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Exploring An Exit To India’s Covid Management Maze

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‘India’s Covid-19 Crisis is Spiraling Out of Control. It Didn’t Have to Be This Way,’ was the headline of the lead article, published in The Time with the cover page ‘India in Crisis.’ All Indians also believe the same, as the current reality is shown virtually live in TV news channels daily, with experts commenting on the same.

Ironically, many in the country’s leadership still remain in a ‘denial mode’, even when the country records globally highest number, ever – over 402,110 daily new Covid-19 cases with 3,688 daily deaths, on April 30, 2021. One can also gauge how grim the situation is from the example of the US alert to its citizens in India. It says, ‘access to medical care is becoming severely limited because of a surge in Covid-19 infections and those wishing to leave the country should take advantage of available commercial transportation options.’

Notably, when most Indians, including the President of India, were taking pride in the country’s ‘Aatma-Nirbhar Bharat Abhiyan,’ especially in the Covid-19 vaccine area, during the pandemic, the stark reality appeared to be quite different. Pandemic demonstrated that each country is, in fact, interdependent. One may not acknowledge it in the days of hubris. However, when a crisis, like Covid 2.0 strikes the nation hard and interestingly – not unannounced, as many experts write, the reality dawns. This is also a reality that India as a nation could not adequately prepare itself for Covid 2.0 onslaught, even over a yearlong Covid 1.0 pandemic.

Nonetheless, India now needs global help, almost for everything – in the prevailing calamity – Oxygen, drugs like, Remdesivir – and vaccines, besides many others. Quite expectedly, witnessing the Covid 2.0 tragedy in India ‘Aid (also) pours in from the world to counter India’s Covid-19 second wave.’ Alongside, along with Indian media, even foreign media reports, ‘Bodies piling up at crematoriums: Record death toll may hide extent of India’s COVID-19 crisis.’

Amid Covid crisis, most countries in the world, including the United Kingdom, the United States,Israel and even India’s neighboring country - Bhutan focused on the mass Covid vaccination drive – at a blistering pace, to create a herd immunity. In this article, I shall explore the drivers and barriers for India to achieve a similar goal, soon.

Current developments with vaccine in India:

The latest development is – after a protracted hesitation, the Government of India opened ‘Covid-19 vaccination for all above 18 years of age,’ effective May 01, 2021. However, not so good news is, this happened at a time when the country is experiencing a Covid-19 vaccine shortage even for all adults above 45 years of age. Believing that government has taken this decision without enough advance preparation, experts warn, India is likely to face extreme Covid vaccine shortage from May 1.

They express concern: ‘India is running out of vaccines just as the new wave of Covid-19 infections batters the country, complicating Prime Minister Narendra Modi’s plan to inoculate the nation’s workforce while threatening to drag out the world’s worst healthcare crisis.’

India rejected ‘emergency use’ of imported Pfizer and other vaccines, unlike other countries:

Some decisions by Indian vaccine expert panel also delayed more vaccine availability in the country for ‘emergency use,’ sooner. For example, Reuters reported on February 05, 2021, ‘Pfizer drops India vaccine application after regulator seeks local trial.’ The Company had applied to the DCGI for a waiver of a local trial for importing its mRNA vaccine in India.

Similarly, as reported on February 25, 2021, ‘Expert panel seeks safety data for Russia’s Sputnik V Covid-19 vaccine before emergency use nod,’ in India. Ironically, it was again rejected on April 01, 2021. However, facing the fierce Covid.2.0 wave Sputnik V vaccine is now being imported from Russia. Similarly, as reported on April 30, 2021, ‘Pfizer begins exporting U.S.-made COVID-19 vaccine to Mexico.’ Pfizer has already exported 10 million doses to Mexico.

In the quagmire of indecision, late decision and other non-life saving priorities are omnipresent:

Many Indian and overseas experts opined that valuable time was lost to have more vaccines in India, by now. This is because, amid a wrenching surge in infections and deaths, on April 14, 2021 – ultimately, India agreed to fast-track vaccine approvals for ‘emergency use,’ without local trial. These are now applicable to all those Covid vaccines that have already been authorized by ‘drug regulators in the US, UK, European Union and Japan or cleared by the WHO, without having to conduct a local bridging trial.

