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Regional Profile

Melbourne anchors Australian biotech sector 8

Law

Competition Bureau updates IP enforcement guidelines 19

moments in time

Genetically modified salmon approved for North American consumption 23

may/june 2016

Championing the Business of Biotechnology in Canada

Room to

Agricultural biologicals take off, balancing industry’s needs with the sustainability consumers crave

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inside

feature

the rise OF ag biO

In an age where GMOs and chemical pesticides are scorned, the agricultural industry has turned to high-tech solutions that utilize natural sources.

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Championing the Business of Biotechnology in Canada

When biotech multinationals need a place to scale up their operations and run clinical trials, they flock to this Australian city, and not just for its amazing weather.

19 CANADIAN IP GuIDeLINeS Get AN uPDAte Find out how recent updates to Canada’s Intellectual Property Enforcement Guidelines will affect the pharmaceutical industry.

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RegionaL PRofiLe

Melbourne anchors Australian biotech sector 8

Law

Competition Bureau updates IP enforcement guidelines 18

moments in time

Genetically modified salmon approved for North American consumption 23

MAy/juNe 2016

EnvironmEntal Sampling

DaviD Suzuki Wanted: healthy biosphere

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Championing the Business of Biotechnology in Canada

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May/June 2016

Critical testing in food facilities

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Room to

eDItoR’S Note 5 CANADIAN NewS 6 woRLDwIDe NewS 7 MoMeNtS IN tIMe 23

The Agricultural biologicals take off, balancing industry’s needs with the sustainability consumers crave

Food Issue

From seeds to safety to product development, labs have a critical role in the food chain

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editor’s note

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Against the

Current T

he back page of this issue, our Moments in Time article, features the AquAdvantage Salmon, the first genetically modified (GM) food animal to be approved for human consumption. The AquAdvantage Salmon received final approval from Health Canada in May. It was approved by the FDA last November. A press release from Health Canada says it and the Canadian Food Inspection Agency have completed thorough and rigorous scientific reviews of AquAdvantage Salmon for food and livestock feed use and determined that it is as safe and nutritious for humans and livestock as conventional salmon. The AquAdvantage Salmon was developed by AquaBounty Technologies Inc. (AquaBounty Technologies’ largest shareholder is Intrexon Corporation, a synthetic biology company with interests in medicine, food and agriculture, fuels and the environment.) to promote rapid growth during early life. This was achieved by introducing a growth hormone gene from the Chinook salmon to an Atlantic salmon. GM foods that have been approved by Health Canada have been consumed in Canada for many years, making this an important issue. Changes to the genes of plants and animals can improve food quality and production – for instance by reducing the need for pesticides, making crops resistant to drought, preventing bruising, or allowing foods to be grown more quickly (see our story on agricultural biologicals on page 13) – but it’s been such a hot button issue for consumers despite the advantages that I’m surprised companies are still willing to swim against the current of consumer disdain and jump through the hoops of regulatory bodies. Obviously the payoff of making it to the end, of having a product approved, can be lucrative. AquaBounty says it is focused on improving productivity in commercial aquaculture, a $157 billion industry and the fastest-growing segment of the worldwide food industry. “We look forward to bringing our nutritious salmon to consumers to enjoy in an environmentally responsible manner without damaging and exploiting the oceans, with the assurance it is as safe and healthy as the Atlantic salmon they are eating now,” Ronald L. Stotish, PhD, Chief Executive Officer of AquaBounty, said in a release. The salmon will not be labelled as GM, something many consumer groups are fighting for. Health Canada requires labelling for food products, including genetically modified foods, where clear, scientifically established health risks or significant changes to the nutritional qualities of the food have been identified and can be mitigated through labelling. For example, an allergen present in a food must be labelled to alert consumers. In this case, given that no health and safety concerns were identified, there are no special labelling requirements. The AquAdvantage Salmon won’t be available right away. Dave Conley, Director of Corporate Communications, says it will be more than a year and in limited quantity. The company’s Panama facility can only produce about 100 tonnes whereas the global salmon farming industry produced 2.5 million tonnes in 2014. Clearly there are advantages to breeding an animal like this, for both consumers and business. There may be disadvantages too, but they haven’t yet been identified. We’ll see whether the consumer will take that chance but in the meantime, I enjoy seeing what Theresa Rogers can happen when science swims against the current. executive Editor

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canadian news

Canadian Species in Danger of Extinction

Several Canadian species of plants, animals and other organisms are on the brink of extinction, according to a recent assessment by the Committee on the Status of Endangered Wildlife in Canada. The Committee met in April to evaluate the conservation status of 26 Canadian species. Ten new species were added to a growing list of 739 with only a few showing signs of improvement over the past decade. Some of the species feared to be in danger are the Sakinaw Sockeye Salmon, the Eastern Persius Duskywing butterfly and several native species of ladybugs.

