Counterfeit goods are an age-old consequence of economic markets. These consequences are especially troubling when raising concerns about the delivery of prescription medicines that the public are presumed to trust. The (WHO) recognizes this. To improve the global supply chain's security, they have defined Pharmaceutical counterfeiting as medicine that is deliberately and fraudulently mislabeled concerning the identity and/or source. Counterfeiting is not limited to either branded or generic products. It occurs in different fashions, such as the inclusion of wrong ingredients, deficiencies of active ingredients, and false packaging.

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Problem with IP Regulations and the Supply Chain

A more technical consequence of pharmaceutical counterfeiting is that these medicines can often violate companies' patent rights offering legitimate medicines. In Canada, three pieces of legislation compose the legal framework surrounding intellectual property rights in the biopharmaceutical industry: (1) ; (2) the ; and (3) "Data Protection" found in ¹. Together, these regulations serve to protect innovations from being stolen or reproduced for consumer use and profit.

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Manufacturers of fake medicines are motivated by profits. They are likely to avoid the expense of precision measurement and formulation that directly infringes upon patent holders' rights. Unfortunately, many technicalities are involved in drafting biopharmaceutical patents, and because counterfeit manufacturers often cut corners in the production process, direct patent infringement may not always occur. Thus, patent holders and regulatory officials have two separate issues on their hands pertaining to supply chain security: counterfeit drugs that fail in effectiveness altogether and efficacious but patent-infringing generic drugs.

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Potential Solutions

Several recommendations to protect biopharmaceutical manufacturers may be offered. First, raising public awareness on the issues of pharmaceutical counterfeiting is essential¹. By pushing for campaigns that warn of pharmaceutical counterfeiting risks, we can limit the purchase and use of these fake medicines¹. Next, improving regulatory oversight could restrict the manufacturing of pharmaceutical counterfeits¹. Criminal sanctions and massive fines would likely deter companies from making counterfeit drugs while strengthening biopharmaceutical intellectual property rights¹. Finally, incentivizing domestic production of pharmaceuticals would limit the import penetration of counterfeits in the market. Nonetheless, a significant consideration for manufacturers is production cost, which is much cheaper in other countries.

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High taxes, high salaries, and, most importantly, inadequate intellectual property protections have discouraged Canadian manufacturing as well.��It is entirely possible that to fully secure the biopharmaceutical supply chain and eliminate counterfeits from the market, Canada will need to shift its focus to strengthening intellectual property rights.

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Written by Khristoff Browning. Khristoff is a first year JD candidate at Osgoode Hall Law School. He is a contributing IPilogue editor and IP Innovation Clinic Fellow.

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In his statement, Fauci referred to the results of where Gilead Sciences’ antiviral drug, remdesivir, was administered to 1,000 patients from several sites around the world. that “the data shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery."

Despite the promising results, the effectiveness of remdesivir in blocking the replication of SARS-CoV-2 (the virus responsible for COVID-19) has received some skepticism. Remdesivir, which was originally developed to was administered in a controlled clinical trial in China where no drop in the viral load was observed. Therefore, the results of this study which was published in the imply that if remdesivir is effective in reducing the duration of illness, those positive effects are not due to its antiviral properties.

Gilead is also facing competition from other big players in the biotech industry. Regeneron has announced that they are ramping up clinical trials for their antibody cocktail and may be able to make it to develop antibody therapeutics to treat and prevent COVID-19.

Despite the skepticism and competition that Gilead is facing for its antiviral drug, further clinical trials continue to be conducted and the California-based company is looking to expand the reach of its treatment.

Gilead Signs Licensing Deals with Firms in Developing Countries

Subsequent to , the pharma company went on to sign licensing deals for the production of generic version of their antiviral drug with firms . Most of the deals were signed with developing countries that face major challenges in accessing affordable health care. These licences are going to stay royalty-free until a more effective treatment is developed or until the World Health Organization declares that COVID-19 is no longer a worldwide emergency.

