Biotechnology Focus December 2018/January 2019

INSIGHTS FOR THE LIFE SCIENCE INDUSTRY

December 2018/January 2019 VOLUME 21, NUMBER 6

Regulation in

Regenerative Medicine

INSIDE:

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FEATURES

contents

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December 2018/January 2019 – VOLUME 21 – NUMBER 6

Patenting diagnostic methods in Canada: A glimmer of light from our southern neighbours?

Personalized medicine, where prevention, diagnosis, and/or treatment of disease is tailored to an individual, is becoming more and more prevalent as scientists uncover new connections between biomarkers and illnesses.

(By Melanie Szweras and Ainslie Parsons)

14

Navigating the regulatory complexity of regenerative medicine in Canada

As the regenerative medicine industry continues to grow and gain value globally and locally, Canada hopes to nurture it through a collaborative approach.

(By Siofradh McMahon)

SPOTLIGHT 16

The evolution of NEOMED-LABS: GSK spin-out to strategic partner (By Michelle Cornish)

14 Navigating the regulatory complexity of regenerative medicine in Canada

17

DEPARTMENTS

Nobel prize-winning treatment for deadly parasitic infections approved in Canada (By Michelle Cornish)

6

Research news

8

Business corner

18

19 Calendar of events

6 Zucara Therapeutics helps people with diabetes sleep safely and soundly www.biotechnologyfocus.ca

Good news for travellers to and immigrants from endemic regions:

Six world-first vaccines among the University of Saskatchewan’s Vaccine and Infectious Disease Organization-International Vaccine Centre contributions to global health (By Sarath Peiris)

December 2018/January 2019 BIOTECHNOLOGY FOCUS 3

PUBLISHER’S note PUBLISHER/ EDITOR-IN-CHIEF Group Publisher

Terri Pavelic J. Richard Jones

Writer

Michelle Cornish

CONTRIBUTING WRITERS

Melanie Szweras

Ainslie Parsons Siofradh McMahon Sarath Peiris Director, Content & Business Development David Blondeau

As we head in to a new year, it’s clear that Canada has many exciting things on the horizon in the life sciences industry. While there are many challenges in the regulation of regenerative medicine, there are also many new treatment options becoming available to Canadians in a wide range of life science fields.

Patent eligibility has been the subject of Canadian courts over the years, but there have been no decisions regarding the eligibility of patents using molecular diagnostic methods. Lawyers Melanie Szweras and Ainslie Parsons discuss Canadian patent guidelines and their associated diagnostic methods in their article Patenting diagnostic methods in Canada: A glimmer of light from our southern neighbours?

In her article, Navigating the regulatory complexity of regenerative medicine in Canada, Siofradh McMahon notes that Canada holds a significant place in the regenerative market industry, and despite the absence of specific guidance regarding these advanced therapies, gaining approval for regenerative medicine therapies in Canada can be less complex than in other ICH jurisdictions.

During the last few years, NEOMED-LABS has shown its potential in the clinical immunology field, going from a GSK spin-out to the subject of an Ampersand Capital Partners acquisition. Michelle Cornish discusses what this means for NEOMED in her article, The evolution of NEOMED-LABS: GSK spin-out to strategic partner.

Treatment options for roundworm and river blindness have expanded thanks to Health Canada’s approval of STOMECTOLTM, and the University of Saskatchewan’s VIDO-InerVac has established itself as a leading global institute in protecting human and animal health. Find out how in Sarath Peiris’s article Six world-first vaccines among the University of Saskatchewan’s Vaccine and Infectious Disease Organization-International Vaccine Centre Contributions to global health.

GRAPHIC DESIGNER CIRCULATION

Elena Pankova circulation@promotivemedia.ca

EDITORIAL ADVISORY BOARD Barry Gee, CDRD; Christine Beyaert, Roche Canada; Nadine Beauger, IRIC; Peter van der Velden, Lumira Capital; Jason Field, Life Sciences Ontario; John Kelly, KeliRo Company Inc.; Raphael Hofstein, MaRS Innovation; Gail Garland, OBIO; Albert Friesen, Medicure Inc.; Andrew Casey, BIOTECanada; Ulrich Krull, UTM; Peter Pekos, Dalton Pharma Services

Biotechnology Focus is published 6 times per year by Promotive Communications Inc. 21374, 2nd Concession Rd East Gwillimbury ON L9N 0H7, Phone 905-727-3875 Fax 905-727-4428 www.biotechnologyfocus.ca E-mail: biotechnology_focus@promotive.net Subscription rate in Canada $35/year; USA $60/year; other countries $100/year. All rights reserved. No part of this publication may be reproduced without written consent. Publications Mail Registration Number: 40052410

Happy reading!

Return undeliverable Canadian addresses to: circulation department – 21374, 2nd Concession Rd East Gwillimbury ON L9N 0H7 National Library of Canada ISSN 1486-3138 All opinions expressed herein are those of the contributors and do not necessarily reflect the views of the publisher or any person or organization associated with the magazine.

4 BIOTECHNOLOGY FOCUS December 2018/January 2019

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R&D news Zucara Therapeutics helps people with diabetes sleep safely and soundly

Approximately 8.3 million people around the world are at risk of dying from hypoglycemia, low blood sugar, during their sleep.

Current treatments for hypoglycemia are administered as rescue therapy after an episode, but Canadian-based Zucara Therapeutics is developing the first once-daily treatment aimed to prevent hypoglycemia in Type 1 diabetics, thus significantly improving their health and quality of life.

“Our technology is aimed at creating the first treatment to prevent clinically significant low blood sugar,” explained Zucara Chief Executive Officer Michael Midmer. Zucara’s lead drug, ZT-01, proved to be safe and effective based on multiple preclinical models of hypoglycemia. Midmer reports Zucara is “extremely happy with the results so far” and they are excited for the next phase.

