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In ex parte re-examination , and more recently in inter partes re-examination , a owner facing dismissal on legislative grounds by an inspector will apply revised claims for further examination by the USPTO in a procedure close to that of amending claims during the initial . Congress made some critical changes to the Act in 2012, the enactment of AIA (America Invents Act). One reform was the implementation of an inter partes examination (‘IPR’) -produced to contest the legitimacy of granted as an affordable method for a third party. Making it from examinational to adjudicatory. The owner has to follow a procedure during these post-grant hearings to amend the grounds of the disputed , also known as ‘substituting’ claims.

While allowed under the law, the owners’ several attempts to replace the claims have been largely unsuccessful during IPR. As of October 1, 2016, there were just five successful motions to change the IPR proposal for replacement claims. Claim amendments in inter partes review have many overlapping similarities with amendments in re-examination . For example, in all cases, the owner is forbidden to broaden the scope of the initial claims or to add new matters, the amendments must respond to the prior art, the modified claims are not considered to be true as the claims of the lawsuit, and the intervening rights are available if the scope of the amended claim is not “substantially identical” to that of the original claim. A much more important difference between the modifications in the re-examination and the others in IPR is the burden of proof. In the case of re-examination, as in the case of ordinary , it is for the examiner to “make a thorough investigation of the available prior art relating to the subject matter of the claimed invention.” The examiner must then clearly explain the basis for each claim rejection. In IPR, there is no examiner involved. Once a prima facie case has been established by the owner that the proposed substitute claims are patentable, the burden transfers to the petitioner who can either contradict the prima facie case by way of the argument or look for additional prior art, making the proposed substitute claims unpatentable.

In Nike Incorporated v. Adidas AG1, the Federal Circuit rejected the argument that “inter partes review … the petitioner shall have the burden of proving a proposition of unpatentability”, and held that, the patent owner carries some affirmative duty to justify substitute claims. Putting the burden on the owner of the patent to justify right to a substitute claims are compatible with the fundamental intent of IPRs-to provide a more effective and simplified patent mechanism that increases the accuracy of and eliminates needless and counterproductive costs of . The rules allow owners to restrict their possible amendment claims to those which are both necessary and more obviously patentable in relation to the prior art by giving the patent owner only a single opportunity to file a petition for amendment. This claim modification procedure would not allow a full remodelling of the claim system, unlike re-examination.

The proprietor of the patent shall clarify in depth the prior art lessons as they apply to the additional restrictions and also explain how the invention becomes distinguishable from the prior art in the proposed claims. Sometimes, this responsibility is underestimated or mistaken. In HTC Corp. v. Specialized Audio Equipment, LLC2, the patent owner argued that in its petition to amend, it could not reasonably address them all with almost 200 prior art record references. Although the patent proprietor may have been correct about the feasibility of addressing a reference to the prior art, it is not what the PTAB demands and held that, “no effort was made to discuss the state of the art as of [the priority] date, or provide any prior art references beyond those already of record that might be material to the added limitations.”.

A requirement was laid down in Idle Free Systems, Inc3. case for dependent proposed claims that, “the patent owner should provide meaningful reasons for additional modifications to dependent claims”. There are also cases when PTAB it denied motions to amend dependent substitute claims with additional modifications by analyzing the dependent claims by “assum[ing] the parent claims to be prior art.”

When IPRs is adopted as an adjudicative method by Congress to replace the re-examination patent owners should be mindful of the considerable variations between amending claims in a re-examination and replacing claims in an IPR. The patent owner, as the moving party, carries the burden of demonstrating a patentable difference between each new replacement claim and the prior art while pursuing an amendment to the IPR. This duty of showing that the owner of the patent is entitled to substitution claims is important, and numerous efforts to replace claims during the IPR have been largely unsuccessful. By adhering to the criteria set out by the PTAB and upheld by the Federal Circuit in recent rulings, patent owners will increase their odds of successful claim modifications.