This is not the first time that Gilead has made deals with generic drug companies for its patented pharmaceuticals. The company has previously worked with firms in lower-income countries to enable development and sales of cheaper alternatives to its and treatments.

Access to healthcare has never been so important than in face of a rapidly-spreading infectious disease that has affected . Existing under the World Trade Organization’s Agreement on allow ) to forgo the consent of a patent holder to copy a patented drug for wide-spread use within the country. However, compulsory licencing of patented medications continues to be a controversial issue for pharmaceutical companies as well as middle-income and poor countries that are not covered by provisions that protect LDCs from intellectual property infringement lawsuits. In fact, a that was brought in 2016 against the government of Colombia by Norvartis, the manufacturer of the cancer drug Gleevec, perfectly captures this ongoing battle between pharma companies and the governments of developing countries. The suit was brought after Health Minister Alejandro Gaviria�� following the issuing of ‘Declaration of Public Interest’ in order to make the leukemia medication more accessible for citizens of Colombia. that Gaviria’s declaration was “issued improperly and creates an unwarranted and damaging precedent that could apply to any patent-covered innovations, not just pharmaceuticals.”

Gilead’s decision to avoid similar legal battles by signing voluntary licensing deals with generic companies and allowing lower-income countries to access cheaper versions of remdesivir has not diminished its potential to make huge profits from its antiviral drug. In fact, experts are now that the sales of remdesivir could reach $7.7 billion USD in 2022.

Gilead’s Stock Market Performance- Gains and Losses

In response to the announcement made by Dr. Fauci regarding the positive effects of remdesivir on COVID-19 patients, in late April. Despite the initial hike in value, Gilead’s stocks took a hit after the results of of its clinical trials were published. Those results were not as impressive as investors had previously hoped, even though they revealed that patients who had received the antiviral drug in addition to standard of care did better than the control group in a five-day treatment course. Following this reporting, Gilead’s share value dropped USD in the span of two trading sessions. Although Gilead’s stocks, some of the long-term demand for remdesivir.

The Bottom Line

The results of conducted to date on patients of COVID-19 show that the effects of the antiviral treatment are moderate and that Gilead’s drug is not a ‘silver bullet’ by any means. There is still little published about the long-term effects of the antiviral drug on patients of COVID-19. Experts are currently looking into in order to optimize the positive effects of the antiviral treatment. It is plausible that similar to the combination therapy that was developed for infection, Gilead’s remdesivir would have to be administered alongside other antiviral agents in order to have significant impact on the virus. Of course, an effective vaccine for COVID-19 could completely change the game for Gilead and its competitors.

Written by Bonnie Hassanzadeh, IPilogue editor and Clinic Fellow at Osgoode Innovation Clinic.

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The Medicines Patent Pool

The (MPP) is a United Nations-backed organization that aims to improve access to HIV medicines for people living in LDCs. In 2014 they launched the (PHTI) to focus on a pressing concern in the African continent: overcoming barriers to develop paediatric formulations of HIV medications. In , they obtained a licence from Merck to develop paediatric formulations of raltegravir, adding this key drug to their pool that already includes lopinavir and ritonavir with AbbVie Inc.

In the , generic manufacturers in the specified LDCs are allowed to research and develop alternate or improved formulations of raltegravir for children. Considering those living in LDCs cannot afford these medications, Merck will not be cannibalizing its own sales. This agreement is significant because Merck retains the right of first refusal of licensure or purchase if the manufacturer develops an improved formulation and intends to market the product outside of the specified countries they serve.

A Unique Opportunity

Improved or altered formulations are methods for drug manufacturers to retain a portion of market share when the patent of the original drug expires (see for example����and��). By expanding the range of licensing agreements beyond HIV medications, drug manufacturers can outsource R&D of new formulations of their patented drugs at no upfront cost, while improving access to life-saving medicines in LDCs. Empowering LDCs to develop its own drug manufacturing industries has many advantages over��the traditional method of directly donating medications.

