Tag Archives: Allergan

Marketing Practices: Why Pharma Does What It Does?

Posted on by
Reply

It started way back – spanning across many developed countries of the world. However, probably for the first time in the last five years, an international media group focused on this issue thriving in India, with so much detail.

Reuters reported it with a headline “In India, gift-giving drives drug makers’ marketing.” The report was supported by a detailed description of the relevant events, with ‘naming and shaming’. It drew the attention of some, apparently including the Department of Pharmaceuticals (DoP), but escaped the attention of many, and finally – got faded away with time, without any reported official investigation.

In this article, I shall revisit this subject against the backdrop of draft pharma policy 2017. My focus will be on the current marketing practices, with the moot question ‘why pharma does what it does’ occupying the center stage of this piece.

Bothering many across the world:

Pharma marketing practices wear different hues and shades. Many of these are contentious, and often perceived as gross ‘malpractices’. Nevertheless, across the world, these have mostly become an integral part of pharma business. Many law-enforcing authorities, including in the US, Europe, Japan and even China, have started taking tough penal action against those transgressions. Interestingly, the draft pharma policy 2017 intends to take this raging bull by its horn, with a multi-pronged approach, as I see it.

It’s a different debate, though, whether the policy makers should bring the mandatory Uniform Code of Pharmaceutical Marketing Practices (UCPMP) under the Essential Commodities Act, or the Drugs and Cosmetics Act of India. Let’s wait and see what exactly transpires in scripting the final version of the new National Pharma Policy to address this issue, comprehensively.

The net impact of the fast evolving ‘newer norms’ of pharma ‘marketing’ practices, has been bothering a large section of the society, including the Governments, for quite some time. Consequently, many top-quality research studies are now being carried out to ascertain the magnitude of this problem. The top ranked pharma market in the world – the United States (US) are leading the way with such analysis. However, I haven’t come across similar India-specific analytical reports, just yet, probably due to lack of enough credible data sources.

Four recent studies:

Several interesting studies supported by a robust database have been carried out in the US during 2016 and 2017 to ascertain whether any direct relationship exists between payments in various forms made to the doctors by the pharmaceutical companies and physicians’ prescribing various drugs in brand names. For better understanding of this issue, I am quoting below, as examples, the gist of just four of such studies:

One of these studies conducted by ProPublica was published in March 2016. It found that physicians in five common medical specialties who accepted, at least one industry payment were more likely to prescribe higher rates of brand-name drugs than physicians who did not receive any payments. More interestingly, the doctors receiving larger payments had a higher brand-name prescribing rate, on an average. Additionally, the type of payment also made a difference: those who received meals alone from companies had a higher rate of brand-name prescribing than physicians receiving no payments, and those who accepted speaking payments had a higher rate of the same than those drawing other types of payments.

The details of the second study published in PLOS on May 16, 2016 states, “While distribution and amount of payments differed widely across medical specialties, for each of the 12 specialties examined the receipt of payments was associated with greater prescribing costs per patient, and greater proportion of branded medication prescribing. We cannot infer a causal relationship, but interventions aimed at those physicians receiving the most payments may present an opportunity to address prescribing costs in the US.”

The third example of such investigative study appeared in the Journal of American Medical Association (JAMA) on August 2016. This cross-sectional analysis, which included 279,669 physicians found that “physicians who received a single meal promoting the drug of interest, with a mean value of less than $20, had significantly higher rates of prescribing rosuvastatin as compared with other statins; nebivolol as compared with other β-blockers; olmesartan as compared with other angiotensin-converting-enzyme inhibitors and angiotensin-receptor blockers; and desvenlafaxine as compared with other selective serotonin and serotonin-norepinephrine reuptake inhibitors.”

This study also concluded that “Receipt of industry-sponsored meals was associated with an increased rate of prescribing the brand-name medication that was being promoted. The findings represent an association, not a cause-and-effect relationship.”

And the fourth analysis on the same subject featuring in the British Medical Journal (BMJ) of 18 August 2016 concluded that “Payments by the manufacturers of pharmaceuticals to physicians were associated with greater regional prescribing of marketed drugs among Medicare Part D beneficiaries. Payments to specialists and payments for speaker and consulting fees were predominantly associated with greater regional prescribing of marketed drugs than payments to non-specialists or payments for food and beverages, gifts, or educational materials.”

Exceptional steps by a few global CEOs – would the rest follow through?