The above developments, I reckon, gave rise to two core issues in vaccinating the Indian population of above 18 years of age – at a ‘blistering pace,’ as happened or is happening in countries, like the UK or the US.

Whereas, for speedy mass vaccination wealthy governments took a quick decision to stock up on COVID-19 shots from Pfizer and Moderna Inc, because of their extremely high efficacy. More so, when safety concerns and production problems temporarily sidelined vaccines from AstraZeneca Plc and Johnson & Johnson.

Two core issues for a speedy vaccination process in India:

No domain experts in the world doubt that mass vaccination is India’s Covid-19 escape route from the prevailing health care massacre. However, arising out of the above developments, successful implementation of Covid vaccination process  on the ground, making it available and affordable to all, poses a giant challenge. Thus, to effectively address the two core issues, with the quality of speed that it deserves, finding answers to the following questions are critical:

  1. How to add speed to the vaccination process?
  2. How to avoid different pricing for the same vaccine for the Central Government, the State Governments and the Private Hospitals? This will give a choice to the population for speedy vaccination, removing many personal apprehensions involving the entire process.  

Let me give an example, each of the most recent quagmire related to each one of the above issues.

All vaccination centers in Mumbai were shut for three days for shortages:

Reuters reported on April 30, 2021 carrying a headline, ‘Indian states run out of COVID-19 vaccines; nationwide inoculation delayed.’ It added, several Indian states have run out of COVID-19 vaccines a day before a planned widening of a nationwide inoculation drive. Interestingly, quoting Indian authorities it elaborated: ‘All vaccination centers in India’s financial capital Mumbai were shut for three days starting Friday due to a shortage of vaccines, as the country posted another record daily rise in coronavirus cases.’ The same saga can be witnessed in the national capital of India. ‘Don’t queue up outside Covid-19 vaccination centers tomorrow, the stock will arrive in 1-2 days,’ urged the Chief Minister of Delhi.

The Government allowed Covishield and Covaxin price increase amid pandemic:

Covishield and Covaxin were being purchased by the central government at a price of Rs. 150 per/dose. While announcing Covid vaccination eligibility to all Indians above 18 years of age – despite vaccine shortages, the government allowed the two Indian vaccine manufacturers to increase the same vaccine prices – for direct supply to the state governments and private hospitals.

The manufacturers lapped up this decision and increased the vaccine prices by several times, amid catastrophic Covid 2.0 pandemic. For example, for state governments the Covishield price was raised to Rs.400/per dose and Rs.600/per dose – for Covaxin. However, facing severe criticism from all quarters the prices were revised to Rs 300 (Covishield) and Rs.400 (Covaxin). Interestingly, still the price increases were double or even more from the initial prices of Rs.150/per dose.  Interestingly, one manufacturer even boasted  this so called ‘price reduction’ from their initial humongous price increases, as a ‘philanthropic gesture’. Interesting indeed!

A hidden solution within Supreme Court questions to the Center:

While hearing a Suo Moto case in connection with the ongoing Covid 2.0 calamity in the country, the Supreme Court of India also took note of the difference in Covid vaccine prices for the Centre and the state governments. It observed Covid vaccine manufacturing is publicly funded, hence are public goods – these are ultimately meant for the people of India. At the same time, the apex court asked some of the following profound questions to the central government on Covid 2.0 management in the country:

  • Why is the center not following the national immunization program policy in its Covid-19 vaccination drive where the Centre will buy all vaccines from the manufacturers?
  • How much investment has the Centre made into the vaccine companies and given advances in the last year?
  • What has been the financial contribution by the Union govt in research etc. in the development of vaccines?
  • How will the Centre ensure registration for vaccines for illiterate people and those without internet access as registration through Co-Win is mandatory in the third phase of vaccination?
  • Will one state get priority access over another in getting the vaccines?
  • How will the Centre ensure equity by private vaccine manufacturers when it is buying only 50 percent of the doses?
  • Has the center considered invoking Section 92 of the patents act and issue compulsory licenses so that drugs can be manufactured while the royalty is sorted?
  • Why are we paying so much for this vaccine for which AstraZeneca has set at a far lower price to the US citizens?