Young Biotech Employee Recognized

Childhood Asthma Receives Funding

Research into the impact of a child’s upbringing and social and physical environments on the development of asthma will receive $2 million from the Canadian Institutes of Health Research (CIHR) and Genome British Columbia (Genome BC) to tackle the condition that affects as many as one in three Canadians. The research is a collaboration between UBC, BC Children’s Hospital, an agency of the Provincial Health Services Authority, and the Canadian Healthy Infant Longitudinal Development (CHILD) Study.

Canada Invests in Immunization App bio business m ay/j u n e 2 01 6

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Canada is investing $3.5 million in an innovative mobile app called ImmunizeCA that helps Canadians keep track of their immunization information. The app allows Canadians to store and manage their families’ vaccination records, and provides access to vaccination schedules based on information specific to people’s home province or territory, and reliable, expert-approved information about vaccinations. It also offers useful tools such as appointment reminders and local outbreak notifications. First launched in 2014, ImmunizeCA will be enhanced and expanded in a collaborative project led by researchers from The Ottawa Hospital.

Mathieu-Marc Poulin was awarded BioTalent Canada’s Catalyst Award for his contribution to the work of his employer, Delivra.

BioTalent Canada recently announced the winner of its first Catalyst Award, for the young employee who contributed most significantly to a Canadian biotechnology employer in the past year. Mathieu-Marc Poulin of Delivra in Charlottetown, PEI, wins bragging rights and a cash prize of $1,000. Poulin’s employer, Delivra, is a developer of transdermal As part of a multi-disciplinary research team, technologies that introduce Poulin’s input as Research and Development pharmaceutical and natural Technician helped Delivra secure funding molecules into the body through from the National Research Council’s the skin, rather than via pills. Industrial Research Assistance Program. As part of a multi-disciplinary research team, Poulin’s input as Research and Development Technician helped Delivra secure funding from the National Research Council’s Industrial Research Assistance Program. His research was also instrumental in Delivra’s development of new transdermal products. Catalyst Award applicants were evaluated along four criteria: Their contribution to their employer’s company culture and sense of innovation, their contribution to achieving a team’s or company’s business objective and the degree to which they assisted their employer in overcoming a business challenge. “BioTalent Canada’s wage subsidy program allowed Delivra to expedite a new research endeavour and meet its target milestones on time and within budget, which would not have been possible otherwise,” says Dr. David C. Baranowski, Director of Research at Delivra. “Importantly, the program allowed us to mold a new graduate into a great fit within the research team and we’ve been impressed at how far Mathieu-Marc has come in such a short period of time.”


worldwide news

Possible Explanation for Why Genetic Code Stopped Growing

Twenty-two pharmaceutical companies were finalists of the 2016 eyeforpharma Philadelphia Awards, including Teva, which won for the Most Valuable HCP or Healthcare Initiative with its foray into Artificial Intelligence; UCB, which picked up the Most Valuable Patient Initiative or Service Award with its Report Cards submission; and TransCelerate, a consortium of top 20 pharmaceuticals which were recognized with the Most Valuable Pharma Collaboration award. Winning projects were selected from hundreds of initiatives from teams across the globe.

Austrian Research Team Tests Mosquitoes for Pathogens

A project funded by the Austrian Science Fund FWF is currently investigating mosquito species found in Austria and their role in the transmission of pathogens. In the past two years, researchers at the University of Veterinary Medicine Vienna (Vetmeduni Vienna) sampled about 30,000 of the insects. Mosquitoes were collected at more than 40 sites in eastern Austria and then subjected to morphological and, for the first time, genetic testing. The research team is currently using molecular methods to screen the mosquitoes for pathogens such as filarial worms, avian malaria and flaviviruses.

New York Lab Launches New Research Initiative Top: ICREA researcher Lluís Ribas de Pouplana headed the IRB Barcelona study. Photo Credit: IRB Barcelona Bottom: A 3-D model of an tRNA molecule. Photo Credit: PabloDans, IRB Barcelona

The discovery could have applications in synthetic biology, where the goal is to increase the genetic code and to modify it to build proteins with different amino acids in order to achieve novel functions.

Cold Spring Harbor Laboratory (CSHL) in New York has announced a new $75 million research initiative. The Center for Therapeutics Research project will see the laboratory apply its biomedical expertise toward advancing therapeutics for genetic diseases. New York State is providing $25 million for construction and equipment funds to modernize an existing facility to house the centre. The renovation project will update the Demerec Laboratory, built in 1953, which has been home to the laboratories of four of CSHL’s eight Nobel Prize winners.

