SEATTLE--In the next six months, Todd Smith will shoot for a milestone at his bioinformatics company: filing for a patent on his software products. It's an exciting prospect, he said, but one that raises questions.
"What kinds of things are patentable? How does the process work? How do I know if what I have is novel?" Smith, president of Geospiza, said he has wondered.
He's not alone. Patent attorneys and agents are fielding more inquiries from bioinformatics companies seeking their expertise on patents--the legal right to exclude others from making, using, or selling an invention.
A bioinformatics company filing for a patent would follow the same path as an inventor of a new sneaker shoelace or toaster oven, but needs to be "very aware of the terrain in software applications," stated Robert Bergstrom, a patent attorney here. "There are some areas where you need to be paying attention. Biotech is special in a lot of ways," he added.
BioInform recently spoke with several patent attorneys who offered this advice to bioinformatics product developers:
* Recognize when you have something patentable, and when you don't. Realizing you have a patentable product is an important first step, according to William Christiansen, a biotech attorney with Seed and Berry, a firm here. "Many times, especially in bioinformatics, individuals doing the groundwork don't realize they have something patentable," Christiansen said, adding, "If you invent something useful in your lab that you don't see in the marketplace, that should be a big clue."
At the same time, double check that your invention is novel. Consider doing a journal search, or hire an attorney to search for you before you start preparing an application and file, suggested Jim White, who specializes in the protection of software-related intellectual property at Seed and Berry. "That way you're not duplicating," he said.
* Hire an attorney or patent agent with the right background. Bergstrom, whose clients include GeneLogic and Hewlett Packard, has a computer science graduate degree and a PhD in biochemistry. His background, he said, maximizes his clients' time and makes for the most comprehensive patent application.
"Very often I'll see that someone will prepare an application versed in one area and not the other," said Bergstrom. "They will just totally miss all the alternate embodiments that may be applicable."
Advice like Bergstrom's doesn't come cheap, however. Attorneys may charge from $10,000 to over $30,000 to prepare and file a patent, including government fees, although inventors do have the right to self-file. "It's almost a universal misconception that one must use a patent attorney to get a valid patent," wrote attorney David Pressman in his book Patent It Yourself. "The laws contain absolutely no requirement that one must have a patent attorney to file a patent application, deal with the US Patent and Trademark Office concerning the application, or to obtain the patent," Pressman argued.
"It's a simple fact," he added, "that many hundreds of patent applications are filed and successfully prosecuted each year by pro se [no lawyer] inventors."
* Understand the rights and scope of a patent. Bergstrom said he has seen inventions involving computational methods for sequencing DNA for which patent filers did not clearly describe the invention and saw their rights slip away.
In one instance, he said, "the computational aspect was well described but the patent preparer totally missed that the same methodology could be applied to protein sequences, for example. If you don't call it out, it's gone. You're not protected."
Still, he added that there are dangers in casting too broad a net in an effort to cover your bases. "When you claim ridiculously broad, and land on prior claims, those claims can easily be challenged and invalidated."
* Pay attention to your bar date. The bar date refers to the day before which a patent application must be filed to avoid losing your patenting rights. The date falls within one year after you first commercialize or publish the details of the invention, such as at a conference presentation or via a press announcement. "It's a very harsh date," Bergstrom said. Miss it, and "after that you have no right. It belongs to the public."
Standards are even tougher for US citizens filing in foreign markets. Most countries don't have this one-year grace period so there are some disadvantages if you sell or publish before filing.
* Understand the difference between patenting in the US and other nations. What if you aren't a US citizen, but want a US patent? No problem. US patent laws make no discrimination with respect to the citizenship of the inventor, according to the US Patent and Trademark Office. Any inventor, regardless of citizenship, may apply for a patent on the same basis as a US citizen.
There are, however, a number of points of special interest to applicants located outside the US. For example, application for a patent in the US must be made by the inventor, who must sign the oath or declaration. This differs from the law in many countries where the signature of the inventor and an oath of inventorship are not necessary.
* Keep track of your patent. Finally, one to three years after you have filed for your patent, it comes through. Celebrate! Then pay attention. Keep an eye on competitors, and on changing standards, especially in the young and dynamic bioinformatics patent world. Recognize future deadlines. For example, to keep your patent enforceable every four years you must pay a fee. "A lot of people have the misconception that once the patent is issued that is the end of the story," Bergstrom said, concluding, "It's really the beginning."
--Amy E. Nevala