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Will ‘Patent Thicket’ Delay Biosimilar Drug Entry in India?

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Do pharma and biotech investors encourage companies indulging in ‘patent thicket?’ This question recently grabbed media headlines. On April 02, 2019, one such report brought out: AbbVie investors are calling for the Chair-CEO power split, flagging the CEO’s USD 4 million bonus payout, fueled by the company’s Humira ‘patent thicket’ strategy related aggressive price hikes. It prolonged the brand’s market monopoly, blocking entries of its cheaper biosimilar equivalents.

I have discussed some related issues in this blog, previously. As the issue is gaining relevance also in the Indian context, this article will deliberate the ill-effects of ‘patent thicket’ on patient health-interest. The sole beneficiaries for the creation of this self-serving labyrinth are the manufacturers of high-priced patented drugs, as reported above. Before I proceed further, let me recapitulate what exactly is a ‘patent thicket.’

‘Patent Thicket’:

The dictionary definition of patent thicket is: ‘A group of patents in a field of technology which collectively impede a party from commercializing its own patents or products in that field.’In the current context, it means a dense web of overlapping patent rights that restrict a generic or a biosimilar drug maker from commercializing its cheaper equivalents post expiry of the original patent.

This scenario has been well-captured by the above media report, which states: “AbbVie leadership has also been accused of creating a ‘patent thicket’ in its battle to stave off biosimilar competitors to Humira.” Boehringer Ingelheim is among the few still fighting AbbVie’s ‘patent thicket’ hoping to launch its Humira biosimilar - Cyltezo, even after receiving US-FDA approval on August 29, 2017. ‘Top biosimilar makers, including Novartis’ Sandoz unit and Mylan, have settled their own Humira patent fights with deals that put off launches until 2023,’ the report indicated.

In its favor: AbbVie says, Cyltezo infringes about 70 patents the company currently holds for Humira. Whereas, ‘Boehringer’s lawyers say AbbVie’s copious patents overlapped in an attempt to exclude competitors from the market.’ Notably, in March this year, New York’s UFCW Local 1500 Welfare Fund, reportedly, also accused AbbVie of using overlapping patents to exclude biosimilars.

‘Patent thicket’ – a way of ‘evergreening’ beyond 20 years patent term:

Much concern is being raised about various ploys of especially by the drug MNC and their lobby groups – directly or under a façade, to delay entry of cheaper generic drugs for greater patient access. Mostly the following two ways are followed for patent ‘evergreening’ beyond the term of 20 years:

  • ‘Incremental innovation’ of the existing patented drugs through molecular manipulation, with its clinical performance and safety profile remaining similar to the original one. As the cost benefits of such drugs are not shared with patients, cannibalizing the sales of the older molecular version with the newer one highlighting its newness, the sales revenue can be protected. With this approach, coupled with marketing muscle power with deep-pocket the impact of generic entry of the older version can almost be made redundant. For example: Omeprazole was first marketed in 1989 by AstraZeneca, under the brand name Losec (later changed to Prilosec at the behest of the US-FDA). When Prilosec’s US patent expired in April 2001, AstraZeneca introduced esomeprazole (Nexium) as a patented replacement drug. Both are nearly identical in their clinical efficacy and safety.
  • ‘Patent thicket’ is yet another tool for ‘evergreening’, delaying launch of similar drugs, or resorting to ‘pay for delay’ sort of deals. As another recent report reiterates, AbbVie’s ‘patent thicket’ for Humira, has deterred other potential challengers, such as Amgen, Samsung Bioepis and most recently Mylan, each of which struck settlements with AbbVie to delay their biosimilar challenges in the United States.

Goes against patients’ health interest:

On May 09, 2018, the Biosimilars Council reported, just as generic medicines saved Americans USD 1.67 trillion in the last decade, biosimilars are poised to do the same – ‘if they aren’t thwarted by delaying tactics instituted by some pharmaceutical companies.’ Echoing similar concern, the outgoing US-FDA Commissioner Scott Gottlieb also, reportedly said, ‘some drugmakers are using unacceptable tactics such as litigation and rebate schemes to stall the entry of cheaper copies.’

‘Of the nine biosimilars the FDA has approved to date, only three have made it into the hands of patients – an alarmingly small number. Patients can’t access the six others due to barriers thrown in their way by pharmaceutical companies that want to protect their monopolies and keep prices high,’ highlights the Biosimilars Council report. Net sufferer of this self-serving ‘patent thicket’ strategy of pharma and biotech players to extend product patents beyond 20 years, are those patients who need these drugs the most – to save their lives.

Despite law, patent ‘evergreening’ still not uncommon in India:

With section (3d) on the Indian Patents Act 2005 in place, the country is expected to protect itself from patent ‘evergreening’ through ‘incremental innovation.’ This section articulates:“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.”

On this ground, Indian Patent Office (IPO) rejected Novartis’ drug Glivec (imatinib mesylate) patent application, which was ultimately upheld by the Supreme Court in 2013. Nevertheless, a study report of April 30, 2018 emphasized: ‘Though the law with regard to anti-evergreening, upheld and clarified by Indian courts, remains on the books, its application by the IPO has been far from satisfactory.’

The esteemed author of the report, after analyzing about 2,300 drug patents, granted between 2009 and 2016 concluded that evergreening practices may be rampant in India. The report pointed out, ‘the IPO could be operating with an error rate as high as 72 percent for secondary patents, despite provisions to keep them in check.’

Are these IPO’s mistakes, or due to external pressure?

As the paper, published in the January 2016 edition of the Journal of Intellectual Property Rights (JIPR) said,‘The multi-national pharma companies (MNCs) and the US-India Business Council (USIBC) have suggested in their report for elimination of Section 3 (d) so that drug patents can be granted in India for incremental improvement and modification. As per US 301 report, India is listed among countries with inadequate IP regime.’ Keeping all these aspects into consideration, the article expressed some key concerns pertaining to the impact of Section 3 (d) with special emphasis on its interpretation. Does it mean any possibility of wilting under such extraneous and high impact pressure?

