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Month: August 2020

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Patents

Is this what we could call Trump’s Triumphant Intellectual property Pact?

It is long known that there has been a clear divide between first-world countries and third-world countries when it comes to fashion or facilities. The same stands true to intellectual property rights as well and this is why the TRIPS Agreement was enforced to gear up the developing nations to reach a sturdy platform incorporating streamlined notions of IP embraced by all countries alike. However, think of it as a mechanism for the developed countries who proliferate and have grabbed much already in the race for acquiring these right to benefit from such a system by furthering their interests. The same ideology can be implanted upon the United States and India, where US has been constantly pushing for the implementation of better practices in IPR through the medium of WTO and other bilateral or regional free trade agreements like those in the form of TRIPS Plus or other flexibilities to ensure smooth entry of US enterprises/ inventors into Indian mainstream and vice-versa.

Recently, the eventful “Namaste Trump” resulted in the exchange of ideas by both the counterparts of which intellectual property emerged to be a topic of sound debate which resulted into the signing of an accord in the form of an MoU to reduce the friction of trade disputes between the two. Despite the hush and muffled speeches, it can however be gathered that this is an initiative which may in future have a direct bearing on protecting international pharmaceutical that some experts quote to have detrimental effect on patentees’ rights. While the terms of the MoU remain undisclosed, it is amply clear that the MoU does not embody any obligation for implementation of laws. In addition to that, the MoU allows “knowledge-sharing” on both the ends to understand and study the nitty-gritties of IP laws.

Image: SUNDAY GUARDIAN LIVE

Therefore, US has proposed to train patent-examiners regarding examination process in the light of US patent laws which might mark the move to change Indian practices in their direction. This is clothed as a training but it resonates to one holding another’s hand to guide that other to do how things are meant to be done, to be done their way! This pact was a probably a result of facing pressure from US by alarming India of warding-off the GSP subsidy (Generalized System of Preferences tariff system) upon certain goods to limit duty-free entry of Indian goods or because of India stooping down to the 40th position on the US Chamber’s International IP Index but the Question is what is the legal basis of these reports and how far can they be imposed? Reports like Special 301 are backed by eco-political interests coupled with R&D activities which is why India or any other country may or may not be obliged to act in a direction quoted, however, it serves as a legit warning.

It is possible that this move is targeted to enhance the understanding of an even stricter implementation of section 3(d) of the Act which is the anti-ever-greening provision in the law which is why a few -saving drugs in India like those for tuberculosis, cancer, diabetes etc. are still expensive because these patented drugs have more than a single patent on them which results in extension of monopoly in the market alongside exorbitant pricing. A recent study indicated that 72 per cent of pharmaceutical granted in India are for minor or marginal improvements on existing drugs which contravene the present Indian Act. The study also said the public interest provisions are not implemented by the Indian office. However, this is not true since India and the US have very different patentability standards. While US is faced with a proliferation of on new uses of a known substance, combinations and new forms of known medicines which is instrumental in keeping generics out of the market and lowering of patentability standards of novelty, non-obviousness and industrial application; India on the other hand strictly limits the patenting of known medicines and has rejected a number of such applications. This weighs in the interest of public-health but against medical inventions.

Even though the MoU doesn’t imply a legal commitment, experts have commented that India should be cautious. Understanding the nature of polarity between the laws in India and US, and considering the fact that Indian Patent law is often looked-up to as a model law for implementing pro-public interest laws, how far does such MoU look reasonable to you is the question we would like to ask.

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Patents

A CURE TO THE PANDEMIC: A PERISCOPIC VIEW


Every household is discussing the possible cure to the cosmopolitan pandemic amidst the trans-border and domestic shutdown to subdue the spread of the disease, making the availability of adequate medicament an outraging issue. In response to offer smooth technology-transfer and accessibility of these necessities, compulsory has gathered much attention.

