Saturday, July 21, 2012

Oral argument on July 20 in Myriad case: analogy to coal extraction gets a workout


Discussion limited to the relevance of Mayo v. Prometheus to the claims before us.
Castanias gets 20 minutes.

Castanias. Non-naturally made human inventions. Mayo's theory was pre-emption. It's not a separate test. Lourie: Here, we are talking about an isolated material that comes from nature. Isn't this a small move? Castanias brings up Bryson's baseball bat imagery.

Remove a trunk of a tree, and say one has invented a trunk of tree? Instead of cutting a tree with an ax, used a laser. Chemical changes at bottom of trunk, but still a tree trunk.

Castanias. Isolated DNA. '282 patent, column 19. Go to column 24, line 9. These inventors decided (Figure 10A) where BRCA 1 gene begins. Where to start, where to end. Like baseball bat. Product of human ingenuity.

Claim 20 is closest of relevance to Mayo. Method of screening. How do you distinguish claim 20 from Mayo. Here, you start with a new manufacture.

Issue of what's in petition vs. GVR.[Bryson issue) We are not limited by what's in petition. Bryson notes the judgment was vacated. Bryson does not think task is restricted by "what's in petition."

Bryson says he is confused by the language of claim 20. "causing cancer" ? What is the method by which this claim actually works? The words "causing cancer" are floating in the claim.

Moore brings up the possibility of holding the isolated gene unpatentable. Is claim 20 still patentable.

Hansen is next. "Stunning breadth" of the claims. Court: breadth is a 112 issue.
Pre-emptive issue. Court: is pre-emption related to Mayo? Court: Mayo dealt with method claims. Isn't the holding with respect to method claims irrelevant to composition claims? Moore: I don't see any relevance of your pre-emption argument.

Hansen goes to claim 20. Lockheed-Martin v. Space Systems. Altered BRCA 1 gene, which has been shown to increase risk of cancer.

Issue of "significantly more." Here, all you do is put stuff together and "see what happens". Just check various growths. Administer man-made drug to human. Under Mayo, looking to see what happens is NOT patentable. Penicillin case. Is effect of penicillin on bacteria not patentable because it is a law of nature?

Next, US (Melissa Patterson ). Court: Is Mayo a tool like the magic microscope a tool? Patterson defends magic microscope. Moore hammers on magic microscope. Are changes made in isolation enough to make this patentable invention. Products of nature should be free to wall.
Taking DNA, converting to RNA, making protein is law of nature. Some of these claims preclude access to a product of nature. Inhibit ability to exploit product of nature. Can the public still use and exploit?

Court: is your view that of USPTO? Matter of different agencies taking different positions. Attorney General Bell and TVA. Here, this is position authorized by Solicitor General.

Patterson: We don't think this is a close case. Brings up tungsten and GE case. Break apart a proton. Isolate a quark. Not patent eligible. When the only changes made are incidental to extraction from environment. You need to remove it from natural environment. Coal extracted from a vein. Myriad does not point to a single way another researcher could extract.

Moore: what about settled expectations of other gene patent holders. There is a lot at stake.
US points to Bilski case, effectively invalidating thousands of patents.
Supreme Court: need to make general rules about section 101.
Pre-empt public's rights to investigate.

Primer/probe issue.

Coal issue. Lots of things can be done AFTER coal extracted.

A "certain 13". Uranium case from CCPA.

Castanias back. Goes to claim 20. "Gene causing cancer inserted into host cell."
In Mayo, use of old drug in a new way can be patented in a method claim. The insertion of the BRCA1 gene is very much like Chakrabarty.
As to composition, Chakrabarty already drew line. Invention of starting and stop points. Inventive judgment.
Is coal extracted from the ground patentable subject matter.
This is different because inventors pick the starting/stop points.
Protein replacement therapy.
Magic microscope. I hope this is invention. By now, it's obvious.
Our invention is what it allows doctors to do.
Human ingenuity is involved in deciding where to clip it.
Robinson treatise of 1890. What skilled artisan would do.
Kidney extraction example. Where to cut the kidney? Then claim isolated kidney as an invention because I determined "where" to cut it.
You are claiming the kidney.
Dr. Watson had his genome sequenced. Had mutation on BRCA1 gene.
Moore: deciding where to cut. this is your whole case?

Matter of obviousness in Mayo. Supreme Court used word "obvious."

Simply put, Chakrabarty drew the line. Nothing in Mayo changed this.

See also U.S. appeals court reconsiders Myriad gene patent ruling
on Association of Molecular Pathology v. U.S. Patent and Trademark Office, No. 2010-1406.

**In passing, the Castanias reference to Watson was interesting, given that Watson opposes the Myriad position. See DNA Structure Co-Discoverer James Watson Weighs In on Ongoing Gene Patent Case . Watson filed an amicus brief which includes the text: “Amusingly, after I gave my first presentation of our DNA structure in June 1953, Leó Szilárd, the Hungarian physicist and inventor of the nuclear chain reaction, asked whether I would patent the structure. That, of course, was out of the question.”


Oral arguments before the CAFC

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