What does “useful”, one of the basic requirements for the patentability of an invention, mean in Canadian patent law? On June 30, 2017, in AstraZeneca Canada Inc. v. Apotex Inc.(AstraZeneca), the Supreme Court of Canada (SCC) ruled that the threshold for utility is low — a mere scintilla will do. In fact, requiring anything more is not only overly onerous; it is incongruent with the Patent Act and antagonistic to the bargain theory on which patent law is based.
PROMISE AS PART OF PATENT BARGAIN
To be eligible for a patent, the law requires that an invention must be, among other things, new, useful and non-obvious. Should a new, useful and non-obvious invention be denied patentability because a patent application and the resulting patent include a superfluous statement as to a specific level of utility that is not fulfilled at the time the application was filed?
The “bargain theory” of patent law is based on the grant to an applicant of the exclusive rights in an invention for a limited period of time in consideration for disclosure of the invention to benefit society. In recent years, a statement of utility in a patent has been considered a “promise”, forming part of the bargain. If a promise extended beyond that which could reasonably have been understood as a hoped for advantage at the time of filing the application, the patent was held invalid for a lack of utility. This is no longer the case.
In AstraZeneca, in a unanimous ruling, the SCC struck down what had come to be called the “promise doctrine” as “unsound”. In doing so, the SCC reversed years of judge-made law and more closely aligned the utility requirement with that of most of the industrialized world.
THE PROMISE DOCTRINE
The requirement that an invention must be useful is enshrined in the definition of “invention” in the Patent Act (Act). But how is usefulness or “utility” assessed?
In a 1981 decision, instead of defining what utility is, the SCC defined what utility is not. The SCC said that there is a lack of utility if “the invention will not work, either in the sense that it will not operate at all or, more broadly, that it will not do what the [patent] specification promises that it will do“. It is the latter part of this statement that led to the promise doctrine.
Over the years, the Federal Court of Canada has interpreted and applied the above language to construe a statement in a patent that speaks of an advantage, directed to what the invention will or will not do, as a promise. This “promise of the patent [was] the yardstick against which utility [was] measured” and had to be either specifically demonstrated or soundly predicted at the filing date of the application. In Canada, unlike some other countries, evidence of events after the filing of the application is prohibited. Additionally, if a patent included multiple promises, each had to satisfy the utility requirement independently.
In the above action, Apotex sought to invalidate AstraZeneca’s patent for the commercially and functionally successful esomeprazole drug, sold under the NEXIUM trade-mark, comprising salts of one of the two mirror image molecules contained in the previously known mixture, omeprazole. Both drugs are used to decrease stomach acid and treat gastric reflux and related conditions; the difference being that the single molecule was found to work better than the mixture.
Apotex succeeded at trial on its argument that AstraZeneca’s patent included a promise of utility beyond a “hoped for advantage”. Specifically, the construed promise said that the new drug is more effective than the previously known mixture and provides less variation in patients’ response.
Esomeprazole did provide an improved therapeutic profile, which did lead to a lower degree of individual variation. However, AstraZeneca did not specifically know this at the time the application was filed and only became aware of it through clinical trials that took place later. The trial court held that, on a purposive construction, the patent as a whole did not provide a sufficient basis to soundly predict this result at the filing date. Therefore, the patent lacked utility and was invalidated. The decision was upheld on appeal.
The result in AstraZeneca was due in part to the fact that the patent was a “new use” case, in which the esomeprazole molecule was previously known and the foundation for the invention was the new (or improved) use. A new use patent is subject to an elevated disclosure requirement, which is meant to prevent an applicant from making an unverified promise to obtain a monopoly on an invention that, but for the promise, would be in the public domain. Importantly, however, even under this standard, if no promise was made in the specification, a “mere scintilla” of utility would have sufficed and the patent would stand.
NEW TEST FOR UTILITY
On further appeal, the SCC considered whether a patented invention that includes a statement that could be construed to be a promise should be required to satisfy that promise at the time of filing of the application.
The biggest challenge the SCC appeared to have with the promise doctrine was that the promise could be found anywhere in the claims or the patent’s description, although the claims alone are traditionally analyzed for the other requirements of patentability and the description is only considered when there is ambiguity in the claims. The SCC concluded that there is no basis in the Act for looking to the description to satisfy utility, and doing so conflates two distinct requirements (utility and disclosure).
The SCC abolished the promise doctrine and replaced it with another, simpler test of utility that requires determination of:
The SCC noted that any degree of usefulness related to the purpose of the invention satisfies this requirement.
