Wednesday, April 8, 2009
IPSC 2009 Update
The submissions deadline for the 9th Annual Intellectual Property Scholars Conference at Cardozo School of Law has been extended to April 30th, 2009. Individual submissions should be directed to David Morrison at dmorriso@yu.edu. For more information, visit www.ipscholars.org.
Tuesday, April 7, 2009
Ariad v. Eli Lilly and In Re Kubin: One Federal Circuit Panel Perpetuates the Lilly Written Description Doctrine, While Another Avoids Addressing It
I am one of those that believes the written description requirement should be used only to police against the introduction of new matter into claims, and not as a separate requirement of patentability. In previous posts , I have explained some of the reasoning behind my objection to what I refer to as the “Lilly written description requirement,” named after the 1997 Regents of UC v . Eli Lilly decision, wherein the Federal Circuit relied on written description to invalidate originally filed claims directed towards the insulin gene. Some judges on the Federal Circuit, in particular Judge Rader and Judge Linn, share this distaste for the Lilly written doctrine. Nonetheless, the trend in recent years, both in the courts and Patent and Trademark Office (PTO) has been towards the perpetuation and expansion of Lilly written description as a distinct doctrine of patentability, and this trend continued last week in Ariad v. Eli Lilly.
In Ariad v. Eli Lilly, the Federal Circuit reversed a Massachusetts District Court and invalidated Ariad's claims broadly reciting methods of repressing the activity of NF-kB, an important regulator on gene transcription. The facts of the case are discussed in earlier posts to this blog. Although my interest in the case has primarily been focused on Lilly's argument that the claims are patent ineligible for wholly encompassing a natural phenomenon, the Federal Circuit panel deciding the case avoided the issue of patent eligibility by ruling that all of the asserted claims failed to comply with the written description requirement.
Ariad’s invalidated claims are reminiscent of the University of Rochester's claims, directed towards methods of inhibiting prostaglandin H synthase-2 (PGHS-2, a also referred to as COX-2), which were held invalid for violating the Lilly written description requirement in University of Rochester v. G.D. Searle, 358 F.3d 916 (Fed. Cir. 2004). The University of Rochester's claims broadly recited "a method for selectively inhibiting PGHS-2 activity in a human host, comprising administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product.” The Federal Circuit found that the claims failed written description requirement because the specification did not specifically describe any non-steroidal compound that would perform the claimed function. Rochester is one of the seminal Lilly written description cases, and marked a significant expansion in the reach of the doctrine. This was the first instance in which the Federal Circuit applied the doctrine to invalidate method claims; prior to Rochester, Lilly written description had only been applied to biomolecules claims, i.e. nucleic acids and antibodies.
Similarly, Ariad’s claims purport to broadly cover methods of inhibiting NF-kB activity, while providing little if any disclosure of molecules capable of accomplishing this inhibition. Ariad attempted unsuccessfully to distinguish its claims from those of the University of Rochester’s, pointing out that the University's claims specifically recited the use of a non-steroidal compound, while Ariad's do not explicitly mention any compound. This strikes me as a ridiculous argument. Essentially, Ariad was arguing that because its claims were drafted more broadly than the University’s, implicitly encompassing any compound that would achieve the desired function, its specification was not required to describe any compound. The Federal Circuit saw through this specious argument, and held that “[R]egardless of whether the asserted claims recite a compound, Ariad still must describe some way of performing the claimed methods."
Turning to Ariad’s specification, the Federal Circuit noted that it identified three classes of molecules potentially capable of reducing NF-kB activity: specific inhibitors, dominantly interfering molecules, and decoy molecules. Regarding the first two classes, the Federal Circuit found that, as of the effective filing date in 1989, the specification failed to provide any more than vague functional descriptions of the molecules.
With respect to decoy molecules, the Federal Circuit acknowledged that the specification provides specific examples of decoy molecules, including structures, leaving "little doubt that the specification adequately described the actual molecules to one of ordinary skill in the art." Nonetheless, the court went on to conclude that the specification failed to adequately describe “using those molecules to reduce NF-kB activity.” It noted that the specification taught a method of reducing NF-kB activity using decoy molecules that would bind NF-kB and thereby effect negative regulation of NF-kB activity, and acknowledged that prophetic examples are routinely used to satisfy the written description requirement in the chemical arts, but nevertheless concluded that the “disclosure is not so much an ‘example’ as it is a mere mention of the desired outcome.” The court failed to articulate why Ariad’s disclosure of using specifically described decoy molecules to negatively regulate NF-kB is insufficient to satisfy written description, except for the conclusory statement that "there is no descriptive link between the table of decoy molecules and reducing NF-kB activity” (emphasis added).
Later, the court provides a more convincing justification its decision to invalidate Ariad's claims, holding that regardless of whether the use of decoy molecules was adequately described, the disclosure was insufficient to "bear the weight of the vast scope of these generic claims.” In other words, the court invoked the Lilly written description requirement to invalidate the claims for being overly broad, claiming more subject matter than was justified by the scant disclosure. In closing, the court pointed out that it was the extreme breadth of the claims that had been their undoing, and that "for its own reasons, Ariad maintained the breadth of these claims to claim construction and into trial. . . . The motto, ‘beware of what one asks for,’ might be applicable here."
In a concurring opinion, Judge Linn agreed that the majority's opinion was supported by Federal Circuit precedent, but reiterated his position that the Federal Circuit has been “misguided” in grafting a separate written description requirement onto section 112, paragraph 1. He criticized the panel majority for relying on the Lilly written description requirement and not addressing the important enablement issues in the case. To quote Judge Linn:
As the majority opinion observes, the claims-in-suit broadly claim any method for reducing NF-kB activity in cells, including both known and unknown methods. We have long held that in order to survive the enablement requirement specification "must describe the manner and process of making and using the invention so as to enable a person of skill in the art to making use the full scope of the invention without undue experimentation.” To my knowledge, however, we have not specifically address this requirement in relation to the type of claim at issue here- that is, claims written broadly enough to cover any method for achieving a particular result. It may be, as Lilly argues, that such a claim can never be valid, since the specification cannot enable unknown methods. This is an important issue that we have left unresolved. It is an issue that we would have been compelled to reach had the case been decided on enablement rounds, a basis found in section 112, instead of on written description grounds, a separate basis not justified under that section or any other provision of the Patent Act.
I agree with Judge Linn in this regard. The fundamental problem with Ariad's claims is that they are simply too broad to be justified by the limited disclosure in the patent specification. The enablement requirement is the appropriate tool for policing claim scope, but as observed by Judge Linn, the courts have failed to articulate a workable standard for policing claim scope. Lilly written description doctrine provides nothing in this regard, but to the contrary simply muddies the doctrinal waters. A good example of this can be seen in the majority's opinion in this case, when it struggles to explain why the disclosure of specific structures for decoy molecules in the specification, coupled with a description of using those molecules to inhibit NF-kB, does not constitute adequate description of how to use the molecules to inhibit NF-kB. The majority’s basis for this conclusion, an alleged lack of a “descriptive link” between the disclosed decoy molecules and reducing NF-kB activity, is bizarre. The specification describes the molecules in explicit structural terms, and describes using them to inhibit NF-kB activity. It seems clear that the Federal Circuit's actual concern was that the specification did not enable the use of these molecules to inhibit NF-kB activity, but because the majority chose to rely on written description rather than enablement it had no established doctrinal basis for invalidating the claims, so it coined and apparently novel “descriptive link” requirement for patentability.