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A study performed at the Institute for Research in Biomedicine (IRB) Barcelona offers an explanation as to why the genetic code, the dictionary used by all organisms to translate genes into protein, stopped growing 3,000 million years ago. In Science Advances, a team of biologists specialized in the field explained a limitation that put the brakes on the further development of the genetic code. The team of scientists demonstrated that the genetic code evolved to include a maximum of 20 amino acids and that it was unable to grow further because of a functional limitation of transfer RNAs – the molecules that serve as interpreters between the language of genes and that of proteins. They explained that that the machinery that translates genes into proteins is unable to recognize more than 20 amino acids because it would confuse them, which would lead to constant mutations in proteins and thus the erroneous translation of genetic information “with catastrophic consequences”. The discovery could have applications in synthetic biology, where the goal is to increase the genetic code and to modify it to build proteins with different amino acids in order to achieve novel functions. Researchers usually use organisms such as bacteria in highly controlled conditions to make proteins of given characteristics, but the Barcelona study demonstrates that the conflict of identity between synthetic tRNAs designed in the lab and existing tRNAs has to be avoided if more effective biotechnological systems are to be achieved.

Eyeforpharma Celebrates Innovation

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MELBOURNE Australian city is a hotspot for biotech multinationals By HeRMIoNe wILSoN

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hen you’re planning a vacation, you probably go through a list of destinations to determine the best spot that will provide you with the right balance of temperature, comfort and great service, all for a reasonable price. It’s not so different than what biotech and biopharmaceutical companies do, except that instead of looking for sunny climes and great hotels, they are more interested in finding a place with a rich pool of technical talent and a welcoming regulatory environment. That place is Melbourne, at least according to Krystal Evans, CEO of the BioMelbourne Network. Not only is the Australian city considered one of the


most livable in the world, Evans says Melbourne is “the city that anchors Australia’s biotech sector.” “We have this precinct area in Melbourne called Parkville and you can stand on the corner and literally see five world-class research institutes and you can walk between them without your coffee getting cold,” she says. Melbourne is the home of medical bionics, Evans says. “We have a strong bionic and neuromodulatory community here.” Case in point is the industry research collaboration that has sprung up in Melbourne and led to a retinal implant that restores sight to the blind, she says. The national consortium, which operates under the name Bionic Vision Australia, is made up of the University of Melbourne, University of New South Wales, the Centre for Eye Research Australia (CERA), the Bionics Institute, and information communications technology research centre National ICT Australia (NICTA).

below left: Krystal evans, CeO, biomelbourne Network below right: Jackie Fairley, CeO, starpharma

the bionic eye “The idea is to put a series of electrodes, a very small implant that goes, in our case, just behind the retina,” explains Robert Klupacs, Executive Chairman of Bionic Vision Technologies (BVT), the company that was created by the consortium to be

the vehicle to lead ongoing development and commercialization. “It’s got a series of electrodes in it designed to stimulate the retina.” Electrodes are implanted behind the retina of the subject and work in concert with an external vision processing unit and a camera attached to a pair of glasses. The camera captures images and transmits the data via the electrode implants to the stimulated retina. “What patients see, they don’t see what you and I see necessarily, they see light signals,” Klupacs says. “They don’t see a tree, but they see a shape, for example, and can now start navigating around that.” There are other bionic eye approaches on the market, he says, but what makes this one unique is the surgical technique and the design of the retinal implant itself. Most implants involve a surgery that requires the eyeball to be taken out and the prosthetic to be effectively stapled to the retina. The Bionic Vision Australia implant is much less invasive. Ours is designed to be put into a physiological pocket that’s just behind the retina,” Klupacs says. “A much easier surgery and designed to, if we develop upgrades or things go wrong, easy to take it out.” The goal is to give people who are profoundly blind a means to get around without the help of a guide dog or a cane. The Bionic Vision Australia consortium eventually hopes to move from the profoundly blind to those who have very limited vision and improve their quality of life as well. A prototype of the group’s retinal prosthetic is currently in preclinical development and they hope to start clinical trials in the latter part of 2016. “It’s taken a while, but we are moving into the fully fledged commercialization and development stage,” Klupacs adds. One of the strengths of Melbourne’s biotechnology sector is its collaborations, Evans says. She points

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to a partnership between GSK and Melbourne’s Monash Institute for Pharmaceutical Sciences, a partnership that has driven growth in the region’s pharmacology and drug development arena. Earlier this year, Melbourne’s Australian Cooperative Research Center for Cancer Therapeutics entered a partnership with Merck, which has led to the development of inhibitors of the enzyme PRMT5, which regulates genes involved in cancerous growth and blood development. “We’re finding that a lot of U.S. and North American companies are actually using some of our manufacturing and design capabilities,” Evans says. “It’s a really nice situation in that Melbourne works while North America sleeps, so you can kind of get 24-hour, around-theclock R&D.”

