In an earlier post, I reported on patent infringement litigation between Cellectis and Precision BioSciences, two companies commercializing engineered I-CreI meganucleases as tools for specifically cleaving a targeted recognition site in double-stranded DNA.
On February 21, the patent office issued two new patents directed towards modified I-CreI meganucleases (8,119,361 and 8,119,381), and on the same day Cellectis filed declaratory judgment action against Precision seeking to establish that these patents are invalid and not infringed. These patents are continuations of 8,021,867, which is the subject of another declaratory judgment action filed by Cellectis last year. On their face, the patents indicate that they are assigned to Duke University, but Cellectis alleges that Precision is the actual owner of the patents. The infringement litigation between the parties began when Cellectis sued Precision for allegedly infringing Cellectis’s patent 7,897,372. The lawsuits have all been filed in Delaware District Court.
On Feb 21, Precision also filed a case in the Eastern District of North Carolina asserting the two newly issued patents against Cellectis.
Based on a quick reading of the claims, it appears that both the Cellectis patent and the Duke/Precision patents are directed towards rationally engineered variants of the I-CreI meganuclease with altered target specificity. The Cellectis and Duke/Precision claims focus on modification at different amino acid residues in protein, but it looks as though there would be substantial overlap in the claim coverage of the Precision and Duke/Precision claims. In particular, the claims all recite “at least” one amino acid substitution as specified by the claim, but all are written to encompass I-CreI meganucleases with additional amino acid modifications, so a I-CreI meganuclease modified at several locations in the amino acid chain could fall within the scope of patents owned by both parties.
Thursday, February 23, 2012
Thursday, February 9, 2012
Will Gene Patents Derail the Next-Generation of Genetic Technologies?: A Reassessment of the Evidence Suggests Not
Last August I posted a draft article debunking the myth that 20% of genes are patented, and explaining that the widespread concern that human gene patents will impede whole genome sequencing is largely based on a misreading of the empirical evidence. I have continued to work on the project, and have just posted a follow-up article on SSRN entitled "Will Gene Patents Derail the Next Generation of Genetic Technologies?: A Reassessment of the Evidence Suggests Not.”. I plan to present some of the results at the USPTO hearings on gene patents and genetic testing to be held at the University San Diego on March 9. A brief abstract summarizing the article is provided below, the full article can be accessed here.
Judge Bryson recently asserted in Association for Molecular Pathology v. US Patent and Trademark Office (dissenting-in-part) that human gene patents “present a significant obstacle to the next generation of innovation in genetic medicine—multiplex tests and whole-genome sequencing.” His concern over the impact of gene patents on genetic testing, which coincides with his position that certain gene patents should be declared patent ineligible, reflects a widely held misperception that 20% of human genes are patented in a manner that would necessarily result in infringement by whole genome sequencing and other forms of genetic testing. In fact, the myth that 20% of human genes are patented is based on a gross misreading of a single "Policy Perspective" article published in Science in 2005, and an unfortunate tendency among many commentators to consider gene patents in abstract terms that disregard the critical role of patent claims in limiting the scope of a patent owner's right to exclude. Analysis of the claims of 533 of the of the patents identified in the Science article as "covering" human genes reveals that most do not include a single claim that would be infringed by whole genome sequencing and other forms of genetic testing. In fact, it seems quite likely that, were they to be litigated, few if any of these gene patents would be found to cover genetic testing or whole genome sequencing. Furthermore, a variety of practical limitations on enforcement and remedies appear to render it unlikely that the owners of these patents would be motivated to assert them against providers of whole genome sequencing and other next-generation diagnostic technologies in a manner that would impede progress in this area. There have been numerous instances in which fears that patents would harm biomedical research and medicine have proven in retrospect to have been greatly exaggerated, and history counsels against overreacting to the current controversy over gene patents. Ironically, it might be the case that the next generation of genetic diagnostic testing innovation will be adversely impacted not by too many patents, but by a lack of adequate patent protection.
