If the pharmaceutical industry has its way, a little-known patent challenge will soon be as antiquated as using bloodletting to treat illnesses.
The downside for consumers, however, is an additional $1.3 billion in estimated pharmaceutical costs to federal health care programs over the next decade, according to The Wall Street Journal. The estimate comes from an analysis performed by the Congressional Budget Office this summer, which hasn't been released to the public, according to the report. The CBO didn't immediately return a request for comment.
At the center of the debate is a process called "inter partes review" (IPR) which was introduced in 2012 as a way to fight patent trolls, or companies that make money through litigating patents but that don't actually create anything. The IPR process allows judges hired by the U.S. Patent and Trademark Office to examine patent challenges, a faster process than the older route of going to court.
So why doesn't the pharmaceutical industry like the IPR process? After all, it's both faster and cheaper than actually going to court. The problem, according to the Journal, is that big pharmaceutical companies believe the IPR process has been abused, citing several challenges from a hedge fund manager who has targeted companies he's selling short.
Of course, generic drug makers are also using the IPR process to challenge brand-name drugs, with The Journal noting that the shorter process uses a legal standard that's not quite as favorable to patent owners. The older process of litigation was created in 1984, and requires the FDA to wait 2 1/2 years before approving generic versions of brand medications whose patents have been challenged in court.
That system "has worked," said Mark Grayson, deputy vice president and spokesman for the Pharmaceutical Research and Manufacturers of America, a trade group that represents biotech companies and biopharmaceutical researchers. "We're saying that there should be one process, and we believe the process that has been set up is working."
While Grayson said that his trade group hasn't seen the CBO report, it doesn't believe receiving an exemption to IPR would lead to higher costs for consumers. Instead, the industry believes that it's left dealing with higher uncertainty and costs because of the two paths for patent challenges, he added.
"We agreed on a system 30 years ago for how generic drugs should be litigated," Tom DiLenge, general counsel of the Biotechnology Industry Organization, told the publication. "Now we're seeing generic drug companies trying to skirt those rules."
On the other hand, such challenges may be more beneficial for consumers who would like to pay less by finding generic versions of expensive brand-name drugs, which is where the CBO estimate comes in.
If pharmaceutical companies are allowed to bypass the IPR, taxpayers would be socked with additional costs of $1.3 billion over the next decade, because generic drug makers would be forced to rely on the older court-based system, delaying the debut of some generic drugs.
Not surprisingly, one of the groups that's opposing exempting the pharmaceutical industry from IPRs is the AARP, the advocacy group for older Americans. In a July letter sent to lawmakers, the AARP and other organizations argued that the IPR system "is largely working," and that changing it could lead to higher costs for Medicare recipients, as well as consumers.
Editor's note: This post has been updated to include comment from the Pharmaceutical Research and Manufacturers of America trade group.