"A page of history is worth a volume of logic”
- New York Trust Co. v. Eisner, 256 US 345, 349 (1921) (Holmes, J.).
Critics postulate that gene patents threaten to impede next-generation genetic testing technologies, such as whole genome sequencing and multiplex genetic testing. We see this concern reflected, for example, in the recent arguments before the Federal Circuit in the Myriad case (Association for Molecular Pathology v. US PTO) where the parties speculated as to whether the challenged patent claims would cover whole genome sequencing. It also seems likely that US governments amicus brief arguing that genomic DNA is patent ineligible was motivated, at least in part, by a desire to clear patents perceived to be an impediment to whole genome sequencing. In considering how to respond to these concerns, we might do well to take the advice of Justice Holmes, and look for guidance to a page of history.
This is not the first time that there has been a call for a prohibition against patenting certain subject matter, based on allegations that patents pose a threat to biomedical research and the public health. In the past, these crusades have often been led by prominent members of the scientific and medical community, who raised alarming concerns that in retrospect seem greatly exaggerated, if not wholly unwarranted.
For example, more than 30 years ago numerous concerned parties filed amicus briefs in Diamond v. Chakrabarty warning that a prohibition against the patenting of genetically modified organisms was necessary to prevent a "gruesome parade of horrible." These briefs quoted a number of scientists, including Nobel laureates, for the proposition that patents on living organisms might pose a serious threat to the human race by encouraging genetic research. In retrospect, the Supreme Court's decision not to follow their advice, and to allow the patenting of genetically modified organisms, is seen as an important milestone that facilitated the growth of biotechnology, thereby facilitating numerous benefits to mankind.
In 1995, a debate raged over the patenting of medical procedures, and the arguments that were raised at that time show striking parallels to today's controversy over gene patents. At that time, the patent office had a long-standing practice of issuing medical procedure patents, but they do not appear to have been the source of any controversy. In fact, the practice had been officially sanctioned by the Board of Patent Appeals and Interferences in 1954, in ex parte Scherer. Apparently, however, most of the public, particularly doctors, were unaware of the practice.
That all changed after a lawsuit was filed in 1993 by a surgeon against a group of doctors alleging infringement of a patent claiming a method of performing cataract surgery. Pallin v. Singer, 36 USPQ2d 1050 (D. Vt. 1995). As described in a leading patent law casebook by Professors Merges and Duffy, "[t]he litigation caused a shudder in the medical community, if only because it called attention to the PTO's practice of allowing surgical patents."
After news of the lawsuit became known, major mainstream media outlets such as the Wall Street Journal, New York Times and Los Angeles Times all published high-profile stories calling attention to the lawsuit. It also became the subject of law review articles decrying the negative effect of these patents on the practice of medicine. The American Medical Association and many physicians raised arguments against medical procedure patents that are highly reminiscent of the claims being made about gene patents today. For example, some doctors argued that medical procedure patents are unethical, and that patents are not needed as financial incentives for doctors to develop better methods for improving patient outcomes. They also argued that patents delay information sharing, and increase the costs patients pay for healthcare. The American Medical Association and many physicians argued patents for medical methods should be prohibited, insisting "that it is impossible to "own" a method of treating patients were performing surgery." Concern was expressed that the medical procedure patents could impede research, forcing researchers to license the patent if they wanted to use the patented technique.
Today, no one is wringing their hands over medical procedure patents. The lawsuit which precipitated the outcry ended in 1996 when the parties stipulated to the patent invalidity due to prior art uses of the claimed technique. Congress intervened in 1996 by enacting 35 USC 287(c), which essentially eliminates the availability of remedies for infringement by medical practitioners. Importantly, Congress did not go along with the suggestion of the American Medical Association and ban the patenting of medical procedures, which can still be patented, and these patents play an important role in incentivizing the development of important innovations such as medical devices.
The limitation on remedies did resolve the concerns that doctors could be sued for performing medical procedures. There appears to be no reported decision in which 35 USC 287(c) has been asserted, and in reality there probably was little threat that the practice of medicine would be harmed by these patents - the lawsuit that triggered all this was probably just an aberration, much like the Myriad suit. Nonetheless, this simple statutory fix addressed the concerns, and since then medical procedure patents have generated little controversy.
In fact, concerns about the gene patent thicket have been with us for more than a decade. Initially, much of the concern was that gene patents would prove an insurmountable obstacle to commercialization of DNA microarrays, based on a perception that since the arrays often comprise DNA sequences representing hundreds or even thousands of unique genes, it would be too difficult to obtain the necessary licenses on the gene patents. In fact, this perceived fear has never come to pass. DNA microarray technology has been the subject of numerous patent infringement lawsuits, but never involving a human gene patent. In a recent book chapter, I discuss possible explanations as to why the postulated gene patent thicket has not presented itself, particularly in the context of microarrays and basic biomedical research. The same rationale would also largely apply to the fears that gene patents will impede the commercialization of whole genome sequencing.
The lesson from all this is that we should be very careful about imposing restrictions on patentability based on perceived fears, when history tells us that in many cases these fears turn out to be vastly overstated. To the extent there are real concerns, there are more targeted solutions than a broad-based attack on patent eligibility, such as the statutory solution to the perceived problem of medical procedure patents.
Tuesday, April 12, 2011
Monday, March 28, 2011
Upcoming Telebriefing on Centocor and Current Status of Lilly Written Description Requirement
On March 31, at 12:00PM Pacific Time, I will be speaking during a Law Seminars International TeleBriefing titled "Centocor Ortho Biotech, Inc. v. Abbott Laboratories, discussing the impact of the U.S. Court of Appeals recent ruling.
The panel consists of:
Donald L. Zuhn, Ph.D, Esq., McDonnell Boehnen Hulbert & Berghoff LLP, Chicago, IL
Courteney C. Brinckerhoff, Esq., Foley & Lardner LLP, Washington, DC
Chris Homan, Ph.D., Esq., University of Missouri--Kansas City School of Law, Kansas City, MO
The cost is $125 per caller and $50 each for additional people on the same line who wish to receive continuing education credit. However, Law Seminars International will offer a discounted registration rate of $100 ($25 off of the regular price) to readers of this blog. To take advantage of this discount, please contact LSI by phone at 206-567-4490 to register and request the Holman's Biotech IP Blog rate. Please note that this discount is available by phone registration only and not via web registration.
Click here to view the online brochure:
http://www.lawseminars.com/detail.php?SeminarCode=11CENTB
The panel consists of:
Donald L. Zuhn, Ph.D, Esq., McDonnell Boehnen Hulbert & Berghoff LLP, Chicago, IL
Courteney C. Brinckerhoff, Esq., Foley & Lardner LLP, Washington, DC
Chris Homan, Ph.D., Esq., University of Missouri--Kansas City School of Law, Kansas City, MO
The cost is $125 per caller and $50 each for additional people on the same line who wish to receive continuing education credit. However, Law Seminars International will offer a discounted registration rate of $100 ($25 off of the regular price) to readers of this blog. To take advantage of this discount, please contact LSI by phone at 206-567-4490 to register and request the Holman's Biotech IP Blog rate. Please note that this discount is available by phone registration only and not via web registration.
