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« Court Report | Main | Patent Profile: Ryogen Announces Issuance of Two Genomics Patents »

April 12, 2009

Comments

Kevin,

Very perceptive comment about the counterbalance between patentability of biotech versus the written description/enablement requirements. I wrote an article in 2003 on the "two-edged" sword of unpredicatability that makes it easier to patent biotech under 35 USC 103 (obviousness), but more difficult to get broader claim scope under paragraphs 1 (written description/enablement requirements) and 2 (definiteness requirement) of 35 USC 112. In fact, instead of using 35 USC 101 as the screen as the Federal Circuit has unfortunately done in Bilski, they would be better off to use paragraphs 1 and 2 of 35 USC 112 to keep claim scope in line. And if you want real "patent law reform", why not bring the patent statutes into the 21st Century by amending 35 USC 101 to make patent subject matter requirement more generous (other than abstract ideas, natural phenomena, iscoveries of laws of nature") and tighten up (and update the at least 60 year old) language of paragraphs 1 and 2 to make them the effective screen for too broad a patent scope, as SCOTUS did in O'Reilly v. Morse. What do you think? And others are free to chime in as well with their thoughts.

Kevin,
Good post. You've no doubt already read it, but others may be interested in Eli Lilly's amicus brief in Kubin, which extensively explores the counterbalance between obviousness and written description as they pertain to patentability of DNA. I believe there was a link to it in one of your earlier Kubin-related posts -- or maybe on Dennis's Patently-O blog.

Thanks, CNS. I'll see if we can link to it.

Kevin,

I finally read the Ariad Pharmaceuticals opinion. The only quibble I've got with Judge Moore's opinion (and normally I've got more quibbles with what Judge Moore says/believes what the patent law is and how it should be applied) is that the appellate standard for reviewing the jury verdict of satisfaction of the written description requirement ("substantial evidence") comes very late (and in my opinion, very tardy) in her opinion. By not describing the appellate standard of review earlier in her opinion (as most other Federal Circuit opinions usually do), it's never clear whether Judge Moore is applying a question of law ("de novo") standard (question of law) or "substantial evidence" standard (is the jury verdict legally supported by the evidence presented to them).

Judge Moore isn't alone in not making clear what the standard of review is. SCOTUS is notorious for being unclear about the standard of review, and it does make a difference. Witness the Grokster case on peer-to-peer file sharing. Grokster is a glaring example of where the opinion of the Court (by Justice Souter), as well as the concurring opinion (by Justice Breyer) would have made you believe their opinions were based on the district court's ruling being a full trial on the merits. But as the concurring opinion of Justice Bader-Ginsburg pointed out early, the ruling by the district court was based on a grant of summary judgment, and stated early in her opinion the correct standard for appellate review of such grants (de novo, with all factual inferences being in favor of the non-moving party). May be I'm being picky here, bu the sloppiness of the appellate courts in this regard can be trying, to say the least.

Kevin,

I respectfully disagree. How can one approve Judge Lourie's statement that "the existence of a general method of isolating cDNA or DNA molecules is essentially irrelevant to the question whether the specific molecules themselves would have been obvious, in the absence of other prior art that suggests the claimed DNAs"?
It is simply logically indefensible. Of course, general methods are relevant since the claimed DNAs are found using those general methods. It is irrelevant that there are 10^36 possible sequences; a skilled artisan (ie a research assistant in the lab) would use those commonly available general methods to arrive at the only correct sequence with a reasonable expectation of success. What evidence do you have that there was no reasonable expectation of success in Kubin? As far as I remember, there were no unexpected results at all. As Judge Rader correctly stated, it is irrelevant that the claimed sequences may have been obtained by methods slightly different from those disclosed in the art; the claims were to sequences, and thus the relevant question is: would a skilled artisan have had a reasonable expectation of success arriving at those sequences using the prior art methods. And the answer is yes.