Despite the pending high-profile withdrawal of the United Kingdom from the EU and growing Euroscepticism around the continent, the EU is determined with its plans to unify patent lawsuits into a consolidated system of courts, ahead. The Unified Patent Court, the current structure, aims to foster “uniformity of the legal order of the Union and the primacy of European Union law.” To achieve this goal, UPC contains a range of regulations aimed at curbing a growing concern affecting jurisdictions around the world: in patent litigation, forum shopping. Over the last two decades, the new European and U.S. system have seen a spike in forum shopping, leading to increased appeals, increased legal expenses, decreased litigation clarity, and the over-concentration of patent proceedings in only a few forums.
The “forum shopping” method encourages patent owners to file infringement suits in courts considered to be complainant-friendly, which easily brings lawsuits to trial and helps to create more favourable jury verdicts. In the other hand, patent owners have opposed venue change because they claim it is yet another way for infringers to avoid punishment by barring them from federal courts where they can get a reasonable trial against richer and more dominant infringers of the company.
Under the patent venue statute, 28 U.S.C. § 1400 (b), “[a]ny civil action for patent infringement may be brought in the judicial district where the defendant resides, or where the defendant has committed acts of infringement and has a regular and established place of business.”[1] The US Code also contains a broader venue statute, 28 U.S.C. § 1391, which states “[e]xcept as otherwise provided by law” and “[f]or all venue purposes,” a corporation “shall be deemed to reside, if a defendant, in any judicial district in which such defendant is subject to the court’s personal jurisdiction with respect to the civil action in question.”[2]
A federal appeals court found in VE Holding Corp. v. Johnson Gas Appliance Co.[3] , that the residence rule in the statute of the general venue must take precedence over the regulation of the statute of the patent venue. This harmless decision allowed claimants in every court where the defendant had any involvement, however tenuous, to institute violation suits. This has resulted in a growing tide of ‘patent trolls’ or non-practicing companies, who now had a relatively simple model for embroiling claimants in lawsuits and obtaining from them settlements or even penalties. This was way back in the early 2000s.
On December 14, 2016, in TC Heartland LLC v. Kraft Foods[4], the High Court decided to reconsider a Federal Circuit ruling in which the Federal Circuit upheld the long-standing tradition of allowing patent suits to be brought in every judicial district in which an allegedly infringing device was marketed by the defendant. In May 2017, the Supreme Court ruled in favour of Heartland, holding unanimously that only in the state where they are incorporated can corporations be sued for patent infringement. It is too early to say what TC Heartland would mean in the long term, but at least it was the Supreme Court’s attempt to minimise forum shopping and improve uniformity and predictability at the district-court level in patent proceedings.
In a case merely because of the choice of forum, Congress and judges have acted with court orders, laws, or public policy to discourage litigants from shopping sites, and to make the justice system predictable, clear, and fair if there is a way for the claimant or defendant to get a particular result in a case. It is unreasonable for the USPTO to encourage a patent drafter to merely modify a few terms without altering the subject matter of the application and to categorise the application more favourably. Big data and text processing make it very easy for patent drafters to enter a drafted application into a text editor with recent technological developments and get a forecast on where the USPTO will categorise the application. More concepts and approaches that would make the classification of an application even more dependent on its subject matter and less dependent on how creatively it is drawn up should be implemented. Such initiatives will improve uniformity and predictability thus, discouraging the drafting of artful patents.

The intellectual property regime is witnessing a constant increase in the pressure of disposing various applications that have been filed at various domestic offices across the world. Nevertheless, in spite of an IP being at the priority, the average time taken to grant a patent is roughly 25-30 months. Patent Prosecution Highway (PPH) developed by United States Patent and Trademark Office (USPTO) is a concept that primarily works on the premise on having a bilateral linkage of two patent offices to alleviate the burden of work. Through this the second patent office (Office of later examination (OLE)) take advantage of the work that has already been completed in the first patent office (Office of earlier examination (OEE)), thereby reducing the burden on the patent office and allowing an expedited patent examination in a second patent office. The first PPH was developed between USPTO and Japan Patent office as a pilot program that began on July 3, 2006, which was implemented on a full time and permanent basis on January 4, 2008. From then, there were various PPH being entered by USPTO with countries like UK, Canada, Korea, Australia, European patent office, Denmark etc. Even in a move to bring this for a global consideration, USPTO launched two pilot programs- Global PPH and IP5 PPH in 2014 thereby expanding the scope to PCT framework as well. Currently the Global PPH has 27 countries and IP5 has 5 countries as on June 2020.

