E-mail Newsletter

  • Enter your e-mail address below to receive the "Patent Docs" e-mail newsletter.

Enter your email address:

Delivered by FeedBurner

Contact the Docs

Docs on Twitter


About the Authors

  • The Authors and Contributors of "Patent Docs" are patent attorneys and agents, many of whom hold doctorates in a diverse array of disciplines.

Disclaimer

  • "Patent Docs" does not contain any legal advice whatsoever. This weblog is for informational purposes only, and its publication does not create an attorney-client relationship. In addition, nothing on "Patent Docs" constitutes a solicitation for business. This weblog is intended primarily for other attorneys. Moreover, "Patent Docs" is the personal weblog of the Authors; it is not edited by the Authors' employers or clients and, as such, no part of this weblog may be so attributed. All posts on "Patent Docs" should be double-checked for their accuracy and current applicability.

Become a Fan

« Adams Respiratory Therapeutics, Inc. v. Perrigo Co. (Fed. Cir. 2010) | Main | USPTO Launches Facebook Page »

August 11, 2010

Comments

Kevin,

I guess you might say Kool-Aid drinking is becoming a sport in our area of the law. What astonishes me (as it did the majority of the panel) was why Judge Dyk raised an issue that none of the parties raised below and certainly wasn't part of the appealed issues. And as you correctly point out the concept of isolated DNA sequences being patent-eligible under 35 USC 1010has been a given for many years. Why raise that issue now?

My claim: an article of manufacture comprising Seq Id X.
My spec: article of manufacture means anything under the sun touched by the hand of man, not including an electronic or printed representation of the sequence or the cell that naturally/natively comprises Seq Id X.

Is the ACLU happy now ?

I've seen stats suggesting that University start-ups account for less than 1% of government funded research. Not a great ROI for Joe Lunchpail. So, who is going to manufacture the diagnostic tests that are being done by Myriad and others once these companies have no (or less) patent protection?

Kevin---with great respect, I think Judge Dyk is exactly right. DNA coding for a protein is no different from water, oil, or air---it exists in nature and cannot be patented. Further, it has long been established that one cannot patent a chemical compound found in a leaf or plant (i.e., for example, taxol isolated and purified from the Yew Tree). It should be remembered that the limitations on the scope of patentable subject matter incorporated into Section 101 are mandated by the constitution. Section 101 was intended to incorporate Supreme Court precedent that had limited the scope of patentable subject matter to exclude natural phenomona and products found in nature. As the Supreme Court recognized more than a century ago, there would be profound First Amendment issues if the patent laws were interpreted to allow products found in nature to become the subject of exclusive patent monopolies. The longstanding and irrefutable principle that a patent cannot be obtain on a product found in nature is a limitation on the scope of patent rights that is constitutional in dimension.

But the biotechnology industry will not face doom if Judge Dyk is correct. Surely patents should be allowed on non-obvious methods of isolating and/or synthesizing DNA, just as there are hundreds of valid patents concerning how to extract or synthesize large quantities of chemical compounds found to exist in plans (i.e., paclitaxel or docetaxel produced from materials derived from Yew trees). And most importantly, patents may be allowed on non-obvious methods of treatment involving use of DNA or modification ("transformation") of DNA existing in nature. If Judge Dyk proves to be correct, this will just be a blip on the radar screen (no pun intended) for the biotechnology industry.

Dear Maurice:

We are going to have to agree to disagree. I think most of the Supreme Court precedent cited in support of your position is improperly and rather glibly recited, since a close reading of what the Court actually said in those cases does not support the proposition.

I also think there is nothing constitutional in the proposition. The only constitutional mandate is to "promote the progress . . . of the useful arts." Providing patent protection does that for "natural products" as much as for man-made machines.

Indeed, there is even more reason to grant patents on such products, since unlike a machine the possiblity exists that "natural products" can be difficult to reverse engineer - making it possible to retard if not prevent disclosure, the hallmark of patenting and why Congress was granted the power to grant patents. And I disagree that there is any policy reason to do so - we want to provide incentives for natural products to be taken from their natural environment and made into useful pharmaceuticals.

We do agree that the biotechnology industry will not face doom, particularly if the Chakrabarty decision is not overturned. But there will be an incentive created, particularly in genetic diagnostics, to maintain as much information as possible as trade secret. This will lead to an extension of the "monopoly" much longer than the term of a patent, and will incentive non-disclosure rather than disclosure. The real losers will be universities and the public.

Thanks for the comment.

I love the Frankfurter concurring opinion, which I will now have to read in its entirety. So thanks for pointing it out.

But let me point that applying its logic, which I think is sound, to AMP v USPTO is likely to have an interesting effect: it would invalidate the *composition of matter* claims that are in Judge Sweet's crosshairs, but not because DNA per se is not eligible for patenting, but because the patent fails to specify the sequence (the properties of the product) and their distinctive features (cancer-causing versus not cancer-causing). That it, it would reach the same result as Judge Sweet's ruling, but on narrower grounds, and grounds that would lead to a legal rule for gene patents. (Unless you've shown what they do, you don't get to claim them.)

