The Ongoing CRISPR Patent War: Broad Institute to Appeal EPO Decision

The clustered regularly interspaced short palindromic repeats (CRISPR) technology is a powerful gene-editing tool that has spawned a billion-dollar industry. It allows scientists to alter, delete and rearrange quickly and precisely the DNA of nearly any organism. For the past three years, the Broad Institute of Harvard and MIT have been engaged in a worldwide patent war against UC Berkeley to determine who invented the use of CRISPR in eukaryotic cells.

In a recent decision, the European Patent Office (EPO) revoked Broad Institute’s European patent No. 2771468. The EPO denied the Broad Institute’s reliance on its US priority provisional application because the named inventors differed between the European patent and the priority US application. The Broad Institute has expressed its intention to appeal the EPO decision.

FOCUS ON MEDICINAL CANNABIS: IP PROTECTION FOR THERAPEUTIC USES

Cannabis has a long history as a medicinal plant, dating back at least to the 19th century. A renewed interest in the therapeutic uses of cannabis emanates from the substantial changes that have taken place in both social attitude and the legal landscape surrounding its use in recent years. The proposed legalization of recreational cannabis in Canada has resulted in a significant growth in the potential economic market associated with cannabis. Since Justin Trudeau became prime minister, after campaigning on a promise to legalize recreational cannabis, the number of medical marijuana users has quadrupled.

Important differences exist in the way that recreational cannabis and medicinal cannabis are developed, tested and marketed to consumers. In this context, recreational cannabis tends to have high levels of psychoactive cannabinoids like Δ9-tetrahydrocannabinolic acid (THC). THC has received much attention for being the main psychoactive component of cannabis. The psychoactive effects of THC are due to its ability to activate type-1 cannabinoid (CB1) receptors that are located mainly in the central nervous system.

In contrast, it is generally desirable for medicinal cannabis to have a minimal level of psychoactive cannabinoids, but to contain high levels of other useful cannabinoids like cannabidiol (CBD). CBD does not appear to have any intoxicating effects such as those caused by THC, but may have effects on anxiety and act as an anti-psychotic. In addition to cannabinoids, cannabis also contains a number of different potentially beneficial compounds, including terpenoids, flavonoids and nitrogenous compounds.

To date, more than 100 different cannabinoids have been identified in cannabis. Some cannabinoids have been used to relieve chronic pain, chemotherapy-induced nausea and vomiting, and anorexia and weight loss associated with HIV/AIDS. However, the full therapeutic potential of these cannabinoids remains to be explored and commercial embodiments of these therapeutic properties can potentially receive patent protection.

This article briefly reviews some potential hurdles to patenting medicinal cannabis-related inventions in Canada, and provides examples of some recently granted patents in this field.

Patentable Subject Matter
A first potential hurdle in seeking patent protection for new applications of medicinal cannabis in Canada is the patentability of methods of medical treatment. In Canada, judicial interpretation of what constitutes an “invention” under section 2 of the Patent Act (RSC 1985, c P-4) has imposed potential hurdles on the ability of applicants to obtain patent protection for medical uses of cannabis.

The Supreme Court of Canada (SCC) held that a method of medical treatment lies outside the definition of “invention”: Tennessee Eastman Co v Canada (Commissioner of Patents), [1974] SCR 111. That decision was fundamentally underpinned by a now-repealed section of the Patent Act that prohibited claims to a medical substance itself, apart from its method of manufacture.  However, this decision remains the governing law in Canada today.

Notwithstanding this position, the use of a substance for a medicinal purpose can be claimed as an invention in Canada, so long as the claims do not require the skill and judgment of a medical practitioner to determine how the substance should be administered. Accordingly, with careful drafting, patent protection may be available for novel therapeutic uses of cannabis and its components in Canada.

Utility
A further complication to securing patent protection for new applications of medicinal cannabis in Canada relates to relatively strict requirements for establishing the utility of an invention. Canadian law requires that an invention be useful as of the filing date of the application. Fanciful, speculative or inoperable inventions are not patent-eligible. A claimed invention is useful if it is capable of a practical purpose, i.e. an actual result: AstraZeneca Canada Inc v Apotex Inc, 2017 SCC 36.

