According to Wolf, Greenfield & Sacks law firm associate Roque El-Hayek, MD, pharmaceutical companies need to consider strategies to cope with the patent rule changes, which will see the number of submitted applications drastically slashed in a bid to streamline the workload of the United States Patent and Trademark Office (USPTO). The changes though, may have an adverse effect on the pharma industry.
The latest changes, announced last week, include a limit on the number of continuation applications, a limit on the number of claims an applicant can file in a single application, and the new rule that certain multiple applications will be treated as a single application.
These are the relaxed rules following a public outcry when the changes, which are aimed at improving patent quality, reducing patent litigation costs and harmonizing patent laws, were first proposed in January last year.
Speaking to US-PharmaTechnologist.com, El-Hayek said "it was hard to tell at this stage" what the exact effect on pharmaceutical companies would be. But it was clear the industry would have to become more careful in what it disclosed when filing patent applications, and it was likely to bear the brunt of the workload burden now in order to get additional applications seen by the office, he said.
"The old rules are gone and we have to deal with the new reality."
The patent lawyer said the industry could go some way to dealing with the changes by developing a filing and prosecution strategy, talking to examiners early on and considering pre-appeals.
"We have to start to think about filing strategies before filing and to respond to office actions quicker because of these limitations," he said.
"[But] we haven't come up with a definitive strategy to deal with it," El-Hayek acknowledged, noting that the coping strategies would be dependent on the industry and the application and would be determined case by case.
The unknowns have left a sour taste in the mouths of those in the pharmaceutical industry, with fears the industry would be "disproportionately affected".
"America's pharmaceutical research companies are concerned with any policies - including those contained in the new rule - that create uncertainty about their ability to fully protect their discovery and creation of new medicines for millions of patients around the world," Pharmaceutical Research and Manufacturers of America (PhRMA) senior vice president Ken Johnson said in a statement regarding the patent changes.
"Put simply, what makes this a serious issue is the fact adequate patent protection is the lifeblood behind development of new treatments at a time when it can take 10 to 15 years to develop a drug at an average cost of $1bn . . . What's clear is patents are a vital incentive for innovation."
The changes announced last week would put many restrictions on the pharma industry, which, according to a report published earlier this month, is the most intellectual property-intensive industry in the US.
The first change limits the number of continuation applications.
Previously there was no limit, so applicants could continue to file as many continuation applications on a developing invention as the applicant wanted. Now there is a limit of two continuation applications and one request for continued examination (RCE).
Applicants can file a petition to be allowed another continuation application or RCE but there is no guarantee this will be approved by the USPTO, and would be costly and labor intensive for the applicant.
The second change limits the number of claims that the applicant can file in a single application.
Previously applicants could file as many as they wanted. Now it is limited to up to 25 claims with no more than 5 independent claims allowed.
An applicant can file more than 25 claims but would need to provide an examination support document containing supplementary information.
The third change requires applicants to identify applications or patents that are commonly owned, have a common inventor, or have a claimed or filing date within two months of each other.
The USPTO will now treat multiple applications with the same claimed filing or priority date having a substantially overlapping disclosure, as a single application for the sake of counting claims. The multiple applications combined (treated as a single application) must have no more than a total of 25 claims.
According to the USPTO, "these changes will allow the office to conduct a better and more thorough and reliable examination of patent applications".
The idea is that the patent examination process would become more effective and efficient by encouraging applicants to use greater precision in describing the scope of their inventions.
"Patent quality is the shared responsibility of applicants and the USPTO," USPTO director and under secretary of commerce for intellectual property Jon Dudas said in a statement when the office announced the changes last week.
"Higher quality applications result in a more effective examination. These rules better focus examination and will bring closure to the examination process more quickly, while ensuring quality and maintaining the right balance between flexibility for applicants and the rights of the public. The US patent system plays a tremendous role in motivating innovation, and these changes to examining patent applications will help ensure that America remains on the leading edge in the knowledge-driven global economy."
While the USPTO hoped efficiency would improve, El-Hayek said he feared the appeal board may become backlogged with appeals.
"Theoretically it may improve efficiency but practically, I'm not so sure."
The rule changes are part of a larger initiative by the USPTO to both improve the quality of the process and to eliminate a backlog of nearly 750,000 unexamined patent applications.
The new changes come into force on November 1.