The company is currently defining their clinical trial plan for Phase 1 and Phase 2 studies. Zucara appreciates the support they have received to date from founding organizations (CDRD and MaRS Innovation), leading diabetes organizations (The Leona M. and Harry B. Helmsley Charitable Trust and JDRF International) and contributors such as the National Research Council of Canada Industrial Research Assistance Program and Accel-Rx Health Sciences Accelerator.

With $7 million US raised to date, Midmer says, “We are currently raising funding to conduct our first clinical studies, and appreciate the support we have received to date from leading institutions and diabetes organizations”. Phase 1 clinical trials will begin in late 2019.

6 BIOTECHNOLOGY FOCUS December 2018/January 2019

Therapure Biomanufacturing announces U.S. FDA approval

A new drug is about to hit select specialty pharmacy shelves. Therapure Biomanufacturing, the Mississauga-based awardwinning contract development and manufacturing division of Therapure Biopharma Inc., announced U.S. FDA accelerated approval of Insmed’s ARIKAYCE. Tharapure’s President and CEO, Nick Green, expressed Therapure’s appreciation for its partnership with Insmed, stating that, “We are privileged to partner with Insmed in the commercial manufacturing of this important therapy that leverages innovative drug delivery technology to address previously unmet but life-threatening pulmonary diseases.” Under its agreement with Insmed, Therapure has built a custom manufacturing suite and is responsible for scale-up, commercial aseptic formulation and fill/finish manufacturing.

ARIKAYCE, an amikacin liposome inhalation suspension designed for the treatment of Mycobacterium avium complex (MAC) lung disease, will be part of a combination antibacterial drug therapy for adults with limited or no alternative treatment options. ARIKAYCE is the first and only treatment approved for MAC lung disease patients, a chronic and debilitating condition which increases patient morbidity and mortality.

“Complex biological therapeutics and innovative drug delivery technology can improve people’s lives, and we look forward to continuing to work with important partners like Insmed to bring these opportunities to market,” said Gabriel de Alba, Chairman of Therapure and Managing Director and Partner at The Catalyst Capital Group Inc.

R&D news

New treatment approved for renal cell carcinoma Mississauga, Ont. based Ipsen Biopharmaceuticals Canada Inc., Canadian affiliate of Ipsen, announced Canada Health’s approval of CABOMETYXTM, a new treatment option for adults with advanced renal cell carcinoma (RCC). Approximately 6,600 Canadians are diagnosed with RCC every year. With the disease often not presenting any symptoms, over 25 per cent of patients diagnosed are in the later stages of the disease, thereby making treatment difficult.

CABOMETYXTM is a multi-targeted tyrosine kinase inhibitor designed for adult patients with advanced RCC who have received prior vascular endothelial growth factor (VEGF)-targeted therapy. In a threephase study, the once per day oral tablet demonstrated statistically significant clinical benefits across three key efficacy endpoints: overall survival (OS), progression free survival (PFS) and objective response rate (ORR). The first and only drug to accomplish this.

Dr. Anil Kapoor, Professor of Oncology and Surgery at the Juravinski Cancer Centre at McMaster University and Chair of the National Kidney Cancer Research Network of Canada says, “The approval of CABOMETYXTM represents a significant advancement for patients who have progressed on prior therapy and should be considered for previously treated patients”.

Health Canada granted CABOMETYXTM priority review status based on the METEOR Phase 3 open-label trial of 658 patients with

advanced RCC where CABOMETYXTM was compared to everolimus. All patients had failed at least one prior therapy.

Study results included a 42 per cent reduction in the risk of disease progression or death and a 34 per cent reduction in the risk of death. Median results on efficacy endpoints for CABOMETYXTM compared to everolimus were OS, 21.4 months versus 16.5 months and PFS, 7.4 months versus 3.8 months. Based on investigator assessment, the ORR showed significant improvement of 24 per cent for CABOMETYXTM versus 4 percent for everlimus.

“Until now, few treatments have demonstrated significantly delayed disease pro-

gression, extended survival and improved response in patients who have progressed on initial therapy,” says Dr. Kapoor. Side effects of CABOMETYXTM include diarrhea, fatigue, nausea, decreased appetite, palmar-plantar erythrodysesthesia syndrome (PPES), hypertension, vomiting, weight decreased, and constipation.

CABOMETYXTM is also approved for use as treatment of advanced RCC in the United States and for use as treatment of advanced RCC in adults who have received prior VEGFtargeted therapy and for previously untreated intermediate or poor risk advanced RCC in the EU, Norway, Iceland, Australia, Switzerland and South Korea.

First new treatment for hemophilia in almost 20 years Approximately 3,000 Canadians are affected by hemophilia A, a rare bleeding disorder where blood cells don’t clot properly leading to uncontrolled and spontaneous bleeding, sometimes into joints or muscles. Frequent bleeding can lead to pain, chronic swelling, deformity, reduced mobility and long-term joint damage.

One-in-three patients can develop inhibitors to current hemophilia A factor VIII (FVIII) replacement therapies. When this happens, traditional infusion treatments are no longer effective. Roche Canada announced Health Canada’s approval of the first new treatment in almost 20 years for

hemophilia A patients with FVIII inhibitors.

The new treatment, HEMLIBRA®, is an emicizumab injection administered under the skin once per week as routine prevention of bleeding or bleeding episodes–much simpler than current therapies involving infusion treatments over long periods of time and often multiple times per week.

Patients using HEMLIBRA® showed a statistically significant reduction (87 per cent) in treated bleeds compared to no preventative treatment. Additionally, 87 per cent of children who received HEMLIBRA® experienced zero treated bleeds over a median observation time of 38.1 weeks.