I also disagree with your broader point on the Lilly/Deuel dichotomy. I think the Federal Circuit's jurisprudence has gone astray from Amgen v. Chugai, when the Federal Circuit treated gene as a chemical compound, essentially ignoring science. I know that you know that gene is not "a complex chemical compound", and that it should not be treated as such. I think that the approach you seem to support ignores science and assumes skilled artisans are robots who would not be able to use commonly known techniques.

I agree with PatentAttorney, whose opinion is shared by every biotech patent prosecutor I've spoken to about the case. Nothing wrong with In re Kubin. It's a very well-written reasonable opinion that is frankly more helpful than harmful to my clients.

Also, Kevin, you'd do well to keep your posts shorter. Remember your audience.

Dear Keep and Patent Attorney:

Not sure what you're saying about my audience, Keep, but with a few exceptions I think my posts are all about the same length.

It may be that many of my brethren agree with the both of you. But I think we need to restate what I said about Kubin:

The problem with the court's reasoning is that in order to obtain the NAIL cDNA from human NK cells, the cells had to be treated with a unique combination of cytokines and other activator molecules. That information is in Example 1 of the Kubin patent, and Kubin maintained that this teaching was absent (as it was) in the prior art throughout prosecution, before the Board and at the CAFC. If that is the case, then "following the prior art" would not have resulted in NAIL cDNA.

The reason that the methods are not the issue stems from their generic nature: if you used a generic chemical method to make a new chemical compound, wouldn't the compound be patentable? I think the same it true with nucleic acids.

I don't think treating nucleic acids as a chemical "ignores science." I think it puts science right where it belongs: the tangible chemical compound, a cDNA molecule, is patentable, while its sequence is not. The sequence is information, freely available for database searches, etc. and that's how it should be. But the gene itself, the chemical is what the inventor is entitled to claim.

And as for Bell, Judge Lourie's point was that the claim was to the specific nucleotide sequence (out of the 10^36 possible sequences) that could encode that nucleotide sequence. Don't be so sure that that same sequence could be obtained no matter what human cell you used: Craig Venter's work has shown that there is an incredible amount of variability between his two chromosomes (i.e., from Mon and Dad, two different humans). The narrowness of the Bell claim may be precisely commensurate with what Bell invented.

I don't think the skilled worker in the art is an unthinking robot; I think that the world is curiouser than we have the capacity to imagine, and that we should be careful in deciding what "would have been" obvious once we know the answer.

Thanks for the comments.

I respectfully disagree, strongly, with your article. Perhaps you have not been present, as have I, when decisions were made not to invest dollars in promising new cures in the area of molecular biology because meaningful protection was not available under the nonsensical doctrine that Judge Lourie has established in view of his failure to recognize that molecular biology is more akin to information technology than it is to chemistry. The need for this judge to see pictures shows a disturbing twentieth century small molecule mindset, which is this judge's background. If I identify the molecule and enable a person skilled in the art to make and use it, that should be sufficient.

You may recall that the court become so fixated on pictures, that it actually in the Enzo case found no written description where one had deposited the plasmid with the claimed nucleotide. In other words, actual possession was not sufficient to show possession. The court did catch itself on reconsideration, but this demonstrated how out of control Judge Lourie's doctrine has become. Although the Federal Circuit avoided the written description question in Kubin, the PTO will no doubt now apply it even with specific SEQ Ids.

This is not a careful balance.

That said, I actually believe that the Ariad decision was correct (although not Lilly which was limited to single enabled species in the claim to a cDNA encoding human insulin), but under the enablement requirement, which seemed to police over-reaching just fine for decades before Judge Lourie felt compelled to create a new requirement out of thin air.

Dear RS:

I cannot disagree that the written description requirement can be abused, but I just as strongly disagree with you about treating DNA as information. While initially attractive, that way lies In re Gleave, where the existence of sense-oriented oligos in the prior art (and a mere list at that) miraculously anticipates different (albeit overlapping) antisense oligos. Nucleic acid complementarity is the magic.

