By Kevin E. Noonan --
The Federal Circuit heard oral argument in Association for Molecular Pathology v. U.S. Patent and Trademark Office (the Myriad case) on Friday, and the cast of characters remained mostly the same. On the panel were Judge Lourie, Judge Bryson, and Judge Moore. Representing Myriad was Gregory Castanias from Jones Day, and Chris Hansen reprised his role as ACLU/AMP advocate. New to the proceedings was Melissa Patterson for the U.S. government, in place of former Acting Solicitor General Eric Katyal who has left the government for private practice. Each side had a nominal twenty minutes to argue, with Mr. Hansen conceding half his time to Ms. Patterson.
Mr. Castanias (at left) began his argument as he would end it, citing Diamond v. Chakrabarty as the seminal authority on the patent-eligibility of product claims and stating that the Supreme Court's decision in Mayo v Prometheus did not change this. Taking the argumentative bull by the horns, he addressed the issue of "preemption" (which would be a theme in both Mr. Hansen's and Ms. Patterson's arguments) by saying that preemption is a proxy for whether there is an invention. Judge Lourie posed the contrast between a law of nature (in Mayo) and an isolated natural material (here) in instances where there was only a "small move" from the naturally occurring molecule. Mr. Castanias answered in a manner that would raise philosophical issues for Myriad later, citing to the expert declarations by the inventors and others on the question of how small the step actually was. Here, his point was that there was a great deal of human ingenuity involved in producing the isolated genomic DNA encompassed by the claims, and that contributes to its inventiveness.
Mr. Castanias then reminded the Court of Judge Bryson's analogy regarding making a baseball bat from wood (and the judge included sculpting a statue of David from marble), which were patent-eligible, and Judge Bryson then asked about whether isolating genomic DNA was like cutting off the branches and roots of a tree and then claiming a trunk (illustrating again that bad analogies make bad law), with the wrinkle that the trunk was produced using a laser that caused chemical changes. Mr. Castanias agreed that this would not be patent-eligible but because it is not an invention, being just a new way to make an old thing. With a gene, he emphasized that it is unknown until an inventor identifies, and in some sense, defines it. Citing the '282 patent, he pointed to Figure 10 and to columns 19 and 24 of the specification, for the teaching that what the patent defines as a "gene" includes the coding sequences, the intervening sequences (or "introns" to the coding sequences "exons") and regulatory sequences that could themselves encompass 100 kilobases (100,000) of DNA. The inventors defined this as the BRCA1 gene, which required an enormous amount of inventive effort, according to Mr. Castanias (making it very unlike a tree trunk). Judge Lourie leant a hand by remarking that the gene is thus "the product of human ingenuity."
Judge Lourie then did Myriad and Mr. Castanias no favors by broaching the issue of claim 20 of the '282 patent and asking him to distinguish this claim from the patent-ineligible claims in Mayo. Mr. Castanias started well, pointing out that, unlike in Mayo, this claim does not encompass the "principle of the holy trinity of well-understood, routine and conventional," as in Mayo, but with something that is not well-understood, routine or conventional, namely the transformed cell.
But then Mr. Castanias and the bench spent what everyone recognized was a few unfruitful minutes discussing whether claim 20 was properly before the Court. Mr. Castanias repeated Myriad's contention from its brief, that AMP not only had not included this claim in its certiorari petition but had affirmatively stated that the method claims were not being appealed. Judge Bryson said that was not the point, and that he (and presumably his colleagues) believed that the Court's "task" was not limited by plaintiffs' certiorari petition (his argument having a strong flavor of not letting the inmates run the asylum). Judge Bryson characterized the current state of the case as a "do-over" where "the vacated judgment is in the same position as it was last year." He then asked for any authority for Myriad's position and Mr. Castanias was unable to provide any (Mr. Hansen, during his argument, was happy to provide the Court with Lockheed Martin Corp. v. Space Systems/Loral, Inc. for authority to the contrary).
Judge Bryson also voiced confusion over the meaning of certain claim language, illustrating again the unusual posture of the case where the claims have never been construed. Mr. Castanias and the Court were unable to parse out the language "causing cancer" in the phrase "growing a transformed eukaryotic host cell containing an altered BRCA1 gene causing cancer in the presence of a compound suspected of being a cancer therapeutic," which is not surprising: the claim is not clearly written, and the word "transform" has two meanings in the art easily conflated. First, a "transformed" cell can mean a cell into which an exogenous DNA has been introduced (most likely the meaning intended in the claim), but it can also mean a cell that has been "oncogenically" transformed to be, inter alia, immortalized so that cell lines can grow indefinitely in vitro. Again, Mr. Hansen came to the rescue, stating properly that his interpretation of the claim was that the BRCA gene in a form associated with cancer in vivo. And Judge Moore chimed in asking whether claim 20 comprising the transformed cell would be patent-eligible if the panel found the isolated DNA claims not to be patent-eligible. For her, "transformation" (unclear whether in the biological or legal sense) was irrelevant.