Compulsory , as the name suggests is a which enables a competent government authority to the use of a patented invention to a third party or a government agency in lieu of a decided royalty rate where the invention has not been used to the benefit of the consuming public for a period of three years. It finds place in both the international instruments, TRIPS Agreement[1] as well as the Doha Declaration on Public Health[2] because of which member-states have been bound to reflect the provisions in their domestic laws with marginal flexibility. India also embraces the provision for compulsory in its Act, 1970 in section 84. In addition to the aforementioned, the Act also empowers the government to acquire the stockpile of patented goods, therefore, if a vaccine is developed in India, the well-being would be best ensured[3]. An exception to compulsory may be observed in times of national/extreme emergency[4] or for public non-commercial use, qualifying countries lacking infrastructure to seek aid from exporting counties by presuming the legal authority to manufacture. India is also a potential exporter which has expressed its willingness to the WTO to use the system to import only in times of national/ extreme emergency. From a diplomatic standpoint, since India is one of the largest exporters of generics, it would in all-likelihood undergo immense pressure from the international community which might not work in its favor[5].

India unlike the USA has enforced a compulsory , even though the Bayh-Dole Act or as otherwise known, the and Trademark Law Amendments Act has incorporated the “march-in-right” provision for compulsory in the US. This could possibly be owing to the stringent and straight-jacketed laws or prior-fulfillment of consumer needs that compulsory has skipped on the soils of America. Even the Least Developed Countries tend to shy away from deploying the said tool because of bilateral restrictions or other trade barriers[6].
Therefore, it becomes pertinent to think of other alternatives to compulsory as well. It is important to consider that only if a patentee disagrees to out an invention can a compulsory be invoked. An initial and suitable recourse in mature regimes, presumably, would be “voluntary ” which would work to benefit all the counterparts, the patentee, the consumer and the government. Also, I believe, where negotiations fail, countries can bank on “parallel imports” from member-states having a bulk of supplies to forego. To state an example, consider the first ever compulsory imposed in India; where Bayer sold the drug Nexavar for 2.84 Lakhs for a month’s dosage and Natco proposed to price the drug as low as Rs 8,880 a month. Similarly, very recently, Remdesivir has reached phase III for clinical trials as a possible cure to Covid-19 which has been priced at the rate of Rs.2,89,900 per patient by Gilead; the same has been proposed to be priced at a low rate of Rs 55,000 per patient by a generic producer, Mylan, which is an outcome of a non-exclusive voluntary . Therefore, this projects the need to negate any aggressive strategy to make available a drug or vaccine since a voluntary may prove to be as beneficial as a compulsory as observed above. Therefore, compulsory “might” not be necessary.

After observing failed negotiation or attempts at securing a voluntary , if compulsory still deems to be the only solution to achieve mass production and outreach, it would require a certain degree of modification and uniformity in domestic laws of the countries seeking to enforce the provision to adjust to the current realities. Like recently, the legislatures in Canada [7], Chile[8] , and Ecuador[9] laid the legal groundwork for the issuance of compulsory to address Covid-19 since each member nation has the freedom to determine the grounds on which the may be granted.

There’s a possibility that the cure to Covid-19 may turn out to be an existing drug that has expired over the years. Even if the discovered cure is -protected, there may be drug donations, discounts, or the holder may offer voluntary at affordable rates.[10] It would be very exciting to find out how the events turn out to be and whether or not a compulsory would be enforced to achieve global outreach of these lifesaving drugs.

[1] Article 31, TRIPS Agreement 1995
[2] Article 5, Doha Declaration on Public health, 2001
[3] Section 102, Act, 1970.
[4] https://www.wto.org/english/tratop_e/trips_e/factsheet_pharm02_e.htm
[5] https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/affordable-access-to-covid-19-drugs-are-voluntary–licences-here-to-stay/articleshow/75756605.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst
[6] Harris D.TRIPS after fifteen years: success or failure, as measured by compulsory . J Intellectual Property Law. 2010;18:387
[7] https://www.canada.ca/en/department-finance/news/2020/04/government-introduces-covid-19-emergency-response-act-no-2-to-help-businesses-keep-canadians-in-their-jobs.html
[8] https://home.kpmg/xx/en/home/insights/2020/04/chile-government-and-institution-measures-in-response-to-covid.html
[9] https://www.mondaq.com/fiscal-monetary-policy/910356/new-measures-against-covid-19
[10] Wong, Hilary. “The case for compulsory during COVID-19.” Journal of global health vol. 10,1 (2020): 010358. doi:10.7189/jogh.10.010358

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Patents

OVERLAPPING IMPLICATIONS OF 3D TECHNOLOGY AND IP RIGHTS


Impervious claims make you win the Technology game.