DNA as information also moves the discovery away from the tangible and chemical and into the realm of knowledge, i.e., unpatentability. One of the beauties of Judge Lourie's approach is that it "renders unto Caesar" in that the information from DNA patenting goes immediately into the public domain, while the tangible cloned genes can be proprietary during the patent term.

It isn't perfect, but I believe Judge Lourie's balance is a reasonable compromise. Enzo was a terrible decision, but one the court corrected promptly (unlike Kubin which will persist). The problem in biotechnology (at least the gene patenting part) is that if enablement is the only standard, then I can claim all mammalian cDNAs encoding gene X once I have cloned 1 of them. Even more than in Brenner v. Manson, this will preclude anyone else from cloning the other orthologs, and thus prevent anyone else from identifying how the human gene, for example, differs greatly from the first-cloned exemplar.

Thanks for the comment.

Dear Kevin,

With respect, the burden was on Kubin to demonstrate, that it was more likely than not, that the a skilled artisan with knowledge of the methods of the prior art would not have arrived at the sequence with the reasonable expectation of success. The Examiner, the Board, and the Federal Circuit (unanimously) all found that Kubin did not meet this burden. I agree that if there was something truly unique about obtaining a nucleotide sequence, then the sequence may not be obvious over the generally known methods. However, this is plainly not the case here; especially since Kubin himself stated in the patent that generally known methods may be used to arrive at the DNA sequence. Here's the money quote from Kubin's disclosure:
"The nucleic acid molecule has been derived from DNA or RNA isolated at least once in substantially pure form and in a quantity or concentration enabling identification, manipulation, and recovery of its component nucleotide sequences by standard biochemical methods (such as those outlined in Sambrook et al...). Given this admission, how can you argue that following the prior art methods would not have resulted in NAIL cDNA?

I would be very interested to read your response. Thank you.

I understand your comments but still obviously disagree. I understand the issue that in molecular biology, in view of the evolutionary relationship among similar molecules in different species, the obtaining of one may enable the obtaining of others and thereby preclude others from being free to practice later discovered molecules. This by the way occurs even in small molecule chemistry where a party is the first to obtain a steroid and uses broad definitions of alkyl groups such that the one who find special advantage with a tert-butyl is dominated. The area of chemistry seemed to survive the same problem and the earlier courts didn't feel compelled to create new law. Keep in mind also that most of these inventions are in the biological treatment area which means that they will be exempted from infringement under Merck during development.

Judge Lourie has acted as a senator and indeed was referred to as "Senator Lourie" during the time the Lilly decision came out (I happen to know one of Judge Bryson's clerks when Bryson joined Lourie in that decision). The policy promotes incrementalism and ignores what the "invention" often is in molecular biology. For example, if my company spends half a billion dollars to discover that the existence of receptor X and the fact that blockage of that receptor will prevent breast cancer, I can get no adequate coverage for my invention under Judge Lourie's regime because I cannot possibly identify in my specification every compound that would block receptor X. Yet with array technology, any reasonably skilled graduate student could with little effort develop dozens, if not hundreds of compounds that bind receptor X. So what is the result? Incrementalism because no one will invest in pioneering technologies.

That said, I understand your concern and your Brenner v. Manson argument. My only response is that this was a legislative issue that could have been resolved, for example, by implementing a research exemption or by mandating compulsory licensing where a pioneer patent dominates later developed technology. My point is simply that it was wrong for an unelected judge to make such policy decisions on his own, outside the legislative process where all concerned could be heard, by creating a new requirement out of thin air.

Hmm, for some reason I cannot see a post that I just wrote. Perhaps, it's some glitch.

Dear PA:

That was the admission the Court used too, but I think I can eat my cake and have it, too on this one.