Mr. Hansen (at right) began his argument by noting what he called the "stunning breadth" of the composition of matter claims, and the "preemptive effect" of such claims, but Judge Lourie interrupted by noting that breadth is properly a concern under Section 112 and not Section 101 of the Patent Act. Mr. Hansen proceeded to read the laundry list of types of nucleic acids recited in the '282 specification, but Judge Lourie again interrupted and asked about the relevance of this to the issues raised in Mayo. In response to Judge Lourie's assertion that the "law of nature" argument in Mayo was not directly relevant to composition claims, Mr. Hansen asserted a "law of nature"/"product of nature" exclusion (the latter being completely fantastical as far as actual case law is concerned), saying that these should be "available to everyone" under Supreme Court precedent. Judge Moore noted that his breadth argument undercut his preemption argument, because if preemption the issue, breadth is irrelevant under Mayo. She indicated that preemption is a "bright line prohibition" and thus this argument is "a waste of time and space."
Wisely, Mr. Hansen took the opportunity to move on to claim 20. In this argument he produced the wildest of wild hair arguments (which is saying something in this case), asserting that Myriad "bought the transformed cell off the shelf" and that "it wasn't their invention." (Reality check: it would have been impossible to produce a recombinant (or "transformed") cell comprising a cancer-causing BRCA gene variant until such a gene was isolated by Myriad.) Judge Lourie pointed out that in Mayo the claims recited administering and determining and the Supreme Court demanded something more, significantly more, asking whether that was not provided in claim 20 (presumably, the transformed cell). Mr. Hansen was able to argue it did not, because having falsely negated the inventiveness of the BRCA transformed cell he could concentrate on the rest of the claim, which recited "[growing said transformed eukaryotic host cell] in the presence of a compound suspected of being a cancer therapeutic, growing said transformed eukaryotic host cell in the absence of said compound, determining the rate of growth of said host cell in the presence of said compound and the rate of growth of said host cell in the absence of said compound and comparing the growth rate of said host cells." Then the claim directs the practitioner to "see what happens," and moreover, with anything -- "salt, sugar, water, oil" as opposed to the non-naturally occurring drug in Mayo -- and without any recitation of the type of "precise numbers" the Supreme Court rejected in Mayo. Judge Moore pointed out that the transformed cell is not found in nature and asked how this differs from Chakrabarty's bacterium. Mr. Hansen merely reminded the Court that the drug in Mayo had not been found in nature. Judge Lourie then raised the example of Penicillin G, which was a natural product and asked whether it should be patent-eligible. Mr. Hansen stated that it depended on "the degree to which it is transformed" (presumably from its natural state) but said that the rule has to be that it doesn't matter for method claims -- "administering and looking to see what happens is not patentable." Judge Lourie sounded skeptical of this reasoning, mentioning that Penicillin G was not patented and there was "a lag" between when it was discovered by Fleming and when it was commercially available.
Mr. Hansen then said that it is well-accepted that patents are not rewarded for being the product of great effort, saying that E=mc2 might have taken great effort but was not patent eligible. Judge Bryson said that wasn't his understanding of AMP's argument and returned the questioning back to claim 20, asking if Mr. Hansen agreed that "if all you did was to put PenG next to bacterium and tested and it worked better than water, then that isn't patentable," which, of course, he did.
Last to speak was the government, represented by Melissa Patterson. Her argument proved that, although former Acting Solicitor General Katyal may be gone, his arguments (and his magic microscope) remain. Ms. Patterson started as Mr. Hansen did, with an argument regarding the "unduly preemptive" scope of Myriad's composition of matter claims. Judge Moore raised the magic microscope, asking whether the government still thought that was a useful test. Ms. Patterson, with the benefit of hindsight characterized it as a metaphor rather than a test, but stated that the government still considered it "useful" as such. The government's position was that the Supreme Court had voiced a "concern" in Mayo regarding the extent to which claims preclude public access to a product of nature; in this version of the government's view, the preemption issues raised for process claims in Mayo are directly applicable to the preemptive issues the government -- and, coincidentally, the ACLU -- raise here. Judge Bryson raised the issue of whether the views of the U.S. government included the views of the Commerce Department and the USPTO, and Mr. Patterson stuck to the "unitary Executive" stance espoused (to some skepticism from Judge Moore) in the previous oral argument in this case.