The majority's main objection to the claims was based on their broad scope relative to the limited disclosure of the specification; as noted by Judge Linn, traditionally the enablement doctrine has been used to police claim scope. The test for enablement is easy to state: a claim fails to satisfy the enablement requirement if the disclosure is not commensurate in scope with the claims. The actual application of the test to real claims and disclosures is anything but straight forward, as noted by Judge Linn in his concurrence, but at least there is an established standard. In contrast, the Federal Circuit has failed to articulate any meaningful criteria for applying Lilly written description to police claim scope that is distinguishable from enablement. This point was made, for example, by Judge Rader in his dissent from the decision not to hear Lizardtech en banc, and I have discussed in my article “Is Lilly Written Description a Paper Tiger?: A Comprehensive Assessment of the Impact of Eli Lilly and Its Progeny on the Court and PTO.” The emptiness of the Lilly written description requirement is reflected in the Ariad majority’s conclusion that the claims were invalid because the disclosure was insufficient to "bear the weight of the vast scope of these generic claims.”
In re Kubin, decided the same day as Ariad v. Lilly, and described in an earlier post, also involved a written description issue. However, in that case the panel declined to address written description has moot in view of the fact that the claims were invalid based on obviousness. The author of Kubin, Judge Rader, apparently decided that Kubin was not appropriate case to take on the Lilly written description requirement, but perhaps he and other critics of the doctrine will have their chance in another case. The patent office has become much more aggressive in applying Lilly written description as a requirement of patentability requirements separate and distinct from the enablement requirement, as discussed in a previous post, so there should be further opportunities to address the issue in the future.
In Ariad v. Eli Lilly, the Federal Circuit reversed a Massachusetts District Court and invalidated Ariad's claims broadly reciting methods of repressing the activity of NF-kB, an important regulator on gene transcription. The facts of the case are discussed in earlier posts to this blog. Although my interest in the case has primarily been focused on Lilly's argument that the claims are patent ineligible for wholly encompassing a natural phenomenon, the Federal Circuit panel deciding the case avoided the issue of patent eligibility by ruling that all of the asserted claims failed to comply with the written description requirement.
Ariad’s invalidated claims are reminiscent of the University of Rochester's claims, directed towards methods of inhibiting prostaglandin H synthase-2 (PGHS-2, a also referred to as COX-2), which were held invalid for violating the Lilly written description requirement in University of Rochester v. G.D. Searle, 358 F.3d 916 (Fed. Cir. 2004). The University of Rochester's claims broadly recited "a method for selectively inhibiting PGHS-2 activity in a human host, comprising administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product.” The Federal Circuit found that the claims failed written description requirement because the specification did not specifically describe any non-steroidal compound that would perform the claimed function. Rochester is one of the seminal Lilly written description cases, and marked a significant expansion in the reach of the doctrine. This was the first instance in which the Federal Circuit applied the doctrine to invalidate method claims; prior to Rochester, Lilly written description had only been applied to biomolecules claims, i.e. nucleic acids and antibodies.
Similarly, Ariad’s claims purport to broadly cover methods of inhibiting NF-kB activity, while providing little if any disclosure of molecules capable of accomplishing this inhibition. Ariad attempted unsuccessfully to distinguish its claims from those of the University of Rochester’s, pointing out that the University's claims specifically recited the use of a non-steroidal compound, while Ariad's do not explicitly mention any compound. This strikes me as a ridiculous argument. Essentially, Ariad was arguing that because its claims were drafted more broadly than the University’s, implicitly encompassing any compound that would achieve the desired function, its specification was not required to describe any compound. The Federal Circuit saw through this specious argument, and held that “[R]egardless of whether the asserted claims recite a compound, Ariad still must describe some way of performing the claimed methods."
Turning to Ariad’s specification, the Federal Circuit noted that it identified three classes of molecules potentially capable of reducing NF-kB activity: specific inhibitors, dominantly interfering molecules, and decoy molecules. Regarding the first two classes, the Federal Circuit found that, as of the effective filing date in 1989, the specification failed to provide any more than vague functional descriptions of the molecules.
With respect to decoy molecules, the Federal Circuit acknowledged that the specification provides specific examples of decoy molecules, including structures, leaving "little doubt that the specification adequately described the actual molecules to one of ordinary skill in the art." Nonetheless, the court went on to conclude that the specification failed to adequately describe “using those molecules to reduce NF-kB activity.” It noted that the specification taught a method of reducing NF-kB activity using decoy molecules that would bind NF-kB and thereby effect negative regulation of NF-kB activity, and acknowledged that prophetic examples are routinely used to satisfy the written description requirement in the chemical arts, but nevertheless concluded that the “disclosure is not so much an ‘example’ as it is a mere mention of the desired outcome.” The court failed to articulate why Ariad’s disclosure of using specifically described decoy molecules to negatively regulate NF-kB is insufficient to satisfy written description, except for the conclusory statement that "there is no descriptive link between the table of decoy molecules and reducing NF-kB activity” (emphasis added).
Later, the court provides a more convincing justification its decision to invalidate Ariad's claims, holding that regardless of whether the use of decoy molecules was adequately described, the disclosure was insufficient to "bear the weight of the vast scope of these generic claims.” In other words, the court invoked the Lilly written description requirement to invalidate the claims for being overly broad, claiming more subject matter than was justified by the scant disclosure. In closing, the court pointed out that it was the extreme breadth of the claims that had been their undoing, and that "for its own reasons, Ariad maintained the breadth of these claims to claim construction and into trial. . . . The motto, ‘beware of what one asks for,’ might be applicable here."
In a concurring opinion, Judge Linn agreed that the majority's opinion was supported by Federal Circuit precedent, but reiterated his position that the Federal Circuit has been “misguided” in grafting a separate written description requirement onto section 112, paragraph 1. He criticized the panel majority for relying on the Lilly written description requirement and not addressing the important enablement issues in the case. To quote Judge Linn:
As the majority opinion observes, the claims-in-suit broadly claim any method for reducing NF-kB activity in cells, including both known and unknown methods. We have long held that in order to survive the enablement requirement specification "must describe the manner and process of making and using the invention so as to enable a person of skill in the art to making use the full scope of the invention without undue experimentation.” To my knowledge, however, we have not specifically address this requirement in relation to the type of claim at issue here- that is, claims written broadly enough to cover any method for achieving a particular result. It may be, as Lilly argues, that such a claim can never be valid, since the specification cannot enable unknown methods. This is an important issue that we have left unresolved. It is an issue that we would have been compelled to reach had the case been decided on enablement rounds, a basis found in section 112, instead of on written description grounds, a separate basis not justified under that section or any other provision of the Patent Act.
I agree with Judge Linn in this regard. The fundamental problem with Ariad's claims is that they are simply too broad to be justified by the limited disclosure in the patent specification. The enablement requirement is the appropriate tool for policing claim scope, but as observed by Judge Linn, the courts have failed to articulate a workable standard for policing claim scope. Lilly written description doctrine provides nothing in this regard, but to the contrary simply muddies the doctrinal waters. A good example of this can be seen in the majority's opinion in this case, when it struggles to explain why the disclosure of specific structures for decoy molecules in the specification, coupled with a description of using those molecules to inhibit NF-kB, does not constitute adequate description of how to use the molecules to inhibit NF-kB. The majority’s basis for this conclusion, an alleged lack of a “descriptive link” between the disclosed decoy molecules and reducing NF-kB activity, is bizarre. The specification describes the molecules in explicit structural terms, and describes using them to inhibit NF-kB activity. It seems clear that the Federal Circuit's actual concern was that the specification did not enable the use of these molecules to inhibit NF-kB activity, but because the majority chose to rely on written description rather than enablement it had no established doctrinal basis for invalidating the claims, so it coined and apparently novel “descriptive link” requirement for patentability.
