Showing posts with label infringed. Show all posts
Showing posts with label infringed. Show all posts
Saturday, May 27, 2017
Jury finds Cellectis meganuclease claims invalid but infringed by Precision Biosciences under Doctrine of Equivalents
Jury finds Cellectis meganuclease claims invalid but infringed by Precision Biosciences under Doctrine of Equivalents
As reported in an earlier post, on March 1, 2011, Cellectis sued Precision Biosciences in the District Court of Delaware [CIV-No.-11-173] for allegedly infringing US patent number 7,897,372, directed to "I-CreI Meganuclease Variants with Modified Specificity.” The companies are both attempting to commercialize engineered meganucleases for use in genetic engineering. The litigation between Cellectis and Precision Biosciences has come to include 20 distinct lawsuits filed in Delaware and Eastern North Carolina (Precision licenses its patents from Duke University), and to involve multiple patents owned by both companies, a couple of which were discussed in this earlier post.
On May 3, the jury issued a verdict with respect to asserted claims 37, 40 and 50 from the ‘372 patent, finding all of the claims invalid for obviousness and inadequate written description. The jury also found that none of the claims are literally infringed by Precision’s meganucleases, and that Precision is not liable for inducing or contributory infringement of the claims. The jury did find that Precision meganucleases infringe claims 37 and 50 under the doctrine of equivalents.
Here are the claims:
37. A recombinant monomer of an I-CreI meganuclease variant comprising at least one mutation in the amino acid sequence of SEQ ID NO: 70, wherein said at least one mutation comprises a substitution at one or more of the amino acids residues at positions 44, 68 and 70 and said monomer further comprises at least one additional mutation of an amino acid residue directly contacting a DNA target sequence wherein said amino acid residue directly contacting a DNA target sequence is selected from the group consisting of positions 26, 28, 30, 32, 33 and 38, wherein said monomer when in a dimeric form is able to cleave DNA.
40. The monomer of an I-CreI meganuclease variant of claim 37, wherein said monomer when in a dimeric form has a modified DNA cleavage specificity relative to the I-CreI meganuclease of SEQ ID NO: 70 in at least one nucleotide in the .+-.3 to 5 triplets.
50. A single-chain chimeric meganuclease comprising the fusion of two different monomers according to claim 37.
Earlier, on April 9, 2013, the District Court issued an order denying multiple motions on summary judgment, including one relating to literal infringement of Claim 40. In one interesting aspect of the decision, the District Court judge held that the term "variant of the wild-type monomer from 1-Crel" (which appears in the preamble of claim 37, from which claim 40 depends) is an indefinite “limitation,” essentially because the court found that one of skill in the art would not be able to discern the breath of the term "variant." The court pointed out that the claim does not limit the number of mutations that could be present in the amino acid sequence of the claimed “variant,” and it is unclear at what point the number of mutations would cause the sequence to diverge so substantially from wild- type as to no longer constitute a "variant" of the wild type protein, but rather a distinct protein. The use of this sort of open-ended "variant" language is not uncommon in patent claims of this type.
It will be interesting to follow this case if it is appealed to the Federal Circuit, particularly with respect to the issue of infringement under the doctrine of equivalents. The most important Federal Circuit precedent in this area of which I am aware comes from Genentech v. Wellcome, a 1994 decision in which the Federal Circuit reversed a jurys verdict which found a claim reciting tissue plasminogen activator (t-PA) infringed under the doctrine of equivalents by a substantially re-engineered, synthetic version of t-PA (marketed as a pharmaceutical). The allegedly infringing product differed substantially in structure from the claimed protein, with 15% fewer amino acids and 10-fold greater half-life. In a concurrence, Judge Lourie pointed out that while the traditional "function-way-result" test for infringement under the doctrine of equivalents might work well for some inventions, such as in the mechanical arts, it seems a poor fit for inventions like recombinant proteins.
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Thursday, March 30, 2017
Jury Finds ABI’s Sale of DNA Sequencing Reagents and Products Infringed Enzos Patent
Jury Finds ABI’s Sale of DNA Sequencing Reagents and Products Infringed Enzos Patent
On November 1, in the case of Enzo Biochem v. Applera (D. Conn. No. 04-00929), a jury found Applied Biosystems Incorporated (ABI) liable for directly infringing US Patent Number 5,449,767 by manufacturing and or selling reagent products used in DNA anaysis and sequencing. The jury also found ABI liable for inducing its customers to infringe the patent by selling DNA sequencing instruments and reagents. The jury found that ABIs infringement was not willful, but nonetheless awarded Enzo $48,587,500 in reasonable royalty damages.
The infringed patent claims certain chemical compounds useful as probes in DNA analysis, for example in DNA sequencing. The patent came out of research conducted in the Yale University laboratory of David Ward, and which the