Click here to view the online brochure:
http://www.lawseminars.com/detail.php?SeminarCode=11CENTB
Tuesday, March 15, 2011
Centocor v. Abbott: The Federal Circuit Struggles to Articulate a Coherent Standard for Compliance with the Lilly Written Description Requirement
I have repeatedly pointed out (on my blog, in a law review article, and in an amicus brief filed in Ariad v. Eli Lilly), that the Lilly Written Description Requirement (LWD) lacks any coherent doctrinal foundation, which has led the courts and PTO to flounder in their attempts to apply the doctrine in a principled and consistent manner. The Federal Circuit's recent decision in Centocor v. Abbott underscores and exemplifies some of the points I've been trying to make.
For example, prior to Centocor the Federal Circuit and PTO had adopted a standard for compliance with LWD for antibodies entirely inconsistent with the standard applied to other biomolecules, including DNA and even other proteins. Strangely, the courts and PTO have refused to acknowledge that antibodies are simply a category of protein, and have never provided any sort of convincing rationale for treating antibodies so differently than other proteins.
Basically, for DNA and other proteins the PTO and courts have held that compliance with LWD requires some adequate level of disclosure of chemical structure, i.e., DNA or amino acid sequence. Although the requirement of structure has not been enforced as stringently as many commentators feared after UC v. Eli Lilly came down in 1997, inadequate disclosure of structure has resulted in claim invalidation in multiple Federal Circuit decisions, such as In re Wallach and Carnegie Mellon University v. Hoffman-La Roche.
However, the PTO has taken the position that a broad genus claim reciting an "isolated antibody capable of binding to [a protein identified as] antigen X” satisfies LWD, even in a case where the specification indicates that not one single antibodies falling within the scope of the claim has never been made, and provides no description of the structural, physical or chemical properties of any antibody falling within the scope of the claim. (See example 13 of the 2008 revised written description training materials; essentially the same example appears in the original 1999 interim guidelines). In other words, an antibody can be purportedly claimed in solely functional terms, without any disclosure of structure for the antibody variable region (the part that binds the antigen), nor even any structural description of the antigen. In Noelle v. Lederman, the Federal Circuit endorsed this approach, characterizing the antibody example in the PTO training materials as "precedent."
In my Ariad v. Eli Lilly amicus brief, I explained why the PTO's attempt to rationalize this dissonant treatment of antibodies under LWD was absolute nonsense as a matter of science.
In Centocor, the Federal Circuit held that a claim reciting a genus of antibodies that bind to a specific epitope of human TNF-alpha was invalid under LWD for failure to disclose sufficient structure. Significantly, the antigen was disclosed, so LWD seemed to be satisfied under the incongruosly permissive approach set forth in Example 13 of the PTO training materials, and endorsed by the Federal Circuit in Noelle. However, the Federal Circuit distinguished the Centocor claim, stating that "while our precedent suggests that written description for certain antibody claims can be satisfied by disclosing a well-characterized antigen, that reasoning applies to disclosure of newly characterized antigens were creation of the claimed antibody is routine." (Emphasis added). The court went on to find that since TNF-alpha was previously characterized, and the production of the claimed antibody "comprising a human constant region" was not routine, the claim failed to satisfy LWD.
I don't necessarily disagree with the court's decision to invalidate the claim, but I do disagree with the court's decision to invalidate the claim under the murky LWD doctrine. This is not an original claim, nothing like it appeared in the priority patent application, and I think traditional written description requirement could have been used to invalidate the claim. The claim also could have been invalidated for lack of enablement, based on the Court's finding that the methodology for producing the claimed antibody was not routine.
Centocor continues the trend of Federal Circuit decisions applying LWD in inconsistent and incoherent manner, lacking any grounding in science, as set forth in greater detail in my Ariad amicus brief. For example, the Centocor panel places great emphasis on the fact that TNF-alpha was not a newly characterized antigen, clearly implying that the requirement for compliance with LWD depends substantially upon whether an invention relates to a newly characterized or previously known biomolecule. But in previous decisions, the Federal Circuit has come to the opposite conclusion, rejecting the argument that the standard for compliance with LWD varies depending upon whether or not the claim involves a newly discovered biomolecule.
For example, in the 2008 Carnegie Mellon University v. Hoffman LaRoche decision, the appellant had argued that LWD’s requirement of structural disclosure only applied to novel DNA sequences, but the Federal Circuit rejected this argument, stating that “nothing in Eli Lilly indicates that that holding was limited to inventions involving novel DNA sequences. Indeed, in University of Rochester, we rejected a similar argument.” (emphasis added)
Another point I have often raised is that the Federal Circuit has failed to articulate any principled distinction between the standard for determining compliance with LWD and the enablement requirement, and this trend continues in Centocor. Recall that the Centocor panel's decision to invalidate the claim under LWD was based on the fact that the antigen had previously been characterized, and the finding that the creation of the claimed antibodies was not "routine." There is nothing in the decision to indicate any distinction between "routine" and "enabled."
For example, the Centocor panel points out that "Centocor simply failed to support its contention that generating fully-human antibodies with the claim properties would be straightforward for a person of ordinary skill in the art given the state of human antibody technology in 1994." (emphasis added). It also found that producing the claimed antibodies "was not possible in 1994
using 'conventional,’ 'routine,' 'well developed and mature' technology."
This is essentially the enablement standard, simply substituting words such as "straightforward," for "without undue experimentation," but failing to articulate any distinction between the level of disclosure necessary to satisfy LWD and enablement.
Neither does the Centocor panel articulate any policy rationale for LWD distinct from that behind the enablement requirement. The panel states that, under LWD, "the scope of Centocor's right to exclude cannot 'overreach the scope of [its] contribution to the field of art as described in the patent specification.’" But this simply paraphrases In re Fisher, a 1970 CCPA decision that held (with respect to the enablement requirement) that the scope of the claim must bear a “reasonable correlation to the scope of enablement provided by the specification to persons of ordinary skill in the art.”
I think it would be better for patent law if the court were to use the enablement requirement to address the patentability of claims such as this, instead of continuing to try to muddle through with the highly flawed LWD.
For example, prior to Centocor the Federal Circuit and PTO had adopted a standard for compliance with LWD for antibodies entirely inconsistent with the standard applied to other biomolecules, including DNA and even other proteins. Strangely, the courts and PTO have refused to acknowledge that antibodies are simply a category of protein, and have never provided any sort of convincing rationale for treating antibodies so differently than other proteins.