As this juggernaut continues to move unrelenting, a few global CEOs have been taking some exceptional steps in this regard, e.g.:

- In December 2013, Sir Andrew Witty –  erstwhile global CEO of  GlaxoSmithKline tossed out the ‘Big Pharma marketing playbook’. He announced, no longer will his company pay doctors to promote its drugs or shell out bonuses to sales reps based on their ability to boost prescription numbers.

- Around September 2015, Brent Saunders – the Global CEO of Allergan was the first major drug company chief to explicitly renounce egregious price increases. Outlining his company’s “social contract with patients,” he vowed that Allergan would:

  • Limit price increases to single-digit percentages, “slightly above the current annual rate of inflation,” net of rebates and discounts
  • Limit price increases to once per year
  • Forego price increases in the run-up to patent expiration, except in the case of corresponding cost increases.

- In October 2016, Joseph Jimenez – the current global CEO of Novartis said, “We tell people, we don’t want you to deliver at any cost. We want you to deliver, but we want you to deliver in the right way,”

It’s probably a different matter, though, that one of these CEOs has already stepped down, another will do so early 2018, and third iconoclast is still in the saddle. They all are still relatively young, as compared to several of their counterparts.

These are some of the laudable steps taken by a few CEOs for their respective global operations. However, the moot question remains: would rest of the Big Pharma constituents come on board, and successfully follow these initiatives through?

That said, the overall scenario in this area, both in India and abroad, continues to remain mostly unchanged.

Why pharma does what is does?

This may not be akin to a million-dollar question, as its right answer is no-brainer – to generate more, and even more prescription demand for the respective focused brands of the concerned pharma companies. In a scenario, as we have seen above, when money can buy prescriptions with relative ease, and more money buys more prescriptions, how do the prescribers differentiate between different brands of the same molecules or combination of molecules, for greater support?

As evident from various available reports, this kind of intangible product differentiation of dubious nature, doesn’t necessarily have a linear relationship with the quantum of money spent for this purpose. Many believe, it is also intimately related to the nature or kind of various ‘gratis’ extended, some of which are highly contentious. Illustratively, how exotic is the venue of so called ‘Continuing Medical Education (CME)’ event, whether located in India or beyond its shores, bundled with the quality of comfort provided by the event managers, or even whether the spouses can also join the doctors for a few days of a relaxed trip with fabulous sight-seeing arrangements.

Regardless of many pharma players’ terming these events as purely educational in nature, lots of questions in this regard – accompanied by proof, have reportedly been raised on the floor of the Indian Parliament, as well, cutting across virtually all political party lines.

Conclusion:

Should anyone tag the term ‘marketing’ against any such pharma business practices, or even remotely accept these as integral parts of any ‘branding exercise’? For better understanding of my readers, I had explained what this buzzword – ‘branding’ really means in the marketing vocabulary.

Be that as it may, where from the pharma companies recover the huge cost of such vexed business practices? Who ultimately pays for these – and, of course, why? So far, in India, the basic reasoning for the same used to be – branded generics provide significantly better and more predictable drug quality and efficacy than non-branded generics, for patients’ safety.

This logic is anchored mainly on the argument that bioequivalence (BE) and bioavailability (BA) studies are mandatory for all generic drug approvals in India. Interestingly, that loose knot has been tightened in the draft pharma policy proposals 2017. Hope, this commendable policy intent will ultimately see the light of the day, unless another innovative new reason pops-up.

Against this backdrop, many ponder: Are the current pharma ‘marketing’ practices, especially in India, akin to riding a tiger? If the answer is affirmative, the aftermath of the new pharma policy’s coming into force – broadly in its current form and with strict enforcement measures, could well be too tough to handle for those drug players without a Plan B ready.

That said, pharma ‘marketing’ ballgame is getting increasingly more complex, with the involvement of several third-parties, as is often reported. Alongside, it’s equally challenging to fathom ‘why pharma does what it does’ to generate more prescription demand at an incremental cost, which far exceeds commensurate incremental value that branded generics provide to patients in India.

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.