Turning back to the merits, Ms. Patterson stated that the government did not consider this a "close case," analogizing (badly) Myriad's claims to patenting an electron or a quark (or a Higgs boson, noted Judge Lourie). She then said that the government did not believe there should be a "huge wall" between the law of nature and product of nature and that the government was seeking to assert a general rule not a rule specific for DNA. She went on to say that changes in a product of nature "incidental to its extraction" raised preemption concerns, citing coal as an example.
Judge Moore raised the issue of "settled expectations" as she had at the previous oral argument, noting that an industry had arisen during the "decades" in which the government (through the USPTO) had granted these patents. Ms. Patterson raised Bilski as an example of where "thousands" of patents had been invalidated and said that the "settled expectations" provided "no reason to alter how a court looks at Section 101," asking the Court to make general (and preclusive) rules on patent eligibility.
Ms. Patterson then turned to a more potentially pernicious portion of her argument, saying that products of nature that differ "only by changes that are incidental to extraction" too broadly preempt the public's ability to study and otherwise use them. Judge Moore raised the issue of primers and probes, which Ms. Patterson dismissed as "depend[ing] on the inherent properties of basepair complementarity" (thus presumably relegating anything that occurs naturally to be patent-ineligible so long as it continues to evince "inherent properties"). Judge Moore continued, asking about Chakrabarty's bacterium and the Court's rubric of things being "distinct and markedly different," to which Ms. Patterson returned to coal and uranium -- as properties discovered but not "invented."
In his rebuttal time, Mr. Castanias clarified the language of claim 20 and disputed Mr. Hansen's allegations that the transformed cell was something Myriad "got of the shelf, like a test tube." He also attacked the government's argument as establishing "no principled line" for making the distinction between patent eligibility and ineligibility, and said that Chakrabarty draws the line. He also distinguished his earlier remarks as not being a "sweat of the brow analysis" for patent eligibility but being the product of "work and inventive judgment."
Judge Moore asked Mr. Castanias to distinguish isolating a gene from extracting coal from rock, which he admitted would not be patent eligible, and mentioned the additional utilities present in an isolated gene, including re-introducing the gene into a cell that had a defective copy. Utility had not been litigated in this case, he reminded the Court, the plaintiffs' having conceded that the isolated DNA had utility.
Judge Bryson returned to his kidney hypothetical from the previous oral argument, and Mr. Castanias attempted to distinguish without much success. Judge Lourie ended this line of questioning by reminding the panel that a kidney is an organ, not a chemical compound, and that the analogy breaks down when that is taken into account.
Mr. Castanias ended his rebuttal argument by rebutting a point persuasive to Judge Bryson in his dissent from the now-vacated decision: that "whole genome sequencing" was not impacted by Myriad's isolated DNA claims. He mentioned that Professor Watson had had his whole genome sequenced without infringement liability. After some additional questions regarding the importance of "where to make the cut" (and some colloquy from Judge Lourie that some of these considerations sound in obviousness, which was not before the Court), Mr. Castanias ended with his most persuasive argument: that Chakrabarty is the answer and Mayo doesn't change it.
One thing is clear from this argument. The danger in AMP's preemption argument, and even more so in the government's argument, is something hinted at in the now-vacated Federal Circuit majority opinion. That is the argument, expressed frankly by the government, that merely isolating something from nature was "not enough" to render it patent eligible. Part of the problem is the government's avowed purpose for setting out "general rules" (one shudders to think of the implications for "bright line" rules made by people who don't understand the implications). Another is the failure to discuss the inseparable impact on what is claimed and how it is claimed. Using one of the examples raised with regard to claim 20, what of the patent-eligibility of penicillin? That question varies with the nature of the claim:
1. Penicillin.
2. An isolated preparation of penicillin having a purity of greater than 99% and capable of killing one million bacterial cells per microgram.
3. A pharmaceutical preparation of penicillin suitable for injecting into a human being to treat a bacterial infection.
Philosophically (while we are talking general principles), the government's position that claims should not be allowed that will preempt a "product of nature" is a good way to create a "tragedy of the commons," because there is no incentive to identify, isolate/extract, test, and produce a drug from a naturally occurring source if its source precludes patent eligibility.
What the government (or that portion of the government populated by the scientifically illiterate or their opposites, the scientific elite who have little appreciation for the legal and practical implications of their positions) does not recognize is that there is a good reason to make the distinction between natural law as in Mayo (even as marginally as the logic of that case is laid out) and isolated products from nature. Patenting a natural law restricts development of any future application of that law during the lifetime of the patent, whereas patenting a chemical compound from nature is limited to that compound. Indeed, it has always been the case that "the public" is free to find new uses for compounds made by others and to patent them, which the original product patentee cannot practice without a license. Thus, product patents by their nature do not have the breadth of method patent claims and do not raise the same issues due to the specificity of what is claimed in a composition of matter claim. That distinction renders much of what the government argues as irrelevant, or at least not tethered to any legitimate policy concern regarding the availability of "products of nature" to the "public."
