Nancy Chen is an IPilogue Writer and a second-year JD/MBA Candidate at the University of Toronto.

In 2020, COVID-19’s emergence prompted scientists across the world to race against time to develop a vaccine, with the pharmaceutical giants Moderna, Pfizer and BioNTech (“Pfizer/BioNTech”) leading the way. Two years later, as the world adapts to the new normal and vaccine supply is no longer a preeminent issue, against Pfizer/BioNTech for unlawfully infringing upon Moderna’s patented mRNA technology in the making of their COVID vaccine. The was filed on August 26, 2022 in the United States District Court for the District of Massachusetts as well as the Regional Court of Düsseldorf in Germany.

Moderna’s position

According to before the District of Massachusetts, Moderna was founded in 2010 “on the promise of developing mRNA technology to create a new generation of transformative medicines.” The company has since been singularly focused on developing all aspects of mRNA medicine, cumulating in the process.

because of their extensive experience researching mRNA technology and using their patented mRNA platform, they were “uniquely positioned” to respond to the COVID-19 pandemic. As a result, Moderna’s mRNA vaccine, Spikevax, successfully reached clinical trials within just two months after the publication of the genetic sequence of the virus. Other were predicting that vaccine development could take years.

Infringement Allegation

In a , Moderna stated that they believed Pfizer/BioNTech unlawfully copied two key features of Moderna’s patented technologies in the development of their mRNA vaccine, Comirnaty. Specifically, Comirnaty contains the exact same chemical modification as Spikevax and it was developed using Moderna’s patented approach “to encode for the full-length spike protein in a lipid nanoparticle formulation for a coronavirus.”

Moderna also that Pfizer/BioNTech did not have the same level of experience as Moderna in developing mRNA vaccines, and despite testing four different vaccine candidates that did not use Moderna’s patented technology, they ultimately knowingly copied Moderna’s platform.

Pfizer/BioNTech addressed the allegations in a , stating that these lawsuits were unexpected given that Comirnaty was based on BioNTech’s own proprietary mRNA technology. They intended to “vigorously defend against all allegations of patent infringement.”

In recognition of the need for ensuring vaccine access, that it will not seek to remove Comirnaty from the market or prevent future sales of this vaccine. The company will also not seek compensatory damages from sales occurring before March 8, 2022, the date the company considers to be the end of the pandemic. Sales to the U.S. government or to a list of 92 low and middle-income countries in the Gavi COVAX Advance Market Commitment will also be excluded from damages.

It is, however, seeking monetary of up to three times the amount of compensatory damages found in relation to all other instances of infringement including reasonable royalties and/or lost profits, together with interest, costs, expenses, disbursements.

Looking forward

Patent lawsuits typically take years to resolve and this particular action is further complicated by . Pfizer/BioNTech has a solid defense by arguing reasonable reliance on Moderna’s to not enforce patents while the pandemic continues. Although Moderna perhaps made this promise in the hopes of an end date to the pandemic, this date will likely be contested given the ongoing nature of COVID-19.

The outcome of this legal dispute will have implications for the future uses of mRNA technology, which boasts the potential for future vaccines against a myriad of diseases such as influenza and HIV. If Moderna succeeds, there may be a chilling effect in biotech development which may be detrimental in the event of another pandemic. It would be interesting to see how courts construe public promises and their validity against patent rights, or if broken promises may affect a company’s goodwill in the eyes of the public.

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Pankhuri Malik is an IPilogue Writer, IP Innovation Clinic Fellow, and an LLM Candidate at Osgoode Hall Law School.

On , the Federal Court of Appeal (“FCA”) the Federal Court’s decision, upholding the validity of two of Bristol-Myers Squibb (“BMS”) and Pfizer’s patents. The relevant patents concerned the active pharmaceutical ingredient Apixaban, used in thrombosis treatment. Apixaban is a selective inhibitor of the enzyme Factor Xa (“FXa”) which works by blocking certain blood-clotting proteins.