USPTO specifically bars those applicants to enter through PPH route where a substantive examination of the application has already been started. The application filed in US must be sufficiently related to the application in the OEE. There should be at least one claim that should correspond to OEE application and all claims mentioned must “sufficiently corresponds” to the allowable or patentable claims in the OEE. The literal interpretation of “sufficiently corresponds” is to consider same or similar scope as an allowable or patentable claim. This can bring us to analyze that the claims which have to be addressed in the OLE must be similar to OEE. This is much obvious since if there are other claims then the purpose of PPH won’t be solved. The aim is to take the work that has been already been completed by the OEE. Hence only those claims on which the work has been sufficiently rendered by OEE will be allowed to go for PPH. Here it is imperative to understand that same or similar scope must not be confused with those claims which introduce a new or different category of claims. Meaning thereby, if a claim in OEE correspond to process of manufacturing but the claim in OLE correspond to product, even if both are of same category will not be considered as sufficiently correspond.

Even if PPH could be advantageous on many fronts, there are some loopholes. Firstly, there is a difference in the ambit of allowable claims in the individual country. All the claims in the OLE must be limited to the scope of claims allowed in OEE. An applicant who has preferred a broader scope of claims might not be able to get through the PPH subject to such limitation. Secondly, on a close analysis there is a difference in the participation requirement for the PPH for each country. Like for example, Japan requires the copies of the USPTO cited references but UK does not require that. Instead it requires submission of search and examination reports of USPTO. Canada requires that the application even of PPH must be made open to public. Korea was the first country among PPH participants which does not restrict participation to those applications that have not yet started the examination. These different requirements prove an uneven arrangement among the countries with the PPH.

Thirdly, almost all the countries have some procedures to provide the applicant an option to speed up the examination process. Canada has a Special Order Request whereby the applicant can request an urgent examination, failure to which will result in prejudice to the person’s rights. Under Section 2.13.4.3 of the Australian Patent Manual of Practice, the applicant can request an expedited examination with a legitimate reason. European Patent Office has a program called PACE in which it allows the applicant to have all examination and communication within tight deadline. Section 17.05.1 of UK Manual of Patent Practice too provides the applicant to get an accelerated search if adequate reason is being provided. Why an applicant should be made to go through PPH and incur extra cost when he has remedies at the local level?

Many stakeholders argue the presence of PPH as parasitic to PCT. But one has to understand that even in the PCT system; the members do not have an opportunity to evaluate the claims that result from prosecution in partner states. This generally results in being distrustful of other’s countries’ examination procedure. Contrary to what happen in PPH, there always is an understanding between OLE and OEE, resulting in the development of trust in one’s other patentability decision. On the contrary, it can even be said that PPH fills the gap of PCT.

If we analyze some recent statistics of 2019, picture might not be so good. USPTO allowance rate for applications that entered the PPH was 84%, as compared to allowance rate across all patent application which were 74%. But from 2006 till 2018 fiscal year end, approximately 55,000 PPH request has been filed at USPTO, as compared to the total number of utility patent application filed in the same period being 6,824,912, certainly because of higher cost and non filing of further amendments subsequently filed with PPH request. Should the USPTO relax or remove the severe constraints, the PPH Program would seem to be a mutually beneficial program for the USPTO and for applicants.

The outbreak of Covid-19 has set the eyes of the world towards finding a suitable vaccine for the virus. This prevailing situation has made various countries to re-think some of the most pressing issues with regard to the regulation. linkage is perhaps one of the most debatable aspects of regulation around the world.

