Apr 052011
 

Last September, I studied and helped write an Amicus brief for the Federal Circuit case Ass’n for Molecular Pathology v. PTO. As I reviewed Judge Sweet’s opinion, it struck me how sweeping and nonconforming to patent law his opinion was. In that light, I’ve been interested in knowing how this case will be decided because with the lower court’s opinion, there seems to be a lot of directions that the court could go in straightening the edges. I just listened to the oral arguments at the Federal Circuit and  here are some thoughts. Judges Bryson, Lourie and Moore made up the panel.

First oralist, Myriad

Representing Myriad, Greg Castanias first talked about jurisdiction. He stressed how there was no immediate threat to the plaintiffs. Plaintiffs who would carry out tests (could or would engage in competitive activities), but there were no real consequences. Courts require actions or meaningful preparations by the declaratory plaintiffs AND affirmative acts taken. One letter was sent out since in 1998. This is against MedImmune’s immediate threat. But is it still a continuing threat? It wasn’t sufficient, according to Castanias.

Next, Castanias made an interesting and new redressability argument. The plaintiffs perceived the threat from the patents as a whole and not individual claims. Why? They wanted to invalidate the whole patents, even though some of the claims were valid.

Next, the debate that garnered the most attention, the composition claims. Isolated DNA never exists in nature, Castanias powerfully articulated. Product of human ingenuity, should be the test. Then there was a discussion on rocks and of course covalent bond breaking. I think that Castanias’ test is a good one that fits the court’s precedent cases. Before the Patent Act of 1952, and indeed even after, courts would kick out inventions as not patentable, but confuse it with terminology of obvious, not useful, or not novel. These cases probably should have used subject matter as their argument, but now that they didn’t, we are stuck with trying to make sense of a couple centuries of patent law.

On to the method claims, a little bit of time was spent on how sequences is not information. I agree with this. The specification, for instance, talked about specific technological methods that can be used to compare and analyze. I agree that this might pass the same analysis as Prometheus.

It was funny when in a hypothetical, Judge Moore referred to how God made her product, not man. I thought that the ACLU crowd might not be too pleased with this analysis!

Second up? ACLU

The ACLU’s Christopher Hansen was next. He first spoke about how Myriad has all but conceded the first half of standing for a declaratory judgment, which I got the sense as well from listening to Castanias. But does Myriad meet the second part of being willing? One declaration says that they will consider. Hmm. To me, this is not enough.

In response to the redressability argument, Hansen said that Myriad doesn’t identify claims that get in the way. Probe and primer claims aren’t identified specifically.

I wished there was more time spent on the merits of the case (my background makes such topics quite interesting to me), but Hansen did discuss how isolating is not purifying. All Myriad does is snip the gene out of the body. It should not matter what instrument is used, if the product is the same as its natural state, it should not be patent-eligible. Applying this to the case at hand, a kidney should not be patent-eligible in much the same way as an isolated DNA is patent-eligible. Whether the method is using tweezers, scalpels, or genomic methodologies.

Solicitor General Neal Katyal on behalf of the US government

The test articulated is the now-famous magical microscope test. If you could see the exact claim in nature, then that is a product of nature. CDNAs are fine because the magical microscope won’t find it.

Even though this oral argument went pretty smoothly for the most part, the government’s position was kind of awkward. This wasn’t really pointed out until the end, but I found it kind of funny. I love Judge Moore’s “you’re not changing anything with this theory of yours? What about the last 35 years buddy? What you are advocating goes against what’s on the PTO’s website right now.”

I got the sense that this case will be decided on jurisdiction from Judge Moore’s question next: Why not Congress? The Federal Circuit doesn’t need to make policy on such a controversial issue as gene patenting. The smartest thing for them to do is kick it out on jurisdiction and have Congress or the PTO make policy on it. Katyal answered that this is a pure question of law, but I don’t really agree. I think that a lot of research should go into deciding whether genes should be patent-eligible.

Finally, I love how Judge Hand made it in to this case. It’s been 100 years and he’s still a legend.

Rebuttal

I got the sense that Judge Moore didn’t understand probes and primers. Correct me if I’m wrong, but you can use a non-CDNA nucleotide as a probe, can’t you? The way she was questioning at this point made it appear that only CDNAs are probe and primer material. Castanias answered that the definition of isolated answers the question that it’s not the entire sequenced genome.

A funny aside, I thought it was funny how everyone seemed to pronounce BRCA differently. When I studied this gene in college, I always went with how Greg Castanias pronounced the acronym, which I think is how Myriad prefers to pronounce it too: Bracka. But Judge Moore used Bricka-1, Judge Bryson used Berca-1  and attorney Hansen decided to not risk it at all, by just spelling it out B-R-C-A.

A good presentation by all parties, overall. I got the sense that the judges were leaning toward standing as the most important issue, even though the ACLU and government wished to talk about other things. That may not be a good thing for their case! I think jurisdiction will prove to be the most powerful argument in favor of Myriad.

 Posted by at 8:09 am