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

On May 31, 2022, the Federal Court of Canada in favour of the plaintiffs, Janssen and Actelion Pharmaceuticals ("Janssen”) in their action against Sandoz. The Court held that Janssen’s combination therapy patent is valid. is often used to treat ailments and medical conditions where treatment through single-agent therapy has proven to be challenging.

Background

The present case concerns the validity of claims 21 to 31 of Janssen’s Canadian combination therapy patent for treatment of diseases involving , including pulmonary arterial hypertension (PAH). The patent seeks to treat the ailments through a combination of Macitentan (sold under the brand name Opsumit) and phosphodiesterase type-5 inhibitor (PDE5-1).

Sandoz sought permission from Health Canada to market generic medicine containing 10mg of Macitentan as the active pharmaceutical ingredient (API) for use alone, or in combination with PDE5-Is. Janssen filed an action before the Federal Court claiming that Sandoz’s generic medicine will infringe upon claims 21 to 31 of the plaintiffs’ patent.

Defences

Sandoz conceded that its proposed medicine does infringe the alleged claims, but defended against Janssen’s claims by raising four different grounds of invalidity. However, the Court rejected Sandoz’s arguments that the combination therapy invention was obvious, lacked a sound prediction of utility, and that the patent was overbroad, and the specifications were insufficient.

1. Obviousness

The Court in held that whether an invention is “obvious” depends on if the skilled person (without any inventiveness), in view of the state of the art and the common general knowledge on the date of publication, would have directly or without difficulty come to the same conclusion as the patent. Plainly, the test can be understood as:

1. Identify the person of skill in the art (“POSITA”), and their common general knowledge;
2. Identify the inventive concept;
3. Identify the difference between the inventive concept and the “state of the art”; and
4. Determine if the difference is obvious or if it requires inventiveness.

The Federal Court followed the test down to the T and held that the available evidence and prior art do not indicate that the POSITA would have considered the combination of Macitentan with PDE5-I to show effectiveness in treatment of ailments involving vasoconstriction, where monotherapies have failed.

Since Sandoz raised the defence of invalidity, Sandoz had the onus to establish obviousness, which it was unable to do.

2. Utility

The requirements to establish a sound prediction of utility were set out in the case of as:

1. A factual basis for prediction;
2. An articulable and sound line of reasoning; and
3. Proper disclosure.

The Court, having considered the POSITA’s common general knowledge and the test results provided in the patent, concluded that the plaintiffs met the requirements of sound prediction of utility.

3. Overbreadth

Here, Sandoz recycled its argument of utility in claiming that the patent does not disclose a sound line of reasoning and claims overtly broad protections. However, the Court relied on its own analysis under Utility and concluded that a sound line of reasoning is present, thereby invalidating the overbreadth argument.

4. Sufficiency

A patent specification is required to provide sufficient disclosures to enable the POSITA to use the invention. Sandoz claimed that the specification of the patent does not enable the POSITA to put the invention to use. The Court reasoned that Sandoz’s “sufficiency” argument contradicted its “obviousness argument.” Further, Sandoz failed to explain the lacunae in the specification that needed filling for the disclosure to be sufficient.

The Judgment

Unable to find merit in Sandoz’s arguments, the Court declared that Sandoz would infringe the asserted claims if granted permission to market its generic medicine in Canada. As of July 20, 2022 Sandoz has filed an against Federal Court’s judgment. ��

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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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To put things into perspective, let’s look at the that arose between the French Institute for Development Research (IRD) and government officials in French Guiana over the patenting of an active ingredient extracted from a local plant that grows in South America. French researchers, through obtaining knowledge from the local community regarding their traditional methods of treating malaria, were able to isolate an active ingredient, which was subsequently patented for its antimalarial properties. IRD argued that the active ingredient was not isolated through traditional Guianese methods of brewing tea from the local plant, rather it was found in a lab setting through methods of . , a legal scholar at the University of Ottawa described this case as . Eventually, the controversy and accusations of biopiracy that followed the dispute led to to share the economic benefits generated from the potential antimalarial drug as well as acknowledging the contributions that the indigenous community in French Guiana had made to the discovery process of the active ingredient, SkE.��

Instances of appropriation of indigenous peoples’ knowledge by research institutes and corporations have led to the implementation of more protections for indigenous populations in the international legal framework. The was adopted to complement the international in order to ensure more equitable sharing of profits with indigenous populations in biodiverse regions of the world as well as greater authority in the ways their local bio-resources are used.

Despite international efforts aimed to combat and mitigate the harmful effects of biopiracy, indigenous knowledge and traditions . With the crisis of climate change looming over the planet and posing an existential threat to life, researchers are increasingly engaging in the genetic modifications of plants aimed at making them more suited for cultivation in harsher climates. These research efforts are often fueled by tapping into natural resources in biodiverse regions of the world, creating greater risks for cases of biopiracy and exploitation to arise. As a result, the issue of biopiracy remains a relevant topic that needs further attention from international law and more protections for local communities in developing countries.

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

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The latest of international trade deals, the TPP, signed October 5^th, 2015, produced about seven pages of patent provisions that, under Canadian law, leave little impact. The Federal government’s is that Canadian law is already in compliance with these provisions. While this might be true, a more objective analysis of the text could support the argument that the TPP does in fact require some legal reform. However, legal reform would not create new legal obligations, as Canada has already committed to that reform under the newly minted Comprehensive Economic and Trade Agreement ()

Of all the TPP’s patent provisions, three concerning pharmaceutical drug patents are most notable. The first is patent term restoration, which extends patent terms in response to administrative delays. And the third is extended data protection specifically for biologics, a new form of prescription drug.