Win-Win?

In the years to come the effects of the patent cliff will continue to eliminate important sources of revenue for Big Pharma. These companies also face the need to increase R&D budgets to avoid grinding drug development to a halt. Undoubtedly, cost-effective ways to extract value from current patents will be crucial. Thus, Big Pharma should pursue an expansion of licensing opportunities with organizations such as MPP with great interest since it serves the dual purpose of improving drug access in developing nations while potentially extending the life cycle of their patented drugs.

Jason Ho is an IPilogue Editor and a JD Candidate at Osgoode Hall Law School.

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To read the report’s section on Canada, click .

Results of the Report: A Commendation with Qualification

In the report, the USTR commends Canada for its recent legislative reform. The two initiatives cited in the report were Canada’s passage of the in June 2012 - legislation that represents Canada’s implementation of the WIPO Internet Treaties - and the introduction of the in March 2013 - which attempts to target commercial-scale trafficking of counterfeit products. Both of these initiatives were endorsed by the USTR, ��who went on to suggest in the report a further expansion of this type of legislation in order to give more power to border officials to seize goods in-transit.

The report was not universally complimentary, however, with the USTR expressing serious concerns regarding Canada’s pharmaceutical industry. One concern that was mentioned was the absence of a right of appeal in the administrative process of Canadian regulatory pharmaceutical approval. In addition, the USTR expressed apprehension regarding the impact of the heightened utility requirements for Canadian pharmaceutical patents. This statement likely refers to the that has taken place over the last decade regarding what constitutes the “utility” required for pharmaceutical patents in Canada; originating from the landmark SCC case .

Reaction to the Report

The movement of Canada from the “Priority Watch List’” to the ‘”Watch List” has been met with some criticism; with some American entities publicly voicing their displeasure with Canada’s new position. The most scathing reaction to the report comes from the Pharmaceutical Research and Manufacturers of America (PhRMA), who stating that they were very “disappointed” with Canada’s changing designation. In the report, PhRMA claims that “Canadian policies and judicial opinions continue to harm international innovators to the benefit of domestic industries” and that the “heightened standard for patentable utility for pharmaceutical patents is inconsistent with Canada’s trade treaty obligations.” The PhRMA statement also contains a critique of India’s pharmaceutical IPR regime - a country that is notorious for their pharmaceutical IP protection. Including these statements side-by-side might reflect the view that the American biopharmaceutical industry has of Canada's pharmaceutical intellectual property laws and policy.

A Precarious Political Climate

Although there have been concerns raised about the legitimacy of the USTR “Special 301 Report” from both and , an evaluation of Canada’s IP regime by its is undoubtedly an important diplomatic and economic concern. Indeed, Canada’s actions over the last few years seem to indicate their intention to conform to the wishes of their American counterparts, with the recent legislative reform that is responsible for Canada’s improvement on the watch list seemingly being a direct response to .

What makes the most recent report particularly interesting is the fact that it has been released at a complex political time period for Canada. The pharmaceutical company Eli Lilly recently launched a , and the (CETA), a free trade agreement between the Canada and the European Union (EU), is bound to be completed in the next few months. The recent legislative changes made by Canada could be viewed as political posturing for the impending CETA, which purportedly has the EU calling for increased . This agreement also allegedly includes an increase in patent protection for innovative pharmaceuticals in Canada at the request of the EU, which for its potential to greatly increase drug costs. However, with drug and health care costs being a sensitive political topic and being significantly in Canada over the next few decades, that the strengthening of IP pharmaceutical protection may not ultimately make it into the final draft of the CETA despite the EU's wishes.