The relevant quote comes from Kubin's counsel during oral argument:

"It [Sambrook] does not tell one with skill in the art how to produce a NK cell library, and if you look at the methodology that's recited in the specification, what they [Kubin] used was a specific mixture of resting cells, resting NK cells and NK cells stimulated with a very specific cocktail of activators. That's not disclosed in Sambrook. That's not disclosed in Valiante. That's not disclosed anywhere[.]"

So the money quote can be correct - Sambrook provides the methodology - but my position can also be correct - that the art didn't teach the skilled worker a source of sufficient mRNA for the Sambrook methods to be productive in producing the NAIL cDNA.

We come back to the critical factual issue - could you follow the art and get NAIL with a reasonable expectation of success. I think the answer is no, because Kubin expressly recited the use of this mixture of cytokines and other activators in Example 1. I don't expect (and there is no requirement that Kubin would have) Kubin to disclose everything that didn't work (because where would it end?) and the fact that he included this requirement in Example 1, plus the consistent argument that the prior art did not teach a method for isolating NAIL cDNA indicates to me that this treatment was necessary.

So, to avoid beating this subject to death, I put it to you: if I am right, do you still think Judge Rader and his panel came to the right decision in Kubin? Because if you do, we'll just have to agree to disagree.

Thanks for the comment.

Dear RS:

"Reach-through" claiming is a problem, no doubt. One way to provide some support for the broad genus of receptor inhibitors might be to disclose more than 1 species of inhibitor and then try to develop a generic structure using chemical modeling tools, etc.

I think that another distinction with small molecule cases (particularly in pharma) is that those cases disclose several dozens if not hundreds of species from which the generic structure is derived. I would make the same argument in a biotech case as I would in traditional pharma: if you have cloned a receptor gene that is inhibited by compound X, show me sufficient examples of species around the X structure that can also inhibit and then you are entitled to the generic inhibitor claim.

I think you point out a real problem, but that your proposed solution - eliminate the written description requirement - is not the answer, in my view.

Thanks for the comment.

"However, this is plainly not the case here; especially since Kubin himself stated in the patent that generally known methods may be used to arrive at the DNA sequence." "Given this admission, how can you argue that following the prior art methods would not have resulted in NAIL cDNA?"


Patent Attorney,

Be very careful with relying on what the applicant says are "generally known methods" for making the nucelotids/cDNA in determining obviousness. As was pointed out by the Federal Circuit as recently as Princeton Biomedicals, it is improper hindsight to detemine obviousness by using applicant's own disclosure as the "road map." That is exactly the trap that Judge Rader fell into in Kubin, and why this opinion has some real problems, including whether a fundamental principal of obviousness (the applicant's own disclosure is not to be used as prior art or as hindsight justification) was violated here.

That the applicant in Kubin said "conventional techniques" could be used to make the nucleotide/cDNA isn't the same as saying that someone, without knowing what nucleotide/cDNA is being targeted, would consider the cDNA obvious. Unless you know what nucleotide/cDNA the applicant was targeting for, you won't even know necessarily what "methods" diclosed in the art could be used to make the nucleotide/cDNA. In fact, and this is the crucial nugget of Deuel which Kubin never properly addresses and which, as Kevin correctly says, turns Deuel on its head, when claiming chemical entities (e.g., nucleotides and cDNA) in structural terms, the prior art must suggest the claimed compounds, not simply the methods for making and/or isolating same.

Dear Kevin:

I appreciate your attempt to have your cake and eat it, too. However, I think the cake is simply too big in this case. ;)

Again, Kubin admitted that Sambrook methods can be used to produce DNA. It is possible that it was simply a boilerplate language someone copied and pasted; however, the fact remains that the admission was made on record. I agree that Kubin didn't have to disclose everything that didn't work; however, he is not entitled to broad compound claims when: 1) he admitted that compounds can be produced by prior art techniques and 2) the claims do not recite any method limitations.

If you are right (ie, if there was no reasonable expectation of success to obtain the compounds practicing prior art methods) AND if Kubin hadn't admitted to the contrary in his own patent, then I agree that Kubin should get his compound claims. For example, had Kubin shown unexpected results, he should have been able to overcome the prima facie case of obviousness.