Thursday, October 20, 2011
Claim Construction Ruling in Arzerra Infringement Case
On October 17, a judge in the Southern District of California issued a significant claim construction ruling in the case of Biogen Idec and Genentech v. GlaxoSmithKline. The plaintiffs allege that defendants anti-CD20 monoclonal antibody Ofatumumab (trade name Arzerra) infringes US patent number 7,682,612. Plaintiffs market a competing anti-CD20 antibody, Rituximab (trade name Rituxan).
Based on my understanding of the case, the ruling appears to be a substantial victory for GlaxoSmithKline.
The disputed claim terms are found in claim 1 of the patent, which recites:
The court construed the terms "anti-CD20 antibody” and “CD20 binding fragment” as “rituximab and antibodies that bind to the same epitope of the CD20 antigen with similar affinity and specificity as rituximab” and "the portion of the anti-CD20 antibody that binds to the same epitope of the CD20 antigen with similar affinity and specificity as rituximab.” This is significant, because Arzerra does not bind to the same epitope as rituximab, which appears to rule out infringement if this construction of the terms is affirmed on appeal.
The plaintiffs argued for a broader construction, such that the disputed terms would cover any antibody that binds to CD20, even antibodies that bind to different epitopes, such as Arzerra. However, the court found that the prosecution history of the patent established that during prosecution plaintiffs represented that the claims were limited to antibodies binding to the same epitope as rituximab, and the court held them to this more limited construction of the term.
The court also construed the terms "does not include treatment with a radiolabeled anti-CD20 antibody" and "radiation is not used" as "excludes the use of a radiolabeled anti-CD20 antibody or the administration of a separate radiolabeled anti-CD20 antibody," and "no form of radiation (including radiolabeled antibodies) is used," respectively. This construction is significant, because it appears to rule out infringement when Arzerra is used in conjunction with Bexxar or Zevalin, which are both radiolabeled anti-CD20 antibodies.
Thanks to Docket Navigator for making me aware of the ruling.
Based on my understanding of the case, the ruling appears to be a substantial victory for GlaxoSmithKline.
The disputed claim terms are found in claim 1 of the patent, which recites:
1. A method of treating chronic lymphocytic leukemia in a human patient, comprising administering an anti-CD20 antibody to the patient in an amount effective to treat the chronic lymphocytic leukemia, wherein the method does not include treatment with a radiolabeled anti-CD20 antibody.
The court construed the terms "anti-CD20 antibody” and “CD20 binding fragment” as “rituximab and antibodies that bind to the same epitope of the CD20 antigen with similar affinity and specificity as rituximab” and "the portion of the anti-CD20 antibody that binds to the same epitope of the CD20 antigen with similar affinity and specificity as rituximab.” This is significant, because Arzerra does not bind to the same epitope as rituximab, which appears to rule out infringement if this construction of the terms is affirmed on appeal.
The plaintiffs argued for a broader construction, such that the disputed terms would cover any antibody that binds to CD20, even antibodies that bind to different epitopes, such as Arzerra. However, the court found that the prosecution history of the patent established that during prosecution plaintiffs represented that the claims were limited to antibodies binding to the same epitope as rituximab, and the court held them to this more limited construction of the term.
The court also construed the terms "does not include treatment with a radiolabeled anti-CD20 antibody" and "radiation is not used" as "excludes the use of a radiolabeled anti-CD20 antibody or the administration of a separate radiolabeled anti-CD20 antibody," and "no form of radiation (including radiolabeled antibodies) is used," respectively. This construction is significant, because it appears to rule out infringement when Arzerra is used in conjunction with Bexxar or Zevalin, which are both radiolabeled anti-CD20 antibodies.
Thanks to Docket Navigator for making me aware of the ruling.