It could be the case that the recent Canadian legislative reform is an effort by Canada to please its biggest trading partners without making drastic changes to its domestic pharmaceutical industry. The issue of rising health care costs is undoubtedly an important domestic political issue, and perhaps the seemingly “Jekyll and Hyde” approach to pharmaceutical and non-pharmaceutical IPR�� is a necessary compromise that Canada has to make in order to function diplomatically with its trading partners while maintaining what it views as a healthy domestic state. It would be hard to name many things that are more complex than trying to adequately fit domestic IP policies within international free trade agreements, but Canada must continue to strive to achieve that seemingly impossible balance. At the end of the day, like in most matters in life (and politics), you certainly can’t please everyone.

Adam Falconi is an IPilogue Editor and a JD Candidate at Osgoode Hall Law School.

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The Canada Gazette published to the Patented Medicines (Notice of Compliance) Regulations, which include much-anticipated provisions for Extraordinary Use New Drugs (EUNDS). This addition is aimed at empowering Canada to prevent and respond to the threat of disease outbreaks and align its approach with that of international equivalents.

Health Canada EUNDS as drugs “that would be used to treat, mitigate or prevent a life threatening or serious health condition in humans which result from exposure to a chemical, biological, radiological or nuclear substance in an emergency situation.” Such contemplated situations include an outbreak of pandemic influenza, an attack with chemical or biological weapons, a chemical spill or a natural disaster. “An EUND... is intended to treat a condition that does not lend itself, ethically or logistically, to study through a traditional clinical trial in humans prior to approval,” wrote Associate Director, Elwyn Griffiths, in 2007. Accordingly, such drugs may be classified as an EUND and thereby become exempt from the usual drug approval channels.

Traditionally, these drugs have been approved through Canada’s . However, in a 2005 , the Office of the Auditor General declared that the SAP was an inappropriate means of authorizing the sale of EUNDS because it was increasingly being employed as a way of obtaining broad access to drugs that were merely in the later phases of clinical trials or in the new drug submission process. As a result, the SAP permitted the sale of drugs without comprehensive pre- or post-market monitoring. Such a consequence defeated the programme’s original purpose of providing access to unauthorized drugs for medical emergencies on a case-by-case basis.

In an effort to put right the shortcomings of the SAP, a new category of drug submission for EUNDS was created by amendment to Canada’s Food and Drugs Regulations. Under this framework, drug manufacturers must still provide efficacy and safety data to qualify for initial market authorization, but such pre-market information is limited to in vitro and animal studies supportive of use in humans. Manufacturers must additionally commit to post-market surveillance and data acquisition and annual reporting, none of which was required under the SAP. There are also new regulatory safeguards, such as limiting the sale of EUNDS to the different levels of Canadian governments for distribution rather than direct sale to consumers.

As the Regulatory Impact Analysis Statement indicates, the cost to industry stakeholders under the new regulations will not be significant considering their current responsibilities under the existing drug development and authorization regime. However, the difference to Canadian patients requiring EUNDS will be significant because of the added protections regarding these drugs and government’s facilitated access to them.

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Among the that died with the end of the 40th Canadian Parliament last Friday was Bill C-393, Canada’s Act to amend the Patent Act. The bill proposes to modify , itself an amendment to the Patent Act passed in 2004.

CAMR’s aim has been to facilitate the process for Canadian companies to produce and market generic versions of medications used to treat HIV/AIDS, malaria, and other diseases. Medicines for these ailments remain prohibitive expensive in developing countries and, despite CAMR’s good intentions, remain largely unavailable even still.

CAMR has been fraught with criticism since its enactment. regularly argue that it is wrapped in red tape; its unnecessarily complex procedures and restrictions make it nearly impossible for companies to do what the system purportedly assists them to do. Indeed, only one order of medicine from one company to a single country has ever been filled under CAMR – and even that company has said that it will not attempt to do so again. These sentiments have been echoed by Médecins Sans Frontières and the very developing countries it aims to serve.