December 2018/January 2019 BIOTECHNOLOGY FOCUS 7

BUSINESS corner Health Canada authorizes Adynovate for Hemophilia A patients under 12 years old On November 21, 2018 Health Canada authorized the use of ADYNOVATE®, an antihemophilic factor (recombinant), PEGylated for the treatment of hemophilia A in children under 12, announced Shire Pharma Canada ULC (Shire Canada), a leading global biotech company focused on rare diseases. The drug was previously approved in November 2016 for use in patients 12 and older.

Eric Tse, General Manager of Shire Canada said, “As a leader in developing innovative therapies to improve care for hemophilia patients, Shire is pleased to now offer a treatment option that can help Canadians manage hemophilia A from early childhood through to adulthood”.

Hemophilia A affects one in 10,000 people and 25 to 30 per cent of people with severe hemophilia will develop inhibitors, a rare but serious response to treatment with clotting factor concentrates. ADYNOVATE® is the first extended half-life PEGylated (recombinant) factor VIII treatment for perioperative management, the control and prevention of bleeding and the prevention or reduction of frequency of bleeding episodes.

“ADYNOVATE®’s unique PEGylation technology allows patients to achieve their treatment goals by providing bleed protection

and extending time between treatments, allowing patients to spend more time leading active lives, doing what they love,” said Tse. Health Canada’s approval was based on the results of a multi-centre, open-label, prospective, uncontrolled Phase 3 clinical study of patients under 12. Of the 66 subjects receiving ADYNOVATE®, 73 per cent

experienced no joint bleeding, 67 per cent had no spontaneous bleeding, and 38 per cent had no bleeding at all during the study.

Paul Wilton, President of the Canadian Hemophilia Society expressed the society’s enthusiasm. “It is an exciting time in hemophilia care, with many promising products in the pipeline and coming to market.”

Ipsen Canada Appoints Ed Dybka as General Manager

Ed Dybka

Ed Dybka took over as General Manager for Ipsen Biopharmaceuticals Canada Inc. effective Oct. 15, 2018. “I am honored to be joining Ipsen Canada at such a transformational time in the company’s history and look forward to working on achieving its mission of improving patients’ lives.

Throughout my career, I have taken great pride in knowing that the work our industry does directly improves the lives of millions of patients across Canada,” said Dybka.

With over 30 years of involvement in the Canadian pharmaceutical industry, Dybka’s most recent experience includes leading the development of an early stage biotech company, a joint venture between MaRS Innovation and The Centre for Drug Research and Development. Prior to this, Dybka served as President and CEO of AstraZeneca Canada Inc. and led the biopharmaceutical start-up Almirall in getting established in Canada.

Ipsen North America CEO Richard Paulson expressed his enthusiasm for Dybka’s appointment. “We are delighted to wel-

8 BIOTECHNOLOGY FOCUS December 2018/January 2019

come Ed to Ipsen Canada as we establish new milestones on our path to maintaining strong growth and further expanding our relationships with researchers and organizations across the Canadian healthcare ecosystem. Ed brings a wealth of leadership expertise, a track record of fostering innovation, and an in-depth understanding of our industry garnered from his extensive work within the Canadian pharmaceutical market. He is a valuable addition to the Ipsen Canada team.”

Paulson also thanked outgoing General Manager Paul Reider who left Ipsen to pursue other opportunities. “Paul has been an instrumental team member and I’d like to thank him for his many contributions and unwavering commitment to the business over the last few years. I wish him well in his new endeavors.”

Headquartered in Mississauga, Ont., Ipsen Biopharmaceuticals Canada Inc. is the Canadian affiliate of Ipsen, focusing on innovation and specialty care.

BUSINESS corner

Douglas A. Hamilton appointed as Vasomune Therapeutics President and CEO In October, Vasomune Therapeutics announced that they’ve appointed Douglas A. Hamilton, former President and CEO of MetaStat Inc., as their President and CEO. Hamilton will also sit on the board of directors and succeeds Parimal Nathwani who remains on the board.

Michael Yonge, Director and Executive Vice President and Chief Administration Officer of Sunnybrook Health Sciences Centre, offered the following sentiments to outgoing president Nathwani. “On behalf of the board and shareholders, I would like to thank Parimal Nathwani for his leadership in creating and guiding Vasomune Therapeutics to its current stage of development, including raising seed financing and orchestrating the co-development deal with Japan-based AnGes Inc.” Hamilton expressed his enthusiasm in joining Vasomune and its team of founders, dedicated scientists, consultants and highprofile institutional investors. In addition to his experience at MetaStat, a precision medicine company discovering and developing novel anti-metastic drugs to treat aggressive cancer, Hamilton, an honours B.Sc. graduate from the University of Toronto department of medical genetics and MBA recipient from Ivey Business School at West-

ern University, has experience at companies like Javelin Pharmaceuticals and PolaRx Biopharmaceuticals.

“We are thrilled to welcome Doug to the leadership role at Vasomune during this exciting time in the company’s history - he has the management expertise required to transition the company from a preclinical to clinical stage,” says Rafi Hofstein, President and CEO of MaRS Innovation, the founding investor of Vasomune. “Attracting an accomplished leader like Doug to Toronto is part of our efforts to entice expats to return to Canada where there is a need for highly trained executives to become involved in

Hamilton Thorne completes $10-million Cdn bought deal private placement

steering start-up companies to success.”

Vasomune Therapeutics, a privatelyowned Toronto-based company, is a leader in developing treatments for diseases associated with blood vessel (vascular) dysfunction and destabilization. “By selectively targeting the host response, Vasomune’s therapeutic approach focuses on a single, non-redundant pathway that inhibits multiple factors responsible for driving run-away inflammatory processes,” said Hamilton.

Left untreated, run-away inflammation can lead to or worsen conditions such as respiratory infections, acute kidney injury and diabetic nephropathy.