Millennial Generation Doctors And Patients: Changing Mindset, Aspirations, And Expectations

Posted on by
Reply

The term ‘Millennial Generation’ normally refers to the generation, born from 1980 onward, brought up using digital technology and mass media. According to ‘Millennial Mindset’ – a website dedicated to helping businesses understand millennial employees and new ways of working, the key attributes of this generation are broadly considered as follows:

  1. Technology Driven:
  2. Socially Conscious
  3. Collaborative

The millennial mindset:

The publication also indicates that the overall mindset of the millennial generation is also vastly different from the previous generations, which can fall into four categories:

  1. Personal freedom, Non-hierarchical, Interdependent, Connected, Networked, Sharing
  2. Instant gratification, Wide Knowledge, Test and learn, Fast paced, Always on, Innovative
  3. Fairness, Narcissistic, Purpose driven
  4. Balance, Eco-friendly and Experience focused

Seeks different professional ecosystem:

In the professional arena too, this new generation’s expectations from the professional ecosystem are often seen to be distinctly different, as they are generally seen to be:

  • Willing to make a meaningful professional contribution, mostly through self-learning
  • Seek maintaining a reasonable balance between work and personal life
  • Prefer flexible work environment, unwilling to be rigidly bound by convention, tradition, or set rules
  • Impatient for fast both personal and organizational growth, often on the global canvas

The ‘Millennial Generation’ in India:

The millennium generation with a different mindset, aspirations and value system, already constitutes a major chunk of the Indian demography. According to the 2011 Census, out of estimated 1.2 billion population, around 701 million Indians (60 percent) are under 30 years of age, which also very often referred to as ‘demographic dividend’ of India.

Currently, a large number of Indians belonging to the millennial generation are entering into the work stream of both national and International companies operating in the country.

The challenge in healthcare arena:

In the healthcare sphere too, we now come across a fast increasing number of technology savvy and digitally inclined patients and doctors of this generation. Accurately gauging, and then meeting with their changing expectations has indeed been a challenging task for the pharma companies, and the related service providers.

Their expectations from the brands and other services, as provided by the pharma companies, don’t seem to be quite the same as before, either, so are the individually preferred communication formats, the way of processing, and quickly cross-verifying the product and other healthcare information. Before arriving at any decision, they were found to keenly observe the way brands are marketed, their intrinsic value, type and the quality of interface for engagement with them by the companies, whenever required.

Thus, from the pharma business perspective, qualitatively different strategic approaches, to both the millennial doctors and patients, would be of increasing importance and an ongoing exercise. The goal posts would also keep moving continuously. Achieving proficiency in this area with military precision, I reckon, would differentiate the men from the boys, in pursuit of business performance excellence.

In this article, I shall primarily discuss on the changing mindset and needs of the patients and doctors of the ‘millennial generation’.

A. Treating millennial patients differently:

Around 81 percent of millennial doctors, against 57 percent of older generation doctors think that millennial patients require a different relationship with their doctors than non-millennial patients. About 66 percent of millennial doctors actually act upon this and change their approach, as the survey reported.

The difference:

The key differences on millennial doctors’ treating millennial patients, are mainly in the following areas:

  • Expects more, doesn’t get swayed away: Millennial doctors are more likely to advise the millennial patients to do additional research on their own for discussion. 71 percent of millennial doctors believe it’s helpful for patients to do online research before their appointment. However, they don’t get swayed by requests from more-informed patients, as only 23 percent of millennial doctors say they are influenced by patient requests when it comes to prescribing a treatment, whereas 41 percent of non-millennial doctors report finding those requests influential.
  • Gets into the details: The millennial doctors are more likely to simplify and streamline explanations for older patients, whereas non- millennial doctors were more likely to simplify explanations for millennial patients too, treating them exactly the same way.
  • Relies on digital resources: Millennial doctors rely mostly on using digital resources for treating millennial patients, but only around 56.5 percent of them do so for non-millennial patients.

B. Treating millennial doctors differently:

For effective business engagement and ensure commensurate financial outcomes, pharma companies will first require to know and deeply understand the changing mindset, expectations, and aspirations of the millennial doctors, then work out tailor-made strategic approaches, accordingly, to achieve the set objectives.

Top 3 expectations from the pharma industry:

According to a June 2016 special survey report on Healthcare Marketing to Millennials, released by inVentive Health agencies, the top 3 expectations of millennial and non-millennial doctors from the pharma industry, are as follows:

Rank Millennial Doctors % Rank Non- Millennial Doctors %
1. Unbranded Disease Information 67 1. Unbranded Disease Information 58
2. Discussion Guides 48 2. Latest Specific News 46
3. Adherence Support 40 3. Healthy Life Style Information 42

Pharma players, therefore, can provide customized offerings and services, in various innovative platforms, based on these top 3 different expectations of millennial and non-millennial doctors, to achieve much needed critical competitive edge for a sustainable business performance.