Bill C-393 aimed to rectify these shortcomings, chiefly by way of a single-licence solution. Under such a system, generic manufacturers would require only a single licence to export a drug to a country in need and to continue that supply as needs evolve, necessitating only one pass through the licensing process. This bold amendment to CAMR grants the wish of many, including Richard Elliott, executive director of the Canadian HIV/AIDS Legal Network, discussed in an .

Passed in the House of Commons by a vote of 172 to 111, with support from MPs of each federal party, Bill C-393 stalled in the Senate. This delay has attracted , even from some Senators.��One called it “an abuse of Parliament” and another said there was simply no procedural grounds for it. Surely the initiative will be brought up again when Parliament reconvenes but, until then, months will pass – and with them, lives.

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The New 91��ɫ Times that many of the major players in the global pharmaceutical industry are set to lose exclusive rights to 10 blockbuster drugs of combined annual sales close to US$50 billion. No mere fluke, this news marks the beginning of an industry-wide downward spiral of patent expirations. As case in point: of the 14 drugs Pfizer considers “,” the U.S. patents of eight are set to expire within the next two years, including the famous Lipitor and Viagra.

Although the coincidence of these expirations is startling, of greater concern is the realization that these companies’ product pipelines have mostly run dry. It isn’t for lack of trying; as the Times observed, industry-wide research and development spending has nearly doubled since 2000, yet the U.S. Food and Drug Administration has been approving fewer and fewer new drugs. The primary culprit of this trend is that many of the large multinational companies have endured significant failures in their clinical research. More specifically, many companies have been narrowly focused on the same therapeutic targets, which have panned out for no one. For instance, industry giants Pfizer, Johnson & Johnson, and Eli Lilly have all been their significant investments in developing an Alzheimer’s disease treatment after years of clinical failures.

This tale of reversing fortunes offers insight into how pharmaceutical companies have adapted their business models (or not) to a system whereby exclusive product ownership rights expire after a set period of time. As mentioned, the classic solutions of simply developing new products or patenting biosimilars of existing brands have proven to be not so simple at all.

In a more recent trend, many of the larger drug companies have sought to buy themselves out of their predicament by acquiring competitors with newer products. As the Times reported, companies Pfizer, Merck, Roche, and Sanofi-Aventis have each paid tens of billions of dollars in acquisitions since 2009. Initially, this strategy works to offset other revenue losses; for example, Pfizer a 3% drop in annual biopharmaceutical revenues of legacy products in 2010, which was compensated for by added revenues from its recently acquired Wyeth products.

However, such acquisitions should perhaps be viewed as only short-term gains. As Gary Pisano of Harvard Business School noted, “.” In a business model that leans so heavily on the patent system, it seems, the only true way to maintain competitive advantage is ongoing and unrelenting innovation.

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WTO members on 2 March 2010, debated the question of whether a 2003 decision designed to improve access to medicines is working. Although opinions expressed in the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Council varied, members agreed that they should look at real-life experiences in order to assess the system.

that at an earlier 12th February informal meeting, several members - including Brazil, China, Cuba, Ecuador, Egypt, India, Indonesia and Venezuela -��said that the so-called “paragraph 6” amendment is not working effectively. Paragraph 6 refers to the 2001 WTO Doha Declaration on TRIPS and Public Health, which mandated that WTO members solve the problem of medicines access for countries lacking domestic drug production capabilities. Therefore to address the problems faced by countries with insufficient or no manufacturing capacity in the pharmaceutical sector - the 30 August 2003 decision of the general council was adopted which later converted into an amendment of the TRIPS agreement on 6 December 2005.

