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In Pharma’s Moment of Truth “What You Do is Who You Are”

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It’s a time when pharma industry will be tested, both by its external and internal customers – more than ever before. Looking back, in search of footprints on the sand is no answer either, as there isn’t any. But, a decision on moving ahead has to be made by each drug company in any case – charting a strategic pathway, in search of business excellence, if not for survival. A possibility looms large that the crisis may even overwhelm a company, if any, ill-conceived or ill-thought through steps are taken.

In that sense, the moment of truth has arrived for the industry – a time when ‘what different you do’ in the value delivery process of the business, will decide ‘who you are.’ One’s ability to lead the company or even follow the leadership, to navigate through this crisis, would determine the present and future success of the corporation. This isn’t an easy task. The evolving processes would be challenging to implement, and the traditional mindset may often act as a retarding force, as it were. In this article, I shall explore this critical area with recent examples, as far as possible.

Ability to fathom its most critical component is the bedrock for next steps:

The most critical component in this situation is the ability to make a careful and unbiased assessment of – how different would the ‘new normal’ be from the ‘old normal.’ The focus should not be on the barriers in making the necessary strategic changes, which I hear too often – but how to steer the business through this unprecedented crisis, regardless tough barriers on the way.

Covid-19 threat isn’t going to go away anytime soon:

However, one thing is for sure – no one knows, not just in India, but globally how big the crisis is, and will assume what form, when and how long. Let me give just three illustrations in this area that will be easily understood by all:

  • Initially, experts used to say, face masks are required only for those having symptoms and people close to them. “Masks are not required for those who doesn’t have symptoms. Whereas, the same experts are saying these days, “data now emerging about asymptomatic patients spreading the infection across the country, masks play an important role in containing the spread.” Thus, one is required to wear a face mask always while going outdoors.
  • Explaining the mode of disease spread, earlier, many experts, including the W.H.O, said that COVID-19 virus is primarily transmitted between people through respiratory droplets and contact routes. Thus, a mask is needed when one goes outdoors. Whereas, now the same experts, including the W.H.O, have confirmed that Coronavirus can be airborne indoors. In that case, one may need to wear a mask even indoors.
  • On April 23, 2020 the Director-General of Indian Council of Medical Research (ICMR), reportedly, claimed that the situation is stable, and the country has been able to ‘flatten the curve.’ But on May 09, 2020, Director, AIIMS, reportedly, said, “Currently, the cases are continuing to grow at a flat rate, sometimes even more. So, it is very difficult to predict when the peak will come; but it is likely to peak around June or July…” Whereas, an MIT study, which has also been reported in the press reveals, “India might see 2.87 lakh Covid cases per day by February 2021.”

These instances drive home the point – although a serious threat of Covid-19 infection will continue in the foreseeable future, but the way it will manifest itself, and the fresh precautionary measures that will deem necessary, may change with time. Let me give one more example of increasing threat of getting re-infected by Coronavirus by already infected individuals has heightened today than in the past.

The battle tactics need to be updated:

Strategy for war against Covid-19 onslaught may broadly remain similar. But the battle tactics in the multiple fronts need to be updated on an ongoing basis. This needs to be based on increasing or narrowing of the spectrum of threat and other critical factors, as scientific evidences will reveal from time to time.

For example, as is unfolding today, a large number of already infected people, particularly living in areas with high population density, may not necessarily develop any long-term immunity against the Coronavirus infection. Such a possibility will have a wide impact on any business strategy in the new normal that an organization may contemplate.

The rationale for constantly updating battle tactics:

Let me now focus on the rationale for constantly updating battle tactics based on scientific evidences with a few contemporary examples. The study, published in the Nature Medicine on June 18, 2020, found that individuals recovering from Covid-19 infection may have immunity only for 2-3 months. Although, it may not necessarily be construed that a recovered person can get re-infected, but any vaccine that may eventually come may need to address such issues, which seems to be a tough call.

Alongside, findings of another large research – Spain’s Coronavirus antibody study, published in The Lancet on July 06, 2020, has also cast doubt on the feasibility of herd immunity as a way of tackling the Coronavirus pandemic. As the BBC News reported on July 07, 2020 - based on these findings, Prof. Danny Altmann, British Society for Immunology spokesperson and Professor of Immunology at Imperial College London has made similar comments on effective vaccine development initiatives.

He said, the study would, “reinforce the idea that faced with a lethal infection that induces rather short-lived immunity, the challenge is to identify the best vaccine strategies able to overcome these problems and stimulate a large, sustained, optimal, immune response in the way the virus failed to do.”

“What You Do is Who You Are”: 

As the saying goes: “What You Do is Who You Are.” With this fast-evolving scenario, pharma leadership will need to effectively address a dual strategic game plan to outmaneuver the barriers of the Covid-19 pandemic:

  • Putting in place a robust operating strategy for customer value delivery process of the business.
  • Capturing the details of new Covid19 related ongoing developments to constantly hone the battle tactics in several different fronts.