The majority's main objection to the claims was based on their broad scope relative to the limited disclosure of the specification; as noted by Judge Linn, traditionally the enablement doctrine has been used to police claim scope. The test for enablement is easy to state: a claim fails to satisfy the enablement requirement if the disclosure is not commensurate in scope with the claims. The actual application of the test to real claims and disclosures is anything but straight forward, as noted by Judge Linn in his concurrence, but at least there is an established standard. In contrast, the Federal Circuit has failed to articulate any meaningful criteria for applying Lilly written description to police claim scope that is distinguishable from enablement. This point was made, for example, by Judge Rader in his dissent from the decision not to hear Lizardtech en banc, and I have discussed in my article “Is Lilly Written Description a Paper Tiger?: A Comprehensive Assessment of the Impact of Eli Lilly and Its Progeny on the Court and PTO.” The emptiness of the Lilly written description requirement is reflected in the Ariad majority’s conclusion that the claims were invalid because the disclosure was insufficient to "bear the weight of the vast scope of these generic claims.”
In re Kubin, decided the same day as Ariad v. Lilly, and described in an earlier post, also involved a written description issue. However, in that case the panel declined to address written description has moot in view of the fact that the claims were invalid based on obviousness. The author of Kubin, Judge Rader, apparently decided that Kubin was not appropriate case to take on the Lilly written description requirement, but perhaps he and other critics of the doctrine will have their chance in another case. The patent office has become much more aggressive in applying Lilly written description as a requirement of patentability requirements separate and distinct from the enablement requirement, as discussed in a previous post, so there should be further opportunities to address the issue in the future.
Monday, April 6, 2009
In Re Kubin: Federal Circuit Clarifies Obviousness Standard in Context of cDNA Cloning Invention
In In re Kubin, an important decision for biotechnology, the Federal Circuit affirmed the Patent and Trademark Office’ (PTO’s) rejection of Amgen’s claims directed to the cDNA encoding the human NAIL protein.
The facts of the case are discussed in detail in a previous post, where I pointed out that Kubin provided the Federal Circuit with a good opportunity to address the current significance of In re Deuel, a 1995 Federal Circuit decision. In particular, does Deuel broadly establish that a nucleic acid is only rendered obvious by the disclosure of a structurally similar nucleic acid in the prior art, the position argued by Amgen and others? Many have interpreted Deuel as imposing an extremely low bar to the patentability of cloned cDNA molecules, and indeed biotechnology in general, and have accepted the conventional wisdom that the disclosure of a protein in the prior art does not render the successful cloning and sequencing of the gene encoding the protein obvious. On the other hand, I have felt that Deuel should be read much more narrowly, particularly in view of subsequent developments in the technology of cloning and the law, particularly the Supreme Court's decision in KSR v. Teleflex. I think that in Kubin the Federal Circuit has answered that question pretty emphatically: while not expressly overruling Deuel, it appears to have effectively limited Deuel to the facts of that case.
While many view Kubin as a substantial change in the law of obviousness, I disagree. Kubin basically says that the successful cloning and sequencing of the cDNA encoding a known protein is obvious, and thus unpatentable, if (1) there was some suggestion or motivation in the prior art to clone the cDNA, and (2) there was a “reasonable expectation of success,” based on "detailed enabling methodology" in the prior art. There is nothing remarkable about this standard - it is entirely consistent with the law of obviousness as it is applied outside the context of gene cloning, and it surprises me that people have believed that a very different standard applies to gene cloning. As I pointed out in my previous post, the BPAI has previously seemed to interpret the holding in Deuel as effectively limited to the specific facts of that case. For example, in Ex parte Goldgaber, decided shortly after Deuel, the BPAI affirmed an obviousness rejection of claims directed to newly isolated cDNA sequences based on prior art teaching the encoded protein and general methodologies for cloning and sequencing cDNA, i.e., facts very analogous to both Deuel and Kubin.
Legal presumptions, burdens of proof and the standard of appellate review were critical in the outcome of this case. First off, the Federal Circuit has held that there is a presumption that anything described in issued US patent is enabled, including prophetic examples, i.e., examples that were never actually carried out. See Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1355 (Fed. Cir. 2003). The PTO relied on this presumption, and Amgen never really argued against it. During oral arguments, the judges on the panel treated this presumption as established law, as it apparently it.
In my view, this presumption that anything asserted in addition patent is enabled makes very little sense. Anybody familiar with actual patents knows that patent specifications are full of wild assertions that are clearly not enabled, and in most cases the patent examiner is in no position to assess the enablement of these assertions. If a prophetic example, or other prophetic assertion in a patent, is not critical to the patentability of the patent claims, there is no reason for the examiner ever to delve into whether the prophetic example could actually be accomplished by one of skill in the art without undue experimentation. Nonetheless, the PTO and courts presume that anything described in a patent application is enabled, and this can be a difficult presumption to overcome in arguing for the patentability of a claim apparently rendered anticipated or obvious by a prophetic disclosure in an issued patent. I have faced this conundrum often in arguing for the patentability of claims with a patent examiner. In my view, a disclosure in a peer-reviewed scientific article is much more likely to be enabled than a prophetic example in a patent, but that is not how the law currently sees things.
In the case of Kubin, the prior art included a patent (Valiante) with a prophetic example essentially describing the cloning of the NAIL cDNA claimed by Kubin. Amgen argued that there was no reasonable expectation that one of skill in the art would have been successful in carrying out Valiante’s prophetic cloning protocol, and they may very well have been correct. Amgen argued that in reality it was much more difficult and complicated then suggested in the prophetic example, and Kubin’s success required a “specific mixture of resting cells, resting NK cells and NK cells stimulated with a very specific cocktail of activators.” But these are technical questions, which Federal Circuit judges are ill-suited to decide de novo. The Federal Circuit was correct to note that the process successfully employed by Kubin to clone the claimed cDNA is irrelevant: the standard is whether one of skill in the art would have had a reasonable expectation of cloning the claimed polynucleotides by any method. In KSR, the Supreme Court correctly chastised the Federal Circuit for considering how difficult the invention was for the alleged inventor (a subjective test), when they should have been considering how difficult the invention would have been for the person having ordinary skill in the art (the correct, objective test). The problem for Amgen was that regardless of the actual difficulties experienced by Kubin, the invention is obvious if one of skill in the art could have cloned a nucleic acid falling within the scope of a claim, by any method. Valiante, a prior art patents, provided a prophetic example purporting to teach just such a method, and because there is a presumption that the example is enabled, the PTO and court presumed that the prior art provided an enabling method for arriving at the claimed nucleic acids with a reasonable expectation of success. Because of the presumption of enablement, the burden was on Amgen to provide evidence that the prophetic example was not actually enabled, and they failed to convince the PTO or the court on this issue.
The standard of review was also important. The Federal Circuit reviews the factual findings of the PTO's Board of Patent Appeals and Interferences for “lack of substantial evidence” to support the findings. In this case, the PTO and Board made a factual determination that the Valiante prophetic example, when combined with other prior art, provided both the motivation to clone the NAIL cDNA and a reasonable expectation of success. As a consequence of the standard of review, the Federal Circuit is required to show a great deal of deference to this factual determination. In effect, if the PTO’s finding of a reasonable expectation of success is at least plausible, based on some substantial evidence, the court will defer to that determination, even if there is also substantial evidence pointing the other direction.