One may possibly find a hidden solution to the question of invoking Section 92 of the Indian Patent Act (IPA 2005) to address some critical Covid vaccine related issues in India.

Is invoking section of IPA 2005 a near-term solution?

As many would know, Section 92 of the Indian Patents Act is a special provision enabling the Central Government to issue Compulsory Licenses for the manufacture of patented drugs in a public health emergency. Section 100 of the IPA enables the Central Government to use patented inventions for government purposes. Curiously, the Supreme Court of India has, reportedly, also observed: “This is an exact case where we should go for compulsory licensing. This is a situation of Public Health Emergency.”

Just to recap, on October 02, 2021, India and South Africa had proposed at the WTO about an IP waiver for Covid-19 drugs and vaccines that could help resolve the urgent issues of access and affordability to these products. It has also been reported: ‘Richer members of the World Trade Organization (WTO) blocked a push by over 80 developing countries on Wednesday to waive patent rights in an effort to boost production of COVID-19 vaccines for poor nations.’

Although, U.S. Trade Representative has recently met with Pfizer and AstraZeneca to discuss this proposed IP waiver for Covid vaccines and drugs, what stops India to invoke Section 92 and 100 of its own Patent Act even during this seemingly uncontrollable Covid 2.0 pandemic?

The April 06, 2021 article of the Observer Research Foundation aptly epitomized the need of the hour. It articulated: ‘As the pandemic continues to rage, countries collectively have to find innovative ways to not just increase the production of vaccines, but also ensure their timely distribution at affordable prices.” Such an initiative may encourage more manufacturers in India to manufacture enough Covid vaccine, facilitating speedy inoculation to Indians and at the same time the government can make its price affordable for all concerned.

Conclusion:

The question, therefore, arises: Is India’s exit to the Covid 2.0 maze now visible? But, before arriving at any possible conclusion in this regard, one may try to address, at least, the following two critical questions:

  • Can Covid vaccines be reverse-engineered by domestic pharma industry without inventors sharing ‘Know-How’?
  • Can the IP waiver by the WTO or invocation of section 92 and 100 of IPA 2005 by India, legally mandate vaccine developers, like AstraZeneca, Pfizer-BioNTech or Johnson & Johnson, to share know-how with others, if they do not want to do so?

The resolution of the above issues won’t happen in a jiffy – at this stage. It may take more time. So, I reckon, will be the search for a permanent exit to India’s Covid 2.0 management maze, to avoid a similar strike by Covid 3.0, if or as and when it will come. Thus, till all adult Indians get vaccinated, each one of us must comply with Covid appropriate behavior responsibly, to save ourselves, our families, neighborhood, and above all our own nation.

By: Tapan J. Ray     

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Awaiting ‘The Moment of Truth’ on ‘Working of Patents’ in India

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By a letter dated October 21, 2014 addressed to the Secretary, Department of Industrial Policy and Promotion (DIPP) of India, the domestic pharma major Cipla has sought for the revocation of five patents of Novartis AG’s respiratory drug Indacaterol (Onbrez) in India, under Sections 66 and 92 of the Indian Patents Act.

Launch of a generic equivalent:

Cipla also announced its decision to launch shortly a generic equivalent of Indacaterol with the brand name Unibrez Rotacaps to satisfy the unfulfilled requirement of the new drug in India.

The Maximum Retail Price for a strip of 10 capsules of Unibrez Rotacaps 150 mcg would cost Rs.130.00 to patients against the equivalent strength of Onbrez of Novartis costing Rs.677.00, which is 420 percent more expensive than the price at which Cipla would sell this drug.

What do the Sections 66 and 92 of the Indian Patents Act say?

- Section 66 of the Indian Patents Act:

“66. Revocation of patent in public interest: Where the Central Government is of the opinion that a patent or the mode in which it is exercised is mischievous to the State of generally prejudicial to the public, if any, after giving the patentee an opportunity to be heard, make a declaration to that effect in the Official Gazette and thereupon the patent shall be deemed to be revoked.”