No matter how the Federal Circuit decides this case, what is at stake is a larger principle. The old aphorism (raised to an anthem by John Cougar Mellancamp) is that if you don't stand for something, you fall for anything. What the Court needs to stand for is the Congressional intent that "anything under the sun made by man" is eligible for patenting. If the Supreme Court indulges in judicial nullification of this intent, so be it (and even the Court recognizes that Congress can amend the law to overcome all but the most fundamental grounds for patent ineligibility). But the Federal Circuit spent a generation under the leadership of Judge Rich, and Judge Markey, and all the other Chiefs and other judges, in fulfilling its mandate of being the court that understands technology and patent law and thus is in the best position to interpret that law and apply it to the cases before it. It should continue to do so.
I wonder whether Mr. Castanias had read Watson's brief. Was it a good strategy to call attention to Dr. Watson?
Posted by: Arthur Gershman | July 24, 2012 at 03:19 AM
"[T]he Federal Circuit spent a generation under the leadership of Judge Rich, and Judge Markey, and all the other Chiefs and other judges, in fulfilling its mandate of being the court that understands technology and patent law and thus is in the best position to interpret that law and apply it to the cases before it. It should continue to do so."
Kevin,
Amen to that.
Posted by: EG | July 24, 2012 at 06:25 AM
While I would personally agree with that "Amen" EG, there appear to be plenty of people who do not share that view of the expansive benefits of patents, and (selectively, for different arts) would find that those like Rich and Markey illegally expanded the purview of patents.
I am skeptical that merely invoking the names of Rich and Markey will sway those that are fundamentally opposed to (the perception of) Rich and Markey. Preaching to the choir will not aid in the act of conversion.
Posted by: Skeptical | July 24, 2012 at 08:46 AM
Dear Arthur:
I think the reference was intentional - his point being that the gene claims are not infringed by whole genome sequencing, something Judge Bryson thought when he wrote his opinion the last time.
Posted by: Kevin E. Noonan | July 24, 2012 at 11:22 AM
Kevin, you seem to think that a patent monopoly is the only possible incentive for producing a drug. Why do you think that? There's no evidence for that belief.
Moreover, products and laws of nature are necessarily part of the commons (which is no tragedy, I'd say), as established by the Supreme Court, but once you move sufficiently downstream, say to where some product becomes something that is now the result only of man's design and intention, then we'd both agree it should be eligible under 101.
In Myriad, if the plaintiffs ultimately prevail, it will not mean the end of life-saving research, as the BRCA genes were being closed in on by numerous research groups, largely publicly-funded, at the time of their discovery, and someone would have produced tests capable of screening for those genes, patents or not, because there was a market. Competition would have meant reasonable prices for those tests, and less-inflated medical costs putting pressure on insurance premiums. That's how the free market works. I don't see the point of worrying so much over ceding some ground back to the scientific commons. It would be just.
Posted by: David Koepsell | July 24, 2012 at 02:01 PM
Seriously, David? In my experience, patent protection is the only incentive to produce a drug today. Perhaps that was not the case before the thalidomide disaster, when it did not cost hundreds of millions of dollars to get FDA approval and when Jonas Salk could test his vaccine on the residents of the local home for retarded children, but not today.
Products of nature are not a Supreme Court recognized exception, no matter how long anyone on your side of the argument makes that claim. But to make the discussion concrete, tell me which of the three penicillin claims you think satisfy 101.
Your ex post facto analysis of what would have happened with the BRCA genes ignores the investment in the methods and infrastructure that enable Myriad to have a track record of never making a mistake. What gets lost is that, today, these patents are unnecessary for Myriad's business. But at the time they were necessary for the investment to set up the tedious, redundant methods of quality control, genetic counseling and insurance reimbursement. That effort would not have occurred without a reasonable ROI, which the patents provided. And heaven forbid having research scientists, or worse clinicians, trying to provide these services - not only isn't it what they do well, it isn't what they should be doing.
At the end of the analysis, I think doing it "your way" would result in fewer genetic tests and those that did exist would be monopolized by the big corporations, who would be able to out compete small companies and steal inventions made by university and other publicly funded scientists. Which is what happened before Bayh-Dole. I don't see making the choices you make, for the reasons you espouse, to be compelling enough to suffer those consequences.