The system of ‘ linkage’ refers to the practice of linking the market approval of the generic product to the status of the innovator’s product. It involves the regulatory body, granting market access, and the office, granting rights to the patentee. If there being an existing patent on the subject drug then the regulatory authority can refrain from providing market approval to the generic manufacturer. This denial often concerns the availability of generic drugs being subjected to such preceding conditions irrespective of any proven affecting the larger issues of access to medicine and in the larger picture, the public health issue.

US’s Hatch Waxman Act brings the linkage regime into force for the explicit need to balance the brand pharmaceuticals firms and the generic firm for the purpose of bringing cheaper medicine “as soon as possible”. The US publishes the Orange Book containing all the approved drugs having the same Therapeutic Evaluation. The Food and Drug Administration (FDA) updates the list of all the drugs and provides the exclusivity information and all the industry while filing for the Abbreviated New Drug Application (ANDA) must show the drug has been used and its expiration. Claims made for favoring linkage regulations imply providing incentives to originator firms making high risk in research and development. The US has favorably insisted on the linkage regulation in its various free trade agreements, and even to the extent, some Asian Countries have amended their local laws to insert the linkage clause. China, South Korea, Singapore being some along with Taiwan being the latest entrant in 2019.

European Union does not have a system of linkage. There were instances where various industries have tried to introduce such provision but they failed and even in a 2006 press release, the European Generic Medicines Association had stated that linkage is contrary to EU regulatory law as it undermined the Bolar provision which sought to encourage quick access to the post-market for EU generic medicines.

Linkage shifts the onus of regulating the from the holder to the regulatory authority. Some previous research claimed that linkage is generally used for delaying the entry of generic drugs, especially by major pharmaceuticals companies following the tendency for positive incentives and reward. But the primary problem might not be linkage as a whole but the nexus between the regulatory authority and office, of which regulatory authority having no expertise, unnecessarily delays the generic entry without proven.

This pandemic does make us realize the importance of not only cheap medicines but also rapid access to medicines. Prompt and affordable access to essential medicines is a component of all domestic and public health models and barring the generic drugs is doctrinally weak which prejudices the historical, epistemological, and jurisprudential foundation of intellectual property.

Introduction

Intellectual property (IP) rights are incentives that fuel innovation and creativity in our ecosystem, however, they are not universal. laws are territorial in nature, hence something patentable in the US may not get protection in India and vice versa. Therefore, it is highly probable that when any invention falls outside the eligibility compartments established under the patent law, it is not patentable. The US judiciary with Alice Corp. v. CLS Bank, S. Ct. (2014), had interpreted the patent eligibility criteria in a narrower sense w.r.t computer-related inventions (CRI). while the Indian Judiciary with Ferid Allani v. Union of India has widened the scope of patentability. This write-up analyzes the repercussions of Alice’s case, and compares and contrasts the CRI in India and the US.

The Building Blocks

With Alice’s case, the Court limited the patent eligibility standards under 35 U.S.C. § 101 for CRI. It applied the mayo test in the context of software. The Supreme Court in Mayo v. Prometheus (2012) a judicial exception of ‘Law of Nature’ that applied besides the novelty and obviousness patent eligibility criteria. The two-step test (1) applied in Alice’s case held that the mere application of abstract ideas using the software will not make a patentable. The narrowing down could be taken as a step to trim off unreasonable CRI applications pending with the USPTO. However, this was done without specifying what would amount to an abstract idea. Now, the task was to show that the invention, however, built on an abstract idea is more than just the idea itself. This inevitably introduced uncertainty within the concerned industry.