Wednesday, October 19, 2011
Pioneer-DuPont Sues Monsanto for Infringing "Low Tech" Agricultural Biotechnology Patents
Yesterday Pioneer Hi-Bred (a subsidiary of DuPont) sued Monsanto, its rival in the agricultural biotechnology sector, for allegedly infringing its patents directed towards a method of increasing "seed vigor" in maize that entails defoliating maize plants during a specific period after pollination. The lawsuit was filed in the Southern District of Iowa, Pioneer's home territory.
The two companies have been involved in a high-profile patent litigation ever since Pioneer announced its plans to release genetically modified maize comprising Pioneers Optimum GAT trait stacked with Monsanto's Roundup Ready trait. Both traits confer resistance to glyphosate (i.e. Roundup), albeit by different mechanisms - Roundup Ready essentially works by rendering the plant resistant to glyphosate, while Optimum GAT causes the plant to express a protein that breaks down the glyphosate molecule.
Pioneer responded by suing Monsanto for antitrust violations, based on the company’s licensing and enforcement practices with respect to its patents covering the Roundup Ready trait. The patent infringement case is scheduled to go to trial next June, while the antitrust counterclaims are scheduled to go to trial April 2013.
The two patents being asserted by Pioneer in the most recent lawsuit are US patent numbers 5,518,989 and 6,162,974. The ‘989 patent claims a method of increasing seed vigor in maize by defoliating plants during a specific time window after pollination, based upon how long the growing plant has been exposed to warm days. The ‘974 patent claims an "assemblage" of maize seeds produced using the method. Here are a couple of representative claims.
Claim 1 from the ‘989 patent:
According to Wikipedia, “GDD [,which stands for Growing Degree Day, is] a measure of heat accumulation used by horticulturists, gardeners, and farmers to predict plant and pest development rates such as the date that a flower will bloom or a crop reach maturity.” Wikipedia states that "plants grow in a cumulative stepwise manner which is strongly influenced by the ambient temperature. Growing degree days take aspects of local weather into account and allow gardeners to predict (or, in greenhouses, even to control) the plants’ pace toward maturity."
The patents state that "functional leaf area can be reduced" (i.e., the plant can be defoliated) using mechanical or chemical means. "Chemical means" would include treatment with an herbicide such as Roundup (the dependent claims explicitly identify Roundup as an herbicide to be used in the method.
The patents remind me of the patents at issue in In re Cruciferous Sprouts litigation that occurred several years ago. In that case, as I recall, researchers at Johns Hopkins University discovered that cruciferous sprouts (e.g., broccoli sprouts) harvested at a particular point in time after germination (in particular, prior to the "two-leaf stage") contain high levels of certain compounds believed to be useful in preventing cancer.
A representative claim at issue in that case recited " “A method of preparing a food product rich in glucosinolates, comprising germinated cruciferous seeds, with the exception of cabbage, cress, mustard and radish seeds, and harvesting sprouts prior to the 2-leaf stage, to form a food product comprising a plurality of sprouts.”
The Federal Circuit held that the claims were invalid based on inherent anticipation. Although the Johns Hopkins researchers might have been the first to recognize the health benefits of eating cruciferous sprouts harvested prior to the two-leaf stage, in fact people had been eating sprouts harvested at this stage for many years. This was surely the correct result - if the claims were held valid, that would mean that Johns Hopkins would have the right to exclude others from doing something that had long been part of the prior art, i.e., eating broccoli sprouts and the like.
The same sort of issue of inherent anticipation could potentially be raised with respect to Pioneer's patents on methods of defoliating maize plants at a certain time after pollination. It would seem to me that if Monsanto can show that, prior to Pioneers invention, maize plants had been defoliated during this stage of growth (perhaps by treatment with Roundup), a court might come to the conclusion that the claims are inherently anticipated.
The claims also might raise issues of patent eligibility, at least in the minds of people like Justice Breyer. Recall that in his LabCorp dissent Justice Breyer expressed a view that a patent claim that preempts substantially all practical use of a newly discovered natural phenomenon is patent ineligible. Some might characterize Pioneer’s discovery that defoliation of maize at a certain time results in increased seed vigor as the discovery of a "natural phenomenon," and conclude that Pioneer’s claims effectively preempt all substantial practical application of this discovery.