Because the question of whether there was a reasonable expectation of success is a factual finding, Amgen faced a very tough burden to prove that there was no substantial evidence supporting the PTO's decision. When compounded with the presumption that prophetic examples appearing in a patent are enabled, it becomes apparent that Amgen could only prevail by providing compelling evidence that, in fact, the cloning of this particular gene was much more difficult and unpredictable than suggested by the cited prior art, and they appear to have failed to meet this heavy burden.
What about the impact of this case on biotechnology? To quote Patent Docs, “the sky is not falling.” For one thing, Kubin does not mean that any patent claiming a cDNA is necessarily obvious if the encoded protein was known in the prior art. It simply means that we can no longer continue to interpret Deuel as establishing that the cDNA is never rendered obvious under those circumstances. Rather, the inquiry should shift to whether or not there was any kind of suggestion or motivation to clone the cDNA, and if there was, whether there was a reasonable expectation of success. In cases where the patent applicant can bring forth sufficient evidence to show that the cloning of a particular cDNA was more technically challenging, creating a sufficient level of unpredictability with regard to success, the invention should still be patentable under Kubin. After KSR, it should be clear that in many cases it will be necessary for a patent applicant to provide evidence of technical challenges and lack of predictable success to overcome an effective presumption that an invention is obvious, and Kubin simply applies that principle to a cDNA cloning invention.
Of course, the Kubin patent application was prosecuted prior to KSR, and it is unclear whether Amgen could have provided more compelling factual evidence that the cloning of this particular gene was actually more technically challenging and unpredictable than normal. The lesson for biotechnology patent prosecutors might be that this factual support of technical unpredictability of success is more important today than it was pre-KSR.
Also, as noted by Patent Docs, while this sort of invention, based on the successful cloning of a cDNA encoding a protein of known significance, was very important in the early days of biotechnology, it is becoming much less relevant with the passage of time. Today, in the age of high-throughput genomics, it is much more likely that a gene will be discovered prior to the isolation and characterization of the encoded protein. For most known proteins of clinical significance, the corresponding cDNA has already been cloned, in which case it is too late to patent the cDNA. If there are cases where the cDNA as yet to be cloned, that suggests that either there was no motivation or suggestion to do it, or that the cloning has proven unusually difficult technically, in which case it is likely nonobvious under Kubin.
In the early days of biotechnology, the main products were biologic drugs which basically were recombinant versions of naturally occurring human proteins. Patents claiming cloned human cDNA were important in protecting these inventions. But the trend in biotechnology is towards monoclonal antibodies and engineered second-generation proteins bearing less and less structural similarity to naturally occurring proteins. As a result, patents on cloned human genes should be less relevant. This might explain my finding, reported in a recent law review article and Science article, that litigation involving human gene patents has dropped off dramatically in recent years, particularly in the area of biologic drugs. Gene patent filings have also reportedly dropped off in recent years.
In sum will, many in biotechnology will view Kubin as a negative development. I am not so sure it will be that significant, unless investors perceive that it does have serious negative implications for biotechnology. I think we should try to counter that - a perception among investors that biotechnology has been harmed by Kubin could cause more damage to biotechnology than the decision itself.
The facts of the case are discussed in detail in a previous post, where I pointed out that Kubin provided the Federal Circuit with a good opportunity to address the current significance of In re Deuel, a 1995 Federal Circuit decision. In particular, does Deuel broadly establish that a nucleic acid is only rendered obvious by the disclosure of a structurally similar nucleic acid in the prior art, the position argued by Amgen and others? Many have interpreted Deuel as imposing an extremely low bar to the patentability of cloned cDNA molecules, and indeed biotechnology in general, and have accepted the conventional wisdom that the disclosure of a protein in the prior art does not render the successful cloning and sequencing of the gene encoding the protein obvious. On the other hand, I have felt that Deuel should be read much more narrowly, particularly in view of subsequent developments in the technology of cloning and the law, particularly the Supreme Court's decision in KSR v. Teleflex. I think that in Kubin the Federal Circuit has answered that question pretty emphatically: while not expressly overruling Deuel, it appears to have effectively limited Deuel to the facts of that case.
While many view Kubin as a substantial change in the law of obviousness, I disagree. Kubin basically says that the successful cloning and sequencing of the cDNA encoding a known protein is obvious, and thus unpatentable, if (1) there was some suggestion or motivation in the prior art to clone the cDNA, and (2) there was a “reasonable expectation of success,” based on "detailed enabling methodology" in the prior art. There is nothing remarkable about this standard - it is entirely consistent with the law of obviousness as it is applied outside the context of gene cloning, and it surprises me that people have believed that a very different standard applies to gene cloning. As I pointed out in my previous post, the BPAI has previously seemed to interpret the holding in Deuel as effectively limited to the specific facts of that case. For example, in Ex parte Goldgaber, decided shortly after Deuel, the BPAI affirmed an obviousness rejection of claims directed to newly isolated cDNA sequences based on prior art teaching the encoded protein and general methodologies for cloning and sequencing cDNA, i.e., facts very analogous to both Deuel and Kubin.
Legal presumptions, burdens of proof and the standard of appellate review were critical in the outcome of this case. First off, the Federal Circuit has held that there is a presumption that anything described in issued US patent is enabled, including prophetic examples, i.e., examples that were never actually carried out. See Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1355 (Fed. Cir. 2003). The PTO relied on this presumption, and Amgen never really argued against it. During oral arguments, the judges on the panel treated this presumption as established law, as it apparently it.
In my view, this presumption that anything asserted in addition patent is enabled makes very little sense. Anybody familiar with actual patents knows that patent specifications are full of wild assertions that are clearly not enabled, and in most cases the patent examiner is in no position to assess the enablement of these assertions. If a prophetic example, or other prophetic assertion in a patent, is not critical to the patentability of the patent claims, there is no reason for the examiner ever to delve into whether the prophetic example could actually be accomplished by one of skill in the art without undue experimentation. Nonetheless, the PTO and courts presume that anything described in a patent application is enabled, and this can be a difficult presumption to overcome in arguing for the patentability of a claim apparently rendered anticipated or obvious by a prophetic disclosure in an issued patent. I have faced this conundrum often in arguing for the patentability of claims with a patent examiner. In my view, a disclosure in a peer-reviewed scientific article is much more likely to be enabled than a prophetic example in a patent, but that is not how the law currently sees things.
In the case of Kubin, the prior art included a patent (Valiante) with a prophetic example essentially describing the cloning of the NAIL cDNA claimed by Kubin. Amgen argued that there was no reasonable expectation that one of skill in the art would have been successful in carrying out Valiante’s prophetic cloning protocol, and they may very well have been correct. Amgen argued that in reality it was much more difficult and complicated then suggested in the prophetic example, and Kubin’s success required a “specific mixture of resting cells, resting NK cells and NK cells stimulated with a very specific cocktail of activators.” But these are technical questions, which Federal Circuit judges are ill-suited to decide de novo. The Federal Circuit was correct to note that the process successfully employed by Kubin to clone the claimed cDNA is irrelevant: the standard is whether one of skill in the art would have had a reasonable expectation of cloning the claimed polynucleotides by any method. In KSR, the Supreme Court correctly chastised the Federal Circuit for considering how difficult the invention was for the alleged inventor (a subjective test), when they should have been considering how difficult the invention would have been for the person having ordinary skill in the art (the correct, objective test). The problem for Amgen was that regardless of the actual difficulties experienced by Kubin, the invention is obvious if one of skill in the art could have cloned a nucleic acid falling within the scope of a claim, by any method. Valiante, a prior art patents, provided a prophetic example purporting to teach just such a method, and because there is a presumption that the example is enabled, the PTO and court presumed that the prior art provided an enabling method for arriving at the claimed nucleic acids with a reasonable expectation of success. Because of the presumption of enablement, the burden was on Amgen to provide evidence that the prophetic example was not actually enabled, and they failed to convince the PTO or the court on this issue.
