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« A Response to Mr. Brill, and a Modest Proposal Regarding Inequitable Conduct | Main | Tafas Files Petition for Rehearing in Tafas v. Doll »

June 03, 2009

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Since "Senator" Lourie usurped the legislative function and conjured up this requirement out of thin air twelve years ago, it has, as Judge Rader predicted, caused horrific consequences to molecular biology patenting by rewarding incrementalism and discouraging broad research. The basic problem is that Lourie, and the powerful private companies that support him, all have a "small molecule" mindset incapable of appreciating that unlike small molecule chemistry, molecular biology disclosure does not require precise structure to put one in possession of a broader invention. There are promising new areas of research that are not being pursued. To the extent that there was overreaching, the enablement requirement seemed to work just fine for decades.

Those who supported the Lilly fiasco pointed out that, at the very least, to the extent an applicant provides specific structure for a new biological molecule, at least it was nonobvious. Kubin was the inevitable comeuppance for those who espoused this position. It was just a matter of time. Now we have a situation where we have the worst of both worlds, where specific structure is required for a claim to DNA but where prior art disclosing a protein invalidates that DNA even though the structure is non-obvious. In essence, it's the nightmare of Judge Lourie on written description and Judge Rader on obviousness. If only it were the other way around.

This issue needs to be addressed, whether by the courts or more appropriately by Congress.

Go Ariad!

Dear Marc:

I certainly agree that the Kubin decision has upset the delicate balance between obviousness and sufficiency of disclosure represented by Deuel and Lilly. But I think the Lilly decision captured an important consideration, even if inexactly, and that the Ariad case represents it well.

Basically, the Ariad claims at issue were that John McDonnell used to call "single means" claims, wherein the method encompassed reducing NFkB activity by any means, known or unknown. Besides being impossibly broad, the claim if interpreted that broadly "reads on" prior art methods (aspirin, antibiotics) that intrinsically work by reducing NFkB activity. This is illustrated in the Amgen v. Ariad case, where the court "drew the line" between what Ariad had described/enabled and the accused infringing activity at the cell membrane, consistent with Ariad's disclosure.

It is certainly possible to misinterpret Lilly, which Enzo did spectacularly (although the court got it right in the end). But the fact is that the structural relationship between related nucleic acids is such that isolating a nucleic acid that encodes one ortholog will enable the skilled worker to isolate any ortholog, and thus abandoning Lilly's interpretation would permit the first to isolate one to have a right to exclude for all. If you think academic researchers are screaming about patents impeding research now (the Myriad case being one example), imagine the situation if Lilly was overturned.

There are other ways to address this, of course, including research exemptions. But the written description requirement sensibly (in my view) says that an inventor can exclude what he has invented and a reasonable penumbra of foreseeable variants. The fact that the complexity of biotechnology makes what's reasonably foreseeable less expansive than in more predictable technologies is both the blessing and the curse of biotech patenting. But one doesn't negate the other.

Thanks for the comment.

Kevin

A couple of points in response to your comment.

First, not even the supporters of the Lilly decision can argue with the fact that Judge Lourie created a new requirement from section 112, first paragraph, that did not exist before 1997. Whether you agree with that requirement (as you do) or disagree with that requirement (as I do), I think as a general proposition it is not the province of an unelected judge, who doesn't hold hearings to hear from disparate interest groups and doesn't face the voters, to set a whole new policy the way that Judge Lourie did. Many of us, including myself, prosecuted perfectly good patents in the late '80s and early '90s following the rules of the game as they existed at the time, only to these those patents fall by the wayside because the Federal Circuit created a new requirment. I would argue that this is the province of Congress.

Second, I completely disagree with your notion of blocking research if Judge's Lourie's doctrine is abandoned. I've had many debates with written description advocates such as yourself, and inevitably, they seem to ignore that we have a perfectly good enablement requirement in the statute that prevented over-reaching for decades. Indeed, I personally believe that many of the patents invalidated on written description could have been just as well invalidated on the grounds of enablement, relying on the Wands factors.
This could address your "single means" concerns for example.

As to blocking research, I think you have it turned around. It is the written description requirement which dissuades investment in cutting-edge research because the discover of a whole new mechanism for treating a disease, e.g., by discovering a new receptor and the effects of blocking it, can get protection only for specific compounds identified to block that receptor. See if you can raise money under that situation? This is not theoretical. I have seen it happen.

Finally, I would cite to the the example of PCR. There was probably no development more significant to molecular biology than PCR, for which Mullis received a patent (and a Nobel prize). Did this block the world from practicing PCR? To the contrary, it was widely available. My friend...you should let the patent system and the free market work. Remember that it is often universities and start-ups that develop the cutting edge new approaches. They cannot begin to develop and market a product, much less endure the expense and complexity of the FDA approval practice, without the help of bigger entities such as big Pharma. If they can get reasonable patent protection, the marketplace and the need for partners will take care of the rest.

