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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Biologics play an important role in the Canadian health care system through their use in treating numerous diseases and medical conditions. of biologic drugs include antibodies and growth factors.

Patents and data protection covering biologic drugs in Canada are beginning to expire thereby creating opportunities to bring more affordable SEB versions to the market. It is important to distinguish between traditional generic pharmaceutical products and SEBs. The term SEB was specifically chosen by the Canadian government to clearly distinguish between the regulatory process and product characteristics for SEBs and traditional generic drug products.

A is a drug that enters the market subsequent to a version previously authorized in Canada and with demonstrated similarity to a reference biologic drug. A SEB relies in part on prior information regarding safety and efficacy that is deemed relevant due to the demonstration of similarity to the reference biologic drug and which influences the amount of and type of original data required.

Because of the significant differences between SEBs and traditional generic drug products Canadian health authorities created new guidelines to govern the approval of new SEBs. Guidance from Health Canada is particularly prudent since the do not contain specific regulatory mechanisms for approval of SEBs. In March 2010, Health Canada released its framework for the approval of SEBs in a document entitled “”. These guidelines indicate that manufacturers seeking approval of a SEB must file a new drug submission as opposed to an abbreviated new drug submission as is the case with traditional generic drug products. While SEBs require a new drug submission they may still rely in part on data from the reference product but may not state that the SEB and the reference product are bioequivalent or are clinically equivalent. The also include SEBs within their scope thus linking patent protection to the approval process and opening the door to patent litigation.

The Canadian pharmaceutical industry is no stranger to patent litigation under the Patented Medicine (Notice of Compliance) Regulations and it appears SEBs will be no different. In early 2012 Teva Pharmaceutical Industries Ltd. (Teva) applied for a Notice of Compliance in order to market a SEB consisting of the protein filgrastim. In their application, Teva made reference to a reference biologic product owned by Amgen Inc. (Amgen).  Amgen commenced a proceeding () under the against Teva seeking an order prohibiting the Minister of Health from issuing a Notice of Compliance for Teva’s filgrastim product prior to the expiry of (the “537 Patent). The 537 Patent is listed on the patent register against Amgen’s biologic filgrastim product. The 537 Patent will expire on July 31, 2024. According to Amgen’s Notice of Application, Teva has made a number of allegations against the 537 Patent including:

• Invalidity of certain claims due to (1) double patenting (2) invalid selection (3) material misrepresentation (4) anticipation (5) obviousness (6) missed conflicts and (7) lack of utility and lack of sound prediction;
• The 537 Patent is not entitled to claim priority from a United States application;
• Claim 43 is the only relevant claim; and
• Claims 12, 16-24, 26, 27, 29-42 and 48-82 will not be infringed.

This proceeding represents the first SEB litigation in Canada. While this litigation will only determine the issue of whether the Court should prohibit the Minister of Health from granting Teva a Notice of Compliance, it will be interesting to see if any novel legal issues arise regarding SEBs. Given that Canadian SEB litigation is in its infancy, this proceeding may have important implications for the future of SEBs in Canada. For an interesting article on Canada’s SEB market the reader is directed to the following .

Sean Jackson is a JD candidate at Osgoode Hall Law School and is currently enrolled in Osgoode’s Intellectual Property Law and Technology Intensive Program.  As part of the program requirements, students are asked to write a blog on a topic of their choice.

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