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.
Most high growth start-ups are fueled by capital – product development, staffing, go-to market. There are many avenues for raising capital and an increasing number of unique investment models available for entrepreneurs to pursue.
Listen to a panel discussion featuring 4 professional investors in early stage businesses. Hear what models they use to invest in, support, and help grow the companies they work with. What financing models and structures are available to entrepreneurs? What criteria to does each investor look for in transaction? What are the best ways to engage with sources of outside capital?
Seating will be limited to 70, so please register early to reserve your spot. Agenda as follows:
The article “5 Ways the Maker Movement can help catalyze a manufacturing renaissance” calls for leaders to “embrace the Maker Movement as a deeply American source of decentralized creativity for rebuilding America’s thinning manufacturing ecosystems.”
Mark Muro of the Brookings Institution and Peter Hirshberg, co-author with me of the Maker City guide, are co-authors of the article, which makes the case that the new administration might want to look to the Maker Movement as a way to think about re-vitalizing manufacturing in America. They could look at places such as the Columbus Idea Factory in Ohio.
We Fact-Checked Seven Seasons Of Shark Tank Deals. Here Are The Results.
On Shark Tank, the deal you make on camera often isn’t the deal you end up getting — if it happens at all.
Photo by Frederick M. Brown/Getty Images)
The hit ABC show that gives entrepreneurs a chance to pitch celebrity investors depicts some business owners walking away with life-changing deals. But more often than not, those hand-shake agreements change or fall apart after taping.
FORBES found that 319 businesses accepted deals on-air in the first seven seasons of Shark Tank. We spoke to 237 of those business owners and discovered 72% did not get the exact deal they made on TV. But tweaked terms or dead deals don’t necessarily spell doom for a business; for many contestants we spoke to, the publicity of appearing on the show ended up being worth more than the deal.
Shark Tank New Dat: Nick DeSantis, Forbes staff
About 43% of the people we spoke with said their deals didn’t come to fruition after the show. They attributed this to sharks pulling out of the agreement or changing the terms to ones that didn’t work for them. Others canceled deals after getting term sheets that included unappealing clauses. And occasionally the deals ended amicably.
Another 29% of the people FORBES interviewed said the equity and investment amount offered on-air changed after taping — but they chose to take the deal anyway. They said that the changes often occur during negotiations or in due diligence, an investigation into a person or business before signing a contract.
Although our analysis was not exhaustive (FORBES was able to interview 74% of contestants who got deals on camera), the numbers suggest that some investors are less likely to change their deals after the cameras stop rolling. Mark Cuban, who by our count closes more deals than any other shark, changed the agreements he made on-air change only 12% of the time.
Design: Nick DeSantis, Forbes staff
ABC is transparent about the due diligence process and isn’t accountable for how deals pan out during negotiations. ABC did not return requests for comment by time of publishing.
We contacted as many of the 319 businesses as possible, but some refused to share how and if their deals evolved, and others simply did not respond. While the results aren’t comprehensive, this is the most complete record of how often deals change after taping and why that occurs.
The goal of entrepreneurs going on Shark Tank is to make a deal and see it close. But if it falls apart, it’s not always a tragedy. About 87% of the businesses we spoke to that didn’t get deals are still operating. The remainder have shuttered, were acquired or sold.
Matt Canepa and Pat Pezet appeared on season four of Shark Tank to pitch their company Grinds, which sells chewable coffee pouches. They agreed to give Daymond John and Robert Herjavec 15% equity for $75,000. However, the deal died in negotiations.
“Pat and I went on the show 100% wanting to get a deal,” Canepa said. “Regardless of whether or not you get the deal, there are a lot of success stories.”Design: Holly Warfield, Forbes staff
In 2012, before their episode aired, Grinds made about $300,000 in sales. The month their segment premiered, the company saw $330,000 in sales.
Grinds brought in $1.35 million the year their episode aired, and have watched that number rise. This year, they are expecting do over $4 million.
Grinds isn’t alone. Nicholas and Alessia Galekovic, cofounders of the grooming accessories company Beard King, made an agreement with Lori Greiner during season seven last year. But around the time they filmed their episode, business took off, and the deal no longer met the needs of the company.
Design: Holly Warfield, Forbes staff
The agreement broke down in negotiations. But in the year after the episode aired, the company did around $700,000 in sales. This year, they are expecting over $1.6 million.
“I think that [Shark Tank is] absolutely amazing,” Nicholas said. “For anyone considering trying out or going for it: It’s well worth it.”
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!