- Section 92 of the Indian Patents Act:

“92. Special provision for compulsory licenses: (1) If the Central Government is satisfied, in respect of any patent in force in circumstances of national emergency or in circumstances of extreme urgency or in case of public non- commercial use, that it is necessary that compulsory licenses should be granted at any time after the sealing thereof to work the invention, it may make a declaration to that effect, by notification in the Official Gazette, and thereupon the following provisions shall have effect, that is to say –

(i) The Controller shall on application made at any time after the notification by any person interested, grant to the applicant a license under the patent on such terms and conditions as he thinks fit;

(ii) In settling the terms and conditions of a license granted under this section, the Controller shall endeavor to secure that the articles manufactured under the patent shall be available to the public at the lowest prices consistent with the patentees deriving a reasonable advantage from their patent rights.

(2) The provisions of sections 83, 87, 88, 89 and 90 shall apply in relation to the grant of licenses under this section as they apply in relation to the grant of licenses under section 84.

(3) Notwithstanding anything contained in sub- section (2), where the Controller is satisfied on consideration of the application referred to in clause (i) of sub- section (1) that it is necessary in –

(i) A circumstance of national emergency; or

(ii) A circumstance of extreme urgency; or

(iii) A case of public non- commercial use, which may arise or is required, as the case may be, including public health crises, relating to Acquired Immuno Deficiency Syndrome, Human Immuno Deficiency Virus, tuberculosis, malaria or other epidemics, he shall not apply any procedure specified in section 87 in relation to that application for grant of license under this section:

Provided that the Controller shall, as soon as may be practicable, inform the patentee of the patent relating to the application for such non-application of section 87.”

Two key reasons:

Anchored on the above two sections of the Indian Patents Act, the two key reasons cited by Cipla for revocation of five patents granted to Indacaterol of Novartis AG are, very briefly, as follows:

Lack of inventive steps and ‘evergreening’ of patents:

The exclusivity given to five patents of Indacaterol is contrary to law due to lack of inventive step, being obvious inventions. Novartis allegedly has indulged in ‘evergreening’ with a number of patents to extend monopoly of the drug much beyond the term of the first patent. Indian law expressly bars ‘evergreening’ as it impedes drug access to a large majority of the patients.

Lack of working of the patents:

Cipla also claimed lack of “working” of those patents in the country, as a mere 0.03 percent of the drug requirement is currently being fulfilled in India. This leaves the percentage of inadequacy in the requirement of the drug per year at a staggering number of around 99.97 percent.

With supporting details, Cipla has stated in its letter that Indacaterol under the brand name Onbrez is imported by Novartis through its licensee Lupin Pharma only. It further pointed out that the Indian law requires all patents to be “worked” within the territory of India.

While adequate quantity of imports may qualify as working, the present case is one in which the patents in question have not been worked through imports of adequate quantity of the drug. Thus reasonable requirements of the public have not been fulfilled, at all.

Abysmally low drug access to Indian patients:

According to Cipla, when there has been a necessity for the availability of Indacaterol to a much larger number of patients afflicted by COPD, that has assumed magnitude of an epidemic, just a miniscule of 0.03 percent of the total drug requirement is currently being met in the country. In 2013, the import of Indacaterol, as reportedly declared in Form 27 by Novartis to the Patent office, was just 53,844 units, which could meet this drug requirement at best of only 4,500 out of 15 million patients, annually.

Despite accepted drug benefits, the doctors are unable to adequately prescribe Indacaterol in India, due to low quantity of the drug import for the public.

Thus, while announcing the launch of cheaper generic equivalents of the drug, Cipla emphasized that its Unibrez Rotacaps would fulfill the requirements of the public, meet public health interest and at the same time increase access to this medicine, with an affordable alternative, for a large number of patients.

Increasing incidence of COPD in India:

In its application to the DIPP, Cipla underscored that Indacaterol is one of the preferred medications to treat widely prevalent Chronic Obstructive Pulmonary Disease (COPD) that has reached the magnitude of an epidemic in India with about 15 million Indians afflicted with the ailment.