So we will continue to differ. Thanks for the comments. Hope you are well (your daughter is growing up too fast!)
Posted by: Kevin E. Noonan | July 24, 2012 at 04:17 PM
Hey Kev, did you like the part in the oral args where the one party noted that Myriad had yet to offer a single use for the whole unisolated gene at issue that would not infringe? Wonder where they got that arg from? Hmmmm, seems like it popped up somewhere nearby to this thread, perhaps where an anon discussed it with a certain Kev. More later on your points you raised in your post.
Posted by: 6 | July 24, 2012 at 07:23 PM
"by saying that preemption is a proxy for whether there is an invention."
It is only a proxy if you're a person with an underdeveloped mind :(
"Here, his point was that there was a great deal of human ingenuity involved"
And nobody cared.
"Mr. Castanias agreed that this would not be patent-eligible but because it is not an invention, being just a new way to make an old thing. "
Since when is a new way to make an old thing necessarily not patent eligible?
Mr. Castinas argues himself in circles.
"The inventors defined this as the BRCA1 gene"
Finally someone defines it.
"which required an enormous amount of inventive effort"
Again, nobody cared.
"making it very unlike a tree trunk"
That's interesting, I'm not 100% sure that anyone has ever extended the effort to define where the trunk of a given specific tree truly ends and the roots begin down to a micro-cellular level. I bet it would take a lot of manpower to do that. Guess tree trunks will be patent eligible when they do it right?
"Mr. Castanias started well,"
If that is "starting well" where you come from then I could have started "awesomely" very easily.
"But then Mr. Castanias and the bench spent what everyone recognized was a few unfruitful minutes discussing whether claim 20 was properly before the Court. "
Yes, what a waste of time that whole bunch of malarky was that you posted the other day.
"Mr. Hansen, during his argument, was happy to provide the Court with Lockheed Martin Corp. v. Space Systems/Loral, Inc. for authority to the contrary"
Because Mr. Hansen was the only attorney other than the gov that knows what the frak is up in the case.
"which is not surprising"
It surprised me that a roomful of patent greats couldn't parse simple language in a simple claim.
"Again, Mr. Hansen came to the rescue"
Because again, he's the only one that understand what is going on. Everyone else apparently took the day off because they know the case is headed to the supremes so that the supremes can overrule Moore.
"Mr. Hansen (at right) began his argument by noting what he called the "stunning breadth" of the composition of matter claims,"
In other words, Mr. Hansen started off awesomely.
"udge Lourie interrupted by noting that breadth is properly a concern under Section 112 and not Section 101 of the Patent Act."
In other words, Judge Lourie is unfamiliar with Prometheus and BFDB.
""law of nature"/"product of nature""
I prefer to think of what they call products of nature as "natural phenomena" since natural products are simply phenomena. But whatever floats your fancy.
"Judge Moore noted that his breadth argument undercut his preemption argument, because if preemption the issue, breadth is irrelevant under Mayo."
Because Judge Moore doesn't understand Mayo as I believe she just got through demonstrating the other day in a decision. Poor Judge Moore, just begging for the Supremes to spell it out for her.
"She indicated that preemption is a "bright line prohibition" and thus this argument is "a waste of time and space.""
Can't wait till this case gets back from the Supremes and she eats those clueless words and I get to lol.
"Wisely, Mr. Hansen took the opportunity to move on to claim 20. "
I disagree, it appears to me that claim 20 will probably pass, at least until I further study what it is actually attempting to preempt. I may have posted on this awhile back.
"Reality check: it would have been impossible to produce a recombinant (or "transformed") cell comprising a cancer-causing BRCA gene variant until such a gene was isolated by Myriad."
And nobody cares Kev. :(
"falsely negated the inventiveness of the BRCA transformed cell"
The preemption doctrine is not about "negating" the "inventiveness". It is about noting if such subject matter has been judicially exempt. If he was using this as his basis, which I forget if he actually did or not, he is mistaken.
"and moreover, with anything -- "salt, sugar, water, oil" as opposed to the non-naturally occurring drug in Mayo"
Yeah, there might be a natural phenom/law at the heart of the claim that I'm just not seeing atm and which they haven't spelled out yet. It may well be preempt.
""if all you did was to put PenG next to bacterium and tested and it worked better than water, then that isn't patentable"
That is a much better argument than what he started out with re: claim 20.
"a "concern" in Mayo regarding the extent to which claims preclude public access to a product of nature"
Aka the basis of the preemption doctrine for the last 50+ years.
"unitary Executive"
Even while we have a substantial number of intellectually deficient people spouting off about the preemption doctrine that they do not understand in the USPTO.
