The New NAFTA Deal

Bill C-4, the Canada–United States–Mexico Agreement Implementation Act, received Royal Assent on March 13, 2020. This new NAFTA deal (known as the NAFTA 2.0) is referred to in Canada as the CUSMA. The CUSMA amends the Criminal Code (s. 35 of the bill), the Copyright Act (s. 23 of the bill) and the Trademarks Act (s.108 of the bill). Some notable terms under the CUSMA include as follows: 1) it is a criminal offence for a person by deceit, falsehood or other fraudulent means, to knowingly obtain a trade secret or communicate or make available a trade secret; 2) the copyright term is increased for some types of works that have a term that is not based on the life of the author from 50 years from the date of creation to 70 or 75 years from the date of creation in some circumstances; and 3) a person is presumed to infringe on a registered trademark if they are found to be importing goods on a commercial scale that bear an identical trademark, or one that cannot be distinguished in its essential aspects from the registered trademark.

See the full text of Bill C-4 here.

An Effective IP Strategy? – Patenting Treatment for COVID-19 Infections

The world is bracing for a pandemic as the novel coronavirus, now officially known as COVID-19, threatens to spread around the globe. In the past few months, COVID-19 has sickened more than 90,000 and killed over3,000 people. The virus has triggered a humanitarian crisis and has sparked a patent controversy surrounding the race for IP rights to potential COVID-19 treatments.

Remdesivir: A Promising Treatment

The World Health Organization has identified more than 70 candidate therapeutics that are potentially worth trying as treatments for COVID-19 infections.

A promising drug is remdesivir, a virus blocker made by Gilead Sciences, Inc. Remdesivir was first developed for treating the Ebola virus but clinical studies showed that it was not particularly effective. Gilead Sciences has secured or applied for composition of matter patents covering remdesivir and related compounds in a large number of countries, including China (e.g. Chinese application Nos. 107074902 and 110636884).

Gilead Sciences later discovered that remdesivir can inhibit a coronaviridae RNA-dependent RNA polymerase, thus preventing coronaviruses, such as SARS or MERS, from multiplying. In 2015, Gilead Sciences filed a US patent application directed to a method of treating a coronavirus infection by administering a therapeutically effective amount of remdesivir. This application No. 16/265,016 was recently allowed. The patent application does not discuss COVID-19 as it was not known to exist at that time. The corresponding Canadian Patent Application No. 2,998,189 is still pending.

Remdesivir’s efficacy against coronaviruses has been shown in both in vitro studies and animal studies (e.g. in mice and monkeys). In January, remdesivir was given to a Washington man infected with COVID-19 and the patient subsequently recovered. However, remdesivir has not yet received regulatory approval. Gilead Sciences also acknowledges that there is no data demonstrating the efficacy or safety of remdesivir in treating COVID-19 infections.

Use of Remdesivir to Treat COVID-19 Infections: Patentability Hurdles

Researchers at the Wuhan Institute of Virology found that a combination of remdesivir and chloroquine is effective in inhibiting COVID-19 in vitro. In announcing their findings, the Chinese institute also revealed that it had filed a Chinese invention patent application and a Patent Cooperation Treaty application to claim the use of remdesivir to treat COVID-19 infections.

Gilead Sciences’ prior patent application and its subsequent studies will undoubtedly pose a patentability hurdle to the Institute’s applications. Gilead Sciences’ prior patent application teaches a method for treating a coronavirus infection with remdesivir. The application includes data showing that remdesivir was effective against SARS and MERS. In addition, a subsequent study showed that remdesivir inhibits SARS’ and MERS’ RNA-dependent RNA polymerase, thus preventing the viruses from multiplying.

A comparison of nucleotide information using BLAST, shows that the RNA-dependent RNA polymerase of COVID-19 (NCBI Accession No. MN975263.1) is about 94% identical to that of SARS (NCBI Accession No. MK062183.1). This similarity in the nucleotide sequences may suggest that what works in treating SARS may also work in treating COVID-19, thereby posing a patentability hurdle to the Wuhan Institute of Virology’s applications.

To obtain patent protection, the Wuhan Institute of Virology will need to prove that the use of remdesivir to treat COVID-19 is new and non-obvious over the prior art. Given that Gilead Sciences has already demonstrated that remdesivir is effective in treating coronaviruses that are highly similar to COVID-19, it may be difficult for the Institute to achieve this.  However, one way this could be achieved is if the Institute can demonstrate unexpected results showing that remdesivir works uniquely or surprisingly well in treating COVID-19 as compared with other coronaviruses already disclosed in Gilead Sciences’ earlier application.

Cross Licensing Potential

Even if the Institute secures its own patent, obtaining a patent on a new use of a patented drug does not give a positive right to use the patented drug. Instead, a patent on the new use would provide a negative right to exclude others from practising the new use of the patented drug.

This means that if the Wuhan Institute of Virology’s Chinese patent application is granted, the Chinese institute will still need a license from Gilead Sciences to make and use remdesivir, including for treatment of coronaviruses, given Gilead Science’s earlier composition of matter and method of use patents and applications. However, having its own Chinese patent could give the Institute more leverage in negotiating licensing fees for remdesivir with Gilead. This is because if Gilead Sciences wishes to use remdesivir to treat COVID-19 in China (and any other countries in which the Institute may secure patent protection), Gilead Sciences will need a license from the Institute.

In this case, the decision of the Institute to seek a patent is not necessarily intended to hinder access to medicine, but could be seen as a strategic use of patent rights to gain negotiation leverage. The Institute states that the decision to seek patent protection is to protect national interests and it will not enforce any patent rights that it may have if foreign companies contribute to the prevention and control of the COVID-19 epidemic.

