be immensely affected, directly questioning the concerned person’s morality (patentee) or the concerned government. Another argument in this regard states that the companies invested a lot of money for the manufacturing of these drugs; if the process of producing the drugs is made available without any due consideration given to the patentee, it might cause huge irreparable loss to the patentee, which is again wrongful. Patentees are always accused of charging a high royalty for the invention, making it difficult to use the marginalized section of people because they cannot afford it.

It is pertinent to quote one of the most famous cases under the pharma sector- NATCO vs. BAYER 

TIMELINE: 

1990: BAYER had manufactured a drug to treat kidney and lung cancer called “SORAFENIB.”

1999: Applied for patents in the USA, and the US Government granted the same.

2000: Applied for the international patent at PCT.

2005: launched the drug under the brand called “NEXVAR.”

2008: Patent was granted to “NEXVAR” by India, started exporting and distributing the drug across the country.

2009: NATCO approached BAYER for the voluntary license, selling the drug at USD 200 (8,800 INR), which was denied by BAYER (who sold at 2,80,428 INR)

2010: M/s Cipla started selling the drug NEXAVAR in India

2011: Natco filed for the compulsory license- which was granted by the controller.

2012: BAYER appealed to IPAB, who upheld the controller’s decision, thereby confirming the grant.

The grounds on which the license was granted were:

1. The price at which the drug was sold in the market was unreasonably high.
2. Bayer Corp failed to meet the requirements of the public- considering the health of the patients.
3. The drug was not tried in the territory of India.

Emphasizing the people’s health and the need for medicines, the compulsory license was granted to NATCO, making it the first company to get a compulsory license in the pharmaceutical industry history.

Going by the same principle and considering the medicine’s urgency to control the death rates due to the coronavirus, it would be the best practice to make the medicines available in the market at the earliest. The patentability of these patent applications can be questioned under the following grounds:

• On an urgent basis, medicine availability is more important than patent battles considering the death rates due to covid.
• Equitable access to all countries – considering the cost and temperature requirements.
• Incentives to the inventors < life of the affected people.
• This calls for exercising rights vested with the government and opting for compulsory licensing (part 2) of the medicines.

THE BOTTOM LINE:

As far as India is concerned, we have strongly opposed patenting the vaccines discovered to treat coronavirus at least until the pandemic last. 

We strongly agree that the rights of the public are more important than private rights. To be precise, the rights to incentive being private rights can be dominated by the right to live, right to health, and most importantly, right to treatment- forming human rights and moral rights, thus can be in short termed as a public right. Will the drug be made available to the public or get drained in the pipeline of patentability, is something we will have to wait and watch what the world has to offer us. Until then, stay safe, stay sanitized, and stay distanced.

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