What Bilski Means For Biotech Patents

eldavojohn writes "Patents aren't just a software thing, and while Bilski's dismissal didn't shake the ground for software, it's certainly making waves in the biotech community. You may recall Prometheus v. Mayo, in which doctors fought a biotech startup's methodology patents. Well, medical method patents are now being reconsidered by order of the Supreme Court. Stocks of biotech startups jumped as this news broke, but questions remain on how the lower Federal Circuit court will rule when it reconsiders these cases of medical testing. It's clear the Supreme Court has 'ruled that judges should be more flexible in determining if methods, rather than objects, are eligible for patents, citing emerging technologies such as medical testing.' So Bilski may result in dire news for medical methods and testing patents."

Comments

Feh

[Pojut]

The SCOTUS really screwed the pooch here. Considering how the oral arguments went, I was very surprised at the opinion they ended up releasing.

Re:Feh

[Pojut]

Um...did you listen to/read the oral arguments from last November? They fucking CRUCIFIED method patents. For some reason, the link I had saved from the Supreme Court website isn't working, but Patently-O did a fine job of picking out the relevant passages:

http://patentlyo.com/patent/2009/11/bilski-v-kappos-supreme-court-arguments.html

Here are some samples from the oral arguments:

JUSTICE BREYER: You know, I have a great, wonderful, really original method of teaching antitrust law, and it kept 80 percent of the students awake. ... And I could probably have reduced it to a set of steps and other teachers could have followed it. That you are going to say is patentable, too?

JUSTICE SCALIA: . . . Let's take training horses. Don't you think that -- that some people, horse whisperers or others, had some, you know, some insights into the best way to train horses? And that should have been patentable on your theory.

JUSTICE SOTOMAYOR: So how do we limit it to something that is reasonable? Meaning, if we don't limit it to inventions or to technology, as some amici have, or to some tie or tether, borrowing the Solicitor General's phraseology, to the sciences, to the useful arts, then why not patent the method of speed dating?

JUSTICE SOTOMAYOR: But a patent limits the free flow of information. It requires licensing fees and other steps, legal steps. So you can't argue that your definition is improving the free flow of information.

Like I said. Fucking. Crucified.

Re:Feh

[h4rr4r]

I realize they said that, and it surprised the hell out of me. These are the same folks who decided corporations could donate as much as they wanted. They made bribery legal.

Re:Feh

[Daniel Dvorkin]

It is not as if supreme court judges can do whatever they want. The law that legally makes corporation into a person caused that decision and should be stricken down, then even a conservative judge woudn't be able to argue for such nonsense.

AFAIK, corporate personhood in US law comes from Santa Clara County v. Southern Pacific Railroad, and has never been codified into law. What the Supreme Court did, it can undo.

Re:Feh

[Daniel Dvorkin]

You need the law that was interpreted during Santa Clara County v Southern Pacific Railroad to mean corporations were people in order to find where the whole thing originates.

The law in question was the 14th Amendment, which says nothing about corporations, and was clearly written to refer to individuals. The corporate intepretation was made up out of whole cloth. It was a mistake, and one which the SC could easily correct.

Re:Huh?

[Grond]

I thought that a patent was still permitted if (1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing. It's hard to believe that a drug or gene couldn't meet those qualifications if a piece of software can.

Well, first, the Supreme Court held that the machine-or-transformation test, which you recited, is only a tool or clue to the patentability of a method, not the sole test. Second, the diagnostic patents being discussed here generally take this form:

"A method for treating disease X, comprising performing test A, observing the result, and administering treatment foo, bar, or baz depending on the result."

The issue here is that in many of these patents test A and treatments foo, bar, and baz are all known in the art. The invention is the discovery of the association or correlation between test results and the optimal treatment (e.g., if you have a certain gene then you get this drug, but if you lack it you should get this other drug). The Federal Circuit has hinted that it is the observing or correlating step that must pass the machine-or-transformation test; (possibly) the testing and (more likely) the treatment steps are merely 'insignificant postsolution activity' that can't rescue the patent from unpatentability.

In my opinion, however, such patents should be granted so long as they are new, useful, nonobvious, and adequately specified in the patent. Subject matter is too crude a tool to filter out undesirable patents. As a society we want investment into new diagnostic methods and personalized medicine. For example, the availability of fast, inexpensive genetic testing has opened up new doors to making sure that people are given the best drug at the best dose, but determining which genes match which drugs and doses will require significant studies. We can encourage investment in those kinds of studies by offering patent protection to the resulting diagnostic and therapeutic methods.

Full Disclosure: I worked with the team that wrote the amicus brief for Dr. Ananda Chakrabarty (of Diamond v. Chakrabarty fame) in the Bilski case.

Bilski Is Necessary, but Deliberately Vague

[krsmav]

IAAL. When SCOTUS takes a patent case, they're like a bull in a china shop. They're not engineers or patent lawyers, so they undo a lot of stuff that has been carefully worked out by the Patent Office and special patent courts. That said, the area of non-device patents has grown enormously over the last few years, and there was a great need to set some ground-rules to cut back on overreaching claims while giving people with new ideas a chance to make a profit from their innovations. In my view, Bilski is a monster (and necessary) bitch slap for methodology patents, which had gotten out of bounds. (IMO, the next one will come on copyright overreaching.) The Supremes deliberately left the opinion vague to let the experts work out the details.