The first of the TPP’s notable provisions, concerning patent term restoration, can be found in articles and . Both provisions offer patent extensions in response to administrative delays. Article 18.46 grants extensions for patent office delays, and extends pharmaceutical patent terms by a time equal to any “unreasonable” delay in a drug's regulatory approval. Article 18.48 is not currently found in Canadian law, nor under .

The purpose of the provision is to recognize that patent enabled drug monopolies are of little value when drugs cannot be legally sold. This is welcome news for those who believe current patent terms successfully , as lost monopoly time would hinder pharmaceutical development. Also, everyone can appreciate how the provision detaches patent terms from flexible regulatory approval processes, adding certainty to IP investments and assurances against regulatory favouritism. Yet some argue term restoration is a tool for IP owners, used to extend an already sufficient monopoly.

The second notable provision is article , patent linkage. of patent linkage argue that tying marketing approval to previous patents creates space for tactical litigation, which can be used to delay generic competition and, in effect, extend patent terms. Although this was a debated topic during and after TPP negotiations, Canada has already employed for some time, and has also committed to linkage rules similar to the TPP since signing CETA.

The last of the TPP’s notable provisions can be found in articles and , which offer . This type of research is necessary for marketing approval and is an expensive cost of drug development. Supporters of data protection argue these provisions shield drug developers from free-riders, thus incentivizing invention. Though opponents might take issue with adding protecting of information on top of invention.

However, these provisions do not create monopolies on information, the way patents create monopolies on invention. Generic companies are free to rely on the same safety and efficacy data as the patent owners, so long as it is reproduced at their own expense.

The TPP grants a five-year protection on drug efficacy and safety data, and an additional three-year protection on research concerning biologic drugs, so-called large molecule drugs. Biologics are an emerging field of pharmaceuticals, and the extended protection is meant to recognize the often high risk and cost associated with exploratory research.

However, some suggests that a longer term of twelve years would be ideal, even considering this advantage. The TPP's compromise is eight years, which reflects Canada's current .

It is difficult to determine whether the provisions presented in the TPP’s patent chapter will help or harm Canadian interests. This determination will depend in no small part on which perspective the analysis is based. The TPP’s patent provisions are likely not immediately useful for consumers of patented drugs. Patent term restoration, patent linkage, and data protection all serve to strengthen patents.

However, these are welcome provisions from the perspective of drug developers, as they increase the value of existing and new patents. In this sense, perhaps the rules are also good for Canada. For example, biologics were given special protection to encourage investment. Canada’s pharmaceutical research and development sector, one of its largest, would likely benefit from this improvement in market conditions, especially since investment in that sector has recently suffered steady .

Matt Wallace is an IPilogue Editor, JD Candidate at University of New Brunswick, and writes on technology law.

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The����IP chapter��includes��several rules that indirectly extend patent terms for pharmaceutical drugs, such as��,��, and��. However, the actual benefit these provisions provide is��

Take patent term restoration for example, which extends patent terms by a time equal��to any “unreasonable” delay in a drug's regulatory approval. This provision's purpose recognizes that patent enabled drug monopolies��are of little value when drugs cannot be sold legally. And��the TPP considers any��five-year��delay��unreasonable.

Patent restoration is��welcome news for those who believe current��patent��terms successfully��,��because��lost monopoly time would hinder pharmaceutical��development.��This provision also detaches patent terms from flexible regulatory approval processes, adding certainty to IP investments. And��it adds assurances against regulatory favouritism. However, some��critics argue term restoration is��a��tool for IP owners used to extend an��already sufficient��monopoly.

Another debated policy found in the TPP is patent linkage. This rule requires generic drug companies to prove their products do��not infringe any existing patents before they can be granted marketing approval.����of patent linkage believe��tying marketing approval to previous patents creates space��for tactical litigation that can be used to delay generic competition��and in effect extend patent terms. However, Canada already��employs patent linkage, and has already committed to linkage rules similar to the TPP by��signing��.

In addition to patent restoration and patent linkage, the TPP��includes two controversial pro-patent provisions that provide data protection to pharmaceutical efficacy and safety research. This research is necessary for marketing approval and is an��expensive cost of drug development. Supporters of the data provisions argue that these protections��incentivize invention by��shielding drug��developers��from��free-riders.

Opponents of these provisions might take issue with protecting information on top of invention. However,��this is not a monopoly on information, and��generic companies are free to use the same data��so long as it is��reproduce at their own expense.

The TTP grants��five year's protection on drug efficacy and safety data, and an additional three year's protection to research concerning biologic drugs, so called��large molecule drugs.��Biologics are an emerging field of pharmaceuticals, and the extended protection is meant to recognize how exploratory research is often more risky and thus more expensive.

One compelling����against special protection concerns the nature of biologic drugs. Whereas traditional small molecule drugs are chemically synthesized and easily reproduced, biologics often have genetic and cellular components that are not as simple, or cheap, to replicate.��Critics think��this creates a natural barrier to entry, giving��biologic developers a first-mover advantage��that sufficiently returns��the risky cost of research, eliminating��any��need for��data protection.

However,��some����suggests, even considering this advantage,��that��a��longer term of twelve years would be ideal. The TPP's compromise is��eight years, which reflects Canada's current��.

As is usually the case with trade deals, the TPP’s patent provisions fall short of both advocates' highest hopes and critics' worst fears. For Canadian law, the TPP will have little effect. But��this��is not necessarily a good thing. Current patent rules may not be best for incentivizing drug development, as��the����over patent policy��suggests. Meaning,��this��failure to change might��successfully impede innovation.

All that can be said with certainty is the TPP will not reduce the price of today's life-saving drugs. Whether innovation properly compensates this cost is for posterity to judge.

Matt Wallace is an IPilogue Editor, JD Candidate at University of New Brunswick, and writes on technology law.

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