The standard of review was also important. The Federal Circuit reviews the factual findings of the PTO's Board of Patent Appeals and Interferences for “lack of substantial evidence” to support the findings. In this case, the PTO and Board made a factual determination that the Valiante prophetic example, when combined with other prior art, provided both the motivation to clone the NAIL cDNA and a reasonable expectation of success. As a consequence of the standard of review, the Federal Circuit is required to show a great deal of deference to this factual determination. In effect, if the PTO’s finding of a reasonable expectation of success is at least plausible, based on some substantial evidence, the court will defer to that determination, even if there is also substantial evidence pointing the other direction.
Because the question of whether there was a reasonable expectation of success is a factual finding, Amgen faced a very tough burden to prove that there was no substantial evidence supporting the PTO's decision. When compounded with the presumption that prophetic examples appearing in a patent are enabled, it becomes apparent that Amgen could only prevail by providing compelling evidence that, in fact, the cloning of this particular gene was much more difficult and unpredictable than suggested by the cited prior art, and they appear to have failed to meet this heavy burden.
What about the impact of this case on biotechnology? To quote Patent Docs, “the sky is not falling.” For one thing, Kubin does not mean that any patent claiming a cDNA is necessarily obvious if the encoded protein was known in the prior art. It simply means that we can no longer continue to interpret Deuel as establishing that the cDNA is never rendered obvious under those circumstances. Rather, the inquiry should shift to whether or not there was any kind of suggestion or motivation to clone the cDNA, and if there was, whether there was a reasonable expectation of success. In cases where the patent applicant can bring forth sufficient evidence to show that the cloning of a particular cDNA was more technically challenging, creating a sufficient level of unpredictability with regard to success, the invention should still be patentable under Kubin. After KSR, it should be clear that in many cases it will be necessary for a patent applicant to provide evidence of technical challenges and lack of predictable success to overcome an effective presumption that an invention is obvious, and Kubin simply applies that principle to a cDNA cloning invention.
Of course, the Kubin patent application was prosecuted prior to KSR, and it is unclear whether Amgen could have provided more compelling factual evidence that the cloning of this particular gene was actually more technically challenging and unpredictable than normal. The lesson for biotechnology patent prosecutors might be that this factual support of technical unpredictability of success is more important today than it was pre-KSR.
Also, as noted by Patent Docs, while this sort of invention, based on the successful cloning of a cDNA encoding a protein of known significance, was very important in the early days of biotechnology, it is becoming much less relevant with the passage of time. Today, in the age of high-throughput genomics, it is much more likely that a gene will be discovered prior to the isolation and characterization of the encoded protein. For most known proteins of clinical significance, the corresponding cDNA has already been cloned, in which case it is too late to patent the cDNA. If there are cases where the cDNA as yet to be cloned, that suggests that either there was no motivation or suggestion to do it, or that the cloning has proven unusually difficult technically, in which case it is likely nonobvious under Kubin.
In the early days of biotechnology, the main products were biologic drugs which basically were recombinant versions of naturally occurring human proteins. Patents claiming cloned human cDNA were important in protecting these inventions. But the trend in biotechnology is towards monoclonal antibodies and engineered second-generation proteins bearing less and less structural similarity to naturally occurring proteins. As a result, patents on cloned human genes should be less relevant. This might explain my finding, reported in a recent law review article and Science article, that litigation involving human gene patents has dropped off dramatically in recent years, particularly in the area of biologic drugs. Gene patent filings have also reportedly dropped off in recent years.
In sum will, many in biotechnology will view Kubin as a negative development. I am not so sure it will be that significant, unless investors perceive that it does have serious negative implications for biotechnology. I think we should try to counter that - a perception among investors that biotechnology has been harmed by Kubin could cause more damage to biotechnology than the decision itself.
Wednesday, March 11, 2009
Biotech and Pharma Provide Little Support in Bilski's Petition for Certiorari
Doll v. Bilski, a controversial Federal Circuit decision that addresses the patent eligibility doctrine, is currently on petition to the Supreme Court for a writ of certiorari. The decision clearly has significant ramifications for the patentability of many life science inventions, particularly in the areas of diagnostics and personalized medicine, as discussed in previous posts, and has already been used to summarily invalidate claims reciting a method for providing an improved vaccination protocol in Classen v. Biogen. The patent eligibility doctrine, as it is currently being applied by the courts, has raised significant concerns on the part of many in the biotechnology and pharmaceutica industries, as evidenced by the number of amicus briefs filed in the case of Prometheus v. Mayo, a patent eligibility case arising out of the life sciences. In view of the importance of the issue to the biotechnology and pharmaceutical industries, and the widely expressed fear that Bilski could preclude the effective patenting of many important biotechnology innovations, one might have thought that the industry would have sided with Bilski in his attempt to overturn the Federal Circuit decision.
In fact, however, a review of the Supreme Court docket conducted March 11, 2009, reveals that only one of the nine amicus curiae briefs that have been filed in support of the petition has come out of the life sciences industry. Notably absent are the major biotechnology and pharmaceutical companies that weighed in to support Prometheus, and representatives of the industry such as the Biotechnology Industry Organization (BIO) and the Pharmaceutical Researchers and Manufacturers of America (PhRMA).
The only biotechnology amicus brief was filed by Medistem (http://www.medisteminc.com/), a publicly traded US biotechnology company whose business focuses on the development of adult stem cell-based medicines, and methods of treatment combining the use of diagnostics and with their medicines, i.e., personalized medicine. In its brief, Medistem argues that the restrictive approach to the patentability of process inventions set forth in Bilski casts a cloud of uncertainty as to whether companies such as Medistem will be able to effectively protect diagnostic and personalized medicine inventions with patents. They point to Judge Rader’s dissent in Bilski, in which he opined that the majority's opinion will “undermine and discourage future research for diagnostic tools," and stress that the unintended consequence of Bilski could be a significant drop-off in investment for the discovery of new diagnostics and clinically relevant biological correlations. Their brief repeatedly references w dire predictions of Judge Rader, such as his view that the majority's ruling in Bilski "inadvertently advises investors that they should divert their unprotectable investments away from the discovery of ‘scientific relationships’ within the body to diagnose breast cancer or Lou Gehrig's disease or Parkinson's or whatever.”
In view of the apparent threat to biotechnology innovation, one might question why it is that other representatives of biotechnology have not supported Bilski's petition. I think it can be explained by a view among many in biotechnology that even though the Federal Circuit decided to Bilski wrongly, and if applied literally the decision could prove detrimental to future life sciences innovation, the hope is that the situation can be rectified at the Federal Circuit level in subsequent panel decision. Their is a fear that the Supreme Court might very well conclude that Bilski's “business method” claims are patent ineligible, and might do so in a manner that creates unintended negative consequences for the patenting of biotechnology inventions. Should the Supreme Court decide to grant certiorari, I believe the biotechnology industry will have to weigh in heavily and attempt to persuade the Supreme Court to decide the case in a manner that clarifies that the machine-transformation test articulated in Bilski is not the only test for patent eligibility of processes, particularly fundamentally biological processes, and that a more flexible and lenient test is more appropriate.