Brand communication process needs a relook:

The above report also noted a number of the interesting trends related to the millennial doctors. I am quoting below just a few of those:

  • Only 16 percent of millennial doctors found pharma promotional materials to be influential when considering a new treatment compared to 48 percent of non-millennial doctors who do.
  • 79 percent of them refer to information from pharmaceutical companies only after they’ve found that information elsewhere.
  • 65 percent of these doctors indicated, they did not trust information from pharmaceutical companies to be fair and balanced, while only 48 percent of their older peers shared that sentiment.
  • 50 percent found educational experiences that are driven by their peers to be the most relevant for learning and considering about new treatments, against 18 percent of non-millennial physicians.
  • 52 percent of them, when learning about new treatment options, favor peers as their conversation partners.
  • They are much more likely to rely on a third-party website for requisite product or treatment information
  • 60 percent of millennial doctors are more likely to see a pharma rep, if they offer important programs for their patients, compared to only 47 percent of non-millennial doctors. This also reflects greater patient centric values of the millennial doctors.
  • However, an overwhelming 81percent of millennial doctors believe that any type of ‘Direct To Consumer (DTC)’ promotion makes their job harder, because patients ask for medications they don’t need.
  • 41 percent of millennial doctors prefer a two-way and an in-person interaction, against just 11 percent of them with online reps. Here, it should be noted that this has to be an ‘interaction’, not just predominantly a monologue, even while using an iPad or any other android tablets.

Redesigning processes to meet changing expectations and needs:

Thus, to create requisite value, and ensure effective engagement with millennial doctors, the pharma companies may consider exploring the possibility of specifically designing their entire chain of interface with Millennials, right from promotional outreach to adherence tools, and from medical communications to detailing, as the survey report highlights. I shall mention below just a few of those as examples:

Communication platforms:

For personal, more dynamic and effective engagement, non-personal digital platforms – driving towards personal interactions with company reps, together with facilitating collaboration between their professional peer groups, came out as of immense importance to them.

Adherence and outcomes:

There is a need for the pharma companies to move the strategic engagement needle more towards patient outcomes. This is mainly because, medication adherence is a large part of the patient outcome equation. It involves a wide range of partnerships, such as, between patients and physicians, and also the physicians and pharma players. This particular need can be best met by offering exactly the type of collaborative approach that millennial doctors favor.

Medical communication:

Redesigning the core narrative of medical communication around a disease state and product, engaging the wisdom and enthusiasm of scientific, clinical, and educational leaders primarily to serve a well-articulated noble cause, are likely to fetch desired results, allaying the general distrust of millennial doctors on the pharma companies, in general.

Medical representative:

Earning the trust of the millennial doctors by respecting, accepting, and appealing to their value systems, is of utmost importance for the medical reps. To achieve this, drug companies would require to equip their reps with tools and programs that offer value in terms of patient support and adherence, while demonstrating compelling outcomes with a positive patient experience, and greater efficiency in treatment decisions.

Building reputation:

The “Purpose Generation” – that’s how millennials are often referred to. In that sense, to build a long lasting business reputation among them, pharma companies need to be in sync with this new generation.

Weaving a trusting relationship with them involves meeting all those needs that these doctors value, such as, adherence solutions, innovative patient support programs, and creating shared value for communities. This would mean, for many drug companies, charting an almost uncharted frontier, where there aren’t many footsteps to follow.

Need to induct younger generation to top leadership positions faster:

To capture these changes with precision, and designing effective engagement strategies for millennial patients and doctors accordingly, an open, innovative and virtually contemporary mindset with a pair of fresh eyes, are essential. As against this, even today, many ‘Baby Boomers’ (born approximately between 1946 and 1956), who have already earned the status of senior citizens, meticulously nursing a not so flexible mind with traditional views, still keep clutching on to the key top leadership positions in the pharma industry, both global and local.

This prevailing trend encompasses even those who are occupying just ornamental corporate leadership positions, mostly for PR purpose, besides being the public face of the organization, sans any significant and direct operational or financial responsibilities. Nevertheless, by pulling all available corporate levers and tricks, they hang-on to the job. In that way, these senior citizens delay the process of change in the key leadership positions with younger generation of professionals, who understand not just the growing Millennials much better, but also the ever changing market dynamics, and intricate customer behavior, to lead the organization to a greater height of all round success.