Pioneer's claims directed towards a "maize seed assemblage" might also raise patent eligibility issues. The claimed maize seeds are arguably not genetically modified, in which case they might be considered "products of nature" and not patent eligible under Chakrabarty. In order to be patent eligible, it would seem that a court would have to determine that either the defoliation resulted in a "man-made" seed, or that grouping seeds in an "assemblage" is sufficient human intervention to establish patent eligibility.
The two companies have been involved in a high-profile patent litigation ever since Pioneer announced its plans to release genetically modified maize comprising Pioneers Optimum GAT trait stacked with Monsanto's Roundup Ready trait. Both traits confer resistance to glyphosate (i.e. Roundup), albeit by different mechanisms - Roundup Ready essentially works by rendering the plant resistant to glyphosate, while Optimum GAT causes the plant to express a protein that breaks down the glyphosate molecule.
Pioneer responded by suing Monsanto for antitrust violations, based on the company’s licensing and enforcement practices with respect to its patents covering the Roundup Ready trait. The patent infringement case is scheduled to go to trial next June, while the antitrust counterclaims are scheduled to go to trial April 2013.
The two patents being asserted by Pioneer in the most recent lawsuit are US patent numbers 5,518,989 and 6,162,974. The ‘989 patent claims a method of increasing seed vigor in maize by defoliating plants during a specific time window after pollination, based upon how long the growing plant has been exposed to warm days. The ‘974 patent claims an "assemblage" of maize seeds produced using the method. Here are a couple of representative claims.
Claim 1 from the ‘989 patent:
1. A method for treating a stand of maize plants, comprising the steps ofClaim 1 from the ‘974 patent:
(A) reducing functional leaf area in substantially all of said plants, wherein said reducing is effected at between about 600 and about 850 GDDs after pollination of said plants, and then
(B) harvesting said stand, such that a seed assemblage is obtained from said stand that is characterized by a level of seed vigor that is enhanced relative to the level of seed vigor in a seed assemblage harvested from a comparison stand of maize plants not subjected to said reducing of functional leaf area.
1. A maize seed assemblage having enhanced seed vigor, wherein said seed assemblage is obtained by the method comprising the steps of:
(a) reducing functional leaf area in substantially all of a stand of maize plants, wherein said reducing is effected at between about 600 and about 850 GDDs after pollination of said plants, and
(b) harvesting said stand to obtain an assemblage of seeds,
wherein said seed assemblage is characterized by a level of seed vigor that is enhanced relative to the level of seed vigor in a seed assemblage harvested from a comparison stand of maize plants not subjected to said reducing of functional leaf area.
According to Wikipedia, “GDD [,which stands for Growing Degree Day, is] a measure of heat accumulation used by horticulturists, gardeners, and farmers to predict plant and pest development rates such as the date that a flower will bloom or a crop reach maturity.” Wikipedia states that "plants grow in a cumulative stepwise manner which is strongly influenced by the ambient temperature. Growing degree days take aspects of local weather into account and allow gardeners to predict (or, in greenhouses, even to control) the plants’ pace toward maturity."
The patents state that "functional leaf area can be reduced" (i.e., the plant can be defoliated) using mechanical or chemical means. "Chemical means" would include treatment with an herbicide such as Roundup (the dependent claims explicitly identify Roundup as an herbicide to be used in the method.
The patents remind me of the patents at issue in In re Cruciferous Sprouts litigation that occurred several years ago. In that case, as I recall, researchers at Johns Hopkins University discovered that cruciferous sprouts (e.g., broccoli sprouts) harvested at a particular point in time after germination (in particular, prior to the "two-leaf stage") contain high levels of certain compounds believed to be useful in preventing cancer.