A fresh pressure from drug MNC on the DCGI:

Since long drug MNCs have been attempting to delay the entry of even those generics, which are fully compliant with the Indian Patent Law 2005. One such effort was their demand for ‘patent linkage’ with the marketing approval of new generic drugs. However, it could not pass through legal scrutiny – first by the Delhi High Court in the Bayer Cipla case in 2010, and then by the Supreme Court – on the same case. The Court, reportedly, ‘noted the Indian patent system was distinct from the drug regulatory system with no linkage between them and so Bayer can’t prevent DCGI from granting marketing approval to generic versions of patented drugs.’

According to another recent media report of April 04, 2019, in a fresh endeavor ‘to delay launch of low priced generic medicine, multinational drug makers have asked the government to create a registry providing information about all drug applications pending manufacturing and marketing approval. The proposal, which is still pending with the Department of Pharmaceuticals (DoP), if accepted, could involve the generic players into expensive and time-consuming litigations, delaying early market entry of the cheaper generic or biosimilar equivalents.

To date, the health ministry has opposed the proposal, as it will be “unfair to local drug manufacturers to disclose their product strategy” and also has “the potential to substantially increase health care costs for the public.” The government further argued, “such information about product applications filed for approval are not disclosed anywhere in the world.”

India encourages new drug innovation, but not at any cost:

Despite shrill and disparaging comments of MNC lobbyists and the strong vested interests, that India’s Patent Law 2005, doesn’t encourage innovation, many independent international experts do praise the same for the following reasons:

  • Does encourage new drug innovation
  • Does extend product exclusivity for twenty years
  • Strikes a right balance with patients’ health interest
  • Indian judicial system deals with patient infringements and disputes, just as any other developed countries
  • Even 14 years after the enactment of patent laws, just one compulsory license has been granted, which is much less than other countries, including the United States.

What India doesn’t legally allow is, unfettered profit making through ‘evergreening of drug patents’ – at the cost of millions of patients-lives. Nonetheless, powered by deep pockets, the pharma and biotech players are unlikely to cease from this practice, anytime soon. Only patient-awareness, and stringent counter-legal measures can contain this unfair game of drug monopoly practices – in the name of ‘encouraging innovation’.

Conclusion:

The article titled, ‘Over patented, overpriced: How Excessive Pharmaceutical Patenting is Extending Monopolies and Driving up Drug Prices’ revealed:“Top grossing drugs have on average 125 patent applications, which are filed with a strategic intent to extend the commercial monopolies far beyond the intended twenty years of protection.” It also quoted American President Donald Trump as saying, “Our patent system will reward innovation, but it will not be used as a shield to protect unfair monopolies.”

Coming back to ‘patent thicket’ and the same classic case, another report of March 20, 2019 indicated, a new class action lawsuit filed by New York’s largest grocery union has accused AbbVie of violating antitrust and consumer protection laws, which AbbVie has defended by saying that its patent strategy for Humira has protected the investments that are necessary to “advance healthcare.”

Pharma and biotech companies’ maintaining patent monopolies far beyond twenty years has significant consequences on India’s healthcare system. Only patent lawyers and experts can possibly answer whether or not the Indian Patent Law 2005 can effectively deal with the practice of ‘evergreening’ with patent thicket. Intriguingly, taking a cue from recent developments, it seems many pharma and biotech investors too, deem ‘patent thicket’ rather distracting for longer-term undiluted focus on new product development, and sustainable investors’ return.

That apart, the question also comes, whether just as ‘antitrust and consumer protection laws’ in the US, the Competition Law of India will be able to do contain such unfair practices? Otherwise, with MNC lobbyists’ renewed activities in this area, ‘patent thicket’, especially for expensive biologic drugs, will delay market-entry of their cheaper biosimilar versions in India, as well, just as what is happening in the developed nations.

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.

‘Patent Linkage’: Can The Core Issue Be Resolved?

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On February 10, 2015, a leading business daily of India, quoted the Commerce Secretary of India – Rajeev Kher, saying, “India needs to relook at its Intellectual Property Rights (IPR) Policy with a view to bring in a differentiated regime for sectors that have a greater manufacturing potential.”

In the present Government regime, it appears virtually impossible to make such important comments out of turn by a senior bureaucrat without the blessings of the Prime Minister’s Office (PMO). I hold this view, despite the fact that the Commerce Secretary reportedly added that his suggestion is “a highly controversial subject and if I discussed this in the government, I think I will be shot down in the very first instance”.

Be that as it may, as I indicated in my just previous article, several recent media reports also speculated, around the same time, that the Government of India is probably considering putting in place ‘Patent Linkages’ and ‘Data Exclusivity’ through administrative measures, without making any amendments in the Patents Act 2005 of the country.

As I had indicated in my blog post of January 19, 2015 titled, “New ”National IPR Policy” of India – A Pharma Perspective”, these speculations originated mainly from the following events:

  • During Prime Minister Narendra Modi’s visit to the United States in September 2014, a high-level Indo-US working group on IP was constituted as a part of the Trade Policy Forum (TPF), which is the principal trade dialogue body between the two countries.
  • Almost immediately after the Prime Minister’s return to India, in October 2014, the Government formed a six-member ‘Think Tank’ to draft the ‘National IPR Policy’ and suggest ways and legal means to handle undue pressure exerted by other countries in IPR related areas. The notification mandated the ‘Think Tank’ to examine the current issues raised by the industry associations, including those that have appeared in the media and give suggestions to the ministry of Commerce and Industry as appropriate.

Speculations arising out of these two events were almost simultaneously fuelled by the following developments:

A. US Trade Representative Mike Froman’s reported affirmation of the following to the US lawmakers during a Congressional hearing held on January 27, 2015:

- “We have been concerned about the deterioration of the innovation environment in India, and we have engaged with the new government since they came into office in May of last year about our concerns.”

- “We held the first Trade Policy Forum in four years in November. I just returned from India yesterday as a matter of fact … and in all of these areas, we have laid out a work program with the government of India to address these and other outstanding issues.”

- “We are in the process of providing comments on that draft policy proposal on IPR, and we are committed to continuing to engage with them to underscore areas of work that needs to be done in copyright, in trade secrets as well as in the area of patents.”

- “We’ve got a good dialogue going now with the new government on this issue, and we’re committed to working to achieve concrete progress in this area.”

B. Union Minister of Commerce and Industry of India specifically seeking American Government’s inputs in the finalization process of the new National IPR policy of the country.