Basically, for DNA and other proteins the PTO and courts have held that compliance with LWD requires some adequate level of disclosure of chemical structure, i.e., DNA or amino acid sequence. Although the requirement of structure has not been enforced as stringently as many commentators feared after UC v. Eli Lilly came down in 1997, inadequate disclosure of structure has resulted in claim invalidation in multiple Federal Circuit decisions, such as In re Wallach and Carnegie Mellon University v. Hoffman-La Roche.
However, the PTO has taken the position that a broad genus claim reciting an "isolated antibody capable of binding to [a protein identified as] antigen X” satisfies LWD, even in a case where the specification indicates that not one single antibodies falling within the scope of the claim has never been made, and provides no description of the structural, physical or chemical properties of any antibody falling within the scope of the claim. (See example 13 of the 2008 revised written description training materials; essentially the same example appears in the original 1999 interim guidelines). In other words, an antibody can be purportedly claimed in solely functional terms, without any disclosure of structure for the antibody variable region (the part that binds the antigen), nor even any structural description of the antigen. In Noelle v. Lederman, the Federal Circuit endorsed this approach, characterizing the antibody example in the PTO training materials as "precedent."
In my Ariad v. Eli Lilly amicus brief, I explained why the PTO's attempt to rationalize this dissonant treatment of antibodies under LWD was absolute nonsense as a matter of science.
In Centocor, the Federal Circuit held that a claim reciting a genus of antibodies that bind to a specific epitope of human TNF-alpha was invalid under LWD for failure to disclose sufficient structure. Significantly, the antigen was disclosed, so LWD seemed to be satisfied under the incongruosly permissive approach set forth in Example 13 of the PTO training materials, and endorsed by the Federal Circuit in Noelle. However, the Federal Circuit distinguished the Centocor claim, stating that "while our precedent suggests that written description for certain antibody claims can be satisfied by disclosing a well-characterized antigen, that reasoning applies to disclosure of newly characterized antigens were creation of the claimed antibody is routine." (Emphasis added). The court went on to find that since TNF-alpha was previously characterized, and the production of the claimed antibody "comprising a human constant region" was not routine, the claim failed to satisfy LWD.
I don't necessarily disagree with the court's decision to invalidate the claim, but I do disagree with the court's decision to invalidate the claim under the murky LWD doctrine. This is not an original claim, nothing like it appeared in the priority patent application, and I think traditional written description requirement could have been used to invalidate the claim. The claim also could have been invalidated for lack of enablement, based on the Court's finding that the methodology for producing the claimed antibody was not routine.
Centocor continues the trend of Federal Circuit decisions applying LWD in inconsistent and incoherent manner, lacking any grounding in science, as set forth in greater detail in my Ariad amicus brief. For example, the Centocor panel places great emphasis on the fact that TNF-alpha was not a newly characterized antigen, clearly implying that the requirement for compliance with LWD depends substantially upon whether an invention relates to a newly characterized or previously known biomolecule. But in previous decisions, the Federal Circuit has come to the opposite conclusion, rejecting the argument that the standard for compliance with LWD varies depending upon whether or not the claim involves a newly discovered biomolecule.
For example, in the 2008 Carnegie Mellon University v. Hoffman LaRoche decision, the appellant had argued that LWD’s requirement of structural disclosure only applied to novel DNA sequences, but the Federal Circuit rejected this argument, stating that “nothing in Eli Lilly indicates that that holding was limited to inventions involving novel DNA sequences. Indeed, in University of Rochester, we rejected a similar argument.” (emphasis added)
Another point I have often raised is that the Federal Circuit has failed to articulate any principled distinction between the standard for determining compliance with LWD and the enablement requirement, and this trend continues in Centocor. Recall that the Centocor panel's decision to invalidate the claim under LWD was based on the fact that the antigen had previously been characterized, and the finding that the creation of the claimed antibodies was not "routine." There is nothing in the decision to indicate any distinction between "routine" and "enabled."
For example, the Centocor panel points out that "Centocor simply failed to support its contention that generating fully-human antibodies with the claim properties would be straightforward for a person of ordinary skill in the art given the state of human antibody technology in 1994." (emphasis added). It also found that producing the claimed antibodies "was not possible in 1994
using 'conventional,’ 'routine,' 'well developed and mature' technology."
This is essentially the enablement standard, simply substituting words such as "straightforward," for "without undue experimentation," but failing to articulate any distinction between the level of disclosure necessary to satisfy LWD and enablement.
Neither does the Centocor panel articulate any policy rationale for LWD distinct from that behind the enablement requirement. The panel states that, under LWD, "the scope of Centocor's right to exclude cannot 'overreach the scope of [its] contribution to the field of art as described in the patent specification.’" But this simply paraphrases In re Fisher, a 1970 CCPA decision that held (with respect to the enablement requirement) that the scope of the claim must bear a “reasonable correlation to the scope of enablement provided by the specification to persons of ordinary skill in the art.”
I think it would be better for patent law if the court were to use the enablement requirement to address the patentability of claims such as this, instead of continuing to try to muddle through with the highly flawed LWD.
Wednesday, February 16, 2011
Market exclusivity, data exclusivity and S. 3921
There has been some confusion lately regarding the distinction between “data exclusivity" and "market exclusivity.” For most newly approved drugs, US law only provides "data exclusivity," five years for small molecule drugs and 12 years under the newly enacted biosimilar legislation. During the period of data exclusivity, generic competitors are prevented from relying on data generated and paid for by the innovator to secure FDA approval for a generic or biosimilar version of the innovator drug. This is not the same as market exclusivity, because a generic company is free to generate all of its data from scratch to obtain marketing approval for their generic version of the drug, although in practice is rarely if ever happens. True market exclusivity would completely preclude generic competition, while data exclusivity simply provides a period of time during which generic competitors are not permitted to rely on innovator's data to obtain marketing approval.
In contrast, the Orphan Drug Act provides a period of true market exclusivity for certain orphan drugs, which precludes FDA from approving a competing version of the same or highly similar drug product to treat the same orphan disease for a period of seven years. The key difference between marketing exclusivity and data exclusivity is that a competitor cannot circumvent marketing exclusivity by generating its own data and submitting a new application for FDA approval, it is an absolute bar to FDA approval of the same drug for the same indication.
Recently, members of Congress sent a letter to the FDA seeking to clarify this point. In the letter, signed by four Senators including Orrin Hatch and John Kerry, the Senators point out that in a recent notice published by FDA seeking comments on the newly enacted biosimilar legislation, FDA incorrectly states that the biosimilar legislation provides a 12 year period of “marketing exclusivity.” The letter quite correctly point out that the biosimilar legislation in fact that does not include any marketing exclusivity period, but rather a 12 year period of data exclusivity.