Through its lawsuit, and subsequent appeal, Pharmascience Inc. (“PMS”) challenged the validity of two of BMS’s patents, Canadian Patent Nos. 2,461,202 (“202”) and 2,791,171 (“171”) on different grounds.

The 202 patent describes the action of many FXa inhibitors, including Apixaban, in thrombosis treatment. This patent was challenged by citing BMS’s expired patent, Canadian Patent Number 2,349,330 (“330”) on the following grounds:

1. Lack of Status as a Selection Patent: Essentially, PMS alleged that the Federal Court did not identify the 202 patent as a selection patent and failed to appreciate that it does not disclose a special advantage over the 330 patent, which is essential for it to be recognized as a selection patent. The FCA, however, reaffirmed the lower court’s finding that a special advantage was disclosed by inference. FCA confirmed that Apixaban, under the 202 patent, was identified from the genus of compounds protected by the 330 patent because it was useful.
2. Anticipation and obviousness, falling within the broad ambit of double patenting: PMS also claimed that the 202 patent did not identify the inventive concept of the claims in issue. PMS claimed that since 202 does not disclose a special advantage, the patent is fatally flawed due to anticipation and obviousness. The FCA disagreed and reaffirmed Federal Court’s finding that apixaban’s inventive concept is that it is an effective FXa inhibitor useful in treatment of Thromboembolic disorders, as opposed to the 303 patent which only had the potential to be useful.
3. Insufficiency: Lastly, PMS challenged the 202 patent as Apixaban was not identified by the patentee at the date of publication of patent; PMS argued that this error constitutes insufficient of identification of the invention. The Court, however, disagreed PMS and held that the relevant specification for determination of sufficiency is the issued patent, and not the publicized patent.

The 171 patent relates directly Apixaban tablets’ formulation, particularly the particle size and dissolution rate of the medicine. The 171 patent describes the method of formulation such that it displays solution-like properties in the body, which optimize absorption.

The primary challenge was obviousness (as discussed ). The contention in this case pertained to a fifth additional component of the test, the “obvious to try” test. This component questions the validity of a patent on grounds that some inventions might be obvious to try due to their chemical structural similarity. PMS claimed that the Federal Court should have concluded that the claims in 171 are invalid because the invention was obvious to try.

However, FCA disagreed. The Court agreed with the lower court in that the formulations of the 171 patent are indeed inventive because a skilled person in the art would not have thought to reduce the particle size to improve absorption, or to target a lower dissolution rate. The FCA held that the lower court considered the correct and relevant factors in determining what would have been obvious to try to a person skilled in the art. The FCA confirmed that the lower court correctly held the patent valid.

Other jurisdictions

It is noteworthy that BMS and Pfizer’s patents for Apixaban have faced similar challenges outside of Canada as well. The companies have, so far, successfully enforced their patents in the . This Canadian decision adds another point to the companies’ win column.

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Brandon Pierre is an IPilogue Writer and a 1L JD Candidate at Osgoode Hall Law School.

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In a dizzying exception to an exception of a rule, the case of ’s HIV drug bictegravir underscores the value of a well-planned legal strategy.

(“ViiV”), majority-owned by (“GSK"), claims that Gilead’s (sold under the brand name “Biktarvy”) directly copied its dolutegravir's formulation under (“patent 385”). The with Gilead paying $1.25 billion USD upfront to GSK in early 2022, followed by paying three percent royalties on all future U.S. sales of Biktarvy.

This article delves into the legal doctrines that support the parties’ claims and the overarching strategy to their settlement. The comments pertain specifically to ViiV Healthcare Company v Gilead (case 18-224) in the U.S. District Court for the District of Delaware.

Note that the doctrine of equivalents, dedication-disclosure, and specific exclusion only apply in the United States. Canada uses a purposive approach (see ).