I hasten to add, a few of the younger global head honcho have now started articulating a different vision altogether, which is so relevant by being a community benefit oriented and patient centric, in true sense. These icons include the outgoing GSK chief Sir Andrew Witty, who explains how ‘Big Pharma’ can help the poor and still make money, and the Allergan CEO Brent Saunders promising to keep drug prices affordable. Being rather small in number, these sane voices get easily drowned in the din of other global head honchos, curling their lips at any other view point of less self-serving in nature. Quite understandably, their local or surrounding poodles, toe exactly the same line, often displaying more gusto, as many believe.

Conclusion:

The triumph of outdated colonial mindset within the drug industry appears to be all pervasive, even today. It keeps striving hard to implement the self-serving corporate agenda, behind the façade of ‘Patient Centricity’. When the demography is changing at a faster pace in many important countries, such as India, a sizeable number of the critical decision makers don’t seem to understand, and can’t possibly fathom with finesse and precision, the changing mindset, aspirations and expectations of the millennial generation doctors and patients.

Expectedly, this approach is increasingly proving to be self-defeating, if not demeaning to many. It’s affecting the long term corporate performance, continually inviting the ire of the stakeholders, including Governments in various countries.

From this perspective, as the above survey results unravel, the millennial doctors and patients, with their changing mindset, aspirations, expectations and demands, look forward to an environment that matches up with the unique characteristics and values of their own generation.

To excel in this evolving scenario, especially in India – with one of the youngest demographic profiles, proper understanding of the nuances that’s driving this change, by the top echelon of the pharma management, is of utmost importance. Only then, can any strategic alignment of corporate business interests with the expectations of fast growing Millennials take shape, bridging the ongoing trust deficit of the stakeholders, as the pharma industry moves ahead with an accelerated pace.

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.

 

India, China Revoke Four Pharma Patents in A Fortnight: A Double Whammy for MNCs?

Posted on by
Reply

Revocation of four pharma patents by India and China within a fortnight has raised many eyebrows, yet again, across the globe. In this short period, India has revoked three patents and China one.

While this quick development is probably a double whammy for the Multinational Corporations (MNCs) operating in both the countries, a future trend could possibly emerge by analyzing and connecting the evolving dots.

On August 8, 2013, a judicial body, the Intellectual Property Apellate Board (IPAB) of India reportedly revoked two patents of Allergan Inc on Combigan and Ganfort, both are Fixed Dose Combination (FDC) drugs of known molecules, used in the treatment of specified eye conditions. Local pharmaceutical player Ajantha Pharma had challenged these patents granted earlier to Allergan Inc. by the Indian Patent Office (IPO), alleging that the patents were obtained on false representation, the compositions were obvious ones, mere admixture of two pharmaceutical substances and not inventions.

IPAB in its order, while revoking the patent, has also said:

  • “The revocation of the patent was sought on various grounds that the patent was obtained on a false suggestion or representation, that it is not an invention, that it is obvious and does not sufficiently disclose and that the Section 8 of the Patents Act, 1970 was violated.”
  • The “respondents (Allergan Inc) have incorrectly deciphered enhancement in therapeutic efficacy as reduction in interocular pressure comparable to serial application.”
  • “The respondent has not shown that it had complied with the Section 8 of Patents Act, 1970.”

Though Allergan claimed to have achieved enhanced efficacy with reduced side effects for these FDCs, the IPAB did not find the claims justifiable. Interestingly, Ajantha’s product reportedly is much less expensive too. As compared to Allergan’s Ganfort drops (3 ml) costing about Rs 580, Ajanta’s equivalent formulation costs just Rs 131.

The other pharma patent revocation of the fortnight:

On July 27, 2013, IPAB revoked yet another patent granted earlier to GlaxoSmithKline (GSK)’s Lapatinib ditosylate salt of its breast cancer drug Tykerb, while upholding the patent on the original API, Lapatinib. IPAB in its order has stated that the ditosylate salt version of Lapatinib is not patentable as per patentability criteria of the Indian Patents Act.

Experts believe, with these decisions, the Indian legal system has clearly demonstrated that despite intense anger, pressure and protests mainly from the United States and Europe, to dilute public health interest related safeguards enshrined in the current Indian patent regime, the rule of law still prevails in the country for IP disputes.