Perhaps FDA should be excused for the lapse. Reporters and commentators routinely refer to the data exclusivity provided for biologics as "market exclusivity." To see what I mean, just do a Google search for “Obama budget biologic marketing exclusivity,” and you will pull up numerous reports from leading news agencies and bloggers reporting that the Obama budget proposes reducing the market exclusivity period for biologics from 12 years to seven years. In fact, there is no market exclusivity period for biologics, only data exclusivity, they should all read the letter from the Senators and stop propagating the misperception that the biosimilar legislation provides a period of market exclusivity.
I suspect part of the reason people have taken to characterizing data exclusivity as market exclusivity is because it suits the purposes of those who would like to speed to market entry by generic competitors by lowering the barrier to entry of generic competition. When you characterize it as market exclusivity, it sounds like market competition has been completely blocked for 12 years, which is very different from a 12 year period in which competitors cannot free ride on data paid for by the innovator.
For example, in a report on biosimilar legislation prepared by the FTC in 2009, a report of which I've been highly critical, the FTC repeatedly refers to the data exclusivity provisions of biosimilar legislation as marketing exclusivity. FTC's mischaracterization of data exclusivity as marketing exclusivity might have been an attempt to strengthen its argument by implying that no biosimilar product could enter the market during the 12 year data exclusivity period, when in fact this is not the case. But this mischaracterization has spread, apparently leading to confusion even at FDA, and thus necessitating this letter from the Senators.
Related to this debate is the "Ethical Pathway Act of 2010," (S. 3921), a bill introduced into the Senate by Senator Sanders on September 29, 2010, which would effectively eliminate any data exclusivity period for both conventional drugs and biologics. Under this proposed legislation, as I read it, an innovator would be forced to share its clinical and animal data with a competitor, to be used by the competitor to obtain FDA approval for a generic or biosimilar product. The bill includes provisions for a "cost-sharing arrangement," pursuant to which the generic company would be required to compensate the innovator for some of the costs incurred in generating the data. If the innovator and generic company cannot agree on the amount, they are required to submit the matter to an arbitrator who is to determine a "reasonable and fair fee.”
The bill identifies specific factors to be considered in determining the "reasonable and fair fee," including "actual out-of-pocket costs of the applicable clinical investigations, the risk of the investigations, as reflected in the probabilities that similar investigations result in successful applications for marketing, any federal grants, tax credits, or other subsidies that reduce the net cost of the investigations, the expected share of the global market for the product involved, by the party seeking to rely upon the investigations for marketing approval, and the amount of time the holder or holders of the relevant applications for licenses has benefited from exclusive rights, and the cumulative revenue earned on the products that relied upon the regulatory tested at issue."
I think it is reasonable to predict that innovators are highly likely to be undercompensated by this imposed "cost-sharing arrangement." Essentially, after the innovator company has taken on a huge amount of risk bringing a drug to patients, and then establishing a market for the drug, this bill would allow a competitor to free ride off all of this risky investment by simply paying some fraction of the cost for clinical trials. As reported last Monday in Reuters, a survey has found that traditional small molecule drugs have only a 7% chance of making it from phase I through FDA approval. The success rate is even lower for some of the most important drugs-4.7% for cancer drugs, and 5.7% for cardiovascular drugs. There needs to be powerful financial incentives to invest huge amounts of money when there is such a low probability of a payoff, which I think helps explain why we are seeing such a dramatic drop-off in pharmaceutical R&D spending and in the rate of new drug approvals.
When generic competition hits the market, the innovator does not just lose a piece of the pie, the pie shrinks dramatically. Innovators need some substantial period of exclusivity on the market in order to bring in the profits that ultimately drive innovation. Patents play an important role in this regard, but patent protection is unpredictable and not always available, even for important and innovative life-saving drugs, and this is particularly true in the case of biologics.
To me, this is analogous to me going to the racetrack with a friend, and deciding to bet $1000 on a longshot horse. If the horse comes in, and I win $25,000, it is certainly not fair for my friend to wait until the race is won and then demand that I accept $500 (half the price of the bet) in exchange for half of the winnings ($12,500). But this is essentially what the "cost-sharing arrangement" under the proposed legislation would entail. In fact, it's even worse than that, because to take the analogy further, since generic competition reduces profits for everyone, we're not talking about sharing $25,000 anymore, but substantially less than $25,000.
While the legislation would hurt innovators, and ultimately innovation, it is premised upon a quite legitimate ethical concern, i.e., conducting clinical trials on human beings when we presumably already know the product is safe and effective raises substantial ethical issues. While I agree this is an entirely valid concern, I don't think it should be addressed in a manner that substantially reduces incentives for future innovation.
I would suggest that perhaps the best way to deal with these concerns is to provide drug innovators with an actual period of marketing exclusivity, independent of patent rights and independent of data exclusivity. This would give innovators a period of market exclusivity in which to recoup profits that incentivize innovation, without having to worry about patent challenges, and without subjecting human subjects to unnecessary clinical trials.
In contrast, the Orphan Drug Act provides a period of true market exclusivity for certain orphan drugs, which precludes FDA from approving a competing version of the same or highly similar drug product to treat the same orphan disease for a period of seven years. The key difference between marketing exclusivity and data exclusivity is that a competitor cannot circumvent marketing exclusivity by generating its own data and submitting a new application for FDA approval, it is an absolute bar to FDA approval of the same drug for the same indication.
Recently, members of Congress sent a letter to the FDA seeking to clarify this point. In the letter, signed by four Senators including Orrin Hatch and John Kerry, the Senators point out that in a recent notice published by FDA seeking comments on the newly enacted biosimilar legislation, FDA incorrectly states that the biosimilar legislation provides a 12 year period of “marketing exclusivity.” The letter quite correctly point out that the biosimilar legislation in fact that does not include any marketing exclusivity period, but rather a 12 year period of data exclusivity.
Perhaps FDA should be excused for the lapse. Reporters and commentators routinely refer to the data exclusivity provided for biologics as "market exclusivity." To see what I mean, just do a Google search for “Obama budget biologic marketing exclusivity,” and you will pull up numerous reports from leading news agencies and bloggers reporting that the Obama budget proposes reducing the market exclusivity period for biologics from 12 years to seven years. In fact, there is no market exclusivity period for biologics, only data exclusivity, they should all read the letter from the Senators and stop propagating the misperception that the biosimilar legislation provides a period of market exclusivity.
I suspect part of the reason people have taken to characterizing data exclusivity as market exclusivity is because it suits the purposes of those who would like to speed to market entry by generic competitors by lowering the barrier to entry of generic competition. When you characterize it as market exclusivity, it sounds like market competition has been completely blocked for 12 years, which is very different from a 12 year period in which competitors cannot free ride on data paid for by the innovator.
