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Biotech startup BioCidePharma is in a tight race to secure international patent rights for its Nasodine staph-infection product. If it falls short of the finish line, it may lose millions in worldwide sales and investment cash.
The technology requiring the patents is called Nasodine, explained James Richards, president and CEO of BioCidePharma, a privately held company based in Sudbury. Nasodine, which comes as a gel or liquid spray, is composed of molecular iodine and kills forms of a highly drug-resistant organism, staphylococcus aureus, including its methicillin-resistant form, known as MRSA. Infections from MRSA kill an estimated 20,000 U.S. patients each year and cost an estimated $20 billion annually for extended hospital care, said Richards, citing industry studies.
Richards estimates Nasodine could make $100 million after five years, and $200 million annually thereafter. However, he needs seed financing of at least $250,000 to pay legal fees and for the translation of the patents into foreign languages by a deadline of Dec. 22. The down market has made raising cash a challenge. “There’s currently more risk aversion among investors than I’ve ever seen,” he said. Richards made his pitch to investors at the recent Speed Venture Summit in Manchester, N.H.
BioCide filed the patent on June 22, 2006, with the U.S. Patent and Trademark Office, after which, like other companies, it faced a series of deadlines. As part of the national filing phase, 30 months after June 22, 2006 — a rapidly approaching Dec. 22, 2008 — the patent applications must be filed in countries where a company wants protection, and in the local language. BioCide’s translations alone will cost about $150,000, Richards said.
Overall, international patent processes are a challenge to small firms, which generally have neither the requisite infrastructure nor the relationships with foreign law firms necessary, noted George Xixis, an attorney with Boston law firm Nutter McClennen & Fish LLP. Startups must come up with a thorough intellectual property strategy and strictly meet the deadlines to succeed. As part of this, a startup can patent not just intellectual property alone, but other components, such as method of use, said Xixis.
“Generally,” said Xixis, “you have to develop your intellectual property strategy in parallel to your product strategy. If you’re using intellectual property as part of a company’s plan, the earlier you put the IP strategy in place, the better.”
“If I don’t raise the money, I lose the foreign filing rights,” Richards explained. Those are worth millions in sales, he estimates, and are key to securing further financing. “An investor wants all the potential opportunity,” he said. “That’s one of the first things investors look at.” His other alternatives include using multilingual friends or independent, lower-cost translators. However, this is risky, as errors could invalidate some of the patent claims. He may also cherry-pick the countries where he’ll file or limit patents to English-speaking countries.
An old hand in the industry, Richards holds a doctorate in microbiology and has participated in founding four biotechnology companies, including Symbollon Pharmaceuticals Inc., a Framingham-based maker of molecular iodine products that also holds the patent on Nasodine, and is collaborating with BioCide.
Either way, Richards is ready for some bootstrap moves. “I’ll borrow money from my brother or my mother or take it from my retirement funds,” he said. “You’ve got to do what you have to do.”
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