Keeping these in perspective, let me try to explore whether or not it would be fair for India deciding to put in place ‘Patent Linkages’ and ‘Data Exclusivity’ through administrative measures, without making any amendments in the Patents Act of the country.

In this article, I shall deliberate on my personal take on ‘Patent Linkage’ and in the next week’s article on ‘Data Exclusivity’.

Definition:

Patent linkage is broadly defined as the practice of linking market approval for generic medicines to the patent status of the originator reference product.

A brief background in India:

The ‘Patent Linkage’ saga has an interesting background in India. I would now try to capture the essence of it, as stated below.

About 7 years ago, probably prompted by intense lobbying by the Pharma MNCs, the then Drug Controller General of India (DCGI) reportedly informed the media, on April 28, 2008, the following:

“We (DCGI) are going to seek the list of the drugs from innovator companies that have received patent in India. Once we have the database of the drugs which have been granted patent, we will not give any marketing approval to their generic versions…The DCGI has issued internal guidelines to this effect and it will also co-ordinate with the health ministry to give a formal shape to the initiative. The government expects to finalize a proper system within the next 2-3 months.”

It was also reported in the same article that Patent attorney Pratibha Singh, who along with Arun Jaitley was representing Cipla in the Tarceva case against Roche said:

“The DCGI does not have the authority to reject marketing application of a generic drug on the grounds that an innovator company has received the patent for the same drug in the country.”

Immediately following the above reported announcement of the DCGI on ‘Patent Linkage’, another media report flashed that the domestic drug companies are strongly objecting to the DCGI’s plans to link marketing approval for a drug with its patent status in the country, citing requirement of additional resources for the same and concern that it could block access to affordable medicines by suppressing competitive forces.

Despite this objection of the domestic Indian pharma companies, a senior official in DCGI office reportedly reaffirmed the DCGI’s intent of establishing the linkage so that no slips happen in the future. The same media report quoted that Government official as saying:

“We will have to amend the rules in the Act. We have to put it before the Drugs Consultative Committee first and this could be around the end of this year.”

Current ‘administrative’ status in India:

Currently in India, there is no provision for ‘Patent Linkage’, either in the Statute or through any administrative measure.

After those potboiler reports, it is quite challenging to fathom, what exactly had happened for the reverse swing thereafter at the DCGI’s office. The bottom line is, the above initiative of the then DCGI for ‘Patent Linkage’ in India ultimately got killed in the corridors of power. Hence, there does not exist any direct or indirect measure for ‘Patent Linkage’ in India, as I write this article.

Current legal status:

In 2008 Bayer Corporation had filed a Writ Petition before the Delhi High Court against Union of India, the DCGI and Cipla seeking an order that the DCGI should consider the patent status of its drug, Sorefenib tosylate, and refuse marketing approval to any generic versions of this drug.

It is worth mentioning, Sorefenib tosylate is used to treat renal cancer and was being reportedly sold in India by Bayer at Rs. 2,85,000 for 120 tablets for a monthly course of treatment.

The appeal in the Delhi High Court was filed against a judgment delivered by Justice Ravindra Bhat on 18 August 2009, rejecting Bayer’s attempt to introduce the patent linkage system in India through a court direction. But, in a landmark judgment on February 9 2010, a division bench of the Delhi High Court dismissed the appeal of Bayer Corporation in this regard. Thereafter, Bayer Corporation moved Supreme Court against this Delhi High Court order.

However, in December 01, 2010, a Division Bench of the Supreme Court rejected the appeal filed by Bayer Corporation against the February 2010 decision of the Delhi High Court. The Apex Court of India ordered, since the Drugs Act does not confer power upon the DCGI to make rules regarding the ‘Patent Linkage’, any such attempt would constitute substantive ultra vires of the delegated power.

RTI helps to get the marketing approval status of drugs:

Currently relevant information on marketing approval application status of generic drugs are not available at the CDSCO website. Hence, some innovator companies have resorted to using Right To Information (RTI) Act to ferret out such details from the DCGI office and initiate appropriate legal measures for patent infringement, well before the generic version of the original drug comes to the market.

A middle ground:

In view of the above order of the Supreme Court, the government of India may try to seek a middle ground without amending any provision of the Patents Act, in any way.

Even avoiding the word ‘Patent Linkage’, the Ministry of Health can possibly help the pharma MNCs achieving similar goal, through administrative measures. It can instruct the DCGI to upload the ‘Marketing Approval’ applications status for various generic products in the Central Drugs Standard Control Organization (CDSCO) website. If for any patented drugs, applications for marketing approval of generic equivalents are made, the available information would enable the patent holder taking appropriate legal recourse for patent infringement, much before the drug is marketed at a heavily discounted price.

It is quite possible that the interested constituents had put requests for such administrative measures even before the earlier Government. As no tangible action has been taken even thereafter, the erstwhile Government probably felt, if introduced, such a system would adversely impact quick and early availability of the generic drugs in the market place.

Conclusion: 

I wrote an article on similar issue in my blog post of August 24, 2009 titled, “Recent Bayer Case Judgment: Patent Linkage: Encouraging Innovation in India.”

Taking all these into consideration, in my view, it is quite possible for the present Indian Government to resolve the core issue related to ‘Patent Linkage’ through administrative measure, without amending any Acts or breaching any case laws of the land.

In the present IPR imbroglio, the above administrative measure could well be a win-win solution for all.

It would help facilitating early judicial intervention by the patent holder in case of prima facie patent infringements, enabling the Government to send a clear reiteration that the patents granted to pharmaceutical products will be appropriately enforced and protected in the country.

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.

New ‘Modi Government’: Would Restoring Cordial Relationship with America Be As Vital As Calling Its Bluff On IP?

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Newspaper reports are now abuzz with various industry groups’ hustle to lobby before the ‘Modi Government’ on their expectations from the new regime. This includes the pharmaceutical industry too. The reports mention that the industry groups, including some individual companies, have started getting their presentations ready for the ministers and the Prime Minister’s Office as soon as a new government takes charge on May 26, 2014.