For example, in a report on biosimilar legislation prepared by the FTC in 2009, a report of which I've been highly critical, the FTC repeatedly refers to the data exclusivity provisions of biosimilar legislation as marketing exclusivity. FTC's mischaracterization of data exclusivity as marketing exclusivity might have been an attempt to strengthen its argument by implying that no biosimilar product could enter the market during the 12 year data exclusivity period, when in fact this is not the case. But this mischaracterization has spread, apparently leading to confusion even at FDA, and thus necessitating this letter from the Senators.
Related to this debate is the "Ethical Pathway Act of 2010," (S. 3921), a bill introduced into the Senate by Senator Sanders on September 29, 2010, which would effectively eliminate any data exclusivity period for both conventional drugs and biologics. Under this proposed legislation, as I read it, an innovator would be forced to share its clinical and animal data with a competitor, to be used by the competitor to obtain FDA approval for a generic or biosimilar product. The bill includes provisions for a "cost-sharing arrangement," pursuant to which the generic company would be required to compensate the innovator for some of the costs incurred in generating the data. If the innovator and generic company cannot agree on the amount, they are required to submit the matter to an arbitrator who is to determine a "reasonable and fair fee.”
The bill identifies specific factors to be considered in determining the "reasonable and fair fee," including "actual out-of-pocket costs of the applicable clinical investigations, the risk of the investigations, as reflected in the probabilities that similar investigations result in successful applications for marketing, any federal grants, tax credits, or other subsidies that reduce the net cost of the investigations, the expected share of the global market for the product involved, by the party seeking to rely upon the investigations for marketing approval, and the amount of time the holder or holders of the relevant applications for licenses has benefited from exclusive rights, and the cumulative revenue earned on the products that relied upon the regulatory tested at issue."
I think it is reasonable to predict that innovators are highly likely to be undercompensated by this imposed "cost-sharing arrangement." Essentially, after the innovator company has taken on a huge amount of risk bringing a drug to patients, and then establishing a market for the drug, this bill would allow a competitor to free ride off all of this risky investment by simply paying some fraction of the cost for clinical trials. As reported last Monday in Reuters, a survey has found that traditional small molecule drugs have only a 7% chance of making it from phase I through FDA approval. The success rate is even lower for some of the most important drugs-4.7% for cancer drugs, and 5.7% for cardiovascular drugs. There needs to be powerful financial incentives to invest huge amounts of money when there is such a low probability of a payoff, which I think helps explain why we are seeing such a dramatic drop-off in pharmaceutical R&D spending and in the rate of new drug approvals.
When generic competition hits the market, the innovator does not just lose a piece of the pie, the pie shrinks dramatically. Innovators need some substantial period of exclusivity on the market in order to bring in the profits that ultimately drive innovation. Patents play an important role in this regard, but patent protection is unpredictable and not always available, even for important and innovative life-saving drugs, and this is particularly true in the case of biologics.
To me, this is analogous to me going to the racetrack with a friend, and deciding to bet $1000 on a longshot horse. If the horse comes in, and I win $25,000, it is certainly not fair for my friend to wait until the race is won and then demand that I accept $500 (half the price of the bet) in exchange for half of the winnings ($12,500). But this is essentially what the "cost-sharing arrangement" under the proposed legislation would entail. In fact, it's even worse than that, because to take the analogy further, since generic competition reduces profits for everyone, we're not talking about sharing $25,000 anymore, but substantially less than $25,000.
While the legislation would hurt innovators, and ultimately innovation, it is premised upon a quite legitimate ethical concern, i.e., conducting clinical trials on human beings when we presumably already know the product is safe and effective raises substantial ethical issues. While I agree this is an entirely valid concern, I don't think it should be addressed in a manner that substantially reduces incentives for future innovation.
I would suggest that perhaps the best way to deal with these concerns is to provide drug innovators with an actual period of marketing exclusivity, independent of patent rights and independent of data exclusivity. This would give innovators a period of market exclusivity in which to recoup profits that incentivize innovation, without having to worry about patent challenges, and without subjecting human subjects to unnecessary clinical trials.
Thursday, February 10, 2011
Does disclosure of laundry list of protein variants provide adequate written description for later claim to specific protein?
The traditional written description requirement prevents patent applicants from amending their claims during patent prosecution to encompass subject matter not disclosed in the patent specification as filed. Clearly, a patent specification that specifically discloses (without claiming) a small number of protein sequences provides adequate written description to support adding a claim later that recites one of those protein sequences. But what if a patent specification effectively discloses all protein sequences, for example, by generically describing "a protein comprising between 10 and 1000 amino acids, wherein at each position in the sequence the amino acid can be any of the 20 genetically coded amino acids.” It defies common sense to think that such a broad, generic disclosure would be sufficient to satisfy the written description requirement with respect to a claim introduced by amendment specifically reciting any protein of this size, even though the disclosure does literally describe any possible protein of 10 to 1000 amino acids in length.
The question then becomes, at what point do we draw the line? In other words, to what extent is it possible for a patent applicant to satisfy the written description requirement with respect to a later added claim directed towards a specific protein sequence by simply disclosing in the specification as filed an astronomical "laundry list" of protein sequence variants that happens to include the later claimed proteinsequence? This is the question that was presented to a district court recently in the lawsuit brought by Novozymes against Danisco/Genencor, alleging infringement of a patent claiming certain alpha-amylase variants genetically engineered for improved thermostability. (Last September I reported on the district court's denial of a motion for preliminary injunction by Novozymes, available here).
The Federal Circuit (and its predecessor court the CCPA) has addressed this question in the context of traditional small molecules. A seminal case is In re Ruschig, a 1967 CCPA decision that held that the mere disclosure of a large genus of molecules is not necessarily sufficient to satisfy the written description requirement with respect to a later claim directed to some species falling within the genus. Under such circumstances, the Ruschig court held that in order to satisfy the written description requirement, the specification must provide "blaze marks" specifically pointing towards the later claimed species.
In 1996, the Federal Circuit applied the Ruschig "blaze mark standard” in Fujikawa v. Wattanasin, and held that the disclosure of a genus did not provide adequate written description of a later claimed sub-genus, pointing out that "just because a moiety is listed as one possible choice for one position does not mean there is [adequate] support for every species or sub-genus that chooses that moiety. Were this the case, a 'laundry list' disclosure of every possible moiety for every possible position would constitute a written description of every species in the genus. This cannot be because such a disclosure would not 'reasonably lead' those skilled in the art of any particular species."
In the Novozymes v. Danisco, the issue was raised in a motion for summary judgment filed by Danisco, arguing that a disclosure in Novozymes specification of a laundry list comprising an astronomical number of protein variants does not provide adequate written description support for a claim added later directed toward a small subset of those variants. The Novozymes patent specification, filed in 2000, disclosed variants of a specific alpha-amylase (the sequence of which was disclosed in the application) comprising an alteration at one or more positions selected from a list of 33 possible positions. The specification went on to define an alteration as either an insertion downstream of the amino acids which occupies position, a deletion of the amino acid which occupies a position, or a substitution of the amino acid which occupies the position with a different amino acid. So there are multiple variable parameters.