Assisted Reproductive Technologies (ART) giant Hamilton Thorne announced the completion of a common share deal that provides them with gross proceeds of $10,000,001 Cdn (the Offering). As a result, the company issued 9,090, 910 common shares at $1.10 Cdn per share.

In addition, the Underwriters Bloom Burton Securities Inc. on behalf of a syndicate including Beacon Securities Limited and Cormark Securities Inc. received 545,454 non-transferable broker warrants and a cash commission of approximately $600,000. Each warrant may be exercised into one common share of Hamilton Thorne at a price of $1.10 Cdn within 12 months.

Net proceeds of the Offering will be used to fund future acquisitions and general working capital expenditures for Hamilton Thorne, the leading global provider of precision instruments, consumables, software and services related to ART and biology research markets.

December 2018/January 2019 BIOTECHNOLOGY FOCUS 9

Diagnostics

| By Melanie Szweras and Ainslie Parsons Bereskin & Parr LLP

Patenting diagnostic methods in Canada: A glimmer of light from our southern neighbours?

Personalized medicine, where prevention, diagnosis, and/or treatment of disease is tailored to a particular individual, is becoming more and more prevalent as scientists uncover new connections between biomarkers and illnesses.

10 BIOTECHNOLOGY FOCUS December 2018/January 2019

H

owever, developments in the Canadian Patent Office (CPO) over the last several years have made it increasingly difficult to patent technologies related to molecular diagnostics.

The following reviews the current position of the CPO with respect to diagnostic patent claims and looks at recent developments in the United States.

At issue are patent claims directed to methods of diagnosing a particular disease in a subject where the inventors have identified a new association between a known biomarker and the disease. Such claims are routinely

Diagnostics

Practically, the diagnostic guidelines instruct Canadian patent examiners to reject most patent claims directed to diagnostic inventions and have made it difficult to secure patent protection for novel, non-obvious, and useful diagnostic inventions in Canada. rejected by Canadian patent examiners for being directed to non-patentable subject matter, despite meeting the other requirements for patentability, namely novelty, utility and non-obviousness.

The Canadian Patent Act defines an invention in Section 2 as “any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter”. A statutory exception is set out in Section 27(8) of the Patent Act, which provides that a patent shall not be granted for “any mere scientific principle or abstract theorem”.

The patent eligibility of various types of subject matter has also been considered by the Canadian courts over the years. However, there have been no decisions specifically speaking to the patent eligibility of molecular diagnostic methods. Rather, current Canadian Examination practice with respect to diagnostic methods is based on a series of Practice Notices released by the CPO starting in 2013.

Practice Notice 2013-02 was published in 2013 following a Federal Court of Appeal case related to the patent eligibility of business methods (Amazon.com v. Attorney General (Amazon.com) ), and provides guidance on the purposive construction of patent claims.

The 2013 Practice Notice describes using a “problem-solution” approach to inform a purposive construction of the claims, including limiting the essential elements of the claims to those that solve the identified problem.

In June 2015, the CPO published a Practice Notice setting out procedures for examiners to follow when considering the patent eligibility of diagnostic method claims (Practice Notice 2015-02). This Practice Notice has now been incorporated into the Canadian Manual of Patent Office Practice (MOPOP).

Both the 2015 Practice Notice and MOPOP (referred to herein as the “diagnostic guidelines”) instruct examiners to identify the problem the inventors set out to solve and

the solution provided by the invention and determine whether elements in the claims are essential (provide a solution to the identified problem) or non-essential (do not provide a solution to the identified problem). If the essential elements are required solely to solve a “data analysis problem” as opposed to a “data acquisition problem”, the claim will be refused as directed to non-statutory subject matter. Examples of “data analysis” problems include the identification of a new and nonobvious correlation, for example, between a known biomarker and a disease state.

The identification of essential elements by way of a problem/solution analysis is generally considered to be inconsistent with the teachings of the Supreme Court in Free World Trust v. Électro Santé Inc. (Free World Trust)2 and Whirlpool Corp. v. Camco Inc. (Whirlpool)3. These cases confirmed the legal principles of claim construction in Canada including a single, purposive approach to claim construction. Under a purposive claim construction, adherence to the language of the claims is promoted, while recognizing that the claims must be read in an informed and purposive manner.

The “data acquisition/data analysis” division which is emphasized in the diagnostic guidelines also has no basis in Canadian case law. Arguably, if the test for statutory process under Section 2 of the Patent Act is met, then the subject-matter must be considered patent eligible, irrespective of any notion of “data acquisition” or “data analysis”.

Practically, the diagnostic guidelines instruct Canadian patent examiners to reject most patent claims directed to diagnostic inventions and have made it difficult to secure patent protection for novel, non-obvious, and useful diagnostic inventions in Canada.

Diagnostic claims in the United States also encounter similar challenges to those in Canada. Indeed, the dearth of Canadian case law and the close timeline between the United States and Canadian prohibitions

against patenting medical diagnostics have led some commentators to suspect that the CPO’s policy is informed at least in part by the position of the United States.

In two decisions, Mayo Collaborative Servs. v. Prometheus Labs., Inc (Mayo)4 and Alice Corp. Pty. Ltd. v. CLS Bank Int’l (Alice)5, the US Supreme Court developed a two-step test to determine patent eligibility. Step one of the test asks whether a patent is directed to ineligible subject matter, namely a law of nature, natural phenomenon, or abstract idea.

If it is, then the second step determines if the patent contains an element or combination of elements sufficient to establish that the claim as whole amounts to “significantly more” than the judicial exception.

Diagnostic method claims have faced challenges in the wake of the Mayo and Alice decisions with courts holding that a correlation between a biomarker and a disease state is an ineligible “law of nature”. Claims are only held to be patent eligible where they include additional limitations that add “significantly more” to the abstract idea, namely activities that are not well-understood, routine and conventional in the field.