Conflicting interests on IP:

While the domestic pharma industry reportedly wants the new Government to take a tough stand on the Intellectual Property (IP) related issues with the United States (US), the MNC lobbyists are raising the same old facade of so called ‘need to encourage innovation’ in India, which actually means, among others, for India to:

  • Amend its well-crafted IP regime
  • Change patentability criteria allowing product patents for even ‘frivolous innovation’ by scrapping Section 3(d) of the Indian Patents Act
  • Introduce Data Exclusivity
  • Implement patent linkages
  • Re-write the Compulsory Licensing (CL) provisions and not bother at all, even if patented drugs are priced astronomically high, denying access to majority of Indian population.

Interestingly MNC Lobby Groups, probably considering rest of the stakeholders too naive, continue to attempt packaging all these impractical demands on IP with unwavering straight face ‘story telling’ exercises, without specificity, on how well they are taking care of the needs of the poor in this country for patented medicines.

This approach though appears hilarious to many, MNC lobbyists with their single minded purpose on IP in India, keep repeating the same old story, blowing both hot and cold, nurturing a remote hope that it may work someday.

Recent views:

On this score, along with a large number of independent experts from across the world, very recently, even the former Chairman of Microsoft India reportedly advised the new ‘Modi Regime’ as follows:

“While the new government must work hard to make India more business friendly, it must not cave in to pressure on other vital matters. For instance, on intellectual property protection, there is enormous pressure from global pharmaceutical companies for India to provide stronger patent protection and end compulsory licensing. These are difficult constraints for a country where 800 million people earn less than US$ 2 per day.”

The Chairman of the Indian pharma major – Wockhardt also echoes the above sentiment by articulating, “I think Indian government should stay firm on the Patents Act, which we have agreed.” 

Other domestic pharma trade bodies and stakeholder groups in India reportedly expect similar action from the ‘Modi Government’.

Strong India matters:

India is the largest foreign supplier of generic medicines to America, having over 40 percent share in its US$ 30-billion generic drug and Over-The-Counter (OTC) product market.

Thus, expecting that Indian Government would wilt under pressure, the 2014 ‘Special 301 Report’ of the US Trade Representative (USTR) on Intellectual Property Rights (IPR) has retained India on its ‘Priority Watch List’, terming the country as violators of the US Patents Law. It has also raised serious concern on the overall ‘innovation climate’ in India urging the Government to address the American concerns in all the IP related areas, as mentioned above. 

My earlier submission in this regard:

In my blog post of February 5, 2014, I argued that patentability is related mainly to Section 3(d) of the Patents Act. and India has time and again reiterated that this provision and all the sections for invoking CL in India are TRIPS compliant. If there are still strong disagreements in the developed world in this regards, the Dispute Settlement Body of the ‘World Trade Organization (WTO)’can be approached for a resolution, as the WTO has clearly articulated that:

“WTO members have agreed that if they believe fellow-members are violating trade rules, they will use the multilateral system of settling disputes instead of taking action unilaterally. That means abiding by the agreed procedures, and respecting judgments. A dispute arises when one country adopts a trade policy measure or takes some action that one or more fellow-WTO members considers to be breaking the WTO agreements, or to be a failure to live up to obligations.”

Thus, it is quite intriguing to fathom, why are all these countries, including the United States, instead of creating so much of hullabaloo, not following the above approach in the WTO for alleged non-compliance of TRIPS by India?

How should the new Government respond?  – The view of a renowned pro-Modi Economist:

Subsequent to my blog post of February 5, 2014, as mentioned above, a recent article dated March 4, 2014 titled “India Must Call The US’ Bluff On Patents” penned by Arvind Panagariya, Professor of Economics at Columbia University, USA, who is also known as a close confidant of Prime Minister Narendra Modi, stated as follows, probably taking my earlier argument forward:

“Critics of the Indian patent law chastise it for flouting its international obligations under the TRIPS Agreement. When confronted with these critics, my (Arvind Panagariya) response has been to advise them:

  • To urge the US to challenge India in the WTO dispute settlement body and test whether they are indeed right.
  • But nine years have elapsed since the Indian law came into force; and, while bitterly complaining about its flaws, the USTR has not dared challenge it in the WTO. Nor would it do so now.
  • Why?
  • There is, at best, a minuscule chance that the USTR will win the case.
  • Against this, it must weigh the near certainty of losing the case and the cost associated with such a loss.
  • Once the Indian law officially passes muster with the WTO, the USTR and pharmaceutical lobbies will no longer be able to maintain the fiction that India violates its WTO obligations.
  • Even more importantly, it will open the floodgates to the adoption of the flexibility         provisions of the Indian law by other countries.
  • Activists may begin to demand similar flexibilities even within the US laws.

On possible actions against India under the ‘Special 301’ provision of the US trade law, Professor Arvind Panagariya argues:

  • “Ironically, this provision itself was ruled inconsistent with the WTO rules in 1999 and the US is forbidden from taking any action under it in violation of its WTO obligations.
  • This would mean that it couldn’t link the elimination of tariff preferences on imports from India to TRIPS violation by the latter.
  • The withdrawal of preferences would, therefore, constitute an unprovoked unilateral action, placing India on firm footing for its retaliatory action.”

US power play on IP continuing for a while:

United States, pressurized by its powerful pharma lobby groups, started flexing its muscle against India for a while. You will see now, how this short video clip captures the American ‘Power Play’ in this area.

Conclusion: 

It is undeniable that there is moderately strong undercurrent in the current relationship between the United States and India, mostly based on differences over the Intellectual Property Rights (IPRs).

The resourceful MNC pharmaceutical lobby groups with immense influence in the corridors of power within the Capitol Hill, are reportedly creating this difference for unfair commercial gain.

All these are being attempted also to blatantly stymieing India’s efforts to ensure access to affordable medicines for a vast majority of the global population without violating any existing treaty commitments, as reiterated by a large number of experts in this area.

Professor Arvind Panagariya reportedly calls it: “The hijacking of the economic policy dialogue between the U.S. and India by pharmaceutical lobbies in the U.S.”

That said, while cordial relationship with the United States in all economic and other fronts must certainly be rejuvenated and adequately strengthened with utmost sincerity, the newly formed Federal Government at New Delhi with Prime Minister Narendra Modi as its bold and strong face, should not hesitate to call the US bluff on IP… for India’s sake.

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.

 

Does China provide a more robust IPR environment than India?