Marc S.

Dear Marc:

To answer your second point first, here is the problem as I see it. I clone gene X from a human cell. Provided that I know the type of human cell I obtained the human gene from, I can take the corresponding other mammalian species cell (at a minimum, since it may be other vertebrate cell or other animal cell etc.) and be fully capable (i.e., enabled) in obtaining all of them as well. So enablement is not a bar to a claim having the scope of "Mammalian (or vertebrate, or animal) gene X."

As for your third point, I understand the "reach through" claiming problem, but I think that Ariad would have had less trouble if they had actually provided more evidence in their earliest priority document about specific molecule types that would work. They would also have had method of screening claims available, to slow down big pharma. But frankly, I think that there is an argument that even under enablement you are not going to be entitled to a claim that would shut down a small molecule drug that inhibits NFkB function based on the type of molecules disclosed in the Ariad patent. Remember, the Rochester court found those claims invalid on both written description and enablement grounds. And the CAFC has limited the scope of claims based on enablement in other contexts (like the Dreamworks case) that would seem to apply with equal force to Ariad's claims.

As for PCR, I agree that Cetus acted to make the procedure widespread, but you may remember that Cetus (and later Roche) prevented clinical, diagnostic or forensic uses of the methods without a specific license, and the label license on Taq polymerase granted the right to use the enzyme for the PCR method only when using a licensed thermocycler (such as the Perkin-Elmer machine, which was partnered with Cetus). I can't remember the name of the company, but there was a competing machine that was the basis for threats of litigation if not actual litigation because it was unlicensed.

I totally agree that universities are not capable of being big pharma, and that the system needs to protect the small as well as the big. And I recognize the practical effects of the way the court has applied the written description requirement. I disagree with your position that Judge Lourie and the court did something ultra vires in Lilly and it sequellae. Congress knows about the written description requirement, and yet I have never seen any proposal in all the bills introduced over the past 5 years that would change the standard. I would argue that Judge Lourie interpreted the statute in light of applying it to the complexities of nucleic acid claims (while acknowledging the "outside the box" application of the law originally by the district court judge).

I agree that the way the written description requirement has been applied has caused the biotech community problems, but in view of the backlash we are now experiencing against patents of all types, it may not be the worst outcome. As it is, to avoid literal infringement of a nucleic acid or recombinantly-produced protein claim requires that the canonical sequence be changed, which imposes its own risks on competitors. For methods and mechanistics, an argument can be made that knowledge of the method should not preclude independent practice of specific compounds that are used in the method.

Not easy questions, but until Kubin there was a balance and now there is not. I think the court would have been better served to have avoided the obviousness issue and decided Kubin on written description, especially because the BPAI expressly held that Kubin's claims were enabled and this would have framed the question nicely (better than in Ariad). But that isn't what happened.

Thanks for the comment.

Good debate. Personally, I side with Marc on the written description question. Until Lilly, the WD requirement had not been used to police anything other than priority. (See Judge Rader's forecful opinions on this subject.) Since Lilly, of course, it's been the bane of big Pharma. I, too, have heard from clients who say that they can't afford (or simply won't risk) investing in pharmaceutical research because the incentives aren't there any more. Here's the calculus as many companies see it: spend hundreds of millions developing a new drug (e.g., receptor antagonist); spend another chunk of money prosecuting the patents to protect that drug; spend several more million dollars litigating the patents; face the possibility--likelier than ever after Lilly--that the patent will be invalidated. Understandably, a lot of companies would rather fold their cards than take their chances, especially when it seems the deck's so stacked against them.

Dear D:

The problem with your scenario is that it has been the opposite of the experience with Lilly, Rochester and Ariad. It is the pharma companies that have prevailed (and except for Lilly, each had a patent on their drug(s) that were not in suit - it was the biological method of action patents that were at issue).

You could (and Marc does) make the argument that it is the university researcher who is in peril, because: 1) she will be doing basic research like isolating COX-2 or identifying NFkB as a transcription factor/gene expression regulator but 2) will not be making small molecule compounds that can be described in sufficient detail to satisfy the written decription requirement ala Lilly.

So if you have an instance where a drug was not pursued, I'd love to hear about it (off-line if confidentiality is a concern). But on the evidence of which I am aware, the written description requirement isn't hurting big pharma.

Thanks for the comment.

I agree with Kevin on virtually every point except the fundamental issue: the so-called "separate written description requirement" is pure fabrication. The enablement requirement for patentability, properly applied, would take care of most claims that are invalid for not being properly described in the specification.