Global Collaborative Effort

Despite the ongoing controversy over the Wuhan Institute of Virology’s attempt to patent the use of remdesivir to treat COVID-19 infections, the Institute’s decision to seek patent protection does not appear to hinder access to medicine at this time as no patent has yet been secured and there have not yet been reports of the Institute trying to assert exclusivity over the treatment of the virus. It is good to see that there has been considerable global collaboration with experts racing against the clock to find a treatment. Gilead Sciences is working with health authorities in China to establish a randomized, controlled trial to determine the efficacy and safety of remdesivir to treat COVID-19.

This scenario illustrates how in today’s innovation-driven economy, IP strategy should be considered as an integral part of an organization’s business strategy, and that humanitarian considerations are not necessarily incompatible with seeking patent protection.

 

*This article was originally published by The Lawyer’s Daily (www.thelawyersdaily.ca), part of LexisNexis Canada Inc.

Spherix Stocks Soar after Executing Option Agreement for Coronavirus Patent

Shares of Spherix Inc. soared on 6 March 2020 shortly after the company announced that it had executed an exclusive option agreement with the University of Maryland, Baltimore, for the technology claimed in a patent entitled “Methods of Treating Coronavirus Infection”. The patent claims a method for treating coronavirus by administering a therapeutically effective amount of kinase signaling inhibitor selected from the group consisting of imatinib mesylate, nilotinib hydrochloride and dasatinib. It will be interesting to see if the method is effective for treating COVID-19.

Read more here.

The End of Crown Copyright?

On February 19, 2020, private member’s bill C-209 was introduced in the House of Commons. Bill C-209, if implemented, would amend section 12 of the Copyright Act to specify that, without prejudice to any rights or privileges of the Crown, no copyright would subsist in any work that is, or has been, prepared or published by or under the direction or control of Her Majesty or any government department.

A publication of bill C-209 can be found here.

Report on Intellectual Property in Ontario’s Innovation Ecosystem

The Expert Panel on Intellectual Property has released its Report on Intellectual Property in Ontario’s Innovation Ecosystem.  Among other things, the report calls for improved education with respect to IP, including for technology transfer staff, students, entrepreneurs, directors and advisors, and improved funding and resources for IP commercialization and protection.

The report recognizes the very important role that intellectual property plays in ensuring the success and prosperity of companies, including small and medium-sized enterprises (SMEs), in the modern economy.

SaskTel Sent Out 30,000 Copyright Infringement Notices Last Year

Since January 2019 SaskTel has sent out approximately 30,000 notifications to customers accused of unauthorized downloading or uploading of copyrighted material. Copyright owners hire companies that track down IP addresses that access movies, such as through peer-to-peer file sharing software, and then obtain court orders requiring SaskTel to divulge the name of the customer associated with the IP addresses. This has resulted in copyright owners like Hollywood studios filing thousands of lawsuits against Canadian individuals, with damages sought typically in the range of $5,000.

Read more here.

Chinese Researchers Apply to Patent Coronavirus Drug

The government-run Wuhan Institute of Virology recently stated that it applied to patent a drug in January for treating the novel Wuhan coronavirus disease.

The antiviral drug, known as remdesivir, was originally developed by a California company Gilead Science Inc.  Gilead originally applied to patent remdesivir three years ago in China for treating coronaviruses broadly, including the 2019-nCoV, which is blamed for the recent Wuhan outbreak. The Wuhan Institute of Virology will need to prove that the drug works uniquely in treating the 2019-nCoV strain in order to obtain patent protection. This action from the Chinese government agency raises concerns that the Chinese government may abuse its regulatory system and give preferential treatment to domestic industry. On the other hand having a patent could give China more leverage in negotiating licensing fees for the drug with Gilead, where China is best placed to conduct valuable research and is in the greatest need for a cure.  More details are available here.

Oyen Wiggs Named in Canadian Lawyer’s “Top 10 Intellectual Property Boutiques”

We’re proud to announce that Oyen Wiggs has been named one of the “Top 10 Intellectual Property Boutiques“ in Canada by Canadian Lawyer Magazine.

“Since 1977, Oyen Wiggs has been the go-to firm for clients in western Canada seeking assistance with IP matters.”—Canadian Lawyer Magazine

To make their selections, Canadian Lawyer asked lawyers, in-house counsel and clients from across the country to vote for the top intellectual property boutiques. You can read more about Canadian Lawyer’s methodology here.

In addition to this recognition, Oyen Wiggs has also been recognized by Lexpert, Best Lawyers, and Above the Law.

Retaining experienced counsel is especially important in the current environment because of significant changes to intellectual property law in the past year, including changes to Canadian Patent law in October 2019 and amendments to the Trademarks Act which came into force on 17 June 2019.

If you are looking for help protecting your innovation or navigating the new legislative regime, the team at Oyen Wiggs is here to help.

 

CIPO Releases IP Canada Report 2019

In late 2019, CIPO released the IP Canada Report 2019, which details trends in patent application filings in Canada and by Canadians abroad.  A main finding reported is that there has been considerable growth in trademark and industrial design filings, each with growth of 54% between 2009 and 2018, while patent filings at CIPO have been more consistent over this period.

To read more about the report, see here.

Innovation UBC 2020 Start-up Idea Competition

Jennifer Marles will be at UBC on February 12, 2020 presenting an introduction to intellectual property for the Innovation UBC 2020 Start-up Idea Competition (Life Sciences).  More information on the competition, the associated educational sessions, and details on how to register can be found here.

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