In an intensely competitive field such as medical devices, it pays to have all of the i's dotted and t's crossed when it comes to protecting patents and being in compliance with federal regulations.
The world has changed many times since Germany's Bayer AG first introduced aspirin in the 1890s, Stephanie Harrington, a speaker at the Plastics in Medical Devices conference said in an April 14 presentation at the event in Westlake.
If [aspirin] was submitted today, that would never be approved by the [Food and Drug Administration]. It does not have an appropriate biocompatibility profile. We have a bar for ourselves for new drugs and new devices that are much higher than what we've done previously, said Harrington, vice president of research and development at Frantz Medical Development Ltd., part of Frantz Medical Group in Mentor, Ohio.
In her talk, Harrington discussed the various FDA classifications for medical devices, such as how the agency is considering changes to the 510(k) pre-market notification process it uses to review and clear certain medical devices marketed in the United States.
A lot of this information is not available to the public, so how would a small business or a medium-size business compete with some of the bigger players who obviously have a large presence and many of the predicate [legally-cleared devices that meet 510(k) standards] to draw from? she said.
FDA in September 2009 asked the Institute of Medicine the health arm of the National Academy of Sciences in Washington to conduct a comprehensive study of the process. The IOM study is not expected to conclude until March 2011. Meanwhile, FDA is conducting its own review of the 510(k) processes.
Harrington cautioned attendees at the conference who are not already medical-device manufacturers to do their homework before entering the marketplace especially those who base their quality measures on specifications developed by the Geneva-based International Organization for Standardization:
If you choose to be listed a medical-device manufacturer, ISO typically looks at your systems. They want to make sure that your processes and your risk management and your quality control are in place to ensure a quality product, Harrington said. FDA cares about that, but they also care about content. If they don't agree with your decisions or if your decisions aren't well-documented then there [will be] repercussions.
Similarly, Jenny Sheaffer, a specialist in intellectual property law, cautioned her audience at an April 14 conference session that inventors' rights including patents, trademarks and copyrights are not to be taken lightly.
Sheaffer, an attorney with Benesch, Friedlander, Coplan & Aronoff LLP in Cleveland, said trademark infringement among medical manufacturers has been obvious in some cases: We've seen some instances from clients where there are knockoff products that are so closely copied that typos in the product labeling are copied and patent numbers are also copied.
Sheaffer cited several figures about the value of protected trade secrets, including:
* A study by London-based audit firm Ernst & Young that projected that patent licensing will be a $500 billion industry by 2015.
* The Washington-based non-profit USA for Innovation estimates the value of U.S. intellectual property to be worth $5.5 trillion.
* According to the Department of Commerce, half of all U.S. exports involve or are related to intellectual property.
On drug-eluting stents alone, there are some 400 U.S. patents on polymers used in their manufacture, Sheaffer said.
If you get a patent on something, it doesn't give you the unadulterated right to practice what's in that patent. It gives you the right to exclude others from the right to practice what's in that patent, she said.
Sheaffer said the U.S. currently is more lenient than other countries, giving inventors and firms up to a year before they sell, offer for sale or publicly disclose inventions but that may change, as the Senate considers moving the U.S from a first to patent to first to file system, where the timing of paperwork is critical, she said.
Companies marketing new plastics, polymers, devices or processes need to be aware of patent treaties between the U.S. and other countries, such as the Patent Cooperation Treaty of 1970, which makes it possible to seek patent protection for an invention simultaneously in several countries by filing an international patent application.
Also, changes made in 2004 to title 35 of the United States Code under the Cooperative Research and Technology Enhancement Act encourages joint research and collaborative efforts among inventors in separate research organizations, Sheaffer said.
When you're getting into joint ventures, or joint research agreements, or collaborations, this is something that you want to think about upfront, she said. Trying to split [ownership] up by inventor name can be really problematic.
Another important consideration for companies is having carefully worded employee agreements, so that if a creative employee leaves one firm to work for another, that ex-employee's work for the first company is protected and can't be co-opted by his or her new employer, Sheaffer said.
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