Within the last year however, there have been some early indications that the landscape in the United States with respect to diagnostic claims may be changing.

In a recent decision, Vanda Pharmaceuticals v. West-Ward Pharmaceuticals (Vanda)6, the United States Federal Circuit held that a diagnostic claim which also recited an administration step was patent eligible. The Court held that while the inventors recognized relationships between a drug and a biomarker, what they claimed was an application of these relationships. Following the Vanda decision, the USPTO issued a memo to examiners providing that method of treatment claims that apply natural relationships should be considered patent eligible and it is not necessary for the method of treatment to include non-routine or unconventional steps to be patent eligible7.

December 2018/January 2019 BIOTECHNOLOGY FOCUS 11

Diagnostics

Claims are only held to be patent eligible where they include additional limitations that add “significantly more” to the abstract idea, namely activities that are not well-understood, routine and conventional in the field.

the patent eligibility of diagnostic method claims in Canada, such a case is not currently on the horizon. In the meantime, it is hoped that the CPO will act to either amend or rescind the diagnostic guidelines. If the present trend in the United States towards enlarging the scope of patent eligibility of diagnostic claims continues, it may be more likely that the CPO will reconsider their current position to bring the office more in line with other jurisdictions. This would be welcome news for those trying to bring new and potentially life-saving diagnostic tests to the Canadian market.

References: 2.

3.

4.

5.

6.

7.

8.

Including a treatment step in a diagnostic claim could also be a useful approach for trying to overcome subject matter objections in Canada, although a few caveats exist. First, as methods of medical treatment are not patentable in Canada, such a claim would need to be carefully drafted to avoid any active steps of medical treatment. In addition, a diagnostic claim that also includes a treatment step will likely be of lower value to a patentee given that divided infringement is an open question in Canada. In particular, it is unclear whether a claim that includes steps of both diagnosis and treatment would be infringed in Canada when two different parties perform each of the steps (divided infringement is also an issue in the United States, although there has been some recent US case law that may make it easier to establish a case for divided infringement).

Another positive development in the United States is the case of Berkheimer v. HP Inc (Berkheimer)8 involving a computer implemented invention. Here, the Federal Circuit held that when analyzing the second step of the Alice/Mayo test, the question of whether the elements of a claim in addition to those reciting judicial exceptions represent “wellunderstood, routine, conventional activity” raises a disputed issue of fact. A subsequently issued memo to examiners from the USPTO

sets out that in light of Berkheimer, a conclusion of “routine and conventional” can only be reached where the elements at issue are “widely prevalent or in common use in the relevant industry” and not merely found in the prior art.9 The teachings of Berkheimer could also potentially be useful in Canadian prosecution to rebut objections from Examiners that claimed steps of “data acquisition” are simply part of common general knowledge, and therefore not relevant to a determination of subject matter eligibility.

Further, the Director of the USPTO recently made remarks stating that new guidance on subject eligibility may be coming soon10. Director Iancu spoke against the conflation of patent eligibility with the other patentability requirements of novelty and nonobviousness, noting that the “proposed new guidance would explain that Supreme Court jurisprudence taken together effectively allows claims that include otherwise excluded matter as long as that matter is integrated into a practical application”. Most recently, two U.S. senators have invited several companies, industry groups, and intellectual property experts to a closed-door meeting in mid-December to discuss possible legislation to reform the standards for patent eligibility in the United States.

While a precedent-setting case on diagnostic methods would be the ideal way to clarify

12 BIOTECHNOLOGY FOCUS December 2018/January 2019

9.

10.

[2000] 2 SCR 1024.

[2000] 2 SCR 1067.

887 F.3d 117 (Fed. Cir. 2018). https://www.uspto.gov/sites/ default/files/documents/ memo-vanda-20180607.PDF 881 F.3d 1360 (Fed. Cir. 2018), rehearing denied (Fed. Cir. May 31, 2018). https://www.uspto.gov/sites/default/ files/documents/ memo-berkheimer-20180419.PDF https://www.uspto.gov/about-us/ news-updates/remarks-director-iancuintellectual-property-owners-46thannual-meeting https://www.uspto.gov/sites/ default/files/documents/memoberkheimer-20180419.PDF https://www.uspto.gov/about-us/ news-updates/remarks-directoriancu-intellectual-property-owners46th-annual-meeting

Melanie Szweras, B. Sc., Ph.D. (Genetics), LL.B. is a Partner with Bereskin & Parr LLP and focuses her practice on biotechnology and pharmaceutical patents including drafting and prosecution of such applications. She also lectures on aspects of Biotechnology and The Application Process at the University of Toronto’s Patent & Trade Secrets Law Course and Osgoode Hall’s LLM Patent Law course.

Ainslie Parsons, B.Sc. (Biology)(Hons.), Ph.D. (Genetics), J. D. is an Associate at Bereskinn & Parr, LLP. A lawyer and registered patent agent, Ainslie’s practice focuses on life sciences matters, including patents, licensing, and related litigation.

She also has experience in the analysis of patent issues such as validity, infringement and freedom to operate.

Biotechnology Focus delivers critical Canadian news and insights, trends and reports, from R&D to business.

www.biotechnologyfocus.ca Focused on moving innovation forward

Best Practices

| By Siofradh McMahon

Navigating the regulatory complexity of

regenerative medicine in Canada

R

egenerative medicine and the advanced therapies being developed in this field have the potential to bring about an entirely novel therapeutic approach to the treatment of human disease. A small number of products have already been approved by regulators around the world, and many more are in development to treat a variety of diseases.

This includes many diseases that have not been well served by current therapeutic approaches, such as intractable cancers and rare genetic disorders.

