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« Biotech/Pharma Patent Issuances Increased 39% in 2010 | Main | Star Scientific, Inc. v. R.J. Reynolds Tobacco Co. (Fed. Cir. 2011) »

September 14, 2011

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Comments

Kevin,

I guess the ACLU didn't shed big enough "crocodile tears" to sway the Federal Circuit. (Serves them right in my opinion have their petition denied out of hand.) And they may be happy with this result anyway, as it clears the way for their inevitable petition to the Supreme Court.

Wootles, on to the USSC!

Not so fast, 6. The court has not ruled on Myriad's petition for rehearing.

Stay tuned.

"Not so fast, 6. The court has not ruled on Myriad's petition for rehearing."

That's what I thought when I first read the title :( But then in my exuberance I set it aside.

Kevin,
I have a question regarding isolated DNA patent-eligibility. Since isolated DNA has the exact same function as that of the genomic DNA ( function yes, but not structure), is it patent-eligible under 101?
In molecular biology, we define genes by its function and not by its DNA composition. And the cDNA is constructed/invented because that it functions similar to that of the gene in its native state.

Dear Biologist:

As Chief Judge Rader has said (in another context), "structure, structure, structure."

And the argument is that there is a different function - for example, I can use the isolated DNA to produce a recombinant cell that makes the protein, or I can produce sufficient quantities of the DNA to sequence it, etc. Many of the gene patents were filed pre-HGP, and isolating a gene really did change it from unknown black box to useful chemical.

But to answer your question another way, here is a hypothetical. I identify a molecule in the human body that regulates blood pressure. I produce it so that it is identical, atom for atom, with the compound in the body, but I make a pill with it that regulates blood pressure with no side effects. So it is identical in structure and identical in function. Should I be able to patent it?

Thanks for the comment.

kevin,
With the isolated cDNA example you stated above, you are making the recombinant protein in large quantities, which will have the SAME function as that of native protein. Hence, it has no distinct character or function when compared to native state.

The question here is ... are you interpreting isolated DNA and genes based on their DNA sequence or on their function? Remember, many gene transcripts give rise to isoforms (differing in their structure) but still have same function and hence we call them with the same name but with alpha, beta etc suffix.

I believe genes and isolated DNA should be compared on the function and genetic information they carry, and not on their sequence. For example, I can make 100 diff. variations of BRCA1 cDNA using degenerate codons and obtain the same protein with identical function. Do you think I invented something new here?!!

Regarding your hypothetical molecule, think INSULIN. People have patented the process to purify insulin, to make genetically engineered insulin, its therapeutic use etc. but not the insulin gene itself.

Dear Biologist:

OK, let's try this again. I isolate a novel chemical from crude oil. I purify it, but it has exactly the same structure and function as in the crude oil (but of course purified away from all the other components of crude oil). It is patentable?

We can do this for many things, but the bottom line is that if you need to "invent" it as you imply, then electromechanical devices are the only things that will be patented. I like my iPod, but I think there are many things that are more important and need patents to protect investment and commercialization.

Thanks for the comment.

Dr Noonan writes:

here is a hypothetical. I identify a molecule in the human body that regulates blood pressure. I produce it so that it is identical, atom for atom, with the compound in the body, but I make a pill with it that regulates blood pressure with no side effects. So it is identical in structure and identical in function. Should I be able to patent it?

Unsatisified with the (to me an appropriate) rebuttal from molecular biologist, Dr. Noonan reformats the hypothetical away from "an invention" directed to a human organism.

But this reformating does not answer the rebuttal.

Further, even though this idea has been covered loosely on other blogs (and far too easily dismissed), now that the law has been passed without ANY of the constraints or limits on the actual language that may have been present in any earlier similar worded bills, the plain meaning of "directed to OR" may eviscerte this art field.

Seeing as there are various time points of implementation in the new law, does anyone know when this quasi-Weldon-amendment-style provision is slotted to be controlling?

I am skeptical that Congress will actually let that happen and expect a technical amendment providing some level of constraint to the art field patent ban. I think the interesting debate will be deciding what that level of contraint will be and what the language of constraint will be.

Dear Skeptical:

Regarding the patent reform provisions, the legislative history (for what that's worth) is that the codification of the Weldon amendment is not directed at stem cells or DNA; however, how a court may interpret the provisions is an open question (albeit one where the court would have to ignore the LH).

As for the rest of the conversation, you take a categorical approach, so that biological molecules are not patent-eligible per se (this is reminiscent of the position taken by the PTO in Chakrabarty and Bergy that living things are not patent-eligible because they are alive - a position rejected by the Supreme Court). My problem (as illustrated by the hypo) is where to draw the line: human DNA? any DNA (including viral, bacterial, plant)? proteins (hormones, antibodies, enzymes)? again, human versions or from any organism? antibiotics or other compounds isolated from plants? any organic molecule (since it has origins in living things)? How broad a sweep do we want in this category, and what is the rationale for drawing the line where you or biologist or anyone taking this position wants to draw it?

While I have philosophical problems with that position, my biggest issue is where should we draw the line, and why? And then, my utilitarian bias asks what are the consequences: what is excluded from patent-eligibility and does that exclusion mean things will not be commercialized that I think should be, or will things be kept as a trade secret and the "monopoly" extended to however long it takes to reverse engineer the invention?

Thanks for the comment.

Kevin
Lets get more technical here regarding patenting cDNA. cDNA is generated by transcribing/copying a mRNA (which is a product of nature) and the resulting cDNA, although different in structure, will perform the same function as that of the mRNA. You cannot patent cDNA construction ( in our case, BRCA1) since this technology is prior art. Or, it can be shot down under obviousness, since it has the same function as that of a gene or mRNA. What else can you do with your cDNA---well go ahead and patent its diagnostic or therapeutic use, which myriad did with their method claims.

All your above hypo scenarios can come under this arguement, i.e. patent the biological use but not the molecule itself.

Dr. Noonan posts:

"the legislative history (for what that's worth) is that the codification of the Weldon amendment is not directed at stem cells or DNA."

Dr. Noonan, WHAT legislative history? Are you forgetting that the legislative history for THIS LAW (this session) does not have the famed "Senate Deal" limiting the patent ban that may have been present in past congressional records (or so I have heard)? Perhaps you can clarify this for me.

Dr. Noonan also states:

"my biggest issue is where should we draw the line, and why?"

I concur, and that is the point that I raise.

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