A representative claim at issue in that case recited " “A method of preparing a food product rich in glucosinolates, comprising germinated cruciferous seeds, with the exception of cabbage, cress, mustard and radish seeds, and harvesting sprouts prior to the 2-leaf stage, to form a food product comprising a plurality of sprouts.”
The Federal Circuit held that the claims were invalid based on inherent anticipation. Although the Johns Hopkins researchers might have been the first to recognize the health benefits of eating cruciferous sprouts harvested prior to the two-leaf stage, in fact people had been eating sprouts harvested at this stage for many years. This was surely the correct result - if the claims were held valid, that would mean that Johns Hopkins would have the right to exclude others from doing something that had long been part of the prior art, i.e., eating broccoli sprouts and the like.
The same sort of issue of inherent anticipation could potentially be raised with respect to Pioneer's patents on methods of defoliating maize plants at a certain time after pollination. It would seem to me that if Monsanto can show that, prior to Pioneers invention, maize plants had been defoliated during this stage of growth (perhaps by treatment with Roundup), a court might come to the conclusion that the claims are inherently anticipated.
The claims also might raise issues of patent eligibility, at least in the minds of people like Justice Breyer. Recall that in his LabCorp dissent Justice Breyer expressed a view that a patent claim that preempts substantially all practical use of a newly discovered natural phenomenon is patent ineligible. Some might characterize Pioneer’s discovery that defoliation of maize at a certain time results in increased seed vigor as the discovery of a "natural phenomenon," and conclude that Pioneer’s claims effectively preempt all substantial practical application of this discovery.
Pioneer's claims directed towards a "maize seed assemblage" might also raise patent eligibility issues. The claimed maize seeds are arguably not genetically modified, in which case they might be considered "products of nature" and not patent eligible under Chakrabarty. In order to be patent eligible, it would seem that a court would have to determine that either the defoliation resulted in a "man-made" seed, or that grouping seeds in an "assemblage" is sufficient human intervention to establish patent eligibility.
Wednesday, October 5, 2011
Patent Battle over Modified Meganucleases Heats Up
Meganucleases are endodeoxyribonucleases characterized by a large recognition site (double-stranded DNA sequences of 12 to 40 base pairs); as a result this site generally occurs only once in any given genome. For example, the 18-base pair sequence recognized by the I-SceI meganuclease would on average require a genome twenty times the size of the human genome to be found once by chance. Meganucleases are therefore considered to be the most specific naturally occurring restriction enzymes.
The high specificity of meganucleases gives them a high degree of precision and much lower cell toxicity than other naturally occurring restriction enzymes; they were identified in the 1990s as particularly promising tools for genome engineering.
However, the meganuclease-induced genetic recombinations that could be performed were limited by the repertoire of meganucleases available. Despite the existence of hundreds of meganucleases in nature, and the fact that each one is able to tolerate minor variations in its recognition site, the probability of finding a meganuclease able to cut a given gene at the desired location is extremely slim. Several research laboratories therefore soon began trying to engineer new meganucleases targeting the desired recognition sites.
Cellectis and Precision Biosciences are two competing biotechnology companies, both seeking to commercialize engineered meganucleases for use in genetic engineering.
On March 1, 2011, Cellectis sued Precision Biosciences in the District Court of Delaware for allegedly infringing US patent number 7,897,372, directed to "I-CreI Meganuclease Variants with Modified Specificity.” That case is presently proceeding with discovery, and trial is set for February 2013.
On September 20, 2011, the US patent office issued US patent number 8,021,867, which is directed towards "Rationally-Designed Meganucleases with Altered Sequence Specificity and DNA-Binding Affinity." The named assignee on the patent is Duke University, but according to Celectis the patent is actually owned by Precision.
On September 30, 2011, Cellectis filed another lawsuit against Precision Biosciences, again in the District Court of Delaware, and this time it is a declaratory judgment action seeking a declaration that the Duke/Precision patent is invalid and not infringed by Cellectis.