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the antiviRaL conDom It could also have something to do with the Australian city’s highly skilled labour force and research capabilities. “Melbourne is based in Victoria, which is the leading state for Australia’s biotechnology sector,” says Jackie Fairley, CEO of biotech Starpharma. “The entire state consists of approximately 150 biotechnology companies, 13 major medical research institutes, 10 teaching hospitals and nine universities. In total they employ roughly 22,000 people in the life sciences sector.” Fairely credits much of Starpharma’s success to research partnerships with local Melbourne universities and research institutes, such as the longstanding collaboration with the Monash Institute of Pharmaceutical Sciences, recently ranked one of the top five pharmacy schools in the world.

vivagel’s active ingredient sPl7013 (blue and red) is believed to bind to specific proteins on the surface of hiv(yellow), preventing fusion with human cells.

Starpharma has developed a drug delivery technology called dendrimers, man-made nanoscale polymers that have been applied to everything from condoms to cancer treatments. In 2015, Starpharma signed an agreement with AstraZeneca to develop and commercialize compounds based on the dendrimer technology. Starpharma dendrimers are being used to coat antiviral condoms which tests have indicated inactivates 99.9 per cent of HIV, herpes, and Human papillomavirus (HPV). The VivaGel condom, manufactured by condom

manufacturer Ansell Limited and Japanese condom manufacturer Okamoto Industries, is the first of its kind. The dendrimers have also been found in clinical trials to improve the efficacy of treatments for bacterial vaginosis and has the potential to improve the efficacy of blockbuster chemotherapy drugs and reduce their side effects. “And that’s just the pharmaceutical applications,” Fairley says. “Starpharma’s patented dendrimers can also be combined with herbicides and pesticides to improve their efficacy,


regional profile

An Attractive Destination Melbourne is also known for its strong clinical trial capabilities, particularly in human trials, Evans says. Australia’s efficient regulatory system , ability to do clinical trials in a timely manner and undertake recruitment, as well as the fact that the data is recognized by the FDA and the EMA (the European regulatory body), attract a lot of North

American companies to its shores to conduct clinical work. It doesn’t hurt that Australia also offers an R&D tax incentive that refunds up to 45 cents on the dollar and is available as a cash refund for companies who are not in profit, allowing them to sustain R&D pipelines for longer and make the most of their research dollars, she says. “It makes Australia a really attractive investment destination because investors know that Australian companies are spending their money but also then being able to reinvest that tax credit back into their R&D programs,” Evans says. “We’ve got the research community, we’ve got the business community, we’ve also got the R&D services community and industry support,” Evans says. “We’ve got life science experts in finance, legal, accounting; every element that you need to go from idea to impact.” When it comes to making Melbourne a welcoming place for multinationals, the BioMelbourne Network team considers itself as being on the frontlines, rolling out the red carpet. “Sometimes I think that the BioMelbourne Network is a bit like a concierge service at a hotel,” Evans says. “We facilitate a lot of international engagement, as well as bringing people to Melbourne as international experts, and also to take Australian innovation global in terms of leading trade delegations and engaging internationally with investors and providing a soft landing space for companies who wish to access and collaborate and partner with Melbourne’s R&D capabilities.” BB

Melbourne

Biotech Facts

• More than 22,000 professionals working in the life sciences sector. • More than 150 biotechnology start-ups and several major international pharmaceutical companies, including GlaxoSmithKline, Merck, AstraZeneca, BristolMyers Squibb, and Pfizer, have significant operations in Melbourne. • Victoria, the Australian state where Melbourne is situated, receives more than 40 per cent of national government medical spending and is the acknowledged leader in medical research. Victorian companies make up 68% of the aggregate value of Australia’s top 20 listed biotechnology companies.

Australia’s efficient regulatory system, ability to do clinical trials in a timely manner and undertake recruitment, as well as the fact that the data is recognized by the FDA and the EMA, attract a lot of North American companies to its shores.

• Australia was ranked 4th in the world in biotechnology by the Scientific American Scorecard. [Scientific American Worldview Overall Scores]

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extension of the performance of actives, better stability and removal of solvents.” Still, it is the pharmaceutical applications of the dendrimer technology that have put Starpharma on the map, she says. “[Melbourne] is a dynamic and creative city that draws talent from both within and outside of Australia, and this no doubt contributes to our success because Starpharma aims to attract some of the best and brightest researchers,” Fairley adds.

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Melbourne

A u s t r a l i a ’s b I o t e c h n o lo g y a n d I n n o vAt I o n c a p i t a l

Melbourne’s strong focus on world class biotechnology capabilities is helping cement its position as one of the world’s leading locations for medical technology and pharmaceutical development. Its success can be attributed to a combination of its educated population, strong academic institutions, favourable regulatory and R&D environment, and a supportive government. Melbourne has pioneered breakthrough technologies and treatments including the discovery of epilepsy genes, development of Relenza, cochlear ear implants, rotavirus vaccines and the discovery of colony stimulating factors now used widely to treat patients with compromised immune systems.