Doctrine of Equivalents

under the doctrine of equivalents, which has two exclusions: dedication-disclosure and specific exclusion.

The prevents parties from circumventing literal infringement by making minor variations to a patented invention. Under the doctrine of equivalents, a patent can be infringed upon if these variations are immaterial. For example, whether a bike has 32 spokes or 36 spokes, it is still a bike.

, Gilead argued that ViiV could not rely on the doctrine of equivalents due to the dedication-disclosure rule and the doctrine of specific exclusion (see page 2).

Dedication-Disclosure Rule

In the U.S., the dedication-disclosure rule states that if a patent discloses or describes a novel feature, but that feature isn’t listed in the patent’s claims, then the feature is dedicated to the public and is not patent-protected (). For example, a patent could describe a bike with two wheels (bicycle), three wheels (tricycle), or four wheels (quadracycle) and then only claim the two-wheeled design. Under this doctrine, the inventor could not then sue another for using the three-wheeled or four-wheeled design.

Gilead posited that since patent 385 described, but did not claim, the formulation used in Biktarvy, it is available to the public and cannot be recaptured through the doctrine of equivalents (). In Canada, and dismissed ViiV’s claims on a similar basis.

Doctrine of Specific Exclusion

The doctrine of specific exclusion states that a product cannot be deemed equivalent to a patented invention if it is literally the opposite of the patented invention. A product can be deemed “outside the reach of the doctrine of equivalents because that [product] is clearly excluded from the [patent’s] claims whether the exclusion is express or implied” (). For example, a patent for an “electric” bike cannot be equivalent to a “non-electric” bike.

Issues regarding expert testimony, construction of legal claims, and legal precedent .

Concluding Remarks

In the end, settlement was in the best interests of both parties. Pursuing protracted lawsuits in , and elsewhere could exponentially increase litigation costs if the matter were left to courts. There are also significant profits at stake. Sales forecasts for the drug were $1B USD in 2018 and rising to $5B USD annually by 2024 (see ). These targets were far surpassed in 2019 when the drug delivered .

The includes a worldwide patent license to certain ViiV patents related to dolutegravir. ViiV also agreed not to enforce their patents against Gilead for any future product containing bictegravir in exchange for royalties. Since the science implies that both bictegravir and dolutegravir have , the agreements suggest both pharmaceutical companies can move forward profitably.

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Andrew Masson is an IPilogue Writer and 1L at Osgoode Hall Law School.

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Two major pieces of patent protection news with global long-lasting significance dropped in early March for drastically different reasons. First, Moderna, a producer of COVID-19 vaccines, that it will never enforce its COVID-19-related patents against 92 low- and middle-income countries. Second, Russia threatened to stop enforcing patent protections for companies based in countries it deems . Although both cases limit patent protection, Moderna’s actions originate from the company whereas the action in Russia is a state removing a foreign company’s protections. ��

Moderna

There are large potential profits but also considerable public health concerns for companies tackling a globally impactful disease like COVID-19. When statistics show that only as of February 2022, people understandably believe companies such as Moderna should prioritize public health over profits and, by association, IP protection. However, it is important to recognize that vaccine research and manufacturing are not free. It has been estimated that starting from scratch could . Thus, there is a large incentive for companies to protect that investment.

To try and combat the issues with vaccinating people in poorer countries, the was created. This program aims to increase vaccination rates in poorer countries and develop vaccine manufacturing pipelines in those areas. I think Moderna signing on with and opting not to enforce their patents in the 92 associated countries is a sacrifice on profits which addresses some larger global health concerns.