In the complaint, Cellectis does not allege that it has explicitly been threatened with a lawsuit by Precision. Instead, it argues that declaratory judgment is appropriate because: both patents-in-suit concern the same field of technology, i.e., "modified" or "altered" I-CreI meganucleases; the Cellectis patent is prior art to the precision patent, the parties in both cases are the same, and the discovery in both cases likely would substantially overlap.
The high specificity of meganucleases gives them a high degree of precision and much lower cell toxicity than other naturally occurring restriction enzymes; they were identified in the 1990s as particularly promising tools for genome engineering.
However, the meganuclease-induced genetic recombinations that could be performed were limited by the repertoire of meganucleases available. Despite the existence of hundreds of meganucleases in nature, and the fact that each one is able to tolerate minor variations in its recognition site, the probability of finding a meganuclease able to cut a given gene at the desired location is extremely slim. Several research laboratories therefore soon began trying to engineer new meganucleases targeting the desired recognition sites.
Cellectis and Precision Biosciences are two competing biotechnology companies, both seeking to commercialize engineered meganucleases for use in genetic engineering.
On March 1, 2011, Cellectis sued Precision Biosciences in the District Court of Delaware for allegedly infringing US patent number 7,897,372, directed to "I-CreI Meganuclease Variants with Modified Specificity.” That case is presently proceeding with discovery, and trial is set for February 2013.
On September 20, 2011, the US patent office issued US patent number 8,021,867, which is directed towards "Rationally-Designed Meganucleases with Altered Sequence Specificity and DNA-Binding Affinity." The named assignee on the patent is Duke University, but according to Celectis the patent is actually owned by Precision.
On September 30, 2011, Cellectis filed another lawsuit against Precision Biosciences, again in the District Court of Delaware, and this time it is a declaratory judgment action seeking a declaration that the Duke/Precision patent is invalid and not infringed by Cellectis.
In the complaint, Cellectis does not allege that it has explicitly been threatened with a lawsuit by Precision. Instead, it argues that declaratory judgment is appropriate because: both patents-in-suit concern the same field of technology, i.e., "modified" or "altered" I-CreI meganucleases; the Cellectis patent is prior art to the precision patent, the parties in both cases are the same, and the discovery in both cases likely would substantially overlap.
Tuesday, September 13, 2011
Mirus Bio Files Lawsuit Alleging that Roche’s FuGENE 6 Transfection Reagent Infringes Patent
On September 12, 2011, Mirus Bio sued Fugent, LLC for allegedly infringing its patent entitled "Process of Transfecting a Cell with a Polynucleotide Mixed with an Amphipathic Compound and a DNA-Binding Protein" (U.S. Patent No. 5,744,335). The patent issued in 1998. Claim 1 of the patent recites:
The complaint alleges that Fugent infringes the patent, both directly and indirectly (i.e., by inducing its customers to infringe the patent, and/or by contributing to the infringing actions of its customers) by making, using, selling and offering to sell the transfection reagent known as FuGene 6.
FuGene 6 is a Roche product, and appears in the Roche Applied Science catalog. I'm not sure what the relationship is between Fugent and Roche, nor why Roche was not named in the lawsuit.
If you go to Mirus Bio website homepage, this is what you will see:
FuGENE® 6 Supply Problems?
Transfect with TransIT®-LT1
Achieve Comparable Performance
"TransIT-LT1 (MirusBio) has the same performance as FuGENE® 6 (Roche) in our comparison tests."
-The RNAi Consortium (TRC), Broad Institute of MIT and Harvard
Perhaps they are referring to the lawsuit when they suggest people will be having supply problems with FuGENE 6, and might need to switch to the Mirus Bio product TransIT-LT1.
Thanks to Docket Report from Docket Navigator for making me aware of the complaint.
A process of transfecting a polynucleotide into a cell comprising: associating a selected cell with an amphipathic compound, an effective amount of a polynucleotide-binding protein, the polynucleotide-binding protein is selected from the group consisting of histone and histone with a nuclear localizing signal, and a selected polynucleotide, in solution, wherein encapsulation of the polynucleotide by the amphipathic compound is not required for transfection.Both companies are located in Madison Wisconsin.