Both the above processes will involve picking up all such validated research findings, mostly on the run. Mostly because, such issues may impact both internal and external customers of the organization, besides competition. Therefore, factoring-in each of those new developments, while constantly sharpening the war strategy and battle tactics in the fast-evolving scenario, will be of crucial. And, what you think or do in this situation will determine who you are – what type leadership traits you exhibit to face the challenges of the new normal, effectively.

Two types of leadership in the new normal:

Amid challenges of the present crisis, I reckon, top leadership will find two broad types of domain leaders – ‘pro-tradition’ and ‘pro-change’ – both will have successful past track records. They need to be identified for appropriate strategic tasks.

As is known to many, a good number of successful leaders are operating through decades around the concept of physical presence of patients while consulting a doctor or other health care providers. Several of them seem to be still unsure about the extent of organizational and operational changes required to face this unprecedented crisis, head-on. Even today, some of them keep trying to impress others by citing instances of what they did so well in the past.

There is nothing wrong in that. But, the business environment and requirements of those days were different – quite different from today’s demand. Curiously, many of such good leaders, with impeccable past success records, seem to be more bothered about seemingly insurmountable barriers on the way. They are afraid of migrating away or jettisoning the traditional pathway of success. Probably, the fear of failure – after achieving success for a long time, is the reason. I consider these successful professionals as ‘pro-tradition’ leaders.

There are also examples of another type of leaders. They are generally younger, looking forward with a contemporary mindset, nurture a can-do spirit with a resilience to bounce back, even in difficult times. Which is why, any transient fear of failure doesn’t usually overwhelm them. And, these leaders, I reckon, may be broadly termed as ‘pro-change’ leaders.

Keeping aside, past success records or future success potential of pharma leaders, in the current scenario – what they actually think or do in the changing environment to steer the organization out of this never-before crisis, will indeed determine ‘who they are.’

A contemporary initiative sets an example:

Top leadership of several drug companies, such as those at Novartis, is leading the way for a change management as the new situation will demand – by setting examples for others. These leaders seem to be taking note of all changes, as discussed above, while giving shape to a strategy, and reshaping the same based on data, as and when required. Interestingly, more technology professionals are getting attracted to pharma operations during Covid-19 pandemic than ever before, as a recent research report unfolds. This is a good omen for pharma and needs to be leveraged, effectively.

The findings of a new research report:

A new research report from Novartis -  A Powerful Pairing,  emphasizes: “The global COVID-19 pandemic sparked a seismic shift in the adoption and scaling of digital technologies across the healthcare sector at a pace never before seen. Almost overnight, organizations had to dial-up their efforts to develop, manufacture and ultimately bring medicines to patients in a socially distant world.” The survey brings out some interesting points, such as:

  • 86 percent of respondents believe the time has come for digital healthcare, and many of them are interested in taking part.
  • Regardless of the sector they currently work in, the two industries that technology professionals would consider switching to, are technology and healthcare and pharma (49 percent for each). This interest rises to 58 percent for workers based in India and 55 percent for those based in China. They feel, Covid-19 pandemic has made them more aware of medical causes around the world and how important they are. Through work in this sector, they can save countless human lives.
  • 52 percent of technology talent sees innovation potential in the healthcare and pharma sector, with the top reason to apply for a job being the opportunity to innovate through technology.
  • 89 percent technology professionals say that data science is important to the development and delivery of healthcare industry solutions and services.

Conclusion:

Surging ahead to reach a million mark, as on July 12, 2020 morning, the recorded Coronavirus cases in the country reached 850,358 with 22,687 deaths. With a record high of 27,755 daily cases yesterday, the pace of climb continues.

It’s now virtually a writing on the wall that India will have to sail through the unprecedented Covid-19 pandemic for quite some time, where unprecedented leadership interventions will be of critical importance – even in pharma. This endeavor will also call for selective induction of competent technology professionals in all pharma business domains, as required. The challenge involves not just carving out the ‘war strategy’, as it were, against Covid-19, but also continually honing the ‘battle tactics’ in multiple fronts – mostly on the run, for desired outcomes.

The situation calls for taking an in-depth inventory of an organization’s existing human resources, based on success ingredients required to turn the tide, which, I reckon, should also be the starting point in this venture. In this moment of truth – standing at the cross-roads of the drug industry, there is no further room for top pharma leadership to procrastinate the decision-making process. All competent professionals should be taken on board. In tandem, both – seemingly ‘pro-tradition’ and ‘pro-change’ leaders, should be encouraged to realize that in the new normal “What You Do is Who You Are” in the future pharma business.

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.