The Infused Uncertainty

With Alice’s decision, the invention industry felt a shockwave as the Court had been strict while interpreting the patent eligibility thresholds. Below mentioned are a few repercussions of the decision that significantly affected the predictability of software .
1. An invention to secure a had to pass the threshold of the trinity of novelty, prior art, and non-obviousness. However, with this decision, the courts stepped in to analyzing the scope of claims. This allows the Courts to inspect even the technical aspects of a claim.
2. In the Post-Alice environment, it is a struggle to secure a for a software-related invention because now the USPTO will reject a CRI blueprint unless it specifically mentions the procedure used to travel from the ‘functionally’ to ‘the code written to achieve this functionality’. In other words, a CRI to get a must lie somewhere in between the claimed functionalities and the code, and this makes describing a CRI a challenging task.
3. On a conjoint reading of the above, it becomes apparent that the business models, engaged in aggregating known parameters/functionalities and making them available in one e-frame, are struggling the most to get a .
4. Undoubtedly, computer software fuels the engine of the Fourth Industrial Revolution, but the distractions surrounding USPTO and lower courts have increased the cost and decreased the quality of a .
5. In 2019, the USPTO attempted to clear the confusion associated with Alice’s decision by issuing guidelines to explain the evaluation process of the claims for eligibility under 35 U.S.C. 101.

The Crossover Journey of CRI patenting

The jurisprudence of computer-related inventions getting patent protection in India is now moving in a direction where it may cross path with the US regime, to some extent. The recent Delhi High Court decision in Ferid Allani v. Union of India interpreted section 3(k) of the Indian Patent Act in the light of the 2016 Guidelines indicating the patentability of CRI in India. It was held that “per se”, in sec. 3(k), should not disturb the patentability of genuine computer-based inventions. This judgment overnight changed the fate of CRI in India, now we have moved from a complete ban to a bit relaxed regime providing room for genuine CRI. The Court observed that the ‘technical contributions shall be examined before rejecting a CRI patent application’. But again, it did not address which inventions can be said to reflect ‘technical contribution’.
The US patent law does not prohibit computer-related inventions to secure patent rights unless otherwise disqualified, on the contrary, the Indian patent law, prior to Ferid Allani’s case, specifically bars CRI from patentability. The US innovation sector after Alice’s decision has faced threats of uncertainty. Meanwhile, in India, Ferid Allani’s decision to some extent has brought certainty and hope for inventors of CRI. In other words, with the judicial interpretation, in the US many pending patent applications were rejected while in India many applications may become eligible for a patent.

Conclusion

The patentability of a CRI, apart from the statue’s requirements, now largely depends on the quality of the patent application and the intelligent of patent claims. These swards help an inventor to successfully defend her case in the courts. It is worth noting that even after roughly six years of Alice’s case the confusion surrounding the subject matter eligibility is deteriorated and hampered the speed invention, now that we are in the age of machine learning and IoT. The economy demands a categorically clear picture regarding the CRI patenting regime owing to the financial aspects of .

Introduction

What is the economic viability of Patents? Ever thought of how patent valuation is done and how patent rights and antitrust laws co-exist? The existence of antitrust laws proves that market dynamics must promote fair competition. However, in the same market, patent rights guarantee a monopolized position. How are they co-existing? And why are they co-existing? An obvious answer is that the market craves for innovation and development. Hence, we need to reward the inventors, but with checks and balances. Therefore, National laws like patent laws and antitrust laws harmonize conflicting interests existing within society and commerce. Further, the ecosystem is full of patents, but the questions worth deliberating upon are whether all the patents have sound economic value? Why do companies go for patent valuation? Indeed, not all patents have economic viability. The quality of patents is directly proportional to the financial returns. Estimation of the worth of a patent forms an indispensable part of constructing business strategies. This post precisely makes two contributions;

1. Outlining the parameters to judge the economic value of a patent.
2. Elaborating on the legal constructs of patent valuation.

Parameters one must consider

1.Patent families and demography

The territorial limitations of patent laws interlock the commercial value of an invention with the demographic boundaries. A study on the patent family size, based on the GDP of a country, while doing multiple international filings will positively affect the patent filing decision of the owner. Because the owner of a valuable patent goes for international protections (1).