"Ms. Patterson raised Bilski as an example of where "thousands" of patents had been invalidated and said that the "settled expectations" provided "no reason to alter how a court looks at Section 101," asking the Court to make general (and preclusive) rules on patent eligibility."
Obviously. As if the lawl on 101 should bend to the PTO misapplying it.
"In his rebuttal time, Mr. Castanias clarified the language of claim 20 and disputed Mr. Hansen's allegations that the transformed cell was something Myriad "got of the shelf, like a test tube." "
In other words, he misunderstood Mr. Hansen's allegation that the cell that was to be used in the transformation was something that Myriad got off the shelf. Mr. Hansen didn't say, and didn't mean, that the cell, already with the gene inside it, was got off the shelf. He meant the base cell, pre-implantation with the gene, was got off the shelf. In other words, Mr. Hansen, who knows what the frak is going on again runs circles around the "legal greats" in the room.
"e also attacked the government's argument as establishing "no principled line" for making the distinction between patent eligibility and ineligibility, and said that Chakrabarty draws the line."
Obviously incorrect, preemption draws a clear line, and Chakrabarty is in complete accord with that line.
"He also distinguished his earlier remarks as not being a "sweat of the brow analysis" for patent eligibility but being the product of "work and inventive judgment.""
In other words, it isn't a sweat of the brow argument, it is a needlessly complicated version of a "sweat of the mind" argument.
" Mr. Castanias ended with his most persuasive argument: that Chakrabarty is the answer and Mayo doesn't change it."
He's right of course, but unfortunately that answer is not the one he wants. Lulz.
Posted by: 6 | July 24, 2012 at 08:14 PM
Now for your commentary Kev:
"The danger in AMP's preemption argument, and even more so in the government's argument, is something hinted at in the now-vacated Federal Circuit majority opinion."
I like that you finally recognize what their actual argument is. Aka the same one I've been drilling into you for years.
"That is the argument, expressed frankly by the government, that merely isolating something from nature was "not enough" to render it patent eligible."
Nothing save for a failure to preempt a judicial exception is "enough" Kev. :(
"Another is the failure to discuss the inseparable impact on what is claimed and how it is claimed."
The draftsman's art was discussed at length in Prom Kev. Why reopen old ground?
"what of the patent-eligibility of penicillin"
Remind me what penicillin is made of and I will help you out.
"Philosophically (while we are talking general principles), the government's position that claims should not be allowed that will preempt a "product of nature" is a good way to create a "tragedy of the commons," because there is no incentive to identify, isolate/extract, test, and produce a drug from a naturally occurring source if its source precludes patent eligibility."
Sure there is, you can still patent the drugs and other true inventions. Nothing is stopping you from doing that. You just don't understand the preemption analysis Kev :(
"does not recognize is that there is a good reason to make the distinction"
The recognize the distinction. The distinction just happens to not be material. Sorry bro.
Posted by: 6 | July 24, 2012 at 08:15 PM
A few notes on the end:
"Patenting a natural law restricts development of any future application of that law during the lifetime of the patent, whereas patenting a chemical compound from nature is limited to that compound."
I think you meant to say:
Patenting a natural law restricts development of any future application of that law during the lifetime of the patent, whereas patenting a chemical compound from nature is limited to restricting development and exploiting any future application of that compound.
"Indeed, it has always been the case that "the public" is free to find new uses for compounds made by others and to patent them, which the original product patentee cannot practice without a license."
I think you meant to say:
Indeed, it has always been the case that "the public" is free to find new uses for compounds made by others and to patent them, which the original product patentee cannot practice without a license, although that person who patented the new use also must pay a fee to the original patentee in order to exploit their new use, or perhaps get an injunction issued against them.
"Thus, product patents by their nature do not have the breadth of method patent claims and do not raise the same issues due to the specificity of what is claimed in a composition of matter claim."
I think you meant to say:
Thus, product patents by their nature in some cases have a much wider breadth than many method patent claims and thus do not raise the exact same issues, although perhaps raising even larger issues, due to the specificity, or not, of what is claimed in a composition of matter claim.
"No matter how the Federal Circuit decides this case, what is at stake is a larger principle."
Amen. Let us all hope and pray that the preemption doctrine prevails against these folks.
Posted by: 6 | July 24, 2012 at 08:16 PM
Poor strategy to cite Dr. Watson. Overall, Castanias did NOT do well. Fortunately for him, the oral argument doesn't matter in deciding the case. The judges have already decided based on the briefs.