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Soon after the Product Patent Act was reintroduced in India effective January 1, 2005, a raging global debate commenced focusing on the robustness of the Indian Patent system. Quite often, many participants in the debate continue to compare the adequacies of the Chinese patent system with the inadequacies of the same in India.

‘The Pharma Letter’ dated October 26, 2010 published an Article captioned, “Intellectual property concerns and domestic bias hold back R&D in Asia-Pacific.”

Asia-Pacific still lags behind in terms of global R&D investments:

Unlike the common perception in India that China is attracting a significant part of the global investments towards R&D, latest data of MedTRACK revealed that only 15% of all drugs development are taking place in Asia-Pacific despite the largest growth potential of the region in the world. The Pharma Letter also reported, “In December 2009, China unveiled that it would give domestic companies making innovative products an advantage in qualifying for government purchases. This measure is likely to further limit foreign investment in product development in China, and negatively affect growth of foreign brands.”

Such type of domestic bias and protectionist’s measures are yet to be witnessed in India.

Since US is a pioneering country in the field of global R&D and its commercial interest related to such initiatives spans across the globe, let me try to analyze this subject, in this article, quoting only from official US publications.

IPR environment in China – the US perspective:

So far as the current IPR environment in China is concerned, US Embassy based in that country has commented as follows:

“Despite stronger statutory protection, China continues to be a haven for counterfeiters and pirates. According to one copyright industry association, the piracy rate remains one of the highest in the world (over 90 percent) and U.S. companies lose over one billion dollars in legitimate business each year to piracy. On average, 20 percent of all consumer products in the Chinese market are counterfeit. If a product sells, it is likely to be illegally duplicated. U.S. companies are not alone, as pirates and counterfeiters target both foreign and domestic companies”.

In the same context the following remarks of Mr. Shaun Donnelly, Senior Director, International Business policy, National Association of Manufacturers (NAM) , USA, made at the Intenational Trade Commission on June 15, 2010 on IPR environment in China, is also quite interesting:

“Unfortunately China remains Ground Zero for international product counterfeiting and Piracy. Despite considerable efforts over many years by US Government agencies and other international partners as well as Chinese Government the Progress has been minimal…. China continued to be the number one source country for pirated goods seized in the US borders accounting for 79% of the total seizures…The top sectors of IPR infringing products seized included footwear, consumer electronics, apparel, computer hardware, pharmaceuticals…”

Patent enforcement in China – the US perspective:

Regarding product patent enforcement is concerned the US Embassy in China comments:

“Though we have observed commitment on the part of many central government officials to tackle the problem, enforcement measures taken to date have not been sufficient to deter massive IPR infringements effectively. There are several factors that undermine enforcement measures, including China’s reliance on administrative instead of criminal measures to combat IPR infringements, corruption and local protectionism, limited resources and training available to enforcement officials, and lack of public education regarding the economic and social impact of counterfeiting and piracy”.

“Notwithstanding the increased number of applications, many patent owners (both foreign and domestic) continue to experience problems with infringement in China. Counterfeiting and other infringing activities are rampant, and critics frequently complain of lax enforcement of intellectual property laws. As a result, any party considering introducing a patented (or patentable) technology into China – especially one that could be easily reverse engineered or duplicated – would be well advised to proceed with extreme caution, seek legal advice from the outset, and plan fastidiously”.

Regulatory Data Protection (RDP) in India:

Regulatory Data Protection (RDP) for Pharmaceutical Products is still not in place in India, as the Government of India has already articulated that RDP is a ‘TRIPS Plus’ requirement and is non-binding to the country. The Government further reiterated that if any or more interested parties will feel that it is not so, they can certainly go to the WTO forum for the redressal of their grievances in this matter.

RDP in China – the US perspective:

However, on this subject the US feels that though RDP for a 5 year period is now in place in China, ‘inadequacies in their current regulatory environment allow for unfair commercial use of safety and efficacy data generated by the global innovator companies.”

In such a scenario the sanctity of RDP gets significantly diluted and may prove to be a virtually meaningless exercise.

Conclusion:

R. Fernando and D. Purkayastha of ICMR Center for Management Research in their article titled, “Pfizer’s Intellectual Property Rights Battles in China for Viagra” had commented as follows:

“Though the foreign research-based pharmaceutical companies were not happy with the lax IPR regime, the booming Chinese pharmaceutical market provided enough incentive for these companies to stay put and fight it out with the local firms for a share in this emerging market”.

Under these circumstances, while recommending for a world class robust patent regime in India to foster innovation in the country, if anybody wants to draw examples from China on the subject, it would indeed be foolhardy.

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.

Will the ‘Bayer–Cipla case’ now put the ‘Bolar Provision’ under judicial scrutiny?

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To enable the domestic pharmaceutical industry gaining a critical mass and cater to the pressing healthcare needs of the nation, in 1970 product patent act was abolished by the government of India. This immensely helped the domestic companies to launch the generic version of innovative medicines at a very low price, making those drugs quite affordable to a large section of the population.
Cost and process efficiencies helped the Indian pharma companies to reach out:

Quickly acquired cost and process efficiencies of the domestic generic pharma companies soon made India a power to reckon within the global generic pharmaceutical industry. Besides fueling the domestic demand of the essential medicines in general and these drugs in particular, the domestic pharma players soon commenced exports of these cheaper but high quality medicines to non-regulated and the least developed countries of the world to cater to their affordable healthcare needs.

India played a key role in combating HIV-AIDS in Africa:

In that process, India also played a critical role to ensure that HIV-AIDS drugs are available to the poor and down trodden in Africa in general and sub-Saharan Africa in particular, at an affordable price.

A paradigm shift:

On January 1, 2005, India stepped in to a new paradigm with re-enactment of the product patent act in the country, which is widely believed to be TRIPS compliant. This consequently ushered in a transition within the Indian pharmaceutical industry from the mindset of an ‘imitator’ to the prestigious status of an ‘innovator’, which ultimately drives the wheel of progress of a nation.

The voice of concern:

At the same time and for the same paradigm shift many expressed their grave concerns about the role that the domestic generic pharmaceutical industry will play in the new paradigm to continue to make cheaper but quality modern medicines available not only to a large section of the Indian society, but also to the needy patients of non-regulated and least developed countries of the world.