Tykerb decision of IPAB follows the landmark judgment of the Supreme Court of India clarifying patentability criteria for incremental innovations.

An interesting precedent set:

In case of Tykerb of GSK, unlike other occasions, for the first time one MNC has challenged the patent of another MNC in India, instead of domestic companies doing so. The German drug manufacturer, Fresenius Kabi, instead of criticizing Indian IP law like other MNCs, had challenged the British drug maker GSK’s patent on the patentability criteria as provided in the Indian Patent Law and obtained a favorable decision from the IPAB against one of their two patent challenges on Tykerb.

A different case, yet worth mentioning:

Earlier, in late 2012, Delhi High Court while recognizing the validity of Roche’s patent for Tarceva (erlotinib), ordered that Cipla’s generic equivalent of erlotinib has different molecular structures. Hence, Cipla has not infringed Roche’s patent.

The generic version of Cipla’s erlotinib is reportedly available at a price of Rs 1,600 against Roche’s price of Rs 4,800 for Tarceva. Though this is not a patent revocation, but an interesting case nevertheless.

Other patent revocations:

Besides the only Compulsory License (CL) issued, so far, by the IPO for Bayer’s Nexavar to Natco (Cost of a pack of 120 tablets of Natco generic is Rs.8,800 against Nexavar’s Rs. 280,000), such patent challenges are now taking place in India quite close on the heels of one another as follows:

Sutent (Pfizer): 

In this case, the patent for liver and kidney cancer drug of Pfizer – Sutent (Sunitinib), granted earlier by the IPO in 2007, was revoked by the IPAB in October 2012, after a post grant challenge by Cipla and Natco Pharma on the ground that the claimed ‘invention’ does not involve inventive steps.

However, on November 26, 2012 in a new twist to this case, the Supreme Court of India reportedly restored the patent for Sutent. Interestingly, at the same time the court removed the restraining order, which prevented Cipla from launching a copycat generic equivalent of Sunitinib.

The cost of 45 day’s treatment with Cipla generic is Rs. 50,000 against Rs. 196,000 of Sutent. (Source ET, April 7, 2013)

Pegasys (Roche):

Again, on November 2, 2012 the IPAB revoked the patent of Pegasys (Peginterferon alfa-2a) – the hepatitis C drug of the global pharmaceutical giant Roche. It is worth mentioning, Pegasys enjoys patent protection across the world.

Though Roche was granted a patent for Pegasys by IPO in 2006, this was subsequently contested by a post-grant challenge by the Indian pharma major – Wockhardt and the NGO Sankalp Rehabilitation Trust (SRT) on the ground that Pegasys is neither a ‘novel’ product nor did it demonstrate ‘inventiveness’ as required by the Patents Act of India.

It is worth noting, although the IPO had rejected the patent challenges by Wockhardt and SRT in 2009, the judicial body IPAB reversed IPO’s decision revoking the patent of Pegasys, costing Rs. 360,000 for a six month course of treatment for a patient.

Iressa (AstraZeneca):

On November 26, 2012, IPAB reportedly denied patent protection for AstraZeneca’s anti-cancer drug Iressa (Gefitinib) on the ground that the molecule lacked invention.

The report also states that AstraZeneca suffered its first setback on Gefitinib in June 2006, when the Indian generic company Natco Pharma opposed the initial patent application filed by the global major in a pre-grant opposition. Later on, another local company, GM Pharma, joined Natco in November 2006.

After accepting the pre-grant opposition by the two Indian companies, IPO in March 2007 rejected the patent application for Iressa Gefitinib citing ‘known prior use’ of the drug. AstraZeneca contested the order through a review petition, which was dismissed in May 2011.

Anti-asthma FDC aerosol suspension (Merck & Co):

Similar to Allergan case, on December 11, 2012 Indian Patent Office (IPO) reportedly revoked a patent granted to an anti-asthma FDC drug of Merck & Co on the ground of lack of invention, after the domestic pharma major Cipla Ltd challenged an earlier granted patent of this FDC drug.

This aerosol suspension combines three molecules: mometasone furoate, formoterol and heptaflouropropane.

A similar asthma treatment, Dulera, reportedly lost its Indian patent held by Novartis AG in 2010.

Patentability for ‘Incremental Innovations’ in India:

Patentability criteria for any ‘incremental innovation’ has been defined in the Section 3(d) of the Indian statute as follows:

“The mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.”