Russia

From a different direction, Russia as a state entity has threatened to stop enforcing IP rights for certain companies. Russia is facing extreme backlash from corporations regarding their actions in Ukraine and many companies are . In response, Russia declared that they will be removing the (also see this ). As this is a recent story, it is unclear how this will be done. The goal seems to be to allow places like McDonald’s to remain open and operate without the consent of the corporation and with the risks of patent infringement. As of now, it appears that Russia plans to . Russia is a party to the , an international treaty that includes the protection of intellectual property in each country. However, Russia appears to be abandoning this commitment for the sake of . ����

In the Future

Other than shaming the actions, I don’t feel like this is the place nor am I the person to talk about the societal and global impact the Russian invasion of Ukraine will have. However, I think practically speaking, the Russian state removing patent protection for certain companies will dramatically affect their future business relationships. As IP lawyer Josh Gerben put it, It is hard to imagine that many companies or other countries will want to pursue business in a country that may not protect their proprietary interests.

On the other hand, the actions of Moderna ought to increase the company’s public perception and practically help poorer nations. Moderna’s may prove to be a vital step in global health initiatives; not only will it help provide poorer countries with much-needed vaccines, but it will also increase the global vaccine supply. In the future, vaccine manufacturing should more rapidly meet demand, and so, hopefully, the delay that many of us Canadians felt in getting vaccinated doesn’t happen again. ��

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On January 10, 2022, the Canadian Competition Bureau (the Bureau) and Health Canada’s Health Products and Food Branch (the HPFB) issued a����to stakeholders on their continued collaboration to support Canadians’ access to safe, effective, and affordable pharmaceuticals and biologics.

Although the Bureau and HPFB are independent entities, they have complementary mandates in the pharmaceutical sector. The Bureau is responsible for administering and enforcing the��Competition Act, which includes addressing competition issues for the pharmaceutical industry. While the HPFB regulates, evaluates, and monitors therapeutic products available in Canada under the��Food and Drugs Act. This overlap has led to past collaboration on several issues, including mergers and acquisitions, deceptive and misleading claims, and claims of abuse of dominance.

As part of their goal for continued collaboration, both entities plan to maintain a channel of communication to ensure the mutual success of their policy objectives. This includes having the Bureau report to the HPFB on aspects of the pharmaceutical regulatory framework that may impact competition, and the HPFB providing feedback to the Bureau when competition-related issues may result in problems for access to medicines.

The Bureau and HPFB have also committed to working together on Bureau-led enforcement actions, such as when generic pharmaceutical companies report having difficulty obtaining reference samples from branded drug manufacturers. These samples are necessary for generic companies to perform testing for regulatory approval and any difficulties in obtaining samples would delay market launch, with corresponding impact on drug availability. Both the Bureau and HPFB have released guidance for providing access to reference samples and plan to continue working together to monitor and address issues in this area. Based on the extent of guidance documents made available from both entities, branded drug manufacturers are advised to anticipate that the Bureau will treat any explanation for delay in supplying reference products with a high degree of skepticism.

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I was largely oblivious to the processes of prescription and generic substitution before my internship at Teva Pharmaceuticals. Little did I know that pharmacists had the discretion of substituting generics for brand name medicines, unless the prescriber had indicated ‘no substitution’ on the prescription, which might occur if a patient had experienced an adverse reaction to an alternative brand. Little did I know that the price of patented medicines is capped on a case-by-case basis by the federal Patented Medicine Prices Review Board. And little did I know that every provincial/territorial jurisdiction in Canada is party to a Tiered Pricing Framework that also places ceilings on generic drug prices relative to the reference brand price. I was fortunate to have a patient and knowledgeable supervisor in Ben Gray with whom to discuss a number of patent issues involving litigation strategy, biologics, skinny labeling, and means by which pharmaceutical companies seek to extend their commercial monopolies.

My internship at Teva afforded me the opportunity to connect with members of the inhouse legal team, including counsel and a law clerk, as well as external counsel to gain a clearer picture of the division of labour on legal matters. In-house counsel oversaw matters on the macro level, sometimes handling matters independently, but also procuring and providing instruction to external counsel and allocating resources across files. External counsel were assigned to individual files, but in-house counsel kept abreast of developments through regular updates to their litigation reports, which provide an overview of ongoing litigation from claims to timelines. The management of intellectual property, having its own dedicated counsel and litigation report separate from all other legal matters, is unsurprisingly a priority for Teva.

