Alex Philippidis Senior News Editor Genetic Engineering & Biotechnology News
Distinctions range from how patentability is determined to how prior user rights are defined.
On the day President Barack Obama enacted the most substantial overhaul to the U.S. patent system in a half century, he mused that somewhere in the nation sat the next Thomas Edison or Steve Jobs, determined to capitalize on new technologies as they did. “If we make it too hard for people with good ideas to attract investment and get them to market, then countries like China are going to beat us at it and beat us to it.”
Aligning U.S. patent law more closely with patent law in the rest of the developed world was among reasons used by President Obama and other supporters of the America Invents Act to advance the measure through six years of Congressional review, culminating with the president signing the bill September 16.
Yet even after the overhaul, U.S. patent law will still hold to sharp differences compared to key areas of the world when it comes to prior user rights, pregrant examination, and postgrant review. Canada, Europe, Australia, and Japan were studied by the US Patent & Trademark Office (USPTO) in a recently released comparison report of one provision of America Invents, the section expanding the “prior user rights.”
When it comes to differences between the U.S., Canada, and Europe, the biggest factors include what prior user rights are based on and how they are defined. There are also differences in how patent applications are handled and patentability determined.
Prior Use and Examination Process
The report was required by America Invents and, not surprisingly, defended the prior-use expansion and the new language requiring defense of those rights “by clear and convincing evidence.” It also labeled prior user rights “a well-accepted practice,” saying that while only a few comments received by USPTO while preparing its study detailed any experience with such rights, none of the comments identified any first-hand negative experiences.
Across Europe and Canada, the prior-user defense can be used against all patent holders; in the US, university patent-holders and their tech transfer organizations are an exception to that rule. Prior use is based on “pure use” in Canada, which is defined as “the purchase, construction, or acquisition” of a later patented invention.
In Europe, France holds a “pure possession” standard that applies to any person who, at the filing date or priority date of a patent, was in possession of the invention. The rest of the continent as well as the U.S. uses a hybrid “use-possession” standard.
A European patent attorney familiar with the U.S. system, Martin MacLean, a partner with Mathys & Squire, told GEN that European patent offices were more insistent than USPTO on seeing pregrant rather than postfiling evidence that patents work according to claim. He also said that European agencies were more consistent than USPTO examiners in examining similar claims during pregrant review.
“You can have different examiners who will raise very, very different objections,” MacLean added with regard to the U.S. system. “Or more relevantly, you could have one examiner who could raise no objection against a particular type of claim or a feature in a claim, and you could have another examiner who could throw the book at you. It is very frustrating.”
Like the U.S., Canada has a three-prong patentability standard that requires inventions to be novel, inventive, and useful. According to the law in Canada and the U.S., the utility standard has to be satisfied through demonstration, either an example in the patent application or in archived data.
However, a recent court decision could change how Canada enforces the utility standard by adding a “sound prediction” test of utility, in which inventors explain why they believe their inventions will work as designed. Kitt Sinden, a professional with the patent-agent partnership Sim & McBurney, explained to GEN how this could impact life science applications. “Say you claim you treat X, Y, and Z diseases, but you only actually have examples of treating disease X; you don’t have anything to show that you’ve demonstrated that it’s useful for Y and Z. If you explain in your application why you believe that it will work for Y and Z based on a sound line of reasoning in your application, you would satisfy utility under ‘sound prediction.’”
On December 6, Canada Federal Court Judge Richard Boivin—the equivalent of a U.S. District Court judge—held that Apotex infringed Sanofi’s ’777 patent, which claims clopidogrel bisulfate (Sanofi’s Plavix), but that the patent was invalid. The patent discloses and claims the enantiomer clopidogrel and its bisulfate salt as well as processes for its manufacture. In the U.S., however, District Judge Sidney Stein in Manhattan found Sanofi’s patent valid and enforceable.
The Canadian court rejected Apotex’ assertions that the ‘777 patent was invalid for overbreadth, insufficiency, lack of novelty, and double-patenting. However, the Federal Court found the patent invalid on the basis of lack of utility, both demonstrated and soundly predicted, as well as obviousness.
Sanofi argued that utility was demonstrated as of the Canadian filing date, at which time a Phase I study was under way. The Federal Court said that the early results known by Sanofi were inconclusive on the issue of the promised utility.
With regard to sound prediction, the Federal Court found that Sanofi had prior experience studying compounds with similar structures to clopidogrel bisulfate. As a result of this track record, the firm established that it had a factual basis and sound line of reasoning for predicting that clopidogrel bisulfate could be used in humans. However, the Court found that the patent did not disclose this “track record,” which the Court held was needed to assist the skilled person to predict the promised use. As a result, the patent failed the disclosure branch of the sound prediction test.
Sinden expressed concern that this recent court decision could be the tipping point, and Canada may write “sound prediction” into law as a criterion for patent examiners to use in assessing utility. “Hopefuly, the courts are going to take a step back and revisit this. It’s not good for patentees,” said Sinden, as applicants may find reviews taking longer as patent examiners would have to ascertain “sound prediction.”
According to Sinden, the “sound prediction” test poses another problem for patentees: Once they discover a compound, gene sequence, or protein and have useful data, inventors are inclined to file as quickly as they can, a consequence of the first-inventor-to-file system the U.S. will adopt in America Invents.
“If you’re going to say it’s useful in humans, it’s almost like the courts are saying, you have to wait till you have data in humans to satisfy that disclosure. From a patentee’s perspective, it’s ludicrous,” Sinden said. “By the time you get into clinical trials and you actually get the data back, it can be several years from when you first discover the compound and realize that it would have potential for use, and you might be missing the boat.”
The challenges faced by Canada, Europe, and the U.S. differ from those of Australia—where lawmakers are debating the first significant rewriting of the nation’s patent law since 1990—and Japan. How the Australian and Japanese systems compare with that of the U.S. will be covered in a follow-up article.
Alex Philippidis is senior news editor at Genetic Engineering & Biotechnology News.