WHAT’S ALL THE FUSS ABOUT?
The only reference in the Act to utility is the reference to “useful” in the definition of “invention”. The promise doctrine appears to have gone far beyond this requirement. As the doctrine became entrenched, numerous patents for drugs were invalidated for an absence of utility despite the commercial success of the drugs.
The costs to the innovative pharmaceutical industry of dealing with the promise doctrine were significant. To illustrate, after two of Eli Lilly’s Canadian patents were invalidated by the promise doctrine, it initiated a C$500-million claim against the Government of Canada, alleging that the doctrine violated the intellectual property standards under the North American Free Trade Agreement (NAFTA). Although the NAFTA challenge failed, the value of challenging the promise doctrine demonstrates how significant the SCC decision on utility will be for patentees going forward.
We were invited to participate last season and now the show is a huge success. It is a great premise, 3 venture capitalist personally product test new outdoor adventure products. Talk about Shark Tank, last season they tested a new shark repellent device in the ocean with school of real mean looking sharks, giving new meaning to the term “wetsuit” for one of the capitalists. These guys are crazy and a lot of fun. Check out the show here http://cnb.cx/2eezoKK
They are looking for all types of outdoor products including but not limited to; camping, hiking, adventure, recreation, outdoor transportation, off roading, renewable energy, survival, etc. I suggest you watch the show and present accordingly. Here is the link to apply www.AdventureCapitalists.com
Harry Wants Women
What a dream come true for the right women, Harry Connick Jr. is looking for women inventors with a great story to tell for his new daytime talk show. This is great exposure! Here is a link to the talent search http://bit.ly/2ddYLZb and here is a link to the show’s website https://www.harryconnickjr.
Dave Yonce Show
Below is the information they sent me about the show. Unlike most product hunts, shows are looking more for personality. Their guide lines are an education in themselves that everyone should read.
Asylum Entertainment and a major cable television network known for its loud, creative content is on the hunt for American entrepreneurs with well-developed concepts or prototypes for new inventions. To be considered, the invention must solve a problem, make a job more efficient, or make life more fun. Areas of interest include, but are not limited to, electronics, weapons, outdoor recreation, adventure, home products, automotive, and power tools.
If selected to appear on the program, Oklahoma-raised inventor and entrepreneur, Dave Yonce, will invest money and time into you and your product, developing it into a working prototype, and in some cases, partnering with you to build your business.
For more information, email: Casting@tikicasting.
Thank you in advance!
Contacting companies for the first time can be scary and uncertain for Inventors. You want to do it right and get the company interested in your product and see it on store shelves. My invention submissions have resulted in licensing deals in toys, tools, eyeglass products, kitchen utensils, and even a device used in the nuclear industry. I did it spending less than $100 on each and some as little as $8. I utilized an NDA and Sell Sheet only, no patent or PPA. My major investment has been my time.
I have been a serial Inventor, a licensing agent and reviewed thousands of Inventor’s products. In short, I see and hear all sides of the inventing process. What I’ve discovered is sometimes inventors can be their own worst enemies. Here’s a list of do’s and don’ts when it comes to submitting pitches or new products to companies that can help you make a better first impression:
1. Don’t send hand-written submissions. Even if you don’t own a computer most libraries have one you can use for free. If a library isn’t an option, go to a FedEx Office (formerly Kinko’s). If you send your submission via snail mail, include a self-addressed stamped envelope. Don’t assume your target company will pay postage.
2. Do put your contact information on each piece of paper you send. That includes samples and prototypes.
3. Don’t waste a product reviewer’s time detailing how you came up with your idea. Focus on the benefits of your product/technology and why it will make the company money. Companies don’t care if your second cousin twice removed worked on your project for two years once he got out of prison.
4. Don’t use the phrase, “My idea is worth millions.” Let the company decide that.
5. Don’t use the phrase, “There is nothing else out there like my idea.” Most of the time you will be wrong.
6. Don’t say you have researched your product idea thoroughly when all you did was walk into a Walmart and didn’t see it on the shelves.
7. Don’t use the phrase, “Everyone will buy one.” This gets back to being realistic about the size of your market. Know who the target customers are. (See Rule #6)
8. Don’t send a prototype to a company unless they asked you to and are expecting it. Companies do not want to keep track of or be responsible for items they did not request in the first place.
9. Do be realistic about your expectations. Understand licensing royalties usually are about 2% to 5%. Greed can kill an otherwise profitable deal.