This amendment has been used only one time, when Canadian drug firm Apotex sent two shipments of AIDS medicines to Rwanda under Canada’s Access to Medicines Regime (CAMR). The effort was led by the Canadian company, which has said it does not plan to repeat the complicated process. Key dates given by Canada, as��reported by��IP watch, included: May 2005, when domestic regulation to allow for export-oriented compulsory licences (passed by the Canadian Parliament a year before) went into effect; December 2005, when Apotex applied to use the system; June 2006 when Apotex's application��was approved; and July 2007 when Rwanda was identified as Apotex’s customer.�� There is a procedural step required by TRIPS in which the patent holders must be contacted to see if they will provide a voluntary licence. After this failed to produce a licence, Apotex applied for a compulsory licence in September 2007, which was then granted in October 2007. The company then had to undergo a review from Rwanda to obtain public tender. After this was granted in May 2008, the drugs were manufactured for a first delivery date in September 2008, nearly 3 years after Apotex applied to use system.

However, compulsory licensing as a policy mechanism can be used to address a number of situations in the context of public health including high prices of medicines, anti competitive practices by pharmaceutical companies, failure by pharmaceutical patent holders to sufficiently supply the market with needed medicines, emergency health situations and the needs for establishing a pharmaceutical base. Compulsory licensing is important for improving access to essential medicines as well as facilitating the development of innovative capacities and Research and Development especially in developing countries. For example, a local working requirement, which is a ground for the issue of such licences, can be important both for improving access to essential medicines as well as facilitating the��technology transfer obligations envisioned in Article 66 of the TRIPS agreement. Further, the countries in need of cheaper versions of patented pharmaceuticals may increasingly face a situation in which they lack the industrial capacity to produce them, while the foreign supplies are unavailable. Due to lack of technical capacity, adequate equipment, human resources, high costs of production, or other obstacles, many developing countries and the LDCs cannot produce the active ingredients needed to manufacture pharmaceutical products. In these circumstances, compulsory licensing is an alternate solution.

The costly prices of medicines should not curtail every human being’s right to good health and for this reason this right is recognized in certain forms as a fundamental right, both under public international law and the domestic law of many civilized nations.�� It is critical that developed countries realize this and therefore create further room for broader interpretation of compulsory licensing. When considering the question of enabling countries lacking manufacturing capacity in pharmaceuticals to make effective use of compulsory licensing, one consideration is enabling the production of generic medicines on larger scale in a simpler fashion.

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According to a AIDS, which is caused due to Human immunodeficiency virus (HIV) killed more than 25 million people worldwide from 1981 to 2006. Already, over six million people with HIV/AIDS are dying because they have no access to lifesaving medicines.�� The current HIV drugs which are in market are available at��prices��that��members of the developing countries can not afford. Therefore on one hand we have the Antiretroviral treatment which reduces both the mortality and the morbidity of HIV infection, but on the other hand, the routine access to antiretroviral medication is not available in some countries at lower costs. A possible��answer to this problem is��a It is a to answer the needs for HIV drugs at lower costs.

A patent pool is a consortium of at least two companies agreeing to cross-licence patents relating to a particular technology.�� The creation of a patent pool can save patentees and licensees, both time and money. To address the issues of pooling HIV drug��patents, ��is promoting patent pools as a strong humanitarian case.

According to SciDev.Net – the Science and Development Network, UNITAID's proposed patent pool would work by collecting patents held by the pharmaceutical companies and making them available to the developing world for drug production or research at the cost of an affordable licence fee or royalty. When a company creates a new drug, the patent protection prohibits other companies from producing and selling the drug or using it for research. Occasionally, the patent-holder may give other organizations access to its protected knowledge, but usually only in an extremely restricted capacity and at high cost — which puts low and middle income countries out of the running.�� The UNITAID HIV patent pool would mean generics could be made immediately, and research could begin into new drug combinations and child-friendly formulations. Some pharmaceutical companies who are considering idea are Johnson and Johnson, Gilead, and Cipla who have been openly supportive, and Novartis and Merck are reportedly in talks with UNITAID. GlaxoSmithKline too haven't ruled out joining the patent pool.