While I did encounter a trademark issue pertaining to licensing the use of Teva’s brand materials, the IP matters I was exposed to mostly concerned patents. Though I have completed a handful of undergraduate courses in chemistry, that information has since laid dormant in my brain—so it was to my relief when Ben assured me that a PhD in chemistry is not a prerequisite to the in-house work that he does. I don’t know that the same can be said for the work of external counsel having now reviewed a couple lengthy Notices of Application pursuant to the PM(NOC) Regulations. Admittedly, I took numerous detours while reading to refresh my memory on the meaning of various terms describing chemical groups and molecular structure.

As Teva markets both brand name and generic products, it also both defends and challenges the validity of patents. I found it valuable to be placed with an entity whose interests lie on both sides of the social bargain in patent law. Updating litigation reports on intellectual property and non-intellectual property matters with law clerk Lynn Chacra allowed me to survey a range of legal issues that can arise for a pharmaceutical company. The matters I engaged with in more depth, though, were IP-related. In the
course of my work, I became more familiar with the Patent Act, the Patented Medicines (Notice of Compliance) Regulations, and the Rules of Civil Procedure. But my takeaways were not limited to hard skills.

Future dealings with most corporate adversaries, co-plaintiffs and co-defendants is to be expected in an oligopolistic industry like pharmaceuticals. As I allude to in the title of this blog—it’s a small world in big pharma. Aside from a firm grasp of the relevant substantive law and procedural frameworks, the importance of soft skills cannot be overstated in building respectful working relationships with adversaries and colleagues alike. For instance, favourable procedural arrangements and even settlements can sometimes be reached on consent of the parties. Co-plaintiffs or co-defendants may also pursue joint litigation to pool resources. It was my pleasure to be placed with an office that exemplifies professionalism from the technical to the relational. Owing to my positive experience with the Teva team, I have arranged to virtually observe an appeal hearing after the formal conclusion of my internship, so I can say with complete sincerity that I would choose this internship again.

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In Canada, methods of medical treatment are unpatentable subject matter. This prohibition originated from an old provision of the Patent Act (Section 41) interpreted by the Supreme Court of Canada in . The statutory provision has since been repealed but the subject matter prohibition survives as a common law doctrine. The justification for the prohibition is agreeable: fear of patent infringement should not deter medical practitioners from applying their exercise of skill and judgment (see ). However, the scope of the prohibition is less agreeable. To this day, the definition of a “method of medical treatment” remains unclear, especially in the context of pharmaceutical use patents. Phelan J. in admitted that the jurisprudence on this matter “is not entirely consistent” (also see Manson J’s comment at ).

For example, consider the following two types of claims:

• “the use of compound X to treat disease Y in a dosage range of A to B mg”
• “the use of compound X to treat disease Y, at a dosage of A mg”

The first claim is invalid because the dosage range encompasses a choice to be made by a medical practitioner prescribing compound X. The second claim specifies a fixed dosage rather than a range and is therefore patentable. The Federal Court made this distinction in . There are many problems with this rule. One problem is that this distinction does not serve the primary goal of unimpeded medical practice, even if a claim for a fixed dose can theoretically be infringed by a physician and therefore interfere with physicians’ exercise of skill and judgment. Furthermore, an interesting is that the distinction is purely formal, as a patentee could simply split a claim with a dosage range into multiple claims with fixed doses. While I agree that courts have fixated too much on form over substance, I am curious about whether a court would treat multiple claims with different doses the same as one claim with a dosage range. Another interesting is that invalidating a claim for encompassing a physician’s exercise of skill and judgment is difficult to reconcile with the Supreme Court’s decision in where a claim for the use of a compound at an “effective amount” was held patentable. Surely, a physician deciding an “effective amount” exercises the same (if not more) skill and judgment required to choose a dosage within a dosage range. ��

In a case from this year, , the common law doctrine became even more convoluted. The Federal Court held that a fixed dose claim, similar to the example above, was unpatentable because the specified dose was “not appropriate for all patients” (partly due to potential adverse effects) and a prescribing physician would need to exercise skill and judgment in deciding whether to prescribe at the claimed dose amount (Manson J at ). This illustrates another problem with the earlier distinction, that a claim with a fixed dose would still encompass a choice to be made by a medical practitioner – the choice to prescribe at the fixed dose or at a different one (or not at all).