2.Game-changing patents

Path-breaking inventions drive future IP business strategies and fuel up the rate of inventions in that area. These finest inventions hold great market value. The quality of the patent is definitely associated with technological resources that a company spends on R&D. Therefore, apt investment in the R&D paves way for great economic returns.

3.The Grant time

Pierre Regibeau, back in 2010, stated that the relationship between patent value and patent grant time is inversely proportional (2). The researchers have proved that valuable inventions get speedy approvals.

4.Claims defining the scope

The scope of rights and liabilities are ascertained by looking at the claims. Therefore, more claims mean the invention will be commercially exploited over a broad market spectrum. This, to some extent, speculates on the economic value of the invention.

5.Future mentions

Future references by fellow inventors of a patent reflect that the patented technology holds a great value in the industry. This also significantly improves the company’s standing in the market.

6.The novelty of a patent

Novelty is coupled with patent value but in a narrow way. The novel patent but a general one may not fetch you high value. The key is to diversify the resources and knowledge base to construct novel results and economic value.

Let’s talk law

The pyramid constructed for economic exploitation of an invention would crumble without a legal shield. Below mentioned are a few essentials to be kept in mind.

1.Ownership and renewal

Patents can have complicated titles, while ownership dictates the control, licensees can only use it. A valuation document will have a checkbox ascertaining the nature of the contract of employment during which the invention was developed. In contractual or work for hire types of employment, the company loses ownership over the invention. Therefore, the valuation of a patent owned by the company would be much higher than the one licensed to it. Further, the renewal is a sine qua non to protect flourishing patents. Generally because, If a patent owner files for renewal, it signifies that there is a market for her patent. Therefore, the length of the patent will directly affect its value.

2.Scope of the invention

An invention to exclude others from copying in the US market must be protected with the USPTO’s patent regime. The specifications and claims, generally, define the scope and ambit of the patent protection. Conventionally, a wider bandwidth of claim results in a high valuation of the patent. An inherent feature of patents is that it can be licensed, therefore, it becomes relevant to consider the terms of licensing to identify legal implications of licensing. Concurrent licensing unlike exclusive licensing will surely reflect lower economic value.

3.Potential lawsuits

An invention generally affects third party players in the industry. Therefore, to ensure that third party rights are not disturbed, the applicant must thoroughly inspect the relevant prior art. Litigation can cost a hefty amount of dollars and loss of reputation. It can stretch over years and can even eat-up on the term of protection. Lawsuits can severely affect the value of a patent, hence, all necessary steps must be taken to avoid it.

4.Indispensable legal support

Legal support is imperative to conduct frictionless business transactions related to patents. Drafting unambiguous contracts is one of the most important tasks. These contracts include both patent and non-patent contracts affecting the value. Consumer relations, workforce intangible assets, etc are equally important to construct value and are smoothly worked out because of legal interference. A pool of money could flood out of the corporation if the legal ends are loosely tied.

Key Takeaways

● The intangibility of a patent makes the process of its valuation complex as the considerations involved are multifold.
● Patent valuation helps enterprises to devise business strategies and gain a competitive advantage in the market.
● The economic exploitation of an invention stands on the shoulder of law, and this dimension shall be given adequate importance. Loose legal support can devalue even economically viable patents.

Bibliography

1. Flignor, P. and Orozco, D. (2006), “Intangible asset and intellectual property valuation: a multidisciplinary perspective”, World Intellectual Property SMEs Newsletter, July, available at: www.wipo.int/sme/en/documents/ip_valuation.htm
2. Squicciarini, Mariagrazia & Dernis, Hélène & Criscuolo, Chiara. (2013) Measuring Patent Quality: Indicators of Technological and Economic Value. 10.1787/5k4522wkw1r8-en.
3. Francois P. Kabore & Walter G. Park, (2019) Can patent family size and composition signal patent value?, 51:60 Appl. Econ 6476, 6476-6477.
4. Pierre Re¤gibeau & Katharine Rockett, (2010), Innovation cycles and learning at the Patent office: Does the early patent get the delay?, 58 J Ind Econ 222, 243- 244

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