TRIPS safeguard provisions:

Although minimum standards of patent protection that patent holders should get have been articulated in TRIPS, it also very clearly specifies three very important public health safeguard provisions simultaneously, which will allow any participating country to utilize these during such types of needs.

These three TRIPS public health safeguard provisions are as follows:

A. Compulsory Licensing:

- There is nothing in TRIPS, which can limit the authority of the government, in any way, to grant compulsory licensing of a patented product for public health safeguard.

B. Parallel importing:

- TRIPS clearly indicates that under WTO dispute settlement body parallel imports cannot be challenged, if there is no discrimination on the patent holders’ nationality.

AND

C. Bolar Provisions

The Bolar Provision:

To enable the generic players launching new molecules at a much cheaper price, the Patent Act 2005 provides for exceptions to the patentee’s exclusive rights under Article 30 of TRIPS, as ‘Bolar Provisions’ in its section 107A(a):

“any act of making, constructing, using, selling or importing a patented invention solely for uses reasonably related to development and submission of information required under any law for the time being in force, in India, or in a country other than India, that regulates the manufacture, construction, use, sale or import of any product.”

This section provides an exemption from patent infringement to the generic manufacturers from producing and importing patented drugs for research and development, related to submission of information for regulatory approvals of generic versions of patented products before the original patents expire. The legislative intent of this section is to ensure that the generic versions of patented products are ready with necessary regulatory approval for market launch, immediately after the innovator products go off patent, rather than going through a long rigorous process of getting the regulatory approval only after expiration of the patent term.

Is the Section 107A now under judicial scrutiny?

This section may be unfairly used by some generic manufacturers, soon after the launch of products patented in India, for unfair commercial reasons. The final judgement on Bayer–Cipla case on Nexavar may throw some light on this important provision. It is quite possible that because of this reason Delhi High court has ordered Cipla to seek the High Court’s permission before market launch of the generic version of Bayer’s patented product.

Conclusion:

Although there is nothing wrong in using a patented molecule for getting regulatory approval with a genuine intent to launch the generic version after the original product goes off patent, it now appears that in absence of Regulatory Data Protection (RDP) both against disclosure and unfair commercial use, this section may most likely to be abused more by some generic players with mala fide commercial interest.

By Tapan 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.

Recent Bayer Case Judgment: Patent Linkage: Encouraging Innovation in India

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Delhi High Court turned down the request of Bayer Corporation in August 18, 2009 to link patent status of its kidney cancer drug Nexavar (sorefenib tosylate) with the marketing approval of the generic equivalent of the same patented molecule manufactured by Cipla, during the patent life of Nexavar in India.Bayer received an Indian patent for Nexavar in March 2008, which is one of the potential blockbuster drugs of Bayer Corporation and is expected to clock an annual global sales turnover of around U.S $1 billion soon.In this particular case, Bayer argued that an approval for its generic equivalent from Cipla would infringe on their patent.

The interim and the final judgment of the Delhi High Court:

Honorable Delhi High Court granted an interim injunction in response to the petition filed by Bayer Corporation and refrained the Drug Controller General of India (DCGI) from granting marketing approval of the generic version of sorefenib tosylate of Cipla, until the final order is passed by the Court.

In its final judgment, the Delhi High Court ruled that Bayer should not have brought this case to the honorable court as the drug regulation is not linked to patent rights in India.

Further, the court could not, “conclude that unpatented drugs are spurious drugs” and said, “this court is constrained to observe that the present litigation was what may be categorized as speculative foray, and attempt to ‘tweak” public policies through court mandated regimes.”

Besides, the honorable Court has asked the Bayer Corporation to pay Rs 6.75 lakh to the Government and Cipla as legal costs.

Will this High Court ruling encourage more such incidence in India?

Some experts feel that the Delhi High Court ruling may encourage generic pharmaceutical companies to launch generic versions of patented drugs in India despite the risk of paying damages, if patent infringement is proved in a court of law.

Keeping all these in view, let us now discuss the relevance of Patent Linkage in India.

What really is a patent linkage?

The process of Patent Linkage establishes a desirable communication process between the Health Ministry and the Patent Offices to prevent marketing approval of generic drugs before expiration of patents granted in India.

It also ensures that one Government Department / Ministry does not impair the efforts of another Government Department / Ministry to provide effective intellectual property protection as required by Article 28 of the WTO TRIPS Agreement.

However, the generic companies argue that the role of the DCGI is restricted to regulating safety and efficacy of the drugs, whereas ascertaining patent status of products fall within the ambit of Indian Patent Offices. Thus these two cannot be linked.

The argument in favour of a robust Patent Linkage system:

1. WTO TRIPS Article 28.1a says that the member countries agree to ensure exclusive rights to patent holder for a specific time period. In case of India, like most other countries, this time period is for 20 years.

2. During this period the member countries agree to prevent third parties from making, using, offering for sale the patented product without the owner’s consent.

3. In India there is no known strong deterrent for patent infringement. In absence of which, the opportunity to make significant commercial gain through patent infringement, on the pretext of extending benefits to patients could indeed be, many a times, difficult to resist.

4. Media reports that the National Pharmaceutical Pricing Authority (NPPA) has raised huge demand in crores of rupees for overcharging the common man, flouting the drug pricing norms, by some of these large companies involved in patent infringement litigations, vindicates the point of their basic overall intention of significant commercial gain over extending pricing benefits to the common man.

Who is responsible to ensure the sanctity of the product patent system in India?

1. The prevailing situation warrants a strong regulatory system, which could prohibit marketing approval of generic equivalents of patented molecules during their patent period.

2. The question that is often raised in this context is who exactly be held responsible for implementation of such a system in our country? While addressing this question one should realize that it is the Government in its entirety and not just the Patent offices or any particular ministry or ministries of the Governments is bound by the WTO TRIPS Agreement. Therefore, it is justifiably the responsibility of all Government departments/ministries to ensure that TRIPS obligations of the Government on proper enforcement of patent are properly met.

3. The process of granting marketing approval for patented molecules, in general, rests on the Ministry of Health (MoH) of WTO member states. Thus for WTO member states to meet TRIPS obligations effective communication between the MoH and the Patent offices of the country is absolutely essential. Such a system will help prevent approval of generic versions of patented molecules before expiration of the product patents.