Melbourne is recognised for its world leading R&D capabilities in: » infectious diseases and immunology » cancer » neurology » regenerative medicine » drug candidate identification and optimisation including medicinal chemistry » high quality, cost effective and fast to approval clinical trials.

More than 50 per cent of Australia’s listed biotechnology and medical equipment companies are located in Melbourne. Its skilled and innovative workforce includes over 21,000 people employed in the pharmaceutical and biotechnology industry and more than 20,000 researchers in universities, hospitals and research institutes. CSL, for example, is Australia’s largest biopharmaceutical company with a market capitalisation of over US$35 billion. Combined annual sales of commercialised biotechnology products from Melbourne totals more than US$9.5 billion a year. Melbourne’s outstanding R&D capabilities underpin the State’s innovative models of health provision and drive new opportunities for international partnerships to develop new products. Melbourne is a leading location for high quality clinical trials by major international pharmaceutical, medical device and diagnostics companies. It has a range of experienced and specialist clinical trial providers and trial sites across all major therapeutic areas to ensure strict adherence to the highest standards of clinical research. The national regulatory pathway, the Clinical Trial Notification scheme, provides for the initiation of first-in-human clinical trials without the need for filing of an IND and often means that trials can begin within a week of registration. The Government has a well-established strategy to help its companies become part of a global supply chain in knowledge creation, research, product development and commercialisation. Its network of 18 global offices is working with international companies to identify new opportunities and potential local partner organisations.

To find out how to grow your business and find out more about Melbourne’s growing medical technology, biotechnology and pharmaceutical sectors please contact the Victorian Government Business Office in New York.

contact Mr nathan elia biotechnology, life Science and Medical technology Manager victorian government business office – new york tel: +1 617 6789 770 Fax: +1 212 573 957 email: nathan.elia@ecodev.vic.gov.au Website: www.invest.vic.gov.au


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RISEof Ag Bio AGRICULTURAL BIOLOGICALS ARE BECOMING MORE MAINSTREAM IN AN INCREASINGLY ECO-FRIENDLY INDUSTRY By HeRMIoNe wILSoN


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here is an increasing demand among consumers for more sustainable practices in agriculture and less dependence on chemicals to control pests and weeds. Genetically modified crops are one solution, but one that makes a significant per cent of the population very uncomfortable. That might explain why, in the last few years, major biotech companies have been moving to invest in the agricultural biologicals industry. “You’re seeing an explosion in this space,” says Shawn Semones, Director of BioAg Application Development at Novozymes in Salem, VA. In December 2010, Novozymes began the process of acquiring EMD/Merck Crop BioScience. In 2012 multinational Syngenta announced that it had agreed to acquire U.S.-based Pasteuria Bioscience, a company known for producing biological products to control plantparasitic nematodes, and later in 2015, Syngenta announced an R&D partnership with DSM “to develop microbial-based agricultural solutions, including bio-controls, bio-pesticides and bio-stimulants,” according to a press release. Also in 2012, Bayer CropScience acquired AgraQuest, a global supplier of biological pest management solutions based on natural microorganisms, and chemical company BASF acquired Becker Underwood, adding biological seed treatment and biological crop protection to its portfolio. It’s a signal that the agricultural biologicals space is destined to grow, Semones says. As for Novozymes, it invested in the agricultural microbials market in 2013 through a longterm strategic partnership with Monsanto, called the BioAg Alliance.

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Susan Boyetchko, researcher for Agriculture and Agri-Food Canada, with a colleague.

the agricultural sector for more than 10 years with products like Jumpstart, which improves yield in broad acre crops like canola, wheat and corn by mobilizing phosphorous in the soil and making it more available to the plant. The company also has a legume inoculant called Optimize which contains microorganisms that colonize the roots of soybeans and captures nitrogen from the air, turning it into a useful form for the plant. “[Microbials] is a relatively young area in agriculture,” Semones says. “We’ve been using inoculants for a hundred years, but the science around the inoculants or the microbial space has really started to accelerate over the last 15 to 20 years.” Our increased ability to sequence the genomes of microorganisms has led to the discovery of novel microbes, he says, and allowed us to better understand how these microbes do what they do, and to formulate and stabilize them so that they can be used in agriculture. “The analytical tools that allow us to understand what the microbes are doing in terms of their metabolome are getting much, much better in terms of precision and resolution,” he says. “We’re getting at tools that track microorganisms and understand what they’re doing when they’re applied to the seed or the soil or the plant.”