“Explanation: For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.”

Indian Patents Act prevails: 

As is well known, way back in 2006, IPO refused to grant patent to the cancer drug Glivec of Novartis on the ground that the molecule is a mere modification of an existing substance known as Imatinib.

In that case, on April 1, 2013 the Supreme Court of India upheld the validity of Section 3(d), where the rules of the game for patentability of incremental pharmaceutical innovations, as captured in the Indian Patents Act 2005, were cast in stone.

Court did not disallow all incremental innovations:

Point 191 in page number 95 of the Glivec judgment very clearly states as follows:

“191. We have held that the subject product, the beta crystalline form of Imatinib Mesylate, does not qualify the test of Section 3(d) of the Act but that is not to say that Section 3(d) bars patent protection for all incremental inventions of chemical and pharmaceutical substances. It will be a grave mistake to read this judgment to mean that section 3(d) was amended with the intent to undo the fundamental change brought in the patent regime by deletion of section 5 from the Parent Act. That is not said in this judgment.”

Thus, it should not be highlighted unfairly by concerned constituents that all ‘incremental innovations’ are not patentable in India. The above judgment just says that Glivec is not patentable as per Section 3(d) of Indian Patents Act based on the data provided and the arguments of Novartis.

Only 3% of patents are challenged:

Quoting a study, a recent media report highlighted that only 3% of the patent applications filed in India since 2006 were challenged. The study concluded, “This demonstrates that given the various resource constraints faced by the Indian patent office, one can never really be sure of the patent quality unless the patent is challenged.”

Rejection by IPO under Section 3d is minimum – is that a key issue?

Another study done by Columbia University reportedly found that out of 214 patents filed in India last year, only 3 patents were rejected by IPO exclusively for failing to prove better efficacy, as required under Section 3d. Turning this finding on its head, would it be reasonable to ponder:

Could this be a key issue for so many patents failing to pass the acid test of judicial scrutiny when challenged?

Government has no role to play in IP disputes:

The proponents of ‘no change required in the Section 3(d)’ argue, patent challenge is a legal process all over the world, where the Government has hardly any role to play in resolving these disputes. The law should be allowed to take its own course for all disputes related to the Patents Act of the country, including Section 3(d).

They also opine that India must be allowed to follow the law of justice without casting aspersions on the knowledge and biases of the Indian judiciary by the vested interests.

That said, there is certainly an urgent need to add speed to this legal process by setting up ‘Fast-track Courts’ for resolving all Intellectual Property (IP) related disputes in a time bound manner.

Pharma patents granted in India:

As reported in the media, pharma MNCs have been granted over 1,000 patents since 2005. Moreover out of 4,036 patents granted in the past six years, 1,130 have been awarded to MNCs, like:

  • AstraZeneca 180 patents
  • Roche with 166 patents
  • Sanofi with 159 patents
  • Novartis with 147 patents

It is therefore understandable, as pharma MNCs have secured more number of pharma patents they are facing larger number of litigations at this point of time.

China and Brazil revoke patents:

Last week, just about a year after China introduced the country’s amended patent law, its State Intellectual Property Office (SIPO) has reportedly revoked the patent on HIV/AIDS and hepatitis B drug – Viread (tenofovir disoproxil fumarate) of Gilead Science Inc. Aurisco, the largest manufacturer of active pharmaceutical ingredients in China, challenged this patent. The ground of patent revocation was that the drug lacked novelty and was not entitled to protection.

In 2008 Brazil also declared the patent of tenofovir invalid. It is worth mentioning that tenofovir of Gilead is the third-best-selling drug of the company, clocking sales of US$ 849 million in 2012.

South Africa mulls new law to stop ‘Evergreening’:

Recently, the Department of Trade and Industry of South Africa has reportedly submitted to the South African Cabinet a draft Intellectual Property Policy with far-reaching changes to the country’s Intellectual Property Rights (IPR) for medicines in order to increase access to cheaper drugs by making it harder for companies to obtain and extend patents.

The draft includes a proposal to introduce a patent examination office to stop pharmaceutical companies from “evergreening” where companies take out new patents based on minor changes or new uses. 

Currently, South Africa uses a depository system, in which patent applications are granted without extensive scrutiny. Experts believe, “this system allows companies to file multiple patents on the same medicine and extend the life of their monopoly, keeping prices artificially high.”