So, what is the solution to this confused area of law? Could not courts create a common law defence for medical practitioners against patent infringement claims? Obviously, some caveats would be needed. One should be that courts must assess whether an infringement action could deter medical practitioners from their duty of care to patients. But a common law solution may be preferable to waiting indefinitely for legislative change. Currently, patents do not pose a serious threat to medical practice because medical practitioners are not targeted by pharmaceutical patentees which prefer going after the generic companies which directly compete with them.

Courts have already virtually created a common law defence, but a needlessly complex and roundabout one that depends on seemingly arbitrary claim-by-claim rulings on patentability. If the jurisprudence remains as it is or continues to develop along these lines, the public could be deprived of some valuable potentially life-saving inventions.

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Natalie Bravo is an IPilogue Writer and a 2L JD Candidate at Osgoode Hall Law School.

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Brief History of Insulin

In 1921, Dr. Frederick Banting, Charles Best, and James Collip successfully isolated the hormone , discovering a new life-saving treatment for managing diabetes in humans. By 1923, insulin was widely-produced and available to the general public.

Dr. Banting and research facilitator Dr. Macleod, refused to put their names on the patent for the drug, with Banting stating Thus, the first patent application for an insulin patent was filed under Best and Collip’s names. However, as all the co-inventors believed that the medicine should be widely available and not restricted by costs, they sold their intellectual property rights to the University of Toronto for Today, contrary to the co-inventors’ intentions, insulin is highly unaffordable for individuals around the world who rely on the lifesaving treatment, including in the United States.

Insulin Price Rise

Over 30 million people in the U.S. live with diabetes and around a third of them require insulin to survive. From 1960 – 2019, the price of a vial increased from , over forty times the rate of U.S. inflation. Soaring prices have left many with few options besides rationing or skipping doses altogether, a practice that has harmful and To put it in perspective, a carton of insulin costs . Many researchers and doctors attribute these price hikes to lax regulatory measures on drug-pricing in the U.S. How do patents play into this? Only a handful of companies control the market and those companies are increasingly modifying their insulin products, improving them, and typically protecting them with additional patents. It’s a practice that some call the “cost of innovation”. However s for the consumer. Most patients are prescribed the newer, modified formulations, instead of the older ones. Unfortunately, no true affordable generic is currently available. Enter : a group of individuals who hope to make insulin more accessible for everyone. ��

Insulin Bio-hackers

is essentially a do-it-yourself (DIY) approach to biology. works to create insulin that is , easily replicable, and most importantly, affordable. The group is comprised of volunteer scientists and community advocates. The . Di Franco himself lives with Type-1 diabetes and was motivated to create the project after witnessing the rising prices of insulin in the U.S.

The project is not limited to the U.S. and, if successful, seeks to provide insulin to other parts of the world where patients similarly struggle to access insulin. To date, the project has made some strides in their discoveries. They announced their first major milestone at the end of 2018, . Open Insulin estimates that they may be able to develop a version of insulin that - a stark difference in price from what is currently available. While optimistic, the project faces various regulatory obstacles. The group will not be able to produce market insulin without the approval. They may, however, publish their findings to help support other biohackers around the globe.

Even if they are unable to release generic insulin to market, their innovative research and goals are making waves, increasing awareness, and inspiring others to push for solutions to the insulin cost problem. Check them out at !

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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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