COPD is now among the top ten causes of disease burden in India. According to Indian Council of Medical Research (ICMR), the overall prevalence rates of COPD in India are 5.0 and 3.2 percent respectively in men and women of and over 35 years of age. The World Health Organization (WHO) also reported that COPD is the cause of death of more people than HIV-AIDS, Malaria and Tuberculosis all put together in the South East Asian Region.

Cipla quoted an Indian Study on “Epidemiology of Asthma, Respiratory Symptoms and Chronic Bronchitis in Adults (INSEARCH)”, which estimated that about 7 percent of deaths annually are a result of Chronic Respiratory Diseases in India.

Importance of Indacaterol in COPD treatment:

Cipla reiterated that Indacaterol is the preferred drug over other beta adrenoceptor agonists, as it has to be consumed only once a day. Moreover, it has a higher potency and prolonged effect as compared to other beta adrenoceptor agonists.

Strong arguments make the case interesting:

Though appropriate legal authorities would take a final call on the subject, prima facie, Cipla seems to have a strong case resting on the pillars of Sections 66 and 92 of the Indian Patents Act.

Since, Cipla has already gone ahead and announced the launch of cheaper generic equivalent of Indacaterol in India, it gives a sense about the company’s confidence in its argument against five valid patents of Novartis on this drug.

On the other hand, one may also justifiably say that Cipla should have waited for the final verdict of the court of law on the validity of five Indacaterol patents in India, before deciding to actually launch a generic version of the patented drug.

It is worth noting that in 2013, Novartis lost a legal battle related to patent grant for its anti-leukemia drug Glivec in the Supreme Court of India. The case lasted over seven years in various courts of law. Interestingly, Cipla had followed similar course of action in the Glivec case too, and had won the case decisively.

‘Form 27’ and the Indian Patent office (IPO):

At this stage it is worth noting, a ‘Public Notice’ dated December 24, 2009 was issued by the Controller General of Patents, Design & Trade Marks, directing all ‘Patentees and Licensees’ to furnish information in ‘Form No.27’ on ‘Working of Patents’ as prescribed under Section 146 of the Patents Act read with Rule 131 of the Patents Rule 2003.

The notice also drew attention to penalty provisions in the Patents Act, in case of non-submission of the aforesaid information.

The information sought by the IPO in ‘Form 27’ can be summarized as follows:

A. The reasons for not working and steps being taken for ‘working of the invention’ to be provided by the patentee.

B. In case of establishing ‘working of a patent’, the following yearly information needs to be provided:

  • The quantity and value of the invention worked; which includes both local manufacturing and importation.
  • The details to be provided, if any licenses and/or sub-licenses have been granted for the products during the year.
  • A statement as to whether the public requirements have been met partly/adequately to the fullest extent at a reasonable price.

The ‘Public Notice’ also indicated that:

• A fine of up to (US$ 25,000 may be levied for not submitting or refusing to submit the required information by the IPO.

• And providing false information is a punishable offence attracting imprisonment of up to 6 months and/or a fine.

The important point to ponder now is, if Cipla’s allegation is correct, what has been the IPO doing with the ‘Form 27’ information to uphold the spirit of Indian Patents Act 2005, thus far?

Conclusion:

For various reasons, it would now be interesting to follow, how does the IPO deal with this case right from here. In any case, information provided through ‘Form 27’ cannot remain a secret. ‘The Right to Information Act (RTI)’ will help ferret more such details out in the open.

As the ‘Moment of Truth’ unfolds in this case, one would be quite curious to fathom how the strong voices against ‘non-working of patents’ and ‘evergreening’ drive home their arguments before the court of justice.

On the other hand, the global innovator companies, their highly paid lobby groups and the USTR are expected to exert tremendous pressure on the Indian Government to protect the global pharma business interests in India, come what may. All these would indeed create a potboiler, as expected by many.

In this complex scenario, striking a right balance between rewarding genuine innovation, on the one hand, and help improving access to affordable modern medicines to a vast majority of the population in the country, on the other, would not be an enviable task for the Indian Government.

As the juggernaut of conflicting interest moves on, many would keenly await for a glimpse of ‘the moment of truth’ based on the judicial interpretation of ‘evergreening’ and ‘working of patents’, for this case in particular.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.