Following its recent issue of a of a US patent, nutraceutical business & technology spoke with Dr Wael Massrieh, VP of scientific affairs at Neptune Biotechnology, to discuss the protection of their innovative platform ... and of the raw material itself.
NBT: Can you comment on Neptune's recently issued US patent novel for omega-3 fatty acid phospholipid compositions suitable for human consumption and what message that sends to the EFA market?
WM: We are extremely proud of achieving both recently issued patents - '348 and '825 - both of which reaffirm Neptune's position as pioneer and leader of the krill oil industry. The '348 patent provides Neptune with the right to exclude others from making, using, selling, offering for sale or importing the patented invention for the term of the patent, which is valid and has full force and effect regardless of any re-examination request made by a third party The USPTO, the foremost reputable authority for awarding patents to their entitled inventors, concluded that the claims are novel and non-obvious - and thus patentable. We hope this sends the message that we are open for business and willing to discuss mutually beneficial agreements with all distributors interested in capitalizing on this rapidly growing krill oil market.
WBT: In a similar vein, one of your customers was recently awarded 'Product of the Year 2011' in Denmark, which suggests positive consumer uptake. What factors do you think led to that success and how can you improve enduser market penetration?
WM: Although Neptune as a manufacturer does not directly market to end-users, we do offer technical, scientific and marketing support for those who require such assistance in their consumer approach. This is the second time in a year that NKO has been recognized as a best product, an achievement of which we are very proud. Consumers are aware that Neptune's krill oils offer them the best quality krill oil that is supported by clinically proven health benefits.
NBT: Critics have recently questioned the sustainability of krill fishing in the Southern Oceans, How would you respond to these comments?
WM: To overcome this highly sensitive issue, Neptune only sources krill through CCAMLR licensed vessels. The Commission for the Conservation of Antarctic Marine Living Resources (CCAMLR) is the only official and reliable international organization involved in Antarctic krill fishery management and is unique in involving the governments of 25 state member nations - in addition to concerned stewardship organizations such as the Antarctic and Southern Ocean Coalition (ASOC), which counts Greenpeace as a member. CCAMLR establishes detailed precautionary measures to ensure and confirm the ecological sustainability of harvesting the Antarctic krill species (Euphausia superba) and has never forecasted a shortage of it. In 2009/10, 1 1 vessels, all of which acted within CCAMLR guidelines, were licensed to fish krill in the Antarctic. The total precautionary catch limit of 2009/201 0 corresponded to 1 .56 % of the total biomass figure of 420 million tonnes and the total catch of all CCAMLR certified vessels for 2009/2010 was only 5.54% of the established quota. Neptune only captured 0.006% of the total biomass and 0.04% of total precautionary catch limit.
NBT: Neptune's chief scientific officer was recently quoted as stating that the patent (US No, 8,030,348) also 'benefits our majority-owned subsidiaries, Acasti Pharma and NeuroBioPharm, as it protects the platform for our pharmaceutical products, ' Is the convergence of the two sectors important to Neptune, and how do you see your nutra/pharma activities aligning in the future?
WM: Our nutra and pharma activities will always be aligned in the sense that Neptune will be the exclusive supplier of raw material to both its pharmaceutical subsidiaries (Acasti Pharma and NeuroBioPharm), which will always have the exclusive world license for Neptune's patents in their respective sectors. On one hand, Acasti Pharma, Inc. is dedicated to the research, development and commercialization of its proprietary product portfolio for the management of cardiometabolic disorders - from prevention to treatment. Acasti develops first-in-class and best-in-class anti-dyslipidemic prescription drugs (Rx), medical foods (MF) and over-the-counter (OTC) products. Acasti's lead product, CaPre, intended for use in the treatment of dyslipidemia, has demonstrated a superior efficacy and safety profile in established preclinical models. NeuroBioPharm, by contrast, is dedicated in the research, development and commercialization of its proprietary product portfolio for the management of neurological disorders, also from prevention to treatment. By targeting the cardiovascular and neurological sectors, Neptune and its subsidiaries have the potential to play a major role in the management of the world's most prevalent human diseases and disorders.
NBT: Perhaps driven by the convergence of the pharma/nutra industries, you've undertaken a large dietary supplement clinical study: what results do you hope to achieve and should this be a model for the whole functional food industry?
WM: Neptune has undertaken several clinical studies to meet the demands of the changing market. Regulatory requirements in Europe, Asia and even the US are becoming stricter and more demanding in terms of the criteria required to obtain and use health claims. With all these clinical studies we are confident of achieving significant results that will provide us with the necessary tools to submit and obtain approved health claims. The design of clinical studies is more critical than ever before and we have accumulated much knowledge of what each international regulatory body requires for approving health claim submissions.
NBT: Finally, like Big Pharma, the nutraceutical industry is becoming more litigious: can we expect to see more IP/patent disputes orare there steps that can be put in place to avoid such issues?
WM: Is Nutra Industry really becoming more litigious? I see the industry becoming a little more structured now that the FDA has decided to play a bigger role in enforcing regulation. However, from an IP point of view, I think there will always be companies that decide to operate regardless of the IP in the market they are targeting. Unfortunately this leads to unnecessary lawsuits for the IP holders who simply wish to protect what has been rightfully granted to them by the USPTO.
For more information
Dr Wael Massrieh
VP of Scientific Affairs
w.massrieh@neptunebiotech.com
www.neptunebiotech.com
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