The number of potential targets, and therefore potential market size, increases year on year; the global regenerative medicine market was valued at $36 billion US in 2016 and is anticipated to grow to $49.14 billion US by 20211.

Canada holds a significant place in this industry, with the discovery of multipotent stem cells by Dr. James Till and Dr. Ernest McCulloch in Toronto in 19612. Since that time, Canada has nurtured foundational science and development efforts in this field, including providing research grants and funding for accelerator organizations, and enabling a flexible regulatory environment

for these and other innovative therapies.

However, this is still an emerging field with new technologies and approaches that are not always supported by the regulations currently governing health care. The following highlights how industry, physicians and Canada’s regulator have worked to overcome the challenges posed by being at the forefront of innovation.

Regulatory flexibility and other reasons to choose Canada While many other jurisdictions have started to incorporate specific regulations and guidance to manage advanced therapies (such as the Advanced Therapy Medical Product guidance in the EU3 and the U.S. FDA’s Regenerative Medicine Policy Framework4), Canada has yet to implement something similar for cell or gene therapies. These products are therefore regulated under the existing regulatory frameworks developed for pharmaceutical and biologic medicinal products, devices and human material for transplant.

In the absence of Canada-specific guidance in this field, manufacturers and developers often use existing guidance available in other

14 BIOTECHNOLOGY FOCUS December 2018/January 2019

International Council for Harmonisation of Technical Requirements for Human Use (ICH) member countries to guide development of their products.

Despite this absence of specific guidance, gaining approval for a clinical trial of a regenerative medicine therapy in Canada can be less complex than in other ICH jurisdictions.

Health Canada encourages developers and manufacturers to discuss issues and concerns early in development. Engagement with Health Canada is offered at no cost and can be readily accessed by all stakeholders, including those based outside of Canada, thus allowing developers to gain early insight into the regulator’s expectations of their development program.

Additional guidance is made available to academic researchers and developers who may have less familiarity with the regulatory process and many organizations, including the Centre for Commercialization of Medicine (CCRM), provide consulting services to assist in this process.

Health Canada uses its discretion when reviewing applications for market authorization and clinical trials and, as a result, the utilization of foreign guidelines to guide

Best Practices development has thus far not posed any significant regulatory challenges. However, it is recognized that this approach is not sustainable and increases ambiguity for industry; an effort is therefore underway to accelerate the development of an appropriate regulatory framework for advanced therapies.

industry stakeholders including biotechnology- and cell therapy-specific working groups. These broad engagements enable discussion of regulatory topics that transcend individual products or companies and are valuable opportunities for interaction for all parties.

Commitment to transparency and collaboration

A path forward

The Government of Canada has committed to implementing a transparency and openness framework and action plan, which includes taking steps to ensure stakeholders are informed and engaged on relevant areas of policy, as well as enabling and enforcing appropriate changes to regulations as needed.

For example, a regulatory modernization exercise is currently underway for which one of the target areas is health and bioscience.

Significant effort has been made to solicit input from stakeholders including issuing an open call for feedback via the Treasury Board of Canada, arranging in-person workshops with interested stakeholders, and setting up a series of smaller workshops and one-to-one meetings with groups across the country.

Aligned to this approach, Health Canada welcomes input from anyone interested in proposed regulations, policies and guidance, which are provided for public consultation.

International developers and manufacturers may also submit responses to these consultations and this can be an opportunity for those stakeholders to gain familiarity in the Canadian ecosystem in advance of entering the market.

Health Canada also works collaboratively with manufacturers and developers by holding regular bilateral meetings with

2.

Health Canada is a full member of ICH, and thus data generated in Canadian clinical trials are applicable and acceptable across all other ICH jurisdictions. With excellent health care and research facilities and a population largely centred in a small number of urban hubs, Canada can be an attractive location to run clinical development programs, including early phase regenerative medicine studies.

In addition, early phase manufacturing of these products can be less burdensome as no separate facility licensing is required to manufacture products for clinical trial use, thus reducing complexity in the early stages of development5.

As the regenerative medicine industry continues to grow and gain value globally and locally, Canada hopes to nurture it through a collaborative approach. While there remains challenges and gaps in the regulation of regenerative medicine therapies in Canada at this time, the Canadian regenerative medicine ecosystem, including industry and the regulator, has worked to find a path forward in the interim and continues to work closely to put in place appropriate regulatory frameworks for the future.

References 1. Regenerative Medicines Market by Therapy (Cell Therapy, Gene Therapy,

3.

4.

5.

Immunotherapy, Tissue Engineering), Product (Cell-based, Acellular), Application (Orthopaedic & Musculoskeletal Spine, Dermatology, Cardiovascular, Central Nervous System), Region - Global Forecast to 2021. marketsandmarkets. com. Website, July 2016 Till, James E., and Ernest A. McCulloch.

“A direct measurement of the radiation sensitivity of normal mouse bone marrow cells.” Radiation research 14.2 (1961): 213-222.

EudraLex The Rules Governing Medicinal Products in the European Union Volume 4 Good Manufacturing Practice. “Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products”. Adopted 2017.

U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research. “Expedited Programs for Regenerative Medicine Therapies for Serious Conditions”. November 2017 Bedford, Patrick, Steven Keizer, and Juliana Jy. “Considering Cell Therapy Product “GMP” Status.” Frontiers in medicine 5 (2018): 118.

Siofradh McMahon is Senior Manager, Clinical Translation and Regulatory Affairs at CCRM, a non-profit organization that works at the nexus of academia, industry and investors to accelerate the translation of scientific discovery into new companies and marketable products for patients. We are focused on regenerative medicine, including cell and gene therapy, and offer consulting services in a variety of areas, including regulatory affairs.