4. Establishing this communication process will ensure that one department/ministry of the Government (say DCGI) does not impair the efforts of another Government department/ministry (say IPOs) to provide effective intellectual property protection as articulated in Article 28.1 of the WTO TRIPS Agreement.

5. This system will ensure that Health Regulatory Authorities do not, even unintentionally, undermine the commitment of the Government to conform to the TRIPS Agreement.

Will India be the unique country if such a system of “Patent Linkage” is put in place?

The answer is obviously ‘no’. The system of Patent Linkage exists around the world.

Following are some examples:

Australia – Health Authorities do not provide marketing approval for a generic copy which would infringe an existing patent.

Brazil – As of 2006, no copies of products still under patent have been launched in the market place. However, the Brazilian Health Agency (ANVISA), grants registration to copy products, based only on the merits of the case from the regulatory point of view, whether or not a patent has been granted for the same.

Canada – Health Regulatory Authorities do not provide marketing approval for pharmaceutical products protected by patents listed in the equivalent of the US FDA Orange Book.

China – The State Food & Drugs Administration (SFDA) must be satisfied that no patent is being infringed before it will issue marketing approval. If there has been litigation over a patent, SFDA will wait until the appeals process has been exhausted before acting.

Jordan – Marketing approval for a pharmaceutical product is not permitted during the period of patent protection.

Mexico – Applicants seeking marketing approval for generic pharmaceutical products in Mexico must certify that their patent rights are not infringed. The Health Regulatory Authorities then check with the Patent Office, which must respond within ten days to confirm whether a patent is involved. While Health Authorities will accept an application of marketing approval during the patent period, grant of marketing approval will be delayed until the patent expires.

Singapore – Applicants seeking marketing approval for generic pharmaceutical products in Singapore must declare that the application does not infringe any patent.

U.A.E – The Health Regulatory Authorities do not provide marketing approval for pharmaceutical products that remain under patent protection in the country.

U.S.A – U.S. FDA maintains a listing of pharmaceutical products known as the Orange Book. The Electronic Orange Book is also available via the internet at: http://ww.fda.gov/cder/ob The U.S. FDA does not authorize the marketing approval for a generic copy of a pharmaceutical product protected by a patent listed in the Orange Book.

Europe – Instead of Patent Linkage, the period of data exclusivity is for 10/11 years.

The Patent Linkage System is in progress in countries like Bahrain, Chile, Dominican Republic – Central America FTA (DR-CAFTA), Morocco and Oman.

Conclusions:

I therefore submit the following recommendations to ensure proper enforcement of products patent in India:

 The status of the grant of patent should be reviewed, through appropriate drug regulatory mechanism, before granting marketing permission to generic formulations and if the concerned innovative product is already patented in India, marketing permission for the generic formulation should be withheld.

 Appropriate mechanism/system should soon be worked out in co-ordination with other Ministries to avoid cases of infringement of product patents in India.

 The procedure (Patent Linkage) of checking the patent status of a product before granting marketing approval already exists in the Form 44. This procedure needs to be effectively implemented soon to encourage innovation in India.

By Tapan 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.

Patent Linkage: an important step yet to be taken by the Government of India for proper enforcement of product patents granted in the country

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The process of Patent Linkage establishes a desirable communication process between the Health Ministry and the Patent Offices to prevent marketing approval of generic drugs before expiration of patents granted in India. It also ensures that one Government Department / Ministry does not impair the efforts of another Government Department / Ministry to provide effective intellectual property protection as required by Article 28 of the WTO TRIPS Agreement.
The system of Patent Linkage exists around the world:Following are some examples:

Australia – Health Authorities do not provide marketing approval for a generic copy which would infringe an existing patent.

Brazil – As of 2006, no copies of products still under patent have been launched in the market place. However, the Brazilian Health Agency (ANVISA), grants registration to copy products, based only on the merits of the case from the regulatory point of view, whether or not a patent has been granted for the same.

Canada – Health Regulatory Authorities do not provide marketing approval for pharmaceutical products protected by patents listed in the equivalent of the US FDA Orange Book.

China – The State Food & Drugs Administration (SFDA) must be satisfied that no patent is being infringed before it will issue marketing approval. If there has been litigation over a patent, SFDA will wait until the appeals process has been exhausted before acting.

Jordan – Marketing approval for a pharmaceutical product is not permitted during the period of patent protection.

Mexico – Applicants seeking marketing approval for generic pharmaceutical products in Mexico must certify that their patent rights are not infringed. The Health Regulatory Authorities then check with the Patent Office, which must respond within ten days to confirm whether a patent is involved. While Health Authorities will accept an application of marketing approval during the patent period, grant of marketing approval will be delayed until the patent expires.

Singapore – Applicants seeking marketing approval for generic pharmaceutical products in Singapore must declare that the application does not infringe any patent.

U.A.E – The Health Regulatory Authorities do not provide marketing approval for pharmaceutical products that remain under patent protection in the country.

U.S.A – U.S. FDA maintains a listing of pharmaceutical products known as the Orange Book. The Electronic Orange Book is also available via the internet at: http://ww.fda.gov/cder/ob The U.S. FDA does not authorize the marketing approval for a generic copy of a pharmaceutical product protected by a patent listed in the Orange Book.

Europe – Instead of Patent Linkage, the period of data exclusivity is for 10/11 years.

The Patent Linkage System is in progress in countries like Bahrain, Chile, Dominican Republic – Central America FTA (DR-CAFTA), Morocco and Oman.

Some people question why should India follow Patent Linkage system in the regulatory approval process?

In India ground realities in the patent enforcement process are quite unique. Thus there is an urgent need for having a Patent Linkage system in place for the following reasons:

1. The Government is granting product patent to encourage, protect and reward innovation in India, it will not be in the best interest of the innovators if the same Government grants marketing approval for a generic equivalent of the patented molecule during the patent life of the product.

2. Unlike many other countries, the Indian Patent Law has provision for both pre-grant and post-grant oppositions. Therefore, if anyone wants to challenge the patent, enough time will be available for the same.

3. After patent is granted for a product in India, if marketing approval is given to a generic equivalent of the same molecule, a dispute or patent infringement may arise. As per the Patents Act 2005, such disputes regarding patent infringement have to be challenged in a High Court. The judicial process is a long drawn one and it is quite possible that the patent life of the concerned molecule would expire during the dispute settlement period, which in turn, would raise doubts about the sanctity of granting a product patent to an innovator in our country.