10. Do read and re-read everything a company sends you to make sure you understand everything in the documents. Don’t assume everything is fine and sign it. I send people my two-page non-disclosure agreement to read and sign prior to sending me anything for review. I have to include in my email an explanation to make sure they fill in their address on the top of the first page, because so many people don’t do it. This is in the first two paragraphs of the first page. So, if they are missing that what else are they missing in a longer document?
11. Don’t write a novel to explain your invention. Be concise and factual. No one wants to read a novel to get your idea. Be able to explain your invention over the phone or in person in 30 seconds or less. Practice your pitch until you can say it in your sleep. Look at the short blurb on the back of a book. It gives you an overall idea of the 300 page book. Your pitch needs to be that short.
12. Make sure you know your product. You should be the expert on your product. Never assume companies will just “Get It.”
13. Don’t send your submission to a company on Monday and call Tuesday to ask when they will be sending you a contract.
14. Do your research before submitting anything to a company. Make sure your submission actually fits their target market. Don’t submit a lawnmower idea to a soap company.(this happens more than you think)
15. Don’t send your invention submission in care of the general bulk mail of a company. Get a specific person’s name in charge of that department – new product development, marketing, inventor submissions, inventor relations, etc. Don’t send “To Whom it may concern.” The most likely place it will find is the trash basket.
16. If you call a company asking for the person in charge of invention submissions, make sure you are ready if you’re put through. This is not the time to forget pen and paper or fumble your pitch. If you get voice mail, leave a short intelligent message with your call-back number.
17. Make sure you know the time zone difference of the location you are calling.
18. Don’t send a company any package that has special storage requirements, contains a live animal or flammable liquids. Real example: An Inventor sent his new food-sealing device with samples of food sealed inside. It was not opened until a week later, by security due to the smell of the leaking packages.
19. Don’t send a company anything you can’t afford to lose. Accidents happen and things can get misplaced. If it’s a one-of-a-kind item, you may want to send a DVD or link to a video showing the product in action. If you post it on Youtube and you have not filed for any patent protection make sure it is set on Private and not Public.
20. When sending email attachments to companies, do make sure it is in a program they have installed on their computers. Not everyone has Filemaker Pro or Microsoft Office 2016. Ask if the company has a size limit on attachments. Moreover, some software automatically kicks out any email with an attachment that is not on a safe email list.
The more you do upfront to make sure you are prepared the better your chances of success.
Why do I need to do a business plan if I just want to sell or license my idea? It is a great question and we get it all the time.
The suggestion of doing a business plan is important for many reasons. If you are fortunate enough to be able to speak to someone or a company that might license your idea or product you need to be prepared. The interested party may ask you any or all of the following questions (example is for a product):
When you do a business plan, you go through all of these things because at the end of the day, if it cost too much to make them, it might not be worth it. There are other costs most inventors do not take into consideration such as Boxing, Labeling, Warehouse space, Marketing or sales reps commission
And there are many other costs involved. So the companies considering your product need to know that you know your business and how they will make money if they license your product. In doing the business plan, you will better understand the real costs involved and will be able to explain why they would want to take on your product. You will also have the data if you should decide to create the business and manufacture it yourself.
Every company we have pitched to has asked many of these questions. They want to know you understand the process. I have seen them ask inventors these questions and when the inventor did not have any answers, the comment is – “Why should I care about your product more than you do if you haven’t taking the time to find out this information?”
There is a lot to consider, after you have come up with the idea, in order for you to make money. It is possible and there is help available.
Keep Inventing Daily!
You have, what you think, is a fantastic idea that will make millions and be perfect for Shark Tank but you don’t know what to do or where to start. Here is a list of the first things to do:
After starting the process, you will see that there is a lot to do before you spend money on a patent or on prototypes. There is help available and it will take time. Just Keep Inventing Daily!
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Tuesday, May 10th starting at 6:00 pm, Startup Grind Orlando & Google for Entrepreneurs will be hosting founders of Fattmerchant, Suneer Madhani & Salman Rehmetullah. Learn more and get your ticket here, and use code “CATALYST” to get $4 tickets (normally $12)!
The event kicks off at 6:00 pm with a casual hour of craft beer, pizza, music, and networking. Around 7:00 pm we’ll start the fireside chat with our featured guest, followed by Q&A and more beer and networking.
Grab your ticket(s) here, and remember to use code “CATALYST” to get them for only $4 each.
See you there!