The complaint alleges that Fugent infringes the patent, both directly and indirectly (i.e., by inducing its customers to infringe the patent, and/or by contributing to the infringing actions of its customers) by making, using, selling and offering to sell the transfection reagent known as FuGene 6.
FuGene 6 is a Roche product, and appears in the Roche Applied Science catalog. I'm not sure what the relationship is between Fugent and Roche, nor why Roche was not named in the lawsuit.
If you go to Mirus Bio website homepage, this is what you will see:
FuGENE® 6 Supply Problems?
Transfect with TransIT®-LT1
Achieve Comparable Performance
"TransIT-LT1 (MirusBio) has the same performance as FuGENE® 6 (Roche) in our comparison tests."
-The RNAi Consortium (TRC), Broad Institute of MIT and Harvard
Perhaps they are referring to the lawsuit when they suggest people will be having supply problems with FuGENE 6, and might need to switch to the Mirus Bio product TransIT-LT1.
Thanks to Docket Report from Docket Navigator for making me aware of the complaint.
Friday, September 9, 2011
University Sues Makers of Heart-Healthy Cookies
In a complaint filed September 7 in the Western District of Wisconsin, Brandeis University joins its exclusive licensee (GFA Brands) in suing a number of cookie companies, including Keebler, Famous Amos, Nestlé's and Pillsbury for infringing its patents directed towards methods of "Increasing the HDL Level in the HDL/LDL Ratio in Human Serum by Balancing Saturated and Polyunsaturated Dietary Fatty Acids." As an example, one of the asserted claims is claim 7 of US patent 5,843,497, which recites:
One might question the University's decision to patent and exclusively license this discovery, and then proceed to join in a lawsuit against cookie manufacturers apparently employing the fruits of university research in an attempt to make healthier cookies. In an article I published a few years ago with Josh Sarnoff entitled Recent Developments Affecting the Enforcement, Procurement and Licensing of Research Tool Patents (available here), we discussed the policy behind the Bayh-Dole Act, which was primarily intended to increase access to, and the dissemination of, federally-funded University research.
Prior to buy Bayh-Dole, there was a sense that much of the fruits of University research was essentially left sitting on the shelf, due to insufficient incentives for the investment necessary to translate basic University research into useful commercial products. In order to increase the social benefit to be derived from federally funded University research, Bayh-Dole facilitated the ability of universities to patent and license discoveries coming out of such research. But, at least to my understanding, the primary policy justification was not to simply create profit centers for Universities, but rather to permit universities to license patented technologies to companies in the private sector who might only be willing to invest in the commercialization of these technologies if there was some patent protection in place. A good example would be a potentially useful pharmaceutical compound - without a patent in place, few companies would be willing to make the substantial investment the would be required to develop and bring to market a drug based on the compound.
In recent years, there has been much criticism of the manner in which some University technology transfer offices operate, and allegations that university patenting and licensing practices at times impede rather than promote dissemination of the fruits of federally funded University research. For example, in congressional hearings held to address the alleged problem of "gene patents," much of the testimony seemed to suggest that it was University patenting and licensing processes that were more problematic than gene patents per se. In an article I published on human gene patent litigation a few years ago (available here) I found that every gene patent litigation involving genetic diagnostic testing (which is the most controversial use of gene patents) involved gene patents arising out of University research.
In 2007, the trustees of the Association of University Technology Managers (AUTM) published a white paper entitled In the Public Interest: Nine Points to Consider and Licensing University Technology. Point 2 states in part that:
In this case, the patented technology does not seem to be the type that required a significant investment of time or resources in order to be implemented, as evidenced by the large number of nonlicensed cookie manufacturers who are allegedly employing the suggested "balance of saturated and polyunsaturated dietary fatty acids" in their cookies, presumably in an effort to provide safer products for consumers.