I think that remains the law after Kubin: show that what you did was not obvious by demonstrating lack of a reasonable expectation of success, for example, by unexpected results, and you'll win on the obviousness issue.

But don't expect to win if you admit that the prior art methods can be used, and then rely on the data from your examples to attempt to show that the claims are not obvious.

Alternatively, one can try to claim the sequences as product-by-process claims. That way, one can rely on the process steps limitations to overcome obviousness and one should get claims of a fair scope, if the process is not obvious, of course. And if the method used to obtain the sequence is so unique and great, then it should matter much less that the claim is a product-by-process claim.

Thanks.


EG:

I totally disagree. The admonition against using the applicant's disclosure as the "road map" is absolutely correct, but it is inapplicable here. It is improper to find obviousness, when there was no reason at all to combine prior art references to arrive at the claimed invention; for example, if a claim is to a composition comprising A, B, and C, it is improper to find obviousness over three references disclosing separately A, B, and C, when a skilled artisan would not have had a reason to combine them BUT for the applicant's disclosure.

Here, this rationale is inapplicable because there was ample reason to obtain the claimed polynucleotide sequences; in fact, I don't think Kubin even argued that such reason was lacking.

Respectfully, it makes no sense to say that the prior art must suggest the claimed compounds, and not the methods of making/isolating them. Of course the sequences are not known until they are arrived at; it is precisely by using these methods that one arrives at the claimed compounds, so they are suggested because a skilled artisan would have every reason to practice prior art methods to arrive at the claimed compounds with a reasonable expectation of success.

This is another illustration why Judge Lourie's transplant of principles that may work for small molecules into the DNA field is so crazy: while it may make sense to hold structurally similar chemicals prima facie obvious because they are expected to have similar properties (although, even here, there's a vast room for disagreement), this approach makes no sense for DNA molecules. First, DNA molecules are not chemicals; even slight variations can lead to drastic differences. Second, and more importantly, one doesn't start tweaking existing DNA molecules to arrive at the new ones; instead, for example, one derives the sequences from known proteins.
Thus, it defies logic to require a showing of structural similarity to find a prima facie case of obviousness. This is why BIO's brief in Kubin didn't make any sense when it tried to suggest that Kubin somehow endangers claims to small molecules.

Dear PA:

You make a fair point. I think the court is cherry-picking its "admissions," but it is consistent with prior caselaw (Sage Products, for example) that the patentee needs to suffer the consequences of deficiencies in their patent. So although I think the disclosure as a whole supports my position, the "admission" language certainly didn't help Kubin.

It is a practice point to note, however, that "boilerplate" (at least unreviewed boilerplate) is a bad idea in most legal documents, maybe nowhere as much as in a patent application.

But in Kubin's defense, you would have needed a very clear crystal ball to have seen this problem coming.

Thanks for the discussion.

Kevin,

I agree that the Court is often cherry-picking the admissions. And I totally agree about avoding unreviewed boilerplate.

I tend to disagree that the overall disclosure in Kubin supported your position, but I need to admit that I haven't spent as much time reading this patent as you have.

As a practice point I would say this case teaches not to be too greedy in your claiming. Although, given that Deuel was controlling law, Kubin probably could not have predicted that it would no longer be controlling by the time patentability of its claims would be determined. Nevertheless, the lesson is to try to use common sense, and you should be OK.

Thanks for the discussion; it was very interesting.

Patent Attorney,

We may have to simply "agree to disagree." The admonition against using the applicant's disclosure as the "road map" is not only absolutely correct, but also applicable to the Kubin case. Judge Rader obviously "peeked" at the applicant's spec (which is OK), but then stepped over the line by using it to confirm his obviousness assessment. That's simply not permissible under Princeton Biochemicals, and other Federal Circuit cases that have repeatedly chastized the PTO for doing same.

The comments to this entry are closed.

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