• Lexaria is a global innovator in drug delivery platforms with an expanding portfolio of patents that currently stands at 34 granted patents and many patents pending worldwide
• These patents pertain to the company’s method of improving bioavailability and taste as well as the use of DehydraTECH(TM) as a delivery platform for a wide variety of active pharmaceutical ingredients (“APIs”)
• The company has, since June 2015, simultaneously filed the US utility patent application and an international patent application under the Patent Cooperation Treaty (“PCT”) procedure, both through the USPTO
• The PCT procedure has made the process of initiating international patent applications a bit easier by eliminating the need to file multiple applications directly to each target country
• Lexaria is looking to leverage the protection its portfolio confers to pursue commercial out-licensing opportunities

“Patenting is one way for a company to differentiate itself. Patents can protect innovation, create licensing value, advance a brand, and reward innovators – all of which contributes to a larger corporate identity,” Alan Fisch of Fisch Sigler, a patent litigation firm in Washington, DC., told WIRED (https://cnw.fm/VvgFi). According to WIRED, patenting can be a process that takes years, ending in success for only about half of patents submitted. So it’s a significant accomplishment and, according to Fisch, “patenting is one way for a company to differentiate itself. Patents can protect innovation, create licensing value, advance a brand, and reward innovators—all of which contributes to a larger corporate identity.”

Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, recently hit a milestone, announcing it had received notification of four newly granted patents that grew its intellectual property (“IP”) portfolio to 34 granted patents worldwide as of July 13, 2023 (https://cnw.fm/J8Bmu), with many more pending worldwide. Lexaria now has patents issued in the United States, Canada, Mexico, Australia, Europe, India, the European Union and Japan, pertaining to its method of improving bioavailability and taste, as well as the use of DehydraTECH(TM) as a delivery platform for a range of active pharmaceutical ingredients (“APIs”).

Formative Years

“Lexaria began filing for DehydraTECH in [June] 2014 with two initial US provisional patent application filings by the original inventors Poppy’s Teas LLC. (“PoViva”), which Lexaria acquired by way of exclusive, worldwide license rights and controlling interest in the founding company,” the company explains in its annual report for FY 2021 (https://cnw.fm/fTIHK). But the provisional applications, which have a 12-month pendency period that cannot be extended, would be pointless if the company did not act within the specified timeline. So, to enjoy the benefit from the earlier filing of the provisional application, the company, on June 2015, filed a nonprovisional utility patent, following which the USPTO issued a patent granted in October 2016. The company’s first in the US, this patent was titled Cannabinoid Infused Food and Beverage Compositions and Methods of Use Thereof (https://cnw.fm/ma13B) under its Patent Family #1.

The company’s decision to first file a provisional application followed by a nonprovisional application has benefits, according to the USPTO. “A provisional application provides the means to establish an early effective filing date in a later-filed nonprovisional patent application filed under 35 USC §111(a). It also allows the term ‘Patent Pending’ to be applied in connection with the description of the invention,” explains USPTO’s website (https://cnw.fm/LM44l). And for a company that was still growing, it provided an effective and fast avenue to gain protection for 12 months before filing the nonprovisional patent.

US Patent Application Process

In its subsequent patent applications, at least in the United States, Lexaria has largely prepared and submitted nonprovisional patent applications, a process that has several steps. Before submitting an application, the applicant must decide on whether to file the application on their own or with the assistance of a registered patent attorney or agent, pay for and conduct a search to establish if the invention has already been publicly disclosed by another party, and create and validate a USPTO.gov account, just to mention a few crucial initial steps.

They then submit the application, whereupon they obtain a filing date. This application should contain the following elements: Utility Patent Application Transmittal Form or Transmittal Letter; appropriate fees (captured in a Fee Transmittal Form); bibliographic data (captured in an Application Data Sheet); specifications, including the description of the patent, at least one claim, and an abstract; drawings (when necessary); executed oath or declaration; nucleotide and amino acid sequence listing (when necessary); and large tables or computer listings (when necessary).

