After a tense 16 days during which the U.S. federal government effectively shut down what it considers “non-essential” activities, American pharmaceutical and biotechnology companies and life-science researchers are deeply concerned about how the temporary lapse in operations will affect their ability to fund projects and apply for patents, trademarks and regulatory approval.
Compared to the last shutdown of nonessential government programs, which lasted more than three weeks from Dec. 16, 1995 to Jan. 6, 1996, those involved in drug discovery and development fared more this time around, as routine operations were curtailed for only two weeks from Oct. 1 to 17. The shutdown came after Congress failed to enact legislation appropriating funds for fiscal year 2014.
Regular government operations resumed Oct. 17 after an interim appropriations bill was signed into law, but consequential damage has been done, says Shawna Cannon Lemon, a patent attorney with the law firm of Myers Bigel in Raleigh, N.C.
“More than likely, there is some level of backlog that has been created that clearly would not have existed had there not been a shutdown,” Lemon tells DDNews. “There a lot of trickle-down and downstream effects that people don’t think about.”
Perhaps the deepest impact was felt by the U.S. National Institutes of Health (NIH), which is already experiencing a significant loss of momentum for biomedical research this year after losing 5 percent, or $1.5 billion, of its 2013 budget to the federal government sequestration—cuts that dog-piled on about a decade’s worth of reductions in federal spending on NIH research.
The NIH furloughed nearly 14,000 employees on Oct. 1, retaining fewer than 5,000 essential staffers “for the safety of human life or the protection of property.” Funding decisions, the enrollment of new patients in clinical trials and any scientific meetings scheduled to be held at NIH facilities came to a halt.
“My grants have been put on hold; the same is true for hundreds of us around the country,” Dr. David A. Scheinberg, chair of the Experimental Therapeutics Center at Memorial Sloan-Kettering Cancer Center, told DDNews during the shutdown. “We can’t contact the government about our grants, either. We were already affected across the board before the shutdown. Already, the number of grants being funded has been reduced, and the grants that are being funded are seeing a reduction in awards. The cost of doing science continues to rise about the cost of inflation, and yet, the amount of money we’re getting is either cut or reduced. The consequence is that our ability to conduct scientific research is curtailed. We’ll all buy fewer animals, test fewer drugs and test fewer assays. Everyone is making judicious cuts to our research programs in the face of these budget restraints.”
An NIH spokesperson noted that NIH labs had electricity throughout the government shutdown, sparing precious cells and tissues stored at sub-zero temperatures. Lab animals were also unaffected. But hundreds of experiments conducted by NIH-funded researchers could take months to restart as the NIH faces a backlog. According to NIH Extramural Research Chief Sally Rockey, “the shutdown came at one of our busiest periods, and it is going to take some time to bring the extramural program back to full strength. We will be rescheduling all October grant application submission deadlines to dates in November so that applicants will have access to NIH staff, help desks and electronic systems. The specific revised due dates will be published in the NIH Guide as soon as we worked them out.”
Dr. Carl F. Nathan, chairman of microbiology and immunology at Weill Cornell Medical College, says he worries that the ongoing budget constraints on biomedical research will force “an innovation gap.”
“Absent any agreement between our government leaders, and combined with outspoken apathy to role science plays in public health, these challenges have a profound effect on career planning,” he says. “I’m seeing extremely talented people deciding that they don’t have a future in research because of the political climate they see here. Instead, they go write ad copy for drug companies. Some join non-profits. Some who decide to continue doing research go to India to do it. It’s heartbreaking.”
The U.S. Food and Drug Administration (FDA) did not accept new fee-based regulatory submissions during the shutdown, although the agency said the lapse period would not affect routine product review processes for submissions within the scope of the Prescription Drug User Fee Act and the Generic Drug User Fee Amendments programs, provided the fees were paid before Oct. 1. Retaining more than half of its employees, the FDA limited its activities to emergency work involving human safety, criminal law enforcement work and activities funded by carryover user-fee balances. However, the two-week shutdown may have created a slight lag time in the FDA’s review of drugs seeking near-term regulatory approval.
The U.S. Patent and Trademark Office (USPTO) remained open during the shutdown, as it has more control over its budget than some agencies and has a reserve fund that can be spent without further appropriations. The USPTO operated on reserve fees collected in the past year, which it could have continued to do for up to four weeks. Had the shutdown stretched out beyond that point, the U.S. Department of Commerce’s “Plan for Orderly Shutdown” would have called for a small staff “to ensure the functionality of the processes and systems minimally necessary” to preserve patent and trademark rights.
While those services aren’t clearly defined, the plan explicitly provides that electronic filing and payment systems should remain open during any closure of the USPTO.
However, the Copyright Office has no such reserve, and thus closed. Registration submissions were accepted both by mail and through the online system for purposes of securing a filing date, but were not processed. Electronic records were available for searching and viewing, but were not updated during the shutdown.
Lemon recommends to her clients that they not delay filings with either office whenever possible, so as to get ahead of any possible service interruptions.
“Going forward, be very aware of your deadlines,” she says. “To whatever extent you can, you may not want to wait until the last minute. Sometimes those things can’t be helped, but other times, I think some businesses don’t make responding to the USPTO a priority for various reasons—scientists may be busy, the liaison to the patent office may be busy. Making filing by a deadline a priority will be helpful.”
A bill to end the shutdown and fund federal agencies through Jan. 15, 2014, passed the Senate and the House and was signed into law on Oct. 17—but the question remains, what will happen after Jan. 15?
Lemon advises her clients to stay informed about any potential future shutdown, as “it’s extremely important to understand what’s going on with the government, because it will eventually affect the patent office.”
“The USPTO is capable of being self-sustainable, but that will not last forever,” she notes. “I’m glad they have a plan, but I am also extremely glad that at least this time, we didn’t have to see how well it worked.”