The 33 positions can be independently altered in three different ways. Any number of the 33 positions can be altered independently, and there are 20 different amino acids from which to choose in deletions or substitutions. Genencor did the math, and concluded that this amounted to a “staggering” 8.598 x 1042 different possibilities, a long laundry list indeed. Novozymes did not dispute this calculation. Furthermore, the specification does not specify what effect a specific mutation would have on thermostability, although one passage in the specification discusses "achieving altered stability, in particular improved stability (i.e., higher or lower), at especially high temperatures."
In 2009, nine years after the specification was filed, Novozymes added the claims at issue in the case, directed specifically toward a subset of the proteins on the laundry list that have a substitution at position 239 in amino acid sequence, resulting in increased thermostability. That is, the claim is limited to one of the 33 amino acid positions identified in the specification as filed (position 239), one of the three alterations (substitution), and one of the possible alterations in stability (increased thermostability).
The court discussed applicable precedents such as Ruschig and Fujikawa, but did not really seem to demonstrate a thorough understanding of the principles behind those decisions. Perhaps this is because, as the judge complained in her decision, "a general difficulty in this case has been the party's tendency to argue past each other." Nonetheless, she ultimately concluded that although "I still have doubts that the specification . . provides an adequate written description for the claims, I conclude that the defendants have not met their burden to prove by clear and convincing evidence that the [patent] is invalid as a matter of law." The decision was largely dictated by the cases procedural posture, which imposed a substantial burden of proof on Danisco in attempting to invalidate an issued patent on summary judgment as a matter of law.
The judge explicitly noted that "it is not without hesitation that I'm denying defendant's motion.” It seems clear that she was bothered by the fact that the originally filed specification discloses such an astronomical number of "possible inventions" without seeming to provide any "blaze marks" directing one towards the later claimed variants. But she went on to point out that even if the claims comply with the written description requirement, "to the extent the specification would require undue experimentation before a person of ordinary skill in the art could discover the claimed invention, that may suggest a lack of enablement rather than a problem with the written description." I think she might have a point there.
A copy of the decision is provided here. Thanks to Docket Navigator (www.docketnavigator.com) for making me aware of this case.
The question then becomes, at what point do we draw the line? In other words, to what extent is it possible for a patent applicant to satisfy the written description requirement with respect to a later added claim directed towards a specific protein sequence by simply disclosing in the specification as filed an astronomical "laundry list" of protein sequence variants that happens to include the later claimed proteinsequence? This is the question that was presented to a district court recently in the lawsuit brought by Novozymes against Danisco/Genencor, alleging infringement of a patent claiming certain alpha-amylase variants genetically engineered for improved thermostability. (Last September I reported on the district court's denial of a motion for preliminary injunction by Novozymes, available here).
The Federal Circuit (and its predecessor court the CCPA) has addressed this question in the context of traditional small molecules. A seminal case is In re Ruschig, a 1967 CCPA decision that held that the mere disclosure of a large genus of molecules is not necessarily sufficient to satisfy the written description requirement with respect to a later claim directed to some species falling within the genus. Under such circumstances, the Ruschig court held that in order to satisfy the written description requirement, the specification must provide "blaze marks" specifically pointing towards the later claimed species.
In 1996, the Federal Circuit applied the Ruschig "blaze mark standard” in Fujikawa v. Wattanasin, and held that the disclosure of a genus did not provide adequate written description of a later claimed sub-genus, pointing out that "just because a moiety is listed as one possible choice for one position does not mean there is [adequate] support for every species or sub-genus that chooses that moiety. Were this the case, a 'laundry list' disclosure of every possible moiety for every possible position would constitute a written description of every species in the genus. This cannot be because such a disclosure would not 'reasonably lead' those skilled in the art of any particular species."
In the Novozymes v. Danisco, the issue was raised in a motion for summary judgment filed by Danisco, arguing that a disclosure in Novozymes specification of a laundry list comprising an astronomical number of protein variants does not provide adequate written description support for a claim added later directed toward a small subset of those variants. The Novozymes patent specification, filed in 2000, disclosed variants of a specific alpha-amylase (the sequence of which was disclosed in the application) comprising an alteration at one or more positions selected from a list of 33 possible positions. The specification went on to define an alteration as either an insertion downstream of the amino acids which occupies position, a deletion of the amino acid which occupies a position, or a substitution of the amino acid which occupies the position with a different amino acid. So there are multiple variable parameters.
The 33 positions can be independently altered in three different ways. Any number of the 33 positions can be altered independently, and there are 20 different amino acids from which to choose in deletions or substitutions. Genencor did the math, and concluded that this amounted to a “staggering” 8.598 x 1042 different possibilities, a long laundry list indeed. Novozymes did not dispute this calculation. Furthermore, the specification does not specify what effect a specific mutation would have on thermostability, although one passage in the specification discusses "achieving altered stability, in particular improved stability (i.e., higher or lower), at especially high temperatures."
In 2009, nine years after the specification was filed, Novozymes added the claims at issue in the case, directed specifically toward a subset of the proteins on the laundry list that have a substitution at position 239 in amino acid sequence, resulting in increased thermostability. That is, the claim is limited to one of the 33 amino acid positions identified in the specification as filed (position 239), one of the three alterations (substitution), and one of the possible alterations in stability (increased thermostability).
The court discussed applicable precedents such as Ruschig and Fujikawa, but did not really seem to demonstrate a thorough understanding of the principles behind those decisions. Perhaps this is because, as the judge complained in her decision, "a general difficulty in this case has been the party's tendency to argue past each other." Nonetheless, she ultimately concluded that although "I still have doubts that the specification . . provides an adequate written description for the claims, I conclude that the defendants have not met their burden to prove by clear and convincing evidence that the [patent] is invalid as a matter of law." The decision was largely dictated by the cases procedural posture, which imposed a substantial burden of proof on Danisco in attempting to invalidate an issued patent on summary judgment as a matter of law.
The judge explicitly noted that "it is not without hesitation that I'm denying defendant's motion.” It seems clear that she was bothered by the fact that the originally filed specification discloses such an astronomical number of "possible inventions" without seeming to provide any "blaze marks" directing one towards the later claimed variants. But she went on to point out that even if the claims comply with the written description requirement, "to the extent the specification would require undue experimentation before a person of ordinary skill in the art could discover the claimed invention, that may suggest a lack of enablement rather than a problem with the written description." I think she might have a point there.
A copy of the decision is provided here. Thanks to Docket Navigator (www.docketnavigator.com) for making me aware of this case.