As a matter of constant debate, it is often cited how traditional Intellectual Property laws and attorneys shall keep-up with the pace of the technical advancement and literal improvements. The recent evolution of 3D printing and its multifold capabilities have reverberated across all fields alike. Additive Manufacturing, commonly known as 3D-printing has revolutionized the manufacturing process with its disruptive advancement in domains like automotives, manufacturing, aerospace, pharmaceutical & healthcare, fashion, retail and sports, leaving aside the fabrication of a human tissue as we’ve already seen in endless episodes of Grey’s Anatomy. Almost a decade back, a for “fused deposition modeling” had expired and inventors began to brain-storm around the periphery of the said invention. Kick starter introduced 3D printing and the hype built then has not witnessed a dip ever since. Tracing the developments from the past few years, the top-10 scoreboards leaders are from US and a few from Germany; these include General Electric, HP Inc. and United Technologies Corporation as the flag bearers.

Although, it has substantially pushed down the cost and issues of feasibility, it certainly has escalated the problem of potential infringements in the domain of intellectual property rights. holders often robe themselves with a rhino’s skin when they hear about how copyrights are infringed by piracy and flouting of , hoping to remain untouched by such technology capable of printing not just books but objects as well.

While brushing upon the issue of , its quintessential to note how there’s a depression in the IP system not catering to flouting of proprietor rights by deployment of such technologies under the existent framework. Considering a CAD file which lays the blueprint for printing an object, incorporates the article’s digital impression which could amount to of copyright as an unfair use of derivative works since it uses technical drawings and diagram models. Such issues cannot be ignored and requires requisite enhancement of the legal framework in the form of digital copyright infringements.  For better protection of these rights against unauthorized use, it would be wise to incorporate a “unique identifier” while generating CAD files to ensure that the end-user is identified before proceeding to access the file. Furthermore, to draw a parallel with landmark copyright case laws, would it not be correct to hold that proprietors of 3D printing technologies are capable of inducing future infringements? Napster and Groxter did not make infringing copies of sound labels but they most certainly aided its user in the process of generating pirated sound records. If the two were shut down on such premise, then why does the same not stand true here.

Another issue is the problem hovering around where a protected technology is facsimiled and an existing object is created using a different mechanism. This also amounts to , provided the fact that the object is protected. A non-patented feature of a patented object can be produced without attracting any objection. To cater to patent infringements facilitated by 3D printing, the provision with respect to indirect infringement can be strictly construed holding inappropriate use of such technology to be legally actionable. The only issue with this approach in the domain of is that to succeed in a case of alleged inducement of , it requires the Plaintiff to establish that the defendants had actual knowledge of the relevant which may be a challenging task. Therefore, one can easily dust their hands claiming that they were unaware of the existence of such and thereby escape liability. This is why we need a straight-jacket formula. It is pertinent to enforce a uniformly regulated system for proportional use of the said technology in the industry. In furtherance of this objective, it is important that the claims in future applications dealing with such kinds of technologies are tightly framed without leaving any potential pits that could be filled in by opportunist which would help in securing such rights in the favor of a handful with controlled administration (through , assignment, etc.). Therefore, lesser the owner of such technologies, greater is the chance to supervise.

Furthermore, the non-functional feature of the replicated object, i.e. the appearance of the same will attract claims of of the design. However, it goes without saying that non-commercial and private use of the said article although manufactured via 3D printing would not gather legal action. To what extent can such fabrication be mapped across the globe is the question where is costly and long-drawn. The number of welcoming issues in the domain is beyond count. To prove a point, consider where the 3D technology is used to print guns and ammunition. Is this not an ethical issue or a safety issue against public safety?

It is the unsaid duty of the government to safeguard the right of a holder in exchange of which it receives disclosure of a patented invention. In furtherance of this objective, the legislative wing of the government shall invite suggestions from the public as well as specialized reports from the government committees to ensure better execution and administration of laws to warrant that such an invention is not frivolously put to use. To end this on a conclusive note, I personally believe that the use of such dynamic technology shall be controlled and supervised since it can have polarized outcomes.

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Patents

PATENT CRISIS: TRAGEDY OF ANTI-COMMONS

“I want the Oompa-Loompa” screamed Veronica Salt, the greedy girl who landed in the walnut shell chute in the movie Charlie and the Chocolate Factory. Man, evitable or inevitably so, is greedy and therefore, came the concept of privatization where fair and equitable distribution became unfeasible.

