Pharmaceutically Speaking, Part 7: Inoculation Litigation

Danie Roy

My fascination with the pharmaceutical IP world usually leads me to wonderful news: generics, stem cell breakthroughs, and bionic eyes, for example. Very rarely, it leads me straight into the realm of disappointment. Today, however, I find myself in the land of complete and utter disbelief.

It’s not the good kind of disbelief, either. I found out that, apparently, Classen Immunotherapies owns patents on immunization schedules. That would be all fine and dandy if the patents didn’t cover ALL THE IMMUNIZATION SCHEDULES. Patently-O did a great overview of  that patent in litigation, and the questions it raises regarding process claims with regard to 35 USC §101. I want to talk about why it is obscenely broad, obvious, and just how outrageous it is that two of the three patents still stand after litigation.

The patents in question, 6,638,739, 6,420,139, and 5,723,283 are effectively claiming the process of testing immunization schedules and choosing the ones least likely to cause health problems in the future. I am not kidding. I’m almost surprised this didn’t get an obviousness rejection somehow involving Louis Pasteur. I then remembered that Mr. Pasteur only invented immunizations, not bothering to come up with schedules.

In any case, the CAFC decided that the questions of patentability lay in whether or not the process was patentable. The process fails the machine or transformation test horribly, and BARELY even has any physical steps. Even the CAFC characterized the steps as largely mental. But two of the patents still stand. Why? According to Judge Rader, the CAFC isn’t going to impose limits to §101 that aren’t there. I’m guessing that this case might make it to the Supreme Court, if sought. Why? Because not only are these patents borderline ridiculous, but a line will eventually be drawn somewhere for §101.

I’m actually slightly more surprised that nobody tried to pull the trigger on the “encompassing a human being” rule. MPEP § 2105 states that “If the broadest reasonable interpretation of the claimed invention as a whole encompasses a human being, then a rejection under 35 U.S.C. § 101 must be made indicating that the claimed invention is directed to nonstatutory subject matter.” We don’t have a solid court ruling on that yet, and the Classen patents are useless unless the method is used as claimed on “mammalian subjects,” which Classen itself identifies as “infants.”

Expect updates as this unbelievable mess unfolds. My head is still hurting over someone actually patenting all the immunization schedules.