Utility can be demonstrated, for example, via working examples, or based on a sound prediction. Whether a prediction is sound is a fact-specific inquiry and depends on the following three factors:

(1) there must be a factual basis for the prediction;

(2) the inventor must have at the date of the patent application an articulable and “sound” line of reasoning from which the desired result can be inferred from the factual basis; and

(3) there must be proper disclosure.

Cannabis research faces a unique set of challenges owing at least in part to the illegal status of cannabis presently in Canada and in many other parts of the world. Certain regulations and policies exist to restrict access to the plant and its derivatives. Additionally, physicians may feel reluctant to refer patients to clinical trials. These challenges complicate an applicant’s ability to gather sufficient experimental data to establish utility.

Because utility is a fact specific inquiry and depends on the scope of the patent claims, diligent consideration of existing experimental data and careful patent drafting are important to secure patent protection for new therapeutic uses of cannabis.

Some Recently Issued Patents Relating to Therapeutic Properties of Cannabinoids
Canadian patent No. 2582289 to Whittle et al. (“Whittle”) discloses that CBD has the ability to modulate the motility of human glioma cells and thereby inhibit brain tumour cell migration. This therapeutic property of CBD was demonstrated by an in vitro cell migration assay.

Another recently issued patent, Canadian patent No. 2636634 to Guy et al (“Guy”), discloses the use of cannabinoid-containing plant extracts of Cannabis sativa in the prevention or treatment of neurodegenerative diseases such as Alzheimer’s disease, Parkinson’s disease, amyotrophic lateral sclerosis, Huntington’s disease, frontotemporal dementia, prion disease, Lewy body dementia, progressive supranuclear palsy, vascular dementia, normal pressure hydrocephalus, traumatic spinal cord injury, HIV dementia, alcohol induced neurotoxicity, Down’s syndrome and epilepsy.

Guy discloses that cannabinoid-containing plant extracts containing a cannabinoid-containing fraction and a non-cannabinoid containing fraction are more efficacious than essentially pure cannabinoids in the prevention of neural degeneration. The cannabinoid-containing fraction has one or more of THC, CBD, cannabigerol (CBG), cannabichromene (CBC), tetrahydrocannabidivarin (THCV), tetrahydrocannabinolic acid (THCA), cannabidivarin (CBDV) and cannabidiolic acid (CBDA). The non-cannabinoid containing fraction has one or more of terpenes, sterols, triglycerides, alkanes, squalene, tocopherol, carotenoids, chlorophyll, flavonoid glycosides and alkaloids.

The claims in Guy are supported by experimental data demonstrating the effects of cannabinoid-containing plant extracts on the concentration of intracellular calcium ions in hippocampal neurones prepared from Lister-Hooded rat pups. The ability to decrease the concentration of intracellular calcium ions in rat hippocampal neurones is expected to have predictive value for promising neuroprotective agents for humans.

Concluding Remarks
The identification and verification of new therapeutic properties of cannabinoids will likely require significant financial investment. Patent protection can ensure a return on such financial investment when the resulting products are eventually commercialized. Companies should consider filing patent applications to secure protection for potentially valuable commercial embodiments of these therapeutic properties before there is any public disclosure thereof.

CIPO Under Fire for Policy on Medical Diagnostic Method Patents

The Canadian Intellectual Property Office (the “CIPO”)  has recently received criticism regarding its policy on diagnostic method patents. A diagnostic method outlines a sequence of steps to be followed to extract diagnostic meaning from data. For example, ascertaining the presence of a disease due to a correlation with a particular analyte falls under the umbrella of diagnostic methods. It is being argued here and here that the CIPO is unlawfully rejecting patent applications directed to diagnostic methods where the inventive feature is a new correlation between a known analyte and a disease.  In contrast, the CIPO accepts as patentable diagnostic methods where the inventive feature is the analyte itself or a new means for detecting the analyte.

CETA Paves the way for “Prosciutto di Parma”

A legal dispute over the name “Parma” may finally have been put to bed by the Canada-European Union (EU) Comprehensive Economic and Trade Agreement (CETA). For years, Maple Leaf Foods has resisted Italian exporters using “Parma” to describe their hams in Canada, relying on their trademark registration number TMA179637 for PARMA. However, under CETA, Canada was required to extend protection for “Prosciutto di Parma” as a geographic indicator of ham from Parma. Now Maple Leaf’s trademark and the geographic indicator will coexist.

See the complete list of geographic indicators here.

Read more on the background of the dispute over “Parma” here.