I need to clarify (so please add to previous post). Applying Justice Frankfurter's criteria to BRCA patent claims *would* probably result in valid claims on the sequences they had characterized and found associated with high inherited risk of breast and ovarian cancer. But they would preclude very general claims for all BRCA sequences that had not been (1) specified in detail, and (2) correlated with phenotype--in this case risk of cancer. That is, a patent would not be able to claim all sequences in a gene that have not been studied for their clinical (or other practical) outcomes. It would, in effect, restrict the scope of claims to disclosed genotype-phenotype correlations, but would not permit claims that would cover all possible sequences that *might* be associated with phenotype but had not actually been studied and disclosed. Valid claims would have to include both the specific sequence(s) and (2) the claimed real-world outcomes.

Dear Bob:

I have no problem with making decisions on claim scope, because that will be dependent on the extent of disclosure (something in an applicant's control). My problem with Judge Sweet's decision (besides its departure from reality with the "physical embodiment" nonsense) is that it provides a per se rule, a "thou shalt not" for gene claims that I think is a poor tool for making the kinds of decisions you envision using claim scope.

I also think that, philosophically, the argument proves too much that genes are unpatentable "natural products," since that logic goes very far towards making medicinal chemistry unpatentable - a result that is as unnecessary as it is fool-hardy.

I'd like your views (offline if you wish) on Heidi Williams' recent genomics analysis; I have neither the time nor the background in economics to assess it, but I have a gut feeling that a close look at her assumptions might reveal some defects in the analysis.

Thanks for the comment, Bob. Hope you are well.

I support the drinking of this kool-aid as it it both delicious and cool while we are having a hot summer.

"This identity might perhaps support the dissent's argument, except that the genetic information is not what is patented."

Are you familiar with the concept of preemption? If a claim to the thing claimed, in this case the isolated gene, would substantially preempt all uses of that "identity" in at least one field, then you're sol.

"Much has been made in some quarters regarding Chief Judge Rader's public statements regarding the gene patenting issue, comments that in at least one instance have been taken (willfully) out of context. "

It is pretty clear the context sir, and it is pretty clear what the man said. it is also abundantly clear what his position is on the way one performs the 101 abstract idea analysis. His approach to Bilski is quite telling.

"But there will be an incentive created, particularly in genetic diagnostics, to maintain as much information as possible as trade secret. This will lead to an extension of the "monopoly" much longer than the term of a patent, and will incentive non-disclosure rather than disclosure. The real losers will be universities and the public."

You say that, but they can already go down that road if they think it would benefit them. I see little "extra" incentive to do so other than the removal of the choice to patent and that is barely any at all. Seems like that is a small price to pay as that would be outweighed a million fold by the genes that the public gets to use freely that are also isolated by NIH et al. like the one in Myriad. Not to mention the fact that a huge number of these isolated genes are already patented and will fall down into the public's hands.

Dear 6:

Two things. First, composition of matter claims "pre-empt" all uses of the claimed composition of matter, insofar as a use, even a new patentable use, will infringe the composition of matter claim. This is also true of machine claims and manufacture claims. Pre-emption as a concept stems from cases on method claims. In addition (just like with DNA claims), what is not claimed is the information inherent in the composition of matter, machine or manufacture, which can be used to make a patentably-distinct composition of matter, machine or manufacture - which is why the phrase is building a better mousetrap.

As for what Judge Rader said, I was in the room and you were not - you are relying on the characterizations of one of the parties to the appeal. It's up to you to decide whom to believe.

Thanks for the comment.

"First, composition of matter claims "pre-empt" all uses of the claimed composition of matter, insofar as a use, even a new patentable use, will infringe the composition of matter claim"

You bring up a good point, if you can find some composition claims that preempt a judicial exception via what you are talking about then congrats, you found an invalid claim.

My guess is that there are some out there. Good luck finding them.

"Pre-emption as a concept stems from cases on method claims."

I'm aware. That's where it usually pops up.

"In addition (just like with DNA claims), what is not claimed is the information inherent in the composition of matter, machine or manufacture, which can be used to make a patentably-distinct composition of matter, machine or manufacture - which is why the phrase is building a better mousetrap."

That is a very weird way of saying what I think you're trying to say, but, in either event, I'm unaware of any "information inherent in the composition of matter, machine or manufacture" in standard claims, but on the other hand, it seems readily apparent what that is in gene claims. Or at least so says expert testimony.

"As for what Judge Rader said, I was in the room and you were not - you are relying on the characterizations of one of the parties to the appeal. It's up to you to decide whom to believe."

True, perhaps I should defer to you on this, but you have yet to provide anything that would refute the characterizations of one of the parties to the appeal.

The comments to this entry are closed.

May 2016

Sun Mon Tue Wed Thu Fri Sat
1 2 3 4 5 6 7
8 9 10 11 12 13 14
15 16 17 18 19 20 21
22 23 24 25 26 27 28
29 30 31