According toan international peer reviewed medical journal, the international medical aid organization Médecins Sans Frontières (MSF) is too calling on nine of the world’s largest drug companies to pool their patents on newer HIV drugs and to make them available in developing countries. The campaign is inviting the companies, which include Abbott Laboratories, GlaxoSmithKline, and Pfizer, to place the patents for a list of HIV drugs into a patent pool set up by UNITAID, that partners with organizations including the World Health Organization and UNAIDS to purchase drugs for developing countries.

However, it is to be seen if this is the appropriate solution; as few countries have issued compulsory licences to allow manufacturers to produce generic versions of patented drugs. This is in compliance with the of the WTO which imposes obligations on member countries with regards to grounds for granting��and importing under as well as compliant with the . WTO members on 6 December, 2005 approved changes in TRIPS agreement, making a permanent decision on patents and public health originally adopted in 2003. This will now formally be built into the TRIPS Agreement when two thirds of the WTO’s members have accepted the change. Once two thirds formally accept it, the amendment will take effect in those members and will replace the 2003 waiver for them. While initially Canada, India, Norway and the EU had changed their laws and regulations in order to implement the waivers and to allow production exclusively for export under compulsory licence, Canada accepted the

But if it comes to financial incentives, UNITAID still needs to come up with a solution for the companies to join as they are unlikely to do so from corporate goodwill alone. Due to the enormous profits that HIV drugs can bring, companies are unlikely to settle for less. In these circumstances, Article 31(f) of TRIPS requires that compulsory licenses be used "predominantly" for local markets. The royalties the patent holder receives by way of compulsory licensing are sufficient enough as they are either set by law or determined through some form of arbitration.

To conclude, the Doha declaration recognizes that there are flexibilities within the TRIPS agreement which can be used for public health purposes and particularly for purposes of taking measures to ensure access to medicines��for all. Therefore it is to be seen how effectively it applies to ensuring access to HIV drugs. On the flip side, UNITAID's proposal for a patent pool comes as the World Intellectual Property Organization (WIPO) is revitalized under new leadership. The new head, Francis Gurry, is trying to revive the organization’s development agenda. Therefore, UNITAID now need to make sure they successfully broker what could be a hugely important deal for the developing world.

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In a recent , Justice Leonard Mandamin upheld federal regulations (created under��Canada's Food and Drug Act), which provides��data protection��for a period of up to��8.5 years. Research-based, innovative drug companies (represented in this litigation by Canada's Research-based Pharmaceutical Companies (CRPA) and Eli Lilly Canada Inc.), consider this ruling a major victory in that it will help to promote the creation, production and distribution of new and innovative drugs in Canada. They claim that the positive effects generated by this ruling will ultimately have the greatest impact on Canadian patients, who will apparently have greater access to a wider variety of innovative medications and vaccines. These companies also stress that a rigorous data protection regime in Canada is necessary to secure sufficient and lasting investment in R&D. It is entirely understandable that potential investors would be hesitant to get involved in a project where data protection is weak.

Conversely, the generic drug companies (represented in this litigation by the Canadian Generic Pharmaceutical Association (CGPA) and Apotex Inc.), argue that this ruling is an unfair one, the negative effects of which, will be felt most markedly by Canadian patients/consumers. , president of the CGPA claims that as a result of this ruling, "brand drug companies will continue to have monopoly rules that go beyond Canada's international trade obligations and beyond similar provisions in the United States." However, according to a recent , it seems highly probable that the United States will be extending the period of data protection in the near future. In a 16-7 vote, the US Senate health committee cast their ballots in favour of a 12 year data protection period.

In my opinion, the most important thing to consider in this debate between research-based, innovative drug companies and their generic counterparts is the interest/well-being of patients/consumers of these drugs. On the one hand, it is important to maintain a financial incentive for brand-name drug companies to continue to research and innovate to ensure that patients are receiving the most highly developed, quality products as possible. On the other hand, if generic drug companies are removed from the equation, it will become progressively easier for brand-name pharmaceutical companies to monopolize their respective markets, eventually causing undue hardship on the consumers who depend on these drugs.

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