Fast-tracking Examination with the EPO

The Patent Prosecution Highway (PPH) pilot agreement between the Canadian Intellectual Property Office (CIPO) and the European Patent Office (EPO) was extended on 6 January 2018 for a further period of three years.  With this extension, the filing date limitation imposed as part of the initial pilot agreement is removed.  Accordingly, to qualify, a Canadian application no longer requires a filing or national entry in Canada that is after 5 January 2015.  More information can be found here.

Cease and Desist Light: Call in the Town Crier to Deliver Your Message

Anheuser-Busch InBev has taken a lighter approach to delivering a cease and desist letter to an upstart craft brewer, opting to send in the town crier to deliver their request that it refrain from using the trademark DILLY DILLY that is used to promote its Bud Light beer.  While the message was clear, the mode of delivery and the offer of two tickets to attend the Super Bowl will likely promote a positive image of a company protecting its trademark rights.

Spotlight: The Outdoors Intellectual Property Blog

The Outdoors Intellectual Property Blog, published by the team at McCoy Russell LLP in Portland, Oregon, is dedicated to intellectual property issues in the outdoor equipment and apparel industry.  Earlier this month, The Outdoors IP Blog featured a spotlight on Oyen Wigg’s associate Stephanie Melnychuk and her article entitled “The Legal Implications of the IRONMAN Tattoo: Trademark and Copyright Issues for Athletes.”  This article was also published in BarTalk, Canadian Bar Association, December 1, 2017.

 

Federal Court Finds Fracking Patent Invalid

The Federal Court of Canada has declared invalid a fracking technology patent owned by Calgary-based Packers Plus Energy Services Inc.  Packers Plus had alleged patent infringement against a number of oil and natural gas service companies. The court dismissed the infringement suits upon finding the technology claimed in the patent to be obvious in view of existing publicly disclosed techniques, thereby holding the patent invalid. See link to article.

Global IP Filings Reached New Highs – Canada is a Popular Place to File

Last week, the World Intellectual Property Organization (“WIPO”) published its World Intellectual Property Indictors 2017 report. WIPO reports that global IP filings have reached new highs. A total of 3.1 million patent applications were filed in 2016, up 8.3% in a seventh straight yearly increase. China received the largest number of applications in 2016 at 1.3 million applications, followed by the U.S. at 605,571, Japan at 318,381, Korea at 208,830, and the European Union IP Office at 159,358. Canada was featured among the top 10 offices in 2016, receiving 34,745 applications.

Global trademark filings also increased, with an estimated 7 million trademark applications filed in 2016, up 16.4% from 2015. China again had the largest volume of filing activity in 2016, receiving around 3.7 million applications, followed by US, Japan and the European Union IP Office.  Canada ranked 13th overall with 555,571 applications filed.

For more information, see WIPO’s press release.

FCA Rules Toronto Real Estate Board Practice of Excluding Data from Virtual Office Websites is Anti-Competitive

On 1 December 2017, the Federal Court of Appeal (“FCA”) dismissed appeals from two decisions of the Competition Tribunal which held that the Toronto Real Estate Board’s (“TREB”) practice in excluding certain data available on the “Multiple Listing Service” or MLS system from being assessable in “Virtual Office Websites” or VOWs results in a substantial prevention or lessening of competition that is in violation of subsection 79(1) of the Competition Act, R.S.C. 1985, c. C-34.

In brief, VOWs are used by many brokers who operate sections of their websites where their clients can log in and view information on properties. TREB’s data feed delivers information to brokers to populate these sections of their websites; however, such data feed does not include all of the information that is in the MLS database. TREB argued that the Competition Tribunal erred in the following issues: that TREB had substantially reduced competition within the meaning of subsection 79(1) of the Competition Act; that TREB’s privacy concerns or statutory obligations constituted a business justification within the scope of paragraph 79(1)(b); and in its consideration of TREB’s claim of copyright in the MLS database such that TREB’s practice should be exempted from being considered an anti-competitive act under the exception provision in subsection 79(5). The FCA dismissed each of these grounds of appeal, and upheld the Competition Tribunal’s decisions.

According to the FCA docket system, TREB filed a Notice of Motion with the FCA on 6 December 2017 for, inter alia, seeking a stay of the FCA decision, pending outcome of TREB’s application for leave to appeal to the Supreme Court of Canada (“SCC”). We await the further word from the SCC to hear if leave will be granted. See full decision here.

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