The Alliance “Novozymes has a rich history in the areas of microbial discovery and microbial fermentation,” Semones says. “We also brought a portfolio of microbial-based products to the table that spanned across biofertility and biopesticides, and when you couple that with Monsanto’s strengths in the area of field research and regulatory market strategies, it was the right collaboration.” – Shawn Semones, Director of BioAg Application Development, Novozymes Novozymes has been in

“We’re getting at tools that track microorganisms and understand what they’re doing when they’re applied to the seed or the soil or the plant.”


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the guaRD Dog In Kingsville, ON, Adjuvants Plus is working to register a biofungicide that promises to eradicate fusarium head blight, a disease that mainly affects wheat crops. The company has licensed two strains of a fungal organism called Clonostachys rosea, one it acquired from Agriculture and Agri-Food Canada and the other from the University of Guelph. “[The organisms] have a biocontrol function,” says President and CEO Bill Brown. “The main mode of action is in fact almost benign. It’s what’s called site occupation or food source denial. Once they’re inside of the plant, others have difficulty getting in because they command their food source.” “They’re a bit like a guard dog,” Brown adds with a laugh. “You get inside the fence and mess with the food dish, it eats you.” Biological products like Adjuvants Plus’ biofungicide would seem like the perfect fit for the niche organic farming industry, but the company has decided to focus on the largescale farming industry instead, where the product can have the most benefit. The Clonostachys rosea-derived biofungicide has a long-term effect on microflora, whereas chemical-based pesticides only linger for a few weeks before they dissipate, Brown says. When used as a seed treatment, the biofungicide follows the roots of the plant as it grows. The company is also exploring foliar options, that is, a mode of application that would allow treatment of the leaves of crops after they have been planted. Once Adjuvants Plus’ biofungicide has been licensed in Canada and the U.S. (currently in talks), it plans to register it

THE BIOAG ALLIANCE THE BIOAG ALLIANCE

Transforming global agriculture Transforming global agriculture

GrowingMonsanto world population and Novozymes and changing join forces diets create toatransform need to produce global agriculture more cropswith sustainable with less input microbial technology

Monsanto join forces Currentand andNovozymes future products from The BioAg Current and future products from The BioAg to transform global with crop yields Alliance will help farmers increase crop yields Alliance will help agriculture farmers increase sustainable usingmicrobial less land,technology water and inputs using less land, water and inputs

HOW THE ALLIANCE WORKS HOW THE ALLIANCE WORKS Microbes from Novozymes R&D

Microbes from Monsanto R&D

Microbes from Novozymes R&D

Microbes from Selected Monsanto R&D Microbes

the bioag alliance is a partnership between monsanto and Novozymes.

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Growing world population and changing diets create a need to produce more crops with less input

Small-Scale Fermentation

Process Optimization

Small-Scale Manufacturing Fermentation

Process Optimization

Manufacturing

Field Testing

Regulatory Selected Registrations Microbes

Field Commercialization Testing

Regulatory Registrations

Commercialization

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Clonostachys rosea – Field Peas Improved Nutrient Uptake with Biofungicide UNTREATED

TREATED

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in Europe as well. Brown says the product could also be used on corn, canola and other cereal crops. “Europe is cancelling hundreds of chemicals in the last five to eight years,” Brown says. “Even some of the fungicides that are presently being used, they’re trying to cut those out.” Biofungicides like Clonostachys rosea present a way to replace or at least halve the use of these chemicals in the agricultural industry, Brown says. “Our goal is to replace 20 or 50 per cent of fungicide use. We know how it works and why it works, because it’s not just a squirt and miss, it’s not [ just] there for seven days. If we use it as a seed treatment, it’s in this root zone for the life of the plant.” natuRe’s way Not all agricultural biologicals come in neat, sprayable packages. Some biopesticides come in the form of other insects, the natural enemies of crop pests. Others come in the form of microorganisms, bacteria and viruses that kill, suppress and control the crop pest population. It’s all about exploiting nature’s various defense mechanisms, says Agriculture and Agri-Food Canada research scientist Susan Boyetchko. She thinks it’s a matter of time before biopesticides replace traditional methods of pest control. “We’re running out of other modes of action, so biologicals really fill that area where we’re trying to find new modes of action,” Boyetchko says. “Basically what we’re doing is using nature’s best, aren’t we?” Agricultural biologicals could be the solution we’ve been looking for to pesticide resistance, though that is not to say resistance would never occur with biologicals, she says. We haven’t been using them long enough to know for sure. “We should not be using biopesticides or anything else as a silver bullet to control the pests,” Boyetchko says. Biopesticides should be considered as an additional control method, to be used alongside other pest control methods. “Why don’t we trick it by using different modes of action that are available to us and it can delay the onset of resistance from occurring?” she says. We are still a long way from replacing traditional pest control methods with biopesticides wholesale, and other biologicals like biocontrol and biofertilizer products are not yet well understood. For now, agricultural biologicals may have the greatest impact on the smaller scale organic farming and high-value fruit and vegetable spheres. “Biologicals are going to be specific for controlling a specific weed or something, so if you’ve got 20 different weeds in your field then you would need 20 different biologicals probably to control them,” says Murray McLaughlin, President and CEO of Sustainable Chemistry Alliance. “It would just get costprohibitive.” There is also the added challenge, he says, that in Canada it takes longer to get biologicals registered than in the U.S. “They tend to be able to get into the market quicker in the U.S.