One might question whether the decision of Brandeis University to exclusively license a patent covering these healthy products was the proper decision, or even whether this might be the sort of technology that would be better left unpatented, particularly if one views the University's primary mission as generating and disseminating useful discoveries such as this.
7. A prepared food product, comprising a cholesterol-free fat composition suitable for human or animal ingestion for increasing the HDL concentration and the HDL/LDL concentration ratio in the blood serum, comprising one part by weight polyunsaturated fat and at least one part by weight cholesterol-free saturated fat, where said fat composition comprises linoleic acid and at least one saturated fatty acid selected from the group including lauric acid, myristic acid, and palmitic acid, said linoleic acid constituting between 15% by weight and 40% by weight of the fat in said fat composition and said saturated fatty acid constituting between 20% and 40% by weight of the fat in said fat composition.Thanks to Docket Report (a service of Docket Navigator) for making me aware of the complaint, which is available here.
One might question the University's decision to patent and exclusively license this discovery, and then proceed to join in a lawsuit against cookie manufacturers apparently employing the fruits of university research in an attempt to make healthier cookies. In an article I published a few years ago with Josh Sarnoff entitled Recent Developments Affecting the Enforcement, Procurement and Licensing of Research Tool Patents (available here), we discussed the policy behind the Bayh-Dole Act, which was primarily intended to increase access to, and the dissemination of, federally-funded University research.
Prior to buy Bayh-Dole, there was a sense that much of the fruits of University research was essentially left sitting on the shelf, due to insufficient incentives for the investment necessary to translate basic University research into useful commercial products. In order to increase the social benefit to be derived from federally funded University research, Bayh-Dole facilitated the ability of universities to patent and license discoveries coming out of such research. But, at least to my understanding, the primary policy justification was not to simply create profit centers for Universities, but rather to permit universities to license patented technologies to companies in the private sector who might only be willing to invest in the commercialization of these technologies if there was some patent protection in place. A good example would be a potentially useful pharmaceutical compound - without a patent in place, few companies would be willing to make the substantial investment the would be required to develop and bring to market a drug based on the compound.
In recent years, there has been much criticism of the manner in which some University technology transfer offices operate, and allegations that university patenting and licensing practices at times impede rather than promote dissemination of the fruits of federally funded University research. For example, in congressional hearings held to address the alleged problem of "gene patents," much of the testimony seemed to suggest that it was University patenting and licensing processes that were more problematic than gene patents per se. In an article I published on human gene patent litigation a few years ago (available here) I found that every gene patent litigation involving genetic diagnostic testing (which is the most controversial use of gene patents) involved gene patents arising out of University research.
In 2007, the trustees of the Association of University Technology Managers (AUTM) published a white paper entitled In the Public Interest: Nine Points to Consider and Licensing University Technology. Point 2 states in part that:
When significant investment of time and resources in a technology are needed in order to achieve its broad implementation, an exclusive license often is necessary and appropriate. However, it is important that technology transfer offices be aware of the potential impact that the exclusive license might have on further research, unanticipated uses, future commercialization efforts and markets. Universities need to be mindful of the impact of granting overly broad exclusive rights and should strive to grant just those rights necessary to encourage development of the technology.In other words, University technology transfer offices are encouraged to only grant exclusive licenses in technology when a "significant investment of time and resources in a technology are needed in order to achieve its broad implementation." To the extent the patents are licensed exclusively, the University "should strive to grant just those rights necessary to encourage development of the technology."
In this case, the patented technology does not seem to be the type that required a significant investment of time or resources in order to be implemented, as evidenced by the large number of nonlicensed cookie manufacturers who are allegedly employing the suggested "balance of saturated and polyunsaturated dietary fatty acids" in their cookies, presumably in an effort to provide safer products for consumers.
One might question whether the decision of Brandeis University to exclusively license a patent covering these healthy products was the proper decision, or even whether this might be the sort of technology that would be better left unpatented, particularly if one views the University's primary mission as generating and disseminating useful discoveries such as this.
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