Nonetheless, Medistem apparently feels that the problems created for biotechnology by Bilski need to be addressed as soon as possible. Or perhaps the company has no confidence that the Federal Circuit will develop an appropriate patent eligibility doctrine for biotechnology inventions on its own. Because Bilski is an en banc decision, Medistem fears that the machine-transformation test established by the majority will be the de facto final word on patent eligibility for all processes. Clearly, the Federal Circuit's recent decision in Classen v. Biogen did not inspire much confidence, but we are hopeful that the court will perform better when it decides Prometheus.
In fact, however, a review of the Supreme Court docket conducted March 11, 2009, reveals that only one of the nine amicus curiae briefs that have been filed in support of the petition has come out of the life sciences industry. Notably absent are the major biotechnology and pharmaceutical companies that weighed in to support Prometheus, and representatives of the industry such as the Biotechnology Industry Organization (BIO) and the Pharmaceutical Researchers and Manufacturers of America (PhRMA).
The only biotechnology amicus brief was filed by Medistem (http://www.medisteminc.com/), a publicly traded US biotechnology company whose business focuses on the development of adult stem cell-based medicines, and methods of treatment combining the use of diagnostics and with their medicines, i.e., personalized medicine. In its brief, Medistem argues that the restrictive approach to the patentability of process inventions set forth in Bilski casts a cloud of uncertainty as to whether companies such as Medistem will be able to effectively protect diagnostic and personalized medicine inventions with patents. They point to Judge Rader’s dissent in Bilski, in which he opined that the majority's opinion will “undermine and discourage future research for diagnostic tools," and stress that the unintended consequence of Bilski could be a significant drop-off in investment for the discovery of new diagnostics and clinically relevant biological correlations. Their brief repeatedly references w dire predictions of Judge Rader, such as his view that the majority's ruling in Bilski "inadvertently advises investors that they should divert their unprotectable investments away from the discovery of ‘scientific relationships’ within the body to diagnose breast cancer or Lou Gehrig's disease or Parkinson's or whatever.”
In view of the apparent threat to biotechnology innovation, one might question why it is that other representatives of biotechnology have not supported Bilski's petition. I think it can be explained by a view among many in biotechnology that even though the Federal Circuit decided to Bilski wrongly, and if applied literally the decision could prove detrimental to future life sciences innovation, the hope is that the situation can be rectified at the Federal Circuit level in subsequent panel decision. Their is a fear that the Supreme Court might very well conclude that Bilski's “business method” claims are patent ineligible, and might do so in a manner that creates unintended negative consequences for the patenting of biotechnology inventions. Should the Supreme Court decide to grant certiorari, I believe the biotechnology industry will have to weigh in heavily and attempt to persuade the Supreme Court to decide the case in a manner that clarifies that the machine-transformation test articulated in Bilski is not the only test for patent eligibility of processes, particularly fundamentally biological processes, and that a more flexible and lenient test is more appropriate.
Nonetheless, Medistem apparently feels that the problems created for biotechnology by Bilski need to be addressed as soon as possible. Or perhaps the company has no confidence that the Federal Circuit will develop an appropriate patent eligibility doctrine for biotechnology inventions on its own. Because Bilski is an en banc decision, Medistem fears that the machine-transformation test established by the majority will be the de facto final word on patent eligibility for all processes. Clearly, the Federal Circuit's recent decision in Classen v. Biogen did not inspire much confidence, but we are hopeful that the court will perform better when it decides Prometheus.
Tuesday, March 3, 2009
CALL FOR PAPERS: 9TH ANNUAL INTELLECTUAL PROPERTY SCHOLARS CONFERENCE
The Intellectual Property Program at the Benjamin N. Cardozo School of Law will host the 9th Annual Intellectual Property Scholars Conference on August 6th and 7th, 2009.
The IP Scholars Conference brings together intellectual property scholars to present their works-in-progress in order to benefit from the critique of colleagues. The conference is co-sponsored by the Berkeley Center for Law and Technology, UC Berkeley School of Law; the Intellectual Property Program, Benjamin N. Cardozo School of Law at Yeshiva University; the Center for Intellectual Property Law and Information Technology, DePaul University College of Law; and the Stanford Program in Law, Science & Technology, Stanford Law School.
Requests to present a work or attend the conference should be submitted electronically, no later than April 13, 2009, to David Morrison at dmorriso@yu.edu. For more information, visit http://www.ipscholars.org.
The IP Scholars Conference brings together intellectual property scholars to present their works-in-progress in order to benefit from the critique of colleagues. The conference is co-sponsored by the Berkeley Center for Law and Technology, UC Berkeley School of Law; the Intellectual Property Program, Benjamin N. Cardozo School of Law at Yeshiva University; the Center for Intellectual Property Law and Information Technology, DePaul University College of Law; and the Stanford Program in Law, Science & Technology, Stanford Law School.
Requests to present a work or attend the conference should be submitted electronically, no later than April 13, 2009, to David Morrison at dmorriso@yu.edu. For more information, visit http://www.ipscholars.org.
Monday, February 9, 2009
Another Amicus in Support of Prometheus: Myriad Genetics
I have already posted (here and here) most of the amicus briefs that have been filed in Prometheus v. Mayo, all arguing for a reversal of the district court’s decision finding that Prometheus’ personalized medicine claim are patent-ineligible under section 101. This third installment brings you the brief filed by Myriad Genetics in support of Prometheus (Myriad Brief) – to my knowledge this was the only outstanding brief that I had not yet posted.
Myriad is a leader in the commercialization of genetics diagnostic testing, probably best known for its BRCA tests used to assess a woman’s genetic predisposition to breast cancer. Since the late 1990s the company has been the subject of widespread criticism, both in the U.S. and abroad, over what many have perceived to be overly aggressive patent enforcement policies, particularly with regard to its BRCA patents. In fact, much of the criticism directed at so-called “gene patents” traces back to the controversy surrounding Myriad. To this day, allegations that Myriad’s patent policies have somehow unduly limited access to BRCA testing services, or even prevented competing laboratories from providing superior BRCA testing services, are cited in support of proposals to ban the patenting of genes and DNA.
Personally, I am skeptical of the charges that have been leveled against Myriad, and to my knowledge many of the allegations have little or no basis in reality. Clearly Myriad has sought to use its patents to block commercial competitors, but my understanding is that the tests they provide are generally high quality, the cost of their testing services is not significantly greater than comparable tests for genetic conditions not covered by patents, and patients are not being denied access to superior testing options by Myriad’s patent enforcement policies. Nevertheless, it is clear that Myriad’s public relations have suffered as a result of the publicity generated by the BRCA patent controversy.
In assessing Myriad’s amicus brief, it is important to realize that for Myriad it is not enough for the Federal Circuit to decide in favor of Prometheus; the manner in which the Federal Circuit reaches its decision is almost as critical Myriad. In other words, Prometheus could prevail in a manner that would nevertheless cast doubt on the patent-eligibility of many of Myriad’s patents, including its BRCA method-of-testing patents. As pointed out in its brief, these process patents play a much greater role in protecting genetic diagnostic testing than do composition of matter claims.