Agricultural biologicals could be the solution we’ve been looking for to pesticide resistance, though that is not to say resistance would never occur with biologicals.


feature story

Types of Agricultural Biologicals (from Agricen.com)

Biostimulants Plant growth/productivity enhancement products.

Biopesticides Plant protection or biocontrol products.

Biofertility Plant nutrition. These products are sometimes separated from biostimulants into a third category.

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than here, so a lot of companies just don’t develop them for the Canadian market,” he says. But are agricultural biologicals sustainable? The answer seems to be an obvious yes, since they are derived from natural sources, but sustainability also involves the ability to reproduce the product, and to package and ship it. And even then, will they be effective when applied to the crops? “Biologicals are usually much more difficult to deal with because they usually need some humidity, some of them you can’t spray in high-intensity daylight, you have to spray in the early morning and late in the morning because they’ll break down quicker in high bright sunlight,” McLaughlin says. “There are a lot of challenges compared to dealing with a synthetic material.” “What makes them tricky is that we’re trying to formulate a living organism,” Boyetchko says. Once you have discovered a microorganism that will be beneficial to crop production, you need to figure out how to make it stable and how to get it to work at a certain time. And just like with chemicals, you have to ensure that biologicals don’t have an adverse effect on the environment, Boyetchko says. They go through the same rigorous testing as synthetic products do. He points out that biopesticides aren’t the only path to sustainability. It all depends on what you mean by sustainability. “Some of the pesticides that are out there are probably plant extracts that will become chemicals and then you can basically make those chemicals synthetically. Depending on what you use to make them, it could be sustainable as long as those products are something that can be renewed and reused.” Still, the agricultural biologicals sector is definitely picking up speed and it can only be to the agricultural industry’s benefit. “People who buy food, they’re demanding all the time that we reduce the pesticide residue in our food supply,” Boyetchko says. “This is one way of doing it.” BB

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Law

CANADIAN COMPETITION BUREAU

UPDATES IP ENFORCEMENT GUIDELINES

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By LIVIA AuMAND, fRANÇoIS BARIL AND PAtRICK CASHIN

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o

n March 31, 2016, the Competition Bureau released its updated Intellectual Property Enforcement Guidelines (the “IPEGs”). Of particular interest to the pharmaceutical industry are the sections of the IPEGs related to the application of competition law to settlement agreements under the Patented Medicines (Notice of Compliance) Regulations (“PM(NOC) Regulations”) and to “soft” product switches.

SETTLEMENTS UNDER THE PM(NOC) REGULATIONS

The IPEGs did not previously set out how the Bureau should approach settlement agreements under the PM(NOC) Regulations. This has been addressed by the updated IPEGs, which indicate that generally, a settlement agreement whereby the generic is permitted to launch before or upon patent expiry will not be reviewed by the Bureau. However, where the agreement also includes a payment from the innovator to the generic, the Bureau may review the agreement under the civil provisions of the Competition Act (the “Act”) dealing with anti-competitive agreements between competitors and, possibly, the abuse of dominance provision. Both of the above-noted civil provisions of the Act require the Bureau to establish that a settlement has had, is having, or is likely to have the effect of substantially preventing or lessening competition in a market. In order to determine whether this test is met, the Bureau will consider what would have likely occurred “but for” the settlement agreement, and assess whether the payment was so large as to significantly affect (delay, cancel or limit) a generic’s entry into the market. In circumstances where the Bureau concludes that the settlement agreement does or is likely to substantially prevent

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or lessen competition, the Bureau will consider whether the agreement generates any countervailing efficiencies. For example, if the restriction on competition led to longterm increases in product selection, quality, output and productivity, the Bureau may not seek a remedy. In the updated IPEGs, the Bureau also clarifies that it will typically not review agreements pursuant to the criminal conspiracy provisions of the Act (e.g. price fixing, market allocation, suppression of supply) unless the settlement clearly extends beyond the exclusionary potential of the patent or is a “sham”. The IPEGs include some specific examples of the types of agreements that might attract such scrutiny: (a) Where the generic is restricted from entry into the market beyond the term of the patent; (b) Where the agreement restricts competition in respect of products not at issue in the application under the PM(NOC) Regulations; or (c) Where the parties recognize that the patent is invalid and/ or not infringed. With respect to investigations relating to abuse of dominance, the updated IPEGs indicate that the Bureau would consider possible bone fide business justifications (pro-competitive rationales for the conduct) in its determination of whether the settlement was anti-competitive. If the Bureau concludes that there has been a breach of the civil provisions of the Act it may seek remedies including