December 2018/January 2019 BIOTECHNOLOGY FOCUS 15

spotlight

| By Michelle Cornish

The evolution of NEOMED-LABS: GSK spin-out to strategic partner

I

n September, the management of NEOMED-LABS together with Ampersand Capital Partners, announced the acquisition of NEOMED-LABS from its not-for-profit founder and parent, the NEOMED Institute.

NEOMED-LABS was formed as a spin-out from GSK’s Clinical Laboratory Services unit in April 2015. Over the years, NEOMED-LABS has gained world-renowned expertise in clinical immunology and has used this strength to form partnerships with many top 10 global vaccine developers, innovative biotechnology companies and prestigious governmental and non-governmental organizations.

State of the art Biosafety Level 2 labs and a team of leading experts positioned NEOMEDLABS as a leading independent player in the immunology field. They have validated more than 30 assays and supported FDA filings of 10 marketed vaccines with $3 billion in cumulative sales. NEOMED-LABS is devoted to personalized service and fast-tracking method validation while providing unrivaled expertise in immunotools engineering and stability testing, The investment in NEOMED-LABS by Ampersand positions NEOMED-LABS to pursue more growth opportunities including expanding both in the market and geographically.

“After a successful spin-out from GSK and strong business performance during its first three years of operation, this investment from Ampersand will help NEOMED-LABS achieve the next level in its evolution and support the growing needs of our customers,” said Benoit

Bouche, President and Chief Executive Officer of NEOMED-LABS. As a middle market private equity firm with a history of investing in growth-oriented investments in the healthcare sector, Ampersand Capital Partners is positioned to keep NEOMED-LABS on their path to unrivaled success. With offices in Boston and Amsterdam, Ampersand’s unique blend of private equity and operating experience enables them to build exceptional long-term performance alongside its portfolio company.

Past accomplishments of Ampersand include building numerous market-leading companies across core healthcare sectors like laboratory products and services, contract manufacturing, pharma services, specialty pharma and healthcare services. Past partnerships include Brammer Bio, Confluent Medical, Genewiz, Genoptix, Talecris Biotherapeutics and Viracor-IBT Laboratories.

“We are excited to partner with Benoit Bouche and his team at NEOMED-LABS” stated Eric Lev, Partner at Ampersand. “We believe NEOMED-LABS has tremendous potential in the clinical immunology field.

Our goal is to actively support management to build the company into the world class leader of immunology-related assay development and clinical trial laboratory services.”

Donald Olds, President and CEO of the NEOMED Institute said, “I am very pleased with the closing of this strategic transaction.

The NEOMED Institute formed NEOMEDLABS in 2015 to preserve over 50 high pay-

ing R&D positions in Quebec and we have accomplished our mission. This transaction positions NEOMED-LABS for future success through access to new capital and the international network and expertise of Ampersand”.

Core objectives of the NEOMED Institute have always been significant future business and employment growth for Quebec and the Canadian life sciences industry. The NEOMED Institute is a Canadian not-for-profit research and development organization with a mission to enable and accelerate the commercialization of life science discoveries.

The NEOMED Institute carries out their mission through two complimentary and integrated divisions: NEOMED Therapeutics and the NEOMED Innovation Centre. NEOMED Therapeutics licenses promising scientific discoveries from Canadian universities and research institutes then funds and develops these discoveries so they are attractive investments for potential partners.

Through the NEOMED Innovation Centre in Montreal, Que., NEOMED hosts 30 life sciences companies and employs over 350 people in two state-of-the-art R&D centres.

Funding for the NEOMED Innovation Centre is provided by pharmaceutical partners, Quebec’s Ministry of the Economy of Science and Innovation and the Networks of Centres of Excellence of Canada.

The NEOMED-LABS partnership with Ampersand will ensure NEOMED reaches their goal of continuing to further significant developments and commercialization in the life sciences industry.

Photo: Paul Eifert

16 BIOTECHNOLOGY FOCUS December 2018/January 2019

Spotlight

| By Michelle Cornish

Good news for travellers to and immigrants from endemic regions:

Nobel prize-winning treatment for deadly parasitic infections approved in Canada

I

ntestinal strongyloidiasis (roundworm) and onchocerciasis (river blindness) are potentially devastating tropical parasitic infections that can be particularly difficult to diagnose, because symptoms can appear decades after infection. The diseases are contracted through direct contact with contaminated soil, in the case of roundworm, and through insect bites in the case of river blindness.

Based on current immigration and travel trends, it is suggested that cases of roundworm could increase, affecting up to 77 per cent of immigrants and refugees in Canada.

Symptoms of both strongyloidiasis and onchocerciasis can include a rash, hives, abdominal pain and unintentional weight loss.

The danger with patients not showing symptoms or being misdiagnosed is that these infections can remain in the body long enough that a patient can become immunocompromised. Dr. Michael Libman, MD, Director of the Centre for Tropical Diseases at McGill University says, if an infection persists for long enough, or the patient becomes immunocompromised, they could experience life-altering or life-threatening complications.”

Once immunocompromised, a patient does not have the ability to respond to an infection

in a normal and expected manner because of their weakened immune system. Health Canada has approved Merck’s STROMECTOL™ (ivermectin), a Nobel prize-winning treatment for both roundworm and river blindness. STROMECTOL™ is included on the World Health Organization’s List of Essential Medicines.

The Nobel prize for physiology or medicine was awarded to William Campbell and Satoshi Omura and Youyou Tu in 20151. Tu discovered artemisinin, a treatment for malaria, while Campbell and Omura discovered ivermectin, the key ingredient in STROMECTOL™, the treatment for roundworm and river blindness.

STROMECTOL™ is administered orally in

a single dose on an empty stomach with the recommended dosage being 200 mcg of ivermectin per kg of body weight for roundworm and 150 mcg per kg of body weight for river blindness. Reported side effects are mild and can include dizziness, fatigue, diarrhea, nausea and vomiting.