In particular, Prometheus and many of its amicus supporters argue that the Federal Circuit should reverse the district court’s erroneous conclusion that the correlation between a non-naturally occurring drug breakdown product and the optimal dosage of the drug (which is itself a non-naturally occurring chemical compound) is a "natural phenomenon." In my Law Professors Brief, for example, we argue that whatever the Supreme Court might have meant when it held that "natural phenomena” are patent-inelgibile, the term cannot be interpreted so broadly as to encompass a correlation that exist solely as a consequence of active human intervention. We also point out that the controversial claim 13 at issue in LabCorp, in contrast to the Prometheus claims, relates to a true natural phenomena involving naturally occurring metabolites and existing independently of any human intervention. Thus, the Federal Circuit could easily find the Prometheus claims patent-eligible without necessarily finding the LabCorp claim patent-eligible.
Importantly, the distinction between natural and non-natural correlations at the center of our argument would not only rescue Prometheus’ claims, but a host of other personalized medicine and method of treatment claims involving non-naturally occurring drugs. However, it would not necessarily save Myriad’s patents, many of which, which like the LabCorp claim, relate to naturally occurring correlations, e.g., the correlation between a mutation in the BRCA gene and a predisposition for cancer.
In its brief, Prometheus characterizes itself as a "personalized medicine company," rather than a genetic diagnostic testing company. To me, it seems a bit of a stretch to label a test for mutations relating to a predisposition for cancer as "personalized medicine." I suppose that in a sense any diagnostic method is designed to address the specific medical needs of an individual patient, but usually the term personalized medicine is meant to suggest something more. Personalized medicine usually refers to a synergistic application of diagnostic testing in conjunction with a specific drug or drugs.
Nevertheless, it is not surprising that Myriad would want to position itself as a personalized doesn't company, in hopes of benefitng from all the positive buzz currently surrounding the field of personalized medicine. All of the amici supporting Prometheus argue that patents could be important incentives in the development of personalized medicine. On the other hand, many have argued that patents are generally not necessary to incentivize the identification of genetic mutations and the development of diagnostic testing services; some have even gone so far as to argue that patents impede the availability of certain diagnostic testing. In 2002, for example, legislation was introduced in Congress that would have shielded certain providers of genetic testing services from patent liability (it did not go anywhere).
In any event, for Myriad it is important that the Federal Circuit decide Prometheus in a manner that does not rely on any distinction between natural and unnatural compounds, but instead in a manner that would also find the LabCorp claim (and by implication Myriad’s genetic diagnostic claims) patent-eligible.
To this end, Myriad argues :
For more on personalized medicine and patents, you might want to check out this recent PTO presentation on the patenting of personalized medicine. Notice that the PTO presentation defines personalized medicine in a manner that would exclude Prometheus' claims (by limiting itself to information from a patient's genotype), but that would broadly encompass Myriad's BRCA claims (because the definition is not limited to the use of drugs). The presentation suggests to me that the PTO would find some of Myriad's issued BRCA testing claims patent ineligible under Bilski, because they are not tied to a machine/apparatus or performing a transformation (see Example 3 in particular).
Patent Doc Kevin Noonan provides his own commentary on the PTO presentation here . For example, he explains that under the PTO approach a patentee might need to include a method of treatment step in order to render a diagnostic claim patent-eligible, but including a treatment limitation raises a practical obstacle to enforcing the patent - there might not be a single entity who infringes all of the claim limitations. Methods of treatment are generally performed by health care providers. As explained by Kevin:
Myriad is a leader in the commercialization of genetics diagnostic testing, probably best known for its BRCA tests used to assess a woman’s genetic predisposition to breast cancer. Since the late 1990s the company has been the subject of widespread criticism, both in the U.S. and abroad, over what many have perceived to be overly aggressive patent enforcement policies, particularly with regard to its BRCA patents. In fact, much of the criticism directed at so-called “gene patents” traces back to the controversy surrounding Myriad. To this day, allegations that Myriad’s patent policies have somehow unduly limited access to BRCA testing services, or even prevented competing laboratories from providing superior BRCA testing services, are cited in support of proposals to ban the patenting of genes and DNA.
Personally, I am skeptical of the charges that have been leveled against Myriad, and to my knowledge many of the allegations have little or no basis in reality. Clearly Myriad has sought to use its patents to block commercial competitors, but my understanding is that the tests they provide are generally high quality, the cost of their testing services is not significantly greater than comparable tests for genetic conditions not covered by patents, and patients are not being denied access to superior testing options by Myriad’s patent enforcement policies. Nevertheless, it is clear that Myriad’s public relations have suffered as a result of the publicity generated by the BRCA patent controversy.
In assessing Myriad’s amicus brief, it is important to realize that for Myriad it is not enough for the Federal Circuit to decide in favor of Prometheus; the manner in which the Federal Circuit reaches its decision is almost as critical Myriad. In other words, Prometheus could prevail in a manner that would nevertheless cast doubt on the patent-eligibility of many of Myriad’s patents, including its BRCA method-of-testing patents. As pointed out in its brief, these process patents play a much greater role in protecting genetic diagnostic testing than do composition of matter claims.
In particular, Prometheus and many of its amicus supporters argue that the Federal Circuit should reverse the district court’s erroneous conclusion that the correlation between a non-naturally occurring drug breakdown product and the optimal dosage of the drug (which is itself a non-naturally occurring chemical compound) is a "natural phenomenon." In my Law Professors Brief, for example, we argue that whatever the Supreme Court might have meant when it held that "natural phenomena” are patent-inelgibile, the term cannot be interpreted so broadly as to encompass a correlation that exist solely as a consequence of active human intervention. We also point out that the controversial claim 13 at issue in LabCorp, in contrast to the Prometheus claims, relates to a true natural phenomena involving naturally occurring metabolites and existing independently of any human intervention. Thus, the Federal Circuit could easily find the Prometheus claims patent-eligible without necessarily finding the LabCorp claim patent-eligible.
Importantly, the distinction between natural and non-natural correlations at the center of our argument would not only rescue Prometheus’ claims, but a host of other personalized medicine and method of treatment claims involving non-naturally occurring drugs. However, it would not necessarily save Myriad’s patents, many of which, which like the LabCorp claim, relate to naturally occurring correlations, e.g., the correlation between a mutation in the BRCA gene and a predisposition for cancer.
In its brief, Prometheus characterizes itself as a "personalized medicine company," rather than a genetic diagnostic testing company. To me, it seems a bit of a stretch to label a test for mutations relating to a predisposition for cancer as "personalized medicine." I suppose that in a sense any diagnostic method is designed to address the specific medical needs of an individual patient, but usually the term personalized medicine is meant to suggest something more. Personalized medicine usually refers to a synergistic application of diagnostic testing in conjunction with a specific drug or drugs.
Nevertheless, it is not surprising that Myriad would want to position itself as a personalized doesn't company, in hopes of benefitng from all the positive buzz currently surrounding the field of personalized medicine. All of the amici supporting Prometheus argue that patents could be important incentives in the development of personalized medicine. On the other hand, many have argued that patents are generally not necessary to incentivize the identification of genetic mutations and the development of diagnostic testing services; some have even gone so far as to argue that patents impede the availability of certain diagnostic testing. In 2002, for example, legislation was introduced in Congress that would have shielded certain providers of genetic testing services from patent liability (it did not go anywhere).
In any event, for Myriad it is important that the Federal Circuit decide Prometheus in a manner that does not rely on any distinction between natural and unnatural compounds, but instead in a manner that would also find the LabCorp claim (and by implication Myriad’s genetic diagnostic claims) patent-eligible.