Mark writes: "It is the written description requirement which dissuades investment in cutting-edge research because the discover of a whole new mechanism for treating a disease, e.g., by discovering a new receptor and the effects of blocking it, can get protection only for specific compounds identified to block that receptor."

The idea that in the 21st century the discovery of a receptor and "the effects of blocking it" (which of the infinite number of "effects", exactly?) entitles one to a patent covering every future method of "blocking" the receptor is insane, to put it mildly.

"the discover of a whole new mechanism for treating a disease"

The signal here that something is amiss is the use of the word "mechanism." Mechanisms and pathways are certainly discoverable, but they themselves aren't patentable, regardless of how information relating to their existence is used.

If, as Kevin suggests, the university researcher is in peril, we should not be looking to the patent system as a means of fixing the problem. Indeed, to the extent that has been done in the past, it is a mistake. Basic biological research should not be encouraged or justified by reference to patent royalties. It should be enouraged and justified by reference to the downstream benefits reaped by our country's citizens and their children. And the money to support the research should come from the beneficiaries, in the form of taxes, where the beneficiaries include those companies earning billions from products derived from publicly-funded university research.

Dear Keep:

I remain skeptical about the capacity for the enablement requirement to perform the task now split between separate written description and enablement requirements. How does your position square with regard to the Board's decision in Kubin, where the Board found the claims to be enabled but not described? For that matter, do you believe that an applicant who discloses one ortholog is entitled to a claim encompassing all orthologs?

Thanks for the comment.

If I can weigh in on the question to Keep, I would respond that the enablement requirement should not ALWAYS result in the same outcome as the WD requirement. Personally, I think Lilly was incorrectly decided as UCal specifically claimed, albeit without the exact structure, the human gene and even Judge Lourie had to acknowledge that the rat cDNA obtained by the University fully enabled the human cDNA by routine screening of a human library. On the other hand, Rochester did not even provide a single example of a molecule and for that matter included small molecules as well as biological molecules in its claim. Accordingly, under the traditional Wands factors, this patent did not meet the enablement requirement.

This addresses Keep's comment that I would be advocating an "insane" position and just demonstrates my earlier point that people seem to forget that enablement, as its been applied for decades, is more than adequate to prevent the insane outcomes.

As to the final point about big pharma and universities, I can tell you that the law right now favors the inventors of incremental improvements on small molecules or the inventors of new novel actives. One need only look at the last five years of Federal Circuit cases to see that these are the types of cases that they are upholding, even post-KSR. What is happening now however is that cutting edge research is not getting funded. I can say this definitively---the WD requirement as now being applied has prevented new avenues of research from being carried out because the nonesensical doctrine only recognizes inventions where someone can see a picture. The court needs to seriously reexamine its approach to molecular biology. I was recently sitting next to an SPE at a meeting who told me that he has biotech examiners now reviewing diaper patents. This is not a surprise to any of us who work in this field. I suspect at some point that self preservation is going to kick in and the PTO will start to reverse course.

As for Kubin, the hapless applicant there provided a specific seq ID and only had the 80% variation occurring in a certain region of the molecule. He complied with the WD guidelines of the PTO by the PTO's own admission. This should pass muster even under the Fed. Cir. standard and again exemplifies the path that Judge Lourie has set us on.

More in a bit but I wanted to comment on a couple statements by Marc: "even Judge Lourie had to acknowledge that the rat cDNA obtained by the University fully enabled the human cDNA by routine screening of a human library."

The rat cDNA enabled certain methods of identifying the human cDNA, which could have been claimed, but the human cDNA sequence itself was not enabled. Indeed, the human cNDA sequence was not even conceived. How can you enable something that has not been conceived?

"the hapless applicant there provided a specific seq ID and only had the 80% variation occurring in a certain region of the molecule."

ONLY 80% variation? That's one out of every five amino acids. And how many functional variants did Kubin synthesize and analyze to deserve a patent on this enormous genus?

First, let me congratulate you all on perhaps the most intelligent and civil "blog" discussion and post string I can remember.

Second, I applaud the petition. It seems beyond legitimate question that the "written description" requirement was a dead letter (if it even existed) outside of priority and interference contexts from the Rushig decision through Lourie's Frankenstein moment in Lilly. This is especially true for non-bio inventions. My practice is primarily in what used to be called the "predictable" arts, EE, ME. The WD requirement, as applied to that area, has taken on an illogical and patent killing role that simply defies common sense or public policy. Overbreadth can be dealt with in the classic way -- primiarly through prior art, and in certain circumstances through enablement. I would suggest that the Lizardtech decision is a perfect example of the Federal Circuit lashing out against a patent it didn't like, but couldn't find prior art to kill, with WD.

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