Federal Courts Get Tough on Patents

In today's legal environment, no drug patent goes unchallenged.

Companies are seeing a spike in cases that invalidate brand name patents partially or completely, a recent analysis found. Patent attorneys believe the trend is driven, at least in part, by generics makers challenging secondary patents that are harder to defend, but which pharma companies obtain in a desperate attempt to extend patent life.

The Federal Circuit has invalidated some or all of the patent claims in all of the 25 to 30 cases published since December 2004, according to calculations done by Robert Schulman, a partner and co-chair of the life sciences group at law firm Hunton & Williams.

Between 2000 and 2004, in contrast, patents were upheld in about 50 percent of 27 published patent challenges.

"If you put it to the judges, they'd probably say it's a coincidence," Schulman said. "But there was clearly a change that occurred."

Schulman's analysis also compared the pharmaceutical industry to other fields, and found that the trend appears to be isolated. He noted that there seems to be a change in the way judges are applying patent law, and pointed to Pfizer's Lipitor (atorvastatin) as an example.

Earlier this month, the US Court of Appeals for the Federal Circuit invalidated one of Lipitor's secondary patents, cutting its marketing exclusivity by one year. Ranbaxy Labs brought the patent challenge.

"To most of us, [the decision] seemed quite extraordinary," Schulman said.

He noted that the case hinged on a legal formality, and industry executives "absolutely should be concerned about this."

The US Appeals court similarly issued a split ruling on five patents for Amgen's Epogen (erythropoietin) this month.

Tim Murphy, a partner at Bromberg & Sunstein, noted that the trend is being seen both in the courts as well as the Patent and Trademark Office.

"Pharmaceutical companies have been very aggressive in extending the life of a patent," he said. "When you're really aggressive, you're bound to have some pushback."

"The court has been subjecting pharma patents to a great degree of scrutiny," agreed Nicholas Groombridge, a partner at Weil, Gotshal & Manges. "My sense is that there have been more challenges to basic patents."

But Groombridge noted that pharma companies are winning more of these cases that involve the core compound. Where patent challengers have been successful, however, is in picking off the "low-hanging fruit," or so-called secondary patents.

Most of the successful cases have involved not the core compound, but an element of its formulation or administration, noted Judy Mohr, a partner at Perkins Coie. "When the claim isn't directed at the core compound, it probably is more open to challenge," she said.

And the growth of the generics industry means that every patent is at risk of being challenged.

"Five, six years ago, there were fewer generic makers with the wherewithal to challenge Big Pharma," Mohr said.

Murphy of Bromberg & Sunstein sees the trend continuing. "Even though the successes may be limited [in winning a secondary patent case] there's so much money at stake."