Sunday, January 30, 2011
Eli Lilly Petitions for Certiorari in Sun v. Eli Lilly
In a previous post to this blog, I discussed the case of Sun Pharmaceuticals v. Eli Lilly, in which a panel of the Federal Circuit dramatically expanded the scopeof the doctrine of obviousness-type double patenting. I also worked with the Biotechnology Industry Organization (BIO) on an amicus brief supporting Lilly's petition for rehearing en banc, available here. The Federal Circuit denied that petition, over a vigorous dissent by four judges (Newman, Rader, Lourie, and Linn), who argued that "[u]ntil recently the law of double patenting was clear, but it has become distorted by divergent statements, leading to this flawed ruling."
Notably, one of the dissenting judges (Rader) was the author of the Geneva opinion, which created the precedential authority upon which the Sun panel justified its decision. But as noted by the four dissenting judges, "extending Geneva to cover the facts of [Sun] does not further the policy of obviousness-type double patenting."
On Friday, Eli Lilly filed a petition for certiorari asking the Supreme Court to review the Federal Circuit's decision in Sun. The question is presented as "[w]hether the Federal Circuit improperly transformed the doctrine of "double patenting," in conflict with a "vast body of precedent" cited by four dissenting judges, by creating a new bright-line rule that invalidates a subsequent patent on a nonobvious, newly discovered use of the basic invention solely because it was disclosed, but not claimed, in the final text of the earlier basic patent."
Lilly's petition cites extensively to the opinion of the four dissenting Federal Circuit judges, including a statement that the Sun decision "violates a vast body of precedent," and a charge that the majorities refusal to rehear the case en banc to resolve the Court’s conflicting precedent in this area constitutes "an indictment of the ability of [that] court to provide stable law in the areas entrusted to [it]."
Notably, one of the dissenting judges (Rader) was the author of the Geneva opinion, which created the precedential authority upon which the Sun panel justified its decision. But as noted by the four dissenting judges, "extending Geneva to cover the facts of [Sun] does not further the policy of obviousness-type double patenting."
On Friday, Eli Lilly filed a petition for certiorari asking the Supreme Court to review the Federal Circuit's decision in Sun. The question is presented as "[w]hether the Federal Circuit improperly transformed the doctrine of "double patenting," in conflict with a "vast body of precedent" cited by four dissenting judges, by creating a new bright-line rule that invalidates a subsequent patent on a nonobvious, newly discovered use of the basic invention solely because it was disclosed, but not claimed, in the final text of the earlier basic patent."
Lilly's petition cites extensively to the opinion of the four dissenting Federal Circuit judges, including a statement that the Sun decision "violates a vast body of precedent," and a charge that the majorities refusal to rehear the case en banc to resolve the Court’s conflicting precedent in this area constitutes "an indictment of the ability of [that] court to provide stable law in the areas entrusted to [it]."
Thursday, December 23, 2010
Lawsuit Alleging Infringement of Canine Genotyping Patent Raise Interesting Patent Eligibility Issues
On December 17 Fred Hutchinson Cancer Research Center and its licensees (Argus Genetics and Mars, Inc.) sued MMI Genomics for infringement of a patent directed towards methods of using genetic testing to identify the breed of the dog (US patent 7,729,863). According to the complaint, MMI Genomics is a company based in Davis, California that provides dog breed identification services associated with its Canine Heritage XL Breed Test product.
Some of the claims in the asserted patent raise interesting issues of patent eligibility, particularly in view of the recent Bilski and Prometheus decisions, both discussed extensively on this blog, and the pending appeal of AMP v. PTO (the ACLU challenge to Myriad’s BRCA gene patents). For example, consider claim 1.
The heart of the claimed method seems to reside in applying an algorithm to genotype information using information derived there from to determine the contribution various dog breeds to dog being tested. If that were all the claim covered, I think under Bilski and Prometheus a court would likely find the claim patent ineligible for embodying a fundamental principle. The fundamental principle might be characterized as an abstract idea, or as a natural phenomenon, either would work.
But the claim includes two elements that might be sufficient to render the claim patent eligible: (1) the step of genotyping a sample taken from the dog, and (2) the use of a "specifically programmed computer." In Prometheus, the Federal Circuit relied heavily on the machine or transformation test in arriving at the conclusion that the claims at issue in that case were patent eligible. I believe that even though the Supreme Court clarified in Bilski that the machine or transformation test is not the only test for patent eligibility, it did acknowledge that the test can be a useful and informative tool for assessing patent eligibility, and I predict that the Federal Circuit will continue to rely heavily on the machine or transformation test when faced with claims such as this, as it did in Prometheus.
Under Prometheus and Bilski, I think this one could come out either way. On the one hand, a court could find that genotyping is inherently transformative, because it necessarily involves physical manipulation of biological samples, in the same way that the step of "determining drug metabolite level” was found transformative in Prometheus, and sufficient to render the claim patent eligible. A court could also find that the use of a "specifically programmed computer" satisfies the machine prong of the machine or transformation test.
On the other hand, a court could characterize the genotyping step as mere data-gathering, i.e., "insubstantial extra-solution activity,” and thus ignore it in the analysis. This is what the Federal Circuit did in In re Grams, and as noted in my previous blog post the Federal Circuit explicitly held in Prometheus that Grams is still good law. In Prometheus, the Federal Circuit distinguish the two cases by pointing out that in Grams the focus of the invention is on the algorithm itself, and that the data-gathering step generically covered many different types of clinical diagnostic tests, whereas the Prometheus claims were targeted to specific drugs and specific diseases. The dog breed testing claim seems to fall somewhere in between. I think a court could go either way, by either stressing that the claim focuses on the algorithm and is not limited to any specific genotype or genetic test, in which case the claim is patent ineligible under Grams, or by stressing that the genotyping step is "central to the purpose" of the claim and thus sufficient to render the claim patent eligible under Prometheus.
Regarding the use of a computer, it is important to note that under In re Bilski the machine or transformation test requires the involvement of a "particular" machine, and many have speculated that a general-purpose computer would not satisfy this requirement of "particularity." Whoever drafted the dog breed testing claim wisely specified that the computer used in the method is "specifically programmed," but I'm not sure if that will be sufficient. A court could dismiss the "specifically programmed" language and find that the mere involvement of the computer does not satisfy the "particularity” aspect of the machine or transformation test.
Claim 35 is similar to claim 1, but instead of reciting the use of a computer, includes a step of "applying a computer-implemented statistical model.” This claim could be more vulnerable than claim 1, since it does not appear to explicitly recite the use of a particular machine.
There are also a number of dependent claims limited to specific SNP markers, specific dog breeds, etc., and these claims should face less of a threat of invalidation for lack of patent eligibility. Patent eligibility analysis often hinges on an assessment of whether the claim preempts all substantial practical uses of an abstract idea or natural phenomenon, so logically the narrower a claim is the more likely it is not preemptive, and thus patent eligible. Although in Bilski the Supreme Court apparently rejected this logic, because it held even relatively narrow dependent claims to be patent ineligible even though they clearly did not preempt all uses of risk hedging (the fundamental principle at issue in that case).
