The case is closely followed by Pfizer, Amgen, Biogen, Wyeth, Novartis, Novo Nordisk, Neurocrine, Isis, Medarex, Genentech, Eli Lilly and of course PhRMA, who are expected to file amici briefs or contribute to those being filed by others.
At stake in the case are the procedural rules for how patents are granted by the U.S. Patent and Trademark Office. The drug business depends heavily on the strength of its patents, which grant exclusive rights to market branded products for years at a time. Thus, patent cases are examined voraciously by drug companies.
The previous ruling by the appeals court said that the USPTO can restrict the way patents are filed. That ruling would limit drug companies to five unique claims and 25 total claims per patent, versus the historic lack of limit.
A simpler system would seem to weaken the defenses of each patent against legal challenge, something that drug companies live in fear of. Companies have argued the new, restricted rules will trigger more appeals of the rules -- and thus make the process even longer.
... the Court's order contained no inkling of the circumstances or rationale that occasioned the Court's decision to rehear the appeal
The rehearing en banc could (and probably should) be directed towards establishing firm parameters on the scope of the Patent Office rulemaking authority. It could also merely reverse the one portion of the decision that went in Tafas/GSK's favor.
- Previous coverage of patent issues:
- Why Abbott Is Allowed to Manipulate GSK and BMS's AIDS Drug Prices
- Will Roberts Recuse Himself If Bayer Case Reaches Supreme Court?
- Tafas v. Doll: Drug Companies Face New Limits on Patents