The USPTO then examines the patent application and sends a Notice of Allowance if it meets all legal patent requirements. The applicant must then pay the issue fee within three months from the date of mailing of the Notice of Allowance, at which point the patent becomes granted (https://cnw.fm/EDzDQ). Patent maintenance fees may apply thereafter.

International Patent Application Under PCT Procedure

A patent granted in the US does not, of course, guarantee international protection for companies like Lexaria targeting the international market. For them, the international patent application is the only recourse. And while it may sound daunting, the Patent Cooperation Treaty (“PCT”), administered by the World Intellectual Property Organizations (“WIPO”) (https://cnw.fm/Mu9vU), has made the process a tad easier.

Under the PCT, applicants can file a single international patent application that they then use as the foundation to file national filings. (National filings are necessary because legal patent requirements vary from country to country, but the steps are largely more or less the same.) Because applicants do not need to file multiple applications directly to each target country, the PCT can save time and money.

It is this route that Lexaria has continually used, starting June 2015 when the company first initiated the simultaneous filing of the US utility patent application and an international patent application under the PCT procedure, both through the USPTO. Lexaria has used the PCT procedure to seek the protection of its IP for multiple patent families, with some applications successful and many more pending worldwide. These granted patents include:

Benefits of Lexaria’s Growing Patent Portfolio

• Patent Family #1: Food and Beverage Compositions Infused with Lipophilic Active Agents and Methods of Use Thereof, granted in the United States, Australia, Japan, Canada, and Europe
• Patent Family #2: Methods for Formulating Orally Ingestible Compositions Comprising Lipophilic Active Agents, granted in Australia, Japan, and Mexico
• Patent Family #3: Stable Ready-to-Drink Beverage Compositions Comprising Lipophilic Active Agents, granted in Australia, India, Japan, and Mexico
• Patent Family #6: Transdermal and/or Dermal Delivery of Lipophilic Active Agents, granted in Canada
• Patent Family #7: Lipophilic Active Agent Infused Compositions with Reduced Food Effect, granted in Japan
• Patent Family #8: Compositions Infused with Nicotine Compounds and Methods of Use Thereof, granted in Canada and Australia
• Patent Family #18: Compositions and Methods for Enhanced Delivery of Antiviral Agents, granted in the United States and Australia
• Patent Family #21: Compositions and Methods for Treating Hypertension, granted in the United States

Lexaria’s approach to seeking protection for its IP has been nothing short of strategic. The company not only pursues international patent protection through filings under the PCT, to which 157 countries are current signatories, but it also follows that up with national filings in jurisdictions with the highest commercial potential. The company also understands the commercial opportunities that a robust patent portfolio confers.

In his latest annual letter to shareholders (https://cnw.fm/IYgr8), CEO Chris Bunka emphasized that “Lexaria’s business model is to out-license our technology in exchange for royalties” and that “any out-licensing transactions Lexaria achieves with pharmaceutical companies may also be accompanied by significant, potentially multi-million dollar staged development milestone fees payable to Lexaria.”

Last summer, the company signed commercial licensing agreements with Japan’s Premier Wellness Science Co. Ltd. (https://cnw.fm/7kKHg), Atlanta-based BevNology (https://cnw.fm/1l4Ao), Denmark’s Valcon Medical A/S (https://cnw.fm/tumiX) and Ireland’s AnodGen Bioceuticals (https://cnw.fm/1P5we). Lexaria is also in discussions with a number of larger companies in Europe and North America regarding the licensed use of DehydraTECH technology for the consumer sectors and within the pharmaceutical industry, according to Bunka. In addition, if and when the company’s remaining patent applications become granted patents, its ability to generate additional license revenues from its IP may increase from multiple other jurisdictions.

For more information, visit the company’s website at www.LexariaBioscience.com.

NOTE TO INVESTORS: The latest news and updates relating to LEXX are available in the company’s newsroom at https://cnw.fm/LEXX

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