Posted by: former clerk | July 25, 2012 at 12:35 AM
Dear Kevin,
Thanks, Amelia is amazing, a wonderful natural phenomenon :)
We agree that regulations have skewed the R&D cycle and market in drugs, but disagree about the relative roles of which regulations need changing, I think. I believe the current system skews R&D toward blockbusters, away from important but less profitable niches, and leads to mainly incremental changes in popular, boutique drugs (like anti-depressants). Contrast this with the early days of chemotherapy agents where, impelled by private foundation and govt. funding, numerous agents were rather rapidly discovered and tested. Albeit, the current testing regime is admittedly very awkward and probably inefficient (and maybe not helpful or necessary)
Regarding genetic tests, the space appears now to mainly occupied by the big players anyway, so your argument about allowing smaller players in seems not to be borne out by the evidence. Of course, my evidence is based only upon my quick scan, I'd be interested to see if in fact patents have opened up that market to entrepreneurs who have thus been able to compete against the big guys. Can you show me some figures on this?
We both know that Myriad's ROI was accomplished long, long ago for BRCA, and despite promises to lower the costs of testing to $300, they never did, instead using insurance to pay their high fees of $3000, costing everyone extra in the process through higher premiums.
Finally "natural phenomena" are explicitly excluded from patents (under Chakrabarthy), and that includes products of nature and processes of nature, both of which are natural AND phenomena (something, fact or occurrence, that is observable by the senses). Unless you have a specific definition of a phenomenon that somehow excludes products, but that would be a non-standard definition.
Anyway, best to you and yours, and at least we both agree that Myriad is set for, at best, a Pyrrhic victory if they prevail, and that will mean SCOTUS will likely doom everyone else for the cost of Myriad's bullheadedness.
as ever,
David
Posted by: David Koepsell | July 25, 2012 at 03:21 AM
As a friendly reminder to everyone, the ONLY claims that would prevent others from determining whether a person carries a mutation are the now invalidated method claims (invalidated by the Federal Circuit, and NOT appealed by Myriad -- and don't forget about the 9-0 Prometheus v. Mayo decision) and possibly the cDNA fragment claims, which are certainly invalid anyway in view of prior art. It's really kind of amazing that Myriad even pressed on. If anyone launches a test that is performed the way Myriad currently performs its test, Myriad will not sue for patent infringement. The only problem is that Myriad has a database of mutations and clinical data that the world does not entirely know about (I say "not entirely" because Myriad used to publish this stuff, but stopped doing so back in 2004 I believe). So if a third party runs the test and discovers a variant, it will be at a disadvantage in terms of identifying the variant as disease-causing or not. This disadvantage should dissipate over time, but it could take awhile. I just wonder what Myriad truly hoped to gain by pressing on.
Posted by: Gary Johnston | July 25, 2012 at 10:32 AM
David,
Myriad may be "bullheaded" on this issue, but that is their choice, as it is your choice (and right) to disagree with me and Kevin on the patent-eligibility of Myriad's claimed isolated DNA sequence.
As far as the "product of nature" doctrine, I would be careful how you rely on that doctrine. Everything on this God-given earth could be considered a "product of nature." The question is whether there's a "difference in kind rather than degree," and that's not always easy to determine.
An example of this is the Pacific Yew, the bark of which contains taxol. You can't chew on the bark of the Pacific Yew and get the anti-cancer benefits of taxol. Instead, you have to extract the taxol and get it into a form that will provide the therapeutic anti-cancer benefit (see Kevin's claim 3); that's what is patent-eligible, not taxol per se (that's Kevin's claim 1).
I wrote a law review article (13 Richmond Law Review 247-78) on the patent-eligibility of microorganisms over 30 years ago (not long after I graduated from law school) involved in the cases of In re Bergy and Diamond v. Chakrabarty which required me to do extensive research on the so-called "product of nature" doctrine (so-called because it wasn't clear if the doctrine really existed, other than in dicta). What I discoverd from doing my legal research is that the doctrine is very murky and difficult to apply. In fact, many of the so-called "product of nature" doctrine cases are actually efforts to patent what were "old" compounds and compositions, thus lacking novelty.
What I found usually matters is whether the properties of the isolated entity (or the structure of the isolated entity itself) are truly different from the native source. If they are, the isolated entity is usually deemed patent-eligible. And if Myriad's claimed isolated DNA sequence is different in structure and/or properties as Myriad asserts it is, then this claimed isolated DNA sequence is patent-eligible, even in view of the "product of nature" doctrine. In this regard, I would suggest reading Professor Holman's amicus brief which expertly explains the technology (and law) involved, and why it's patent-eligible.
That's my 2 cents which you are free to accept or disagree with as you choose. And yes, kids are wonderful to watch as the grow up (and it does seem they grow too fast for us to comprehend). Do enjoy each moment of Amelia's life. My two boys are now 22 and 24, and I still remember many moments from their early childhood. Do treasure them.