Conclusions:

I therefore submit the following recommendations to ensure proper enforcement of products patent in India:

 The status of the grant of patent should be reviewed, through appropriate drug regulatory mechanism, before granting marketing permission to generic formulations and if the concerned innovative product is already patented in India, marketing permission for the generic formulation should be withheld.

 Appropriate mechanism/system should soon be worked out in co-ordination with other Ministries to avoid cases of infringement of product patents in India.

 The procedure (Patent Linkage) of checking the patent status of a product before granting marketing approval already exists in the Form 44. This procedure needs to be implemented.

India has instances where marketing permission has been granted by the DCGI for a generic product even when a product patent already exists for the same molecule in India. Such instances put the patent holder in a hardship and avoidable litigation involving huge resources both in terms of time and money. Situation like this can be effectively avoided by ascertaining the patent status before granting marketing permission to a generic manufacturer through an appropriate drug regulatory system, as indicated above.

By Tapan 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.

On ‘Patent Linkage’ – a rational argument on an emotive debate

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WTO TRIPS Article 28.1a says that the member countries agree to ensure exclusive rights to patent holder for a specific time period. In case of India, like most other countries, this time period is for 20 years.During this period the member countries agree to prevent third parties from making, using, offering for sale the patented product without the owner’s consent.In India, during last twelve months, at least 4 patents were infringed by the local generic companies. All these cases are currently under litigation. No one at this stage will possibly be able to hazard a guess as to when will these cases ultimately get resolved. If it takes another two to three years to get the final verdict from the honourable High Courts, the revenue of the innovator companies who have already launched their patented products in India will get shaved off, at least for this period, leaving a very adverse commercial impact on them. There is a theoretical possibility that it may take even more time for the honourable High Courts to resolve these cases and during the remaining period of limited patent life of these products the cases may not get resolved, at all.

Moreover, in India there is no known strong deterrent for patent infringement. In absence of which, the opportunity to make significant commercial gain through patent infringement, on the pretext of extending benefits to patients could indeed be, many a times, difficult to resist. Media reports that the National Pharmaceutical Pricing Authority (NPPA) has raised huge demand in crores of rupees for overcharging the common man, flouting the drug pricing norms, by some of these large companies involved in patent infringement litigations, vindicates the point of their basic overall intention of significant commercial gain over extending pricing benefits to the patients. The moot question that follows is who is responsible to ensure the sanctity of the product patent system in India?

The prevailing situation warrants a strong regulatory system which could prohibit marketing approval of generic equivalents of patented molecules during their patent period.

The question that is often raised in this context is who exactly be held responsible for implementation of such a system in our country? While addressing this question one should realize that it is the Government in its entirety and not just the Patent offices or any particular ministry or ministries of the Governments is bound by the WTO TRIPS Agreement. Therefore, it is justifiably the responsibility of all Government departments/ministries to ensure that TRIPS obligations of the Government on proper enforcement of patent are properly met.

The process of granting marketing approval for patented molecules, in general, rests on the Ministry of Health (MoH) of WTO member states. Thus for WTO member states to meet TRIPS obligations effective communication between the MoH and the Patent offices of the country is absolutely essential. Such a system will help prevent approval of generic versions of patented molecules before expiration of the product patents.

Establishing this communication process will ensure that one department/ministry of the Government (say DCGI) does not impair the efforts of another Government department/ministry (say IPOs) to provide effective intellectual property protection as articulated in Article 28.1 of the WTO TRIPS Agreement.

This system will ensure that Health Regulatory Authorities do not, even unintentionally, undermine the commitment of the Government to conform to the TRIPS Agreement.

My experience of the last three years of post product patent regime in India prompts the need for establishing a “Patent Linkage” system without further delay, not only for effective patent protection but also to encourage innovators to get more involved and engaged in the process of innovation in India.

Will India be the unique country if such a system of “Patent Linkage” is put in place? The answer is obviously ‘no’.

In the largest market of the global pharmaceutical industry, the USA, such a system exists. US FDA maintains a listing of pharmaceutical products known as the ‘Orange Book’. The soft copy of the ‘Orange Book’ is also available through internet at: http:/www.fda.gov/cder/ob/.

US FDA does not authorize marketing approval of generic versions of patented molecules listed in the ‘Orange Book’.

What then happens in the second largest market of the global pharmaceutical industry, the European Union (EU)? In the EU, sanctity of the product patent is ensured by granting 10/11 years data exclusivity. Thus, if any company intends to introduce a generic version of a patented molecule, it will have to generate its own sets of entire regulatory data through a very long and expensive process, which may take several years. Even after spending huge amount money and time towards generation of their own clinical data, there is no guarantee that such companies will be able to market the product without getting involved into expensive patent infringement litigation. Thus in the EU, the deterrent to make such an ambitious attempt is humongous.

Various types of ‘Patent Linkage’ system also exists in Australia, Canada, Mexico, Jordan, UAE, Singapore, China etc. While putting in place of such a system is reportedly in progress in countries like, Chile, Dominican Republic – Central America, Bahrain, Morocco, Oman etc.

To conclude, in my view, when the Government of India is the sole authority to grant product patents in India, it is the responsibility of the same Government to protect those patents through its Health Regulatory System i.e. DCGI’s office. I reckon, such a system already exists in India. The procedure of (‘Patent Linkage’) checking the patent status before granting marketing approval already exists in FORM 44, which is an application to the DCGI for grant of permission to import or manufacture a New Drug or to undertake clinical trial in India. In the first page of FORM 44 (available in the website of the DCGI) under ‘Particulars of New Drug’ in point 8, it seeks details of the ‘Patent Status of the drug’. Can this information be not effectively utilized to justifiably deny marketing approval of a generic version of a patented molecule during its patent life in India? If not, it is difficult to make out what purpose will the DCGI utilize this information for?

Thus in my view, the procedure to be followed for ‘Patent Linkage’ in India is already in place. There is hardly any need to reinvent this wheel either. The Health Regulatory Authority of India should now make this procedure work effectively in its obligation to adhere to the commitment of the national Government to honour Article 21.1 of WTO TRIPS Agreement.

By Tapan 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.