Law

A may be impeded. As the innovator undertook this product switch strategy primarily to retain its market position past patent expiry, it could be viewed as something more than just the exercise of IP rights. In the updated IPEGs, the Bureau notes that “soft” product switches would likely not raise any issue under the Act. An example of a “soft” switch would be similar to the scenario above, but instead of removing Product A from the market, an innovator simply stops promoting Product A to health care professionals. Product A would still be available for purchase; however, the innovator would actively market Product B instead. Since the generic is still interchangeable with Product A, there is less of a chance that a “soft” product switch will be viewed as having been done primarily for the purpose of illegitimately retaining market share by the innovator.

In the updated IPeGs, the Bureau also clarifies that it will typically not review agreements pursuant to the criminal conspiracy provisions of the Act unless the settlement clearly extends beyond the exclusionary potential of the patent or is a “sham”.

PRODUCT SWITCHES

Product switching is a practice whereby a company stops marketing or producing one product, while concurrently beginning to market a new, similar product (e.g. a slightly different formulation or dose). While there are many reasons to do so that will not give rise to competition law issues (e.g., product improvement, refinement), the Bureau has identified situations where product switching may give rise to issues under the Act. In the previous version of the IPEGs, the Bureau cautioned that “hard” switches might attract scrutiny under the abuse of dominance sections of the Act. An example of a “hard” switch would be where an innovator has a successful product (“Product A”), set to lose patent protection, and the innovator introduces a slightly different form of that product (“Product B”) which remains under patent protection for several more years. The innovator then removes Product A from the market prior to patent expiry, which leads health care professionals to switch to Product B. Since any generic that would have been competitive with Product A would not be interchangeable with Product B, the generic’s entry upon patent expiry of Product

CONCLUSION

The Bureau has made no secret of its scrutiny of the pharmaceutical sector over the last several years and its concern regarding end of patent strategies which may block or delay generic access to market. In the absence of Canadian case law on the issue, the new IPEGs provide some muchneeded clarity regarding the Bureau’s approach to settlements and product switching which should assist innovators in understanding the sometime complex intersection between their IP rights and their obligations under the Act. BB

LIST OF ADVERTISERS & WEBSITES MANDEL page 2............................................................................................www.mandel.ca EPPENDORF page 4.................................................................................... www.eppendorf.com MELBOURNE page 12 .................................................................................www.invest.vic.gov.au CITY OF MISSISSAUGA page 18 ................................................................................. winthehumanrace.ca BIO-RAD page 22 ....................................................................................... www.bio-rad.com VWR page 24 ............................................................................................. www.vwr.com

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prohibition orders and, in the case of abuse of dominance, administrative monetary penalties of up to $10 million for a first offence and up to $15 million for subsequent offences.

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moments in time

From the Lab to the Kitchen

Photo Credit: AquaBounty Technologies

ewfoundland researchers from Memorial University had a hand in developing the first genetically modified (GM) food animals to be approved for human consumption. Dr. Garth Fletcher, head of the Department of Ocean Sciences, and Dr. Choy Hew, a former Department of Biochemistry researcher, co-invented the technology behind the AquAdvantage Salmon, an Atlantic salmon that reaches market size more quickly than non-GM farm-raised Atlantic salmon. Fletcher and Hew first began their work in the early 1980s with the idea of using gene transfer to produce strains of Atlantic salmon that could better tolerate the harsh winter conditions of the Newfoundland and Labrador waters. The researchers explored adding an “antifreeze� protein gene to the salmon, but although they figured out how to transfer the gene, once it was expressed in the fish it only produced trace amounts of antifreeze that were insufficient to protect the salmon. Fletcher and Hew decided instead to use their technique to transfer a growth hormone gene and develop a fast-growing salmon. They first began testing the technique in 1989 and within months they started to produce fish that were five to six grams in weight, as opposed to the quarter of a gram that non-GM salmon of the same age weigh. Fletcher and Hew eventually patented their research and co-founded the company AquaBounty Technologies in 1991. The company is headquartered in Maynard, Massachusetts. AquAdvantage Salmon was approved as a food by the FDA on Nov. 19, 2015. It was just approved for sale in Canada in May. BB

Dr. Garth Fletcher, Department of Ocean Sciences, Memorial University

http://today.mun.ca/news.php?id=9830

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Bio Business May/June 2016  
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