“We recognize that STROMECTOL™ is globally considered the standard-of-care with over 20 years of real-world experience, and that there is an unmet medical need in Canada.

As a committed partner in health, Merck Canada Inc. is proud to provide a therapeutic choice, where previously treatment options were limited,” said Anna Van Acker, President and Managing Director, Merck Canada Inc. “Having STROMECTOL™ now routinely available reinforces our ongoing commitment of improving the lives of Canadian patients.”

Merck has been a leading global biopharmaceutical company for over a century, known as MSD outside the United States and Canada, operating in more than 140 countries. They produce innovative medicines and vaccines to combat some of the world’s most challenging diseases including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer’s disease and infectious diseases like HIV and Ebola.

Reference: 1. Tambo, E. et al. 2015. Nobel prize for the artemisinin and ivermectin discoveries: a great boost towards elimination of the global infectious diseases of poverty. Infect Dis Poverty, 4:58. https://www.ncbi. nlm.nih.gov/pmc/articles/PMC4692067/

“If an infection persists for long enough, or the patient becomes immunocompromised, they could experience life-altering or lifethreatening complications.” ­ — Dr. Michael Libman, MD

December 2018/January 2019 BIOTECHNOLOGY FOCUS 17

spotlight

| By Sarath Peiris

Six world-first vaccines among the University of Saskatchewan’s Vaccine and Infectious Disease Organization-International Vaccine Centre contributions to global health

T

he University of Saskatchewan (USask) Vaccine and Infectious Disease Organization-International Vaccine Centre (VIDO-InterVac) has established itself as a leading global institute in protecting human and animal health since 1975, with six world-firsts among the eight vaccines it has commercialized.

The financial impact of these vaccines on industry in Saskatchewan alone has amounted to more than $1.2 billion over a 10-year span, said Dr. Andrew Potter (DVM), outgoing director and CEO of VIDO-InterVac. Two more vaccines are expected to soon receive marketing licences.

“Eight or 10 vaccines over a 40-year-plus window might not seem that great, but when you look at the number of world-firsts, it has been a remarkable accomplishment,” said Potter. “We have done things and continue to do things that are high risk, which nobody else will take on.”

The world-firsts include two vaccines against calf scours, potentially fatal diarrhea caused by bacteria and viruses, among other things. Two vaccines that Potter was instrumental in developing to protect cattle against shipping fever, a type of pneumonia, were the first created with genetic engineering and helped stem losses of more than $1 billion annually for the cattle industry.

Other world-firsts included a vaccine against a fatal intestinal bleeding disease in turkeys (hemorrhagic enteritis) and a vaccine co-developed in 2008 with University of British Columbia researchers to control human infections and environmental contamination by reducing the spread of E.coli 0157 bacteria by cattle.

Infectious diseases result in poultry mortality rates as high as 50 per cent, and cause industry losses of billions of dollars annually.

Food-borne illnesses resulting from E. coli and other toxins are responsible for more than 400,000 human deaths each year.

The other two commercialized vaccines, for swine pneumonia and bovine respiratory disease, were not world firsts, “but they were better than anything else out there,” said Potter.

The two vaccines expected to be licensed soon will protect against:

“RSV costs governments tens of millions for clinical treatment, patient transport and hospitalization, so a vaccine would be an ideal solution.” — Dr. Andrew Potter (DVM), outgoing director and CEO of VIDO-InterVac.

• Porcine epidemic diarrhea virus (PEDv), which has killed more than eight million piglets in North America since 2013 with losses of more than $400 million. The vaccine is being field tested in Saskatchewan and was recently used in Manitoba after a PEDv outbreak. Huvepharma has partnered with VIDO-InterVac to develop the technology for commercial production in North America.

• Contagious bovine pleuropneumonia, a cattle lung disease that is costing smallscale African farmers $60 million a year.

The vaccine has entered commercial production in Kenya and will be rolled out to other African countries.

18 BIOTECHNOLOGY FOCUS December 2018/January 2019

VIDO-InterVac’s new manufacturing facility to produce vaccines and other biologics (drugs produced from living organisms or components of living organisms) for clinical studies and animal vaccines will come on stream in 2020.

The first human clinical trial at the manufacturing facility is scheduled to start sometime in 2019 on the respiratory syncytial virus (RSV).

The virus produces severe lung diseases including bronchiolitis and pneumonia in infants and young children and is a leading viral cause of infant death, especially in northern communities.

Potter said RSV costs governments tens of millions for clinical treatment, patient transport and hospitalization, so a vaccine would be an ideal solution.

The clinical trial involves a novel vaccine developed by VIDO-InterVac researchers that preclinical studies suggest is safe, effective, and induces long-lasting immune responses.

It also induces robust immune responses in newborn animals and is effective for maternal immunization.

Research is ongoing for a variety of other vaccines ranging from human and bovine tuberculosis to Zika, Ebola, Middle East Respiratory Syndrome (MERS), and influenza.

“All of the easy-to-tackle diseases are done,” said Potter. “We are down to the tough ones that are left, such as a TB vaccine, on which many billions have been spent worldwide already.”

He said global partnerships will be the key to tackling emerging and re-emerging zoonotic diseases (transferring from animals to humans and humans to animals) as VIDOInterVac tackles the challenges ahead—a reason why the organization recently signed a memorandum of understanding with Nanjing Agricultural University in China to develop a vaccine research institute.

VIDO-Intervac conducts more than 150 infectious disease and vaccine studies annually with a team of over 45 PhD-level scientists among its 160-plus employees and offers a wide range of services to industry partners.

It has more than 80 registered patents and is one of the world’s most advanced containment Level 3 facilities with capacity to conduct large animal research.

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