What is the tragedy of the commons and its anti-thesis, the tragedy of anti-commons?? To begin with, think of everyone having unlimited access to fuel and what could possibly happen? Obvious enough, it would lead to stocking-piling and over-utilization due to a huge appetite of some and lack of foresight of many for envisioning the sustainability of the commonly held resource. This is the tragedy of the commons as coined by Gareet Hardin[1], where while exposed to limited resources, each individual chiefly thinks of his own desires leading to overconsumption, as also held by Aristotle.[2] On the contrary, there is the issue of rigid privatization of rights over the limited resource where it could lead to possible under-utilization and prevent others from obtaining access. This is the tragedy of the anti-commons as coined by Michael Heller.[3] This metaphor, used for connoting economic principles has found application in law and as well.

The sequel of this problem can have catastrophic effects, especially, in the bio-technological or pharmaceutical field. To cite an example, a while ago, a scientist had invented a prospective treatment for Alzheimer’s but the same could not enter the market because of a dozens of underlying , each seeking to monopolize the invention. The drug eventually never saw daylight even though it could’ve saved a million lives and generated humongous revenue. This is the reason why the regime was incorporated in the international and domestic matrix to strike a perfect balance between monopolizing an inventor’s interest while at the same time securing the public good. This is why we need to think of a probable solution in the light of cosmopolitan technologies. Thomas Hazlett terms this as “tragedy of the telecoms” while referring to the like phenomena in relation  to the high-tech frontiers.[4] The similar concept is not just applicable for but also in the field of art, falling under the domain of Copyrights[5], where mix-ups, mash-ups and remixing different pieces of prior-owned resources are clubbed to create a collage work.

In the realm of , anti-commons usually exist due to stacking of and introducing fragmented technology. Generating fragments of a patented article and scattering ownership of each concurrent fragment could lead to acquiring a bundle of rights in order to enforce one single right. This would result in a very costly transaction which could have a profound impact on developing and making the product available at a rationale cost in the market. Therefore, an agreement to subsidize or rationalize royalties for potential or assignments over upstream technology to enable the introduction of a downstream technology at reasonable rates could propose to be a better idea. This could be facilitated by Reach Through Agreements (RTLAs) as an advantageous tool to both, the holder as well as the forthcoming researcher.

Therefore, to divert the loss arising out of the tragedy, improvement and modification of policy regulations or police advocacy, privatization and cooperative engagement are the broad solutions possible. As deduced above, privatization may not always result in desired outcomes, therefore to address policy concerns through strengthening anti-trust laws and cooperative management of resources appears to be a good option. However, in the light of prevailing circumstances, the state is apparently withdrawing from its civic role; policy regulation may or may not be the solution, widely depending upon the long-stretched implementation period. Therefore, the most viable solution is to enhance cooperative efforts and subdue heterogeneous interests for decreasing the transaction costs. This is where pools may come handy. E.g.: to make compliant to DVD ROM and DVD- Video, Sony, Philips, Pioneer, Toshiba Corporation, Hitachi Ltd., Matsushita Electric Industrial Co., Ltd., Mitsubishi Electric Corporation, Time Warner Inc., and Victor Company of Japan, Ltd. all joined hands.[6] The kind of strategy deployed would largely depend upon the economic principles followed by a State and the adaptability to a newfound norm.

[1] https://www.britannica.com//tragedy-of-the-commons

[2] Aristotle, The Politics and the Constitution of Athens (S. Everson (ed), B. Jowett (trans) Cambridge: Cambridge UP, 1996) 33

[3] Heller, Michael A (January 1998). “The tragedy of the ant commons: property in the transition from Marx to markets” (PDF). Harvard Law Review. 111 (3): 621–688. doi:10.2307/1342203. ISSN 0017-811X. JSTOR 1342203.

[4] T.W. Hazlett, ‘Spectrum Tragedies’(2005) 22 Yale Journal of Regulation 242; R. H. Ziedonis,‘Don’t Fence Me In: Fragmented Markets for Technology and the Strategies of Firms’ (2004) 50 Management 804

[5]F. Parisi and B. Depoorter, ‘Fair Use and Copyright Protection: A Price Theory Explanation’ (2003) 21 International Review of Law and Economics 453.

[6]  Clark, Jeanne, POOLS: A SOLUTION TO THE PROBLEM OF ACCESS IN ?, December 5, 2000 http://www.uspto.gov/web/offices/pac/dapp/opla/patentpool.pdf

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