Posted by: EG | July 25, 2012 at 10:47 AM
To Eric I would like to say, first of all mazel tov on his family, and then point out that I have similar fond memories of the infancy and childhood of my Simon, now 27 years old. In fact, it was in the delivery room that I first became truly aware of God's handiwork in our lives. This faith persists and convinces me that despite the accusation of Vitalism, a human being is distinguishable from a dog (ALDF v Quigg) or a microorganism. I rest my case.
Posted by: Arthur Gershman | July 25, 2012 at 07:23 PM
Eric,
Thanks for that, I have read your article, and it does a good job of pointing out the positive law. I am concerned foremost with finding some ontological distinction that would justify the Court's exclusion of products of nature, making sense of that, and applying it in some rational way. I don't believe the positive law has done that, and because of that, I think there is injustice that requires fixing. I think that a rational border between the natural and the non-natural is where human design and intention combine, and think that justice is served if we limit patent-eligibility to only the non-natural. That's why I press on.
I echo Arthur's "mazel tov," and am enjoying every moment I can of this wonderful adventure. We're enjoying it so much, we may try to make another ;)
all my best,
David
Posted by: David Koepsell | July 26, 2012 at 02:42 AM
I vaguely remember David, from another time when he escaped from the assylum. Although we rarely agree, I find his bloviations entertaining. In regards to his comment that Myriad's $3000 fee is high, this needs to be placed in context and not a launching pad to discredit Myriad which provided one of the few successes in personalized medicine. A group at Duke undertook a study and found that the BRCA test is not costly relative to other tests. There is a more systemic problem of transaction costs that raise medical costs, which is not Myriad's fault.
Posted by: Randall Mayes | July 29, 2012 at 04:12 PM
Randy, enduring your contempt and vituperations is a badge of honor. Hope all is well with you, seriously.
Posted by: David Koepsell | July 30, 2012 at 02:23 AM
I'd also note that nowhere in my comment do I state that Myriad's test is "too" expensive, but I do note that the government's exclusive monopoly has allowed them to keep that price, despite their promises at one time to lower it, without the danger of free market competition to force their price closer to the actual costs.
Finally, I assume Randy's mis-spelling of "assylum" moreover was intended to be cute.
as ever,
David
Posted by: David Koepsell | July 30, 2012 at 07:18 AM
David, I apologize for the misspelling. The perils of using a smart phone I suppose. I applaud your attempt to distract from the actual topic.
I do not accept the premise of the basic arguments you propose. Myriad has a legal patent and develops arguably the most successful diagnostic tool in personalized medicine. So, lets sue the hell out of them (over and over). Shouldn't your side be mad and follow up on the suit against the government for granting the patent and then failing to march in? Instead the government is submitting amicus for the plaintiffs and you are mad at Myriad. How does all of this make sense?
Posted by: Randall Mayes | July 31, 2012 at 04:11 PM
Randy, a couple of observations in response:
- I know you disagree with the basic premise that a govt-sponsored monopoly is not a free-market mechanism. Like many of Ayn Rand's followers, you have that blind spot.
- Who is suing "over and over?" The challenge to gene patents in this case is unique. Moreover, the original suit DID name the USPTO as a defendant.
- yes, I'm mad at the USPTO for granting a patent that I believe is not eligible. It's a shame the courts have to step in and set them straight, as I hope they do.
- I'm not "mad" at Myriad. I can hardly blame anyone who is given a govt-sponsored monopoly under the guise of the law for using it to their fullest extent to make as much profit as possible. I never claimed any moral duty otherwise. My entire argument has always been that the subject matter granted protection is outside the rational bounds of patent because it is a "phenomenon of nature." I do find it bothersome that Myriad had at one point claimed they would offer their tests for as little as $300 (Skolnick said this himself) and then never followed through. Nice bait and switch. But fair business, certainly.
- The DOJ is clearly at odds with the USPTO on this issue, but far be it from me to disagree with representatives of the government when they do take rational positions, as the DOJ has in this case.
It all makes perfect sense, when you don't distort my claims or arguments.
all my best,
David
Posted by: David Koepsell | August 01, 2012 at 06:14 AM
I have studied Rand, but do not consider her a gospel. There are limitations to free markets, so we have a self regulating system resulting in
a trade off of a temporary monopoly in the US. Australia no longer honors the patent on the test. In the original law suit, the USPTO is a defendant, but seems to be out of the fire recently. So is whomever is the march in police. It is them that have dropped the ball regarding licensing and pricing. Can we agree in that?
Posted by: Randall Mayes | August 01, 2012 at 11:22 AM