To this end, Myriad argues :
[Although the] recitation of administering an unnatural drug is one valid basis for finding the Prometheus claims patent-ineligible, [the court should] find that the Prometheus claims are patent-eligible . . . on a more fundamental level shared by the claims in LabCorp. . . . From a policy perspective, this is the critical point in this case. If this Court finds Prometheus is claims patent-ineligible, the industry of personalized medicine as a whole will be in jeopardy. If, on the other hand, this Court holds that Prometheus is claims are patent-eligible solely because they recite an unnatural drug, then only a very small segment of personalized medicine will be spared. Virtually all of the rest of the industry will be wiped away because most personalized medicine products are unrelated to drug therapies.
For more on personalized medicine and patents, you might want to check out this recent PTO presentation on the patenting of personalized medicine. Notice that the PTO presentation defines personalized medicine in a manner that would exclude Prometheus' claims (by limiting itself to information from a patient's genotype), but that would broadly encompass Myriad's BRCA claims (because the definition is not limited to the use of drugs). The presentation suggests to me that the PTO would find some of Myriad's issued BRCA testing claims patent ineligible under Bilski, because they are not tied to a machine/apparatus or performing a transformation (see Example 3 in particular).
Patent Doc Kevin Noonan provides his own commentary on the PTO presentation here . For example, he explains that under the PTO approach a patentee might need to include a method of treatment step in order to render a diagnostic claim patent-eligible, but including a treatment limitation raises a practical obstacle to enforcing the patent - there might not be a single entity who infringes all of the claim limitations. Methods of treatment are generally performed by health care providers. As explained by Kevin:
[I]t may frequently be the case that the actor who performs the diagnostic step of determining whether a patient bears a diagnostically-relevant SNP is a different actor than the one who performs the method of treatment step. This dichotomy of action then directly implicates the principle enunciate[d] in the Muniauction case, that a claim cannot be infringed by joint tortfeasors unless there is one actor exercising direction and control over the others.
Thursday, February 5, 2009
Novartis Files Amicus Brief Supporting Prometheus
For those following Prometheus v. Mayo, I am posting an amicus brief filed by Novartis in support of Prometheus, and the patentability of the personalized medicine claims at issue (Novartis Brief). Prometheus’ appellate brief, and amici briefs filed by myself on behalf of a group of patent law professor, BIO, and AIPLA are provided on an earlier post, along with some commentary.
In its brief, which asks the court to reverse the district court’s grant of summary judgment to Mayo on the grounds of section 101 invalidity, Novartis echoes many of the arguments made in the other briefs, i.e., that the district court erred in focusing its analysis on certain elements of the claim (in particular the "wherein clauses") while failing to consider the claim as a whole, that the claim as a whole satisfies the Bilski machine-transformation test, that the district court’s rationale, if taken to its logical extreme, would put claims to methods of treatment employing new drugs at risk, and that the decision threatens to stifle innovation in personalized medicine and health care in general.
Novartis also makes an argument that I don’t think appears in any of the other briefs that have been filed. In particular, Novartis argues that the district court’s claim construction is flawed because the court erroneously disregarded the claim’s preamble. In considering this argument, it is useful to look at the actual claim language.
Patent claims can generally be broken down into three discrete elements – the preamble, transition and body. Most commonly, the transition is the word “comprising” (a word that has special significance in claim interpretation), the preamble is the language preceding the transition, and the body is the remainder of the claim. Thus, the preamble of Prometheus’ claim is “a method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder,” and the body of the claim is everything after “comprising.”
Significantly, the general rule is that the claim preamble is not taken into account when construing the scope of the claim. Rather, the function of the preamble normally is merely to identify what kind of invention is being claimed. It is the body of the claim which provides the claim limitations which define the claimed subject matter. However, as correctly noted by Novartis, the general rule against using the preamble in claim construction does not apply in certain circumstances, particularly when the preamble is “necessary to give life, meaning, and vitality” to the claim. Novartis argues, I think rather persuasively, that the claims at issue might warrant a consideration of the preamble in a manner that constrains the scope of the claims. I’m not sure if Prometheus ever made this argument; I don’t believe it appears in their appellant brief.
According to Novartis, consideration of the preamble and claim construction limits the claim to a “method of optimizing treatment whereby a dose administered to a patient is adjusted based on the determination of a level of drug metabolite.” If Novartis is correct, it could have some bearing on the patent eligibility of the claim. For example, in Bilski the Federal Circuit noted that the fundamental test for patent eligibility involves a determination of whether the claim “wholly preempts” a fundamental principle. In Prometheus, the alleged fundamental principle is the correlation between the level of drug breakdown products and optimal drug dosage. Alternatively, one might argue that the “wherein” clauses (which are really at the heart of the discovery upon which Prometheus' invention is based) constitute an attempt to patent a mental process, i.e., the recognition of a correlation. But when the claim is construed as limited to a method of optimizing treatment, it would appear that there are other substantial and useful non-infringing uses of the correlation, thus avoiding preemption of the principle.
In its brief, which asks the court to reverse the district court’s grant of summary judgment to Mayo on the grounds of section 101 invalidity, Novartis echoes many of the arguments made in the other briefs, i.e., that the district court erred in focusing its analysis on certain elements of the claim (in particular the "wherein clauses") while failing to consider the claim as a whole, that the claim as a whole satisfies the Bilski machine-transformation test, that the district court’s rationale, if taken to its logical extreme, would put claims to methods of treatment employing new drugs at risk, and that the decision threatens to stifle innovation in personalized medicine and health care in general.
Novartis also makes an argument that I don’t think appears in any of the other briefs that have been filed. In particular, Novartis argues that the district court’s claim construction is flawed because the court erroneously disregarded the claim’s preamble. In considering this argument, it is useful to look at the actual claim language.
Claim 1 of U.S. Patent No. 6,355,623 is representative:
A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:
(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and
(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,
wherein the level of 6-thioguanine less than about 230 pmol per 8 x 108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and
wherein the level of 6-thioguanine greater than about 400 pmol per 8 x 108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.
Patent claims can generally be broken down into three discrete elements – the preamble, transition and body. Most commonly, the transition is the word “comprising” (a word that has special significance in claim interpretation), the preamble is the language preceding the transition, and the body is the remainder of the claim. Thus, the preamble of Prometheus’ claim is “a method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder,” and the body of the claim is everything after “comprising.”
Significantly, the general rule is that the claim preamble is not taken into account when construing the scope of the claim. Rather, the function of the preamble normally is merely to identify what kind of invention is being claimed. It is the body of the claim which provides the claim limitations which define the claimed subject matter. However, as correctly noted by Novartis, the general rule against using the preamble in claim construction does not apply in certain circumstances, particularly when the preamble is “necessary to give life, meaning, and vitality” to the claim. Novartis argues, I think rather persuasively, that the claims at issue might warrant a consideration of the preamble in a manner that constrains the scope of the claims. I’m not sure if Prometheus ever made this argument; I don’t believe it appears in their appellant brief.
According to Novartis, consideration of the preamble and claim construction limits the claim to a “method of optimizing treatment whereby a dose administered to a patient is adjusted based on the determination of a level of drug metabolite.” If Novartis is correct, it could have some bearing on the patent eligibility of the claim. For example, in Bilski the Federal Circuit noted that the fundamental test for patent eligibility involves a determination of whether the claim “wholly preempts” a fundamental principle. In Prometheus, the alleged fundamental principle is the correlation between the level of drug breakdown products and optimal drug dosage. Alternatively, one might argue that the “wherein” clauses (which are really at the heart of the discovery upon which Prometheus' invention is based) constitute an attempt to patent a mental process, i.e., the recognition of a correlation. But when the claim is construed as limited to a method of optimizing treatment, it would appear that there are other substantial and useful non-infringing uses of the correlation, thus avoiding preemption of the principle.
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