Claim 36 appears to be a Beauregard claim, a claim directed toward computer readable medium on which a computer program is inscribed. It would be interesting to see how this claim holds up, it is my understanding that the status of this sort of claim has not been entirely resolved post-Bilski, I saw some posts on this topic on Patently-O a while back.
Claim 37 seems even more problematic to me. I don't know that it can be called a Beauregard claim, it appears to basically be directed toward a computer readable medium on which a data structure is stored, which I am guessing is not the same thing as a computer program. I would be particularly interested in seeing how court deals with this claim.
Some of the claims in the asserted patent raise interesting issues of patent eligibility, particularly in view of the recent Bilski and Prometheus decisions, both discussed extensively on this blog, and the pending appeal of AMP v. PTO (the ACLU challenge to Myriad’s BRCA gene patents). For example, consider claim 1.
1. A method for determining the contributions of canid populations to a canid genome, comprising: (a) genotyping a sample obtained from a test canid to determine the identity of one or both alleles present in the test canid genome for each of a set of markers, wherein the set of markers is indicative of the contributions of canid populations to the genome of the test canid; (b) using a specifically programmed computer comprising an algorithm to compare the identity of one or both alleles for each of the set of markers determined to be present in the test canid genome to a database comprising a plurality of canid population profiles, wherein each canid population profile comprises genotype information for the set of markers in the canid population; and (c) determining the contributions of canid populations to the test canid genome.
The heart of the claimed method seems to reside in applying an algorithm to genotype information using information derived there from to determine the contribution various dog breeds to dog being tested. If that were all the claim covered, I think under Bilski and Prometheus a court would likely find the claim patent ineligible for embodying a fundamental principle. The fundamental principle might be characterized as an abstract idea, or as a natural phenomenon, either would work.
But the claim includes two elements that might be sufficient to render the claim patent eligible: (1) the step of genotyping a sample taken from the dog, and (2) the use of a "specifically programmed computer." In Prometheus, the Federal Circuit relied heavily on the machine or transformation test in arriving at the conclusion that the claims at issue in that case were patent eligible. I believe that even though the Supreme Court clarified in Bilski that the machine or transformation test is not the only test for patent eligibility, it did acknowledge that the test can be a useful and informative tool for assessing patent eligibility, and I predict that the Federal Circuit will continue to rely heavily on the machine or transformation test when faced with claims such as this, as it did in Prometheus.
Under Prometheus and Bilski, I think this one could come out either way. On the one hand, a court could find that genotyping is inherently transformative, because it necessarily involves physical manipulation of biological samples, in the same way that the step of "determining drug metabolite level” was found transformative in Prometheus, and sufficient to render the claim patent eligible. A court could also find that the use of a "specifically programmed computer" satisfies the machine prong of the machine or transformation test.
On the other hand, a court could characterize the genotyping step as mere data-gathering, i.e., "insubstantial extra-solution activity,” and thus ignore it in the analysis. This is what the Federal Circuit did in In re Grams, and as noted in my previous blog post the Federal Circuit explicitly held in Prometheus that Grams is still good law. In Prometheus, the Federal Circuit distinguish the two cases by pointing out that in Grams the focus of the invention is on the algorithm itself, and that the data-gathering step generically covered many different types of clinical diagnostic tests, whereas the Prometheus claims were targeted to specific drugs and specific diseases. The dog breed testing claim seems to fall somewhere in between. I think a court could go either way, by either stressing that the claim focuses on the algorithm and is not limited to any specific genotype or genetic test, in which case the claim is patent ineligible under Grams, or by stressing that the genotyping step is "central to the purpose" of the claim and thus sufficient to render the claim patent eligible under Prometheus.
Regarding the use of a computer, it is important to note that under In re Bilski the machine or transformation test requires the involvement of a "particular" machine, and many have speculated that a general-purpose computer would not satisfy this requirement of "particularity." Whoever drafted the dog breed testing claim wisely specified that the computer used in the method is "specifically programmed," but I'm not sure if that will be sufficient. A court could dismiss the "specifically programmed" language and find that the mere involvement of the computer does not satisfy the "particularity” aspect of the machine or transformation test.
Claim 35 is similar to claim 1, but instead of reciting the use of a computer, includes a step of "applying a computer-implemented statistical model.” This claim could be more vulnerable than claim 1, since it does not appear to explicitly recite the use of a particular machine.
There are also a number of dependent claims limited to specific SNP markers, specific dog breeds, etc., and these claims should face less of a threat of invalidation for lack of patent eligibility. Patent eligibility analysis often hinges on an assessment of whether the claim preempts all substantial practical uses of an abstract idea or natural phenomenon, so logically the narrower a claim is the more likely it is not preemptive, and thus patent eligible. Although in Bilski the Supreme Court apparently rejected this logic, because it held even relatively narrow dependent claims to be patent ineligible even though they clearly did not preempt all uses of risk hedging (the fundamental principle at issue in that case).
Claim 36 appears to be a Beauregard claim, a claim directed toward computer readable medium on which a computer program is inscribed. It would be interesting to see how this claim holds up, it is my understanding that the status of this sort of claim has not been entirely resolved post-Bilski, I saw some posts on this topic on Patently-O a while back.
36. A computer readable medium comprising stored thereon: (a) a data structure stored thereon for use in distinguishing canid populations, the data structure comprising: (i) a marker field, which is capable of storing the name of a marker or of an allele of the marker; and (ii) a genotype information field, which is capable of storing genotype information for the marker in a canid population, wherein a record comprises an instantiation of the marker field and an instantiation of the genotype information field and a set of records represents a canid population profile; and (b) computer-executable instructions for implementing a method for determining the contributions of canid populations to a canid genome, comprising: (i) obtaining the identity of one or both alleles in a test canid genome for each of a set of markers; and (ii) determining the contributions of canid populations to the test canid genome by comparing the alleles in the test canid genome to a database comprising canid population profiles, wherein each canid population profile comprises genotype information for the set of markers in the canid population.
Claim 37 seems even more problematic to me. I don't know that it can be called a Beauregard claim, it appears to basically be directed toward a computer readable medium on which a data structure is stored, which I am guessing is not the same thing as a computer program. I would be particularly interested in seeing how court deals with this claim.
37. A computer-readable medium comprising a data structure stored thereon for use in distinguishing canid populations, the data structure comprising: (a) a marker field, which is capable of storing the name of a marker or of an allele of the marker; and (b) a genotype information field, which is capable of storing genotype information for the marker in a canid population, wherein a record comprises an instantiation of the marker field and an instantiation of the genotype information field and a set of records represents a canid population profile, wherein the marker field comprises a set of markers indicative of the contributions of canid populations to the genome of a test canid.
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