As you may recall from my previous post, a company called Ariad is suing Lilly & Co. over alleged infringement of a patent related to NF-κB activity. NF-κB is a protein which regulates inflammation and immune response in cells; as such, it is considered by many to be a great target for new drugs.

In my previous post, I expressed skepticism that the so-called 'Baltimore patent' will be upheld. I have since bothered slugging through some of the patent code (U.S.C. 35), and have refined my thoughts a little more.

One of the strongest arguments I can think of against Ariad is that the Baltimore patent had simply not reduced the claimed invention to practice. According to 35 U.S.C. § 112:

The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.

As an example, consider two fairly representative claims from the Baltimore patent:

1. A method of inhibiting expression, in a eukaryotic cell, of a gene whose transcription is regulated by NF-κB, the method comprising reducing NF-κB activity in the cell such that the expression of said gene is inhibited.

6. A method for diminishing induced NF-κB-mediated intracellular signaling comprising reducing NF-κB activity in cells such that NF-κB-mediated intracellular signaling is diminished.

Obviously creating a particular drug requires vastly more resources than claiming what amounts to a big-picture idea for a research project. The court will have to decide whether or not the Baltimore patent ever actually reduced to practice their claimed invention. It is a fundamental requirement that a patent describe an invention well enough for a person having ordinary skill in the art (of biochemistry, in this case) to be able to create and use the invention. This is what The People receive in exchange for granting an exclusive license to the inventor.

Furthermore, according to 35 U.S.C. § 102(g), Lilly need only show that it conceived of the two drugs and worked "with reasonable diligence" to create them before the priority date of the Baltimore patent. Lilly also has to show that it didn't "abandon, suppress, or conceal" those two drugs. Since Lilly claims it disclosed the medical properties of Xigris and Evista before the Baltimore inventors conceived of their idea, it will be very difficult for Ariad to show that Lilly had concealed Evista or Xigris before the Baltimore patent's priority date.

The courts must consider "not only the respective dates of conception and reduction to practice of the invention, but also the reasonable diligence of one who was first to conceive and last to reduce to practice." Lilly, it seems to me, need only prove that they worked with reasonable diligence to reduce their two drugs to practice, while Ariad and the patent holders have to prove that they have sufficiently disclosed their invention such that any skilled worker could create and use it.

As a fairly skilled worker in the art of biochemistry, I wouldn't have any idea where to start to create and use some of the claimed inventions in the Baltimore patent. It is pretty clear to me that the Baltimore patent has not sufficiently disclosed their invention; as such I continue to expect that the appellate court will decide for Lilly & Co. and set aside the jury's previous verdict.