Innovators Angry:

In this context, the following report recently captured the anger of the innovator companies and stated that the US drug giants are once again pushing for stronger patent protection in India:

“A coalition of U.S. lawmakers and business groups outlined concerns about Indian policies as a threat to American exports, jobs and innovation in a letter to President Barack Obama on June 18. Among the business groups were the Pharmaceutical Research and Manufacturers of America and the Biotechnology Industry Association. On June 14, the top Democrat and Republican on the Senate Finance Committee urged that Kerry raise trade concerns on his visit.”

Quoting US Chamber of Commerce’s Global Intellectual Property Center another report highlighted, “Recent policy and judicial decisions that invalidate intellectual property rights, which have been increasing in India, cast a daunting shadow over its otherwise promising business climate. From the revocation of patents to the staggering rates of piracy, India stands alone as an international outlier in IP policies. This trend is bad for investment, innovation and international trade.”

Does it benefit patients? 

In the paper titled ‘TRIPS, Pharmaceutical Patents and Access to Essential Medicines: Seattle, Doha and Beyond’, published in ‘Chicago Journal for International Law, Vol. 3(1), Spring 2002’, the author argues, though the reasons for the lack of access to essential medicines are manifold, there are many instances where high prices of drugs deny access to needed treatments for many patients. Prohibitive drug prices, in those cases, were the outcome of monopoly due to strong intellectual property protection.

The author adds, “The attempts of Governments in developing countries to bring down the prices of patented medicines have come under heavy pressure from industrialized countries and the multinational pharmaceutical industry”.

While the ‘Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPS)’ of the World Trade Organization (WTO) sets out minimum standards for the patent protection for pharmaceuticals, it also offers adequate safeguards against negative impact of patent protection or its abuse in terms of extraordinary and unjustifiable drug pricing. The levels of these safeguards vary from country to country based on the socioeconomic and political requirements of a nation, as in India.  

Following table is an example of price differential between patented and generic equivalents of those molecules used in the treatment of HIV/AIDS:

1

2

3

3TC (Lamivudine)

Zerit (Stavudine)

Viramune (Nevirapine)

Price / Year / Patient in US$

Price / Year / Patient in US$

Price / Year /Patient in US$

GSK

Cipla

Hetero

BMS

Cipla

Hetero

B.I.*

Cipla

Hetero

3271

190

98

3589

70

47

3508

340

202

(Source: Third World Network, *B.I: Boehringer Ingelheim) 

Patentability for ‘genuine innovations’:

A report on ‘Patentability of the incremental innovation’ indicates that the policy makers keeping the following points in mind formulated the Indian Patents Act 2005:

  • The strict standards of patentability as envisaged by TRIPS pose a challenge to India’s pharmaceutical industry, whose success depended on the ability to produce generic drugs at much cheaper prices than their patented equivalents.
  • A stringent patent system would severely curtail access to expensive life saving drugs to a large number of populations in India causing immense hardships to them.
  • Grant of a product patents should be restricted only to “genuine innovations” and those “incremental innovations” on existing medicines, which will be able to demonstrate significantly increased efficacy over the original drug.

Conclusion:

A study by the ‘Indian Pharmaceutical Alliance (IPA)’ indicates that 86 pharmaceutical patents granted by the IPO post 2005 are not breakthrough inventions but only minor variations of existing pharmaceutical products and demanded re-examination of them.

Since, most of the above patents have not been challenged, as yet, the quality of these patents cannot be ascertained beyond any reasonable doubt, as we discuss today.

If the apprehension, as expressed above in the IPA study has any merit, right answers to the following questions, I reckon, would help charting out the future direction for the IP ecosystem of India:

  • Is there a theoretical possibility of revocation of all these 86 already granted product patents, if and when challenged in a court of law?
  • Is the current Patents Act of India pragmatic?
  • Does it reasonably benefit both the innovators and the Indian patients,  signifying a paradigm shift in the global IPR scenario?
  • Will it inspire other countries also to emulate similar IP system in the years ahead?
  • Will it then invite more intense ire of the global pharma innovator companies creating increasing  pressure on the Indian Government to amend the current Patents Act?
  • Being under continuous public scrutiny, would it be feasible for any Indian Government, now or in future, in the near or medium term, to amend the Indian Patents Act due to any amount of outside pressure?
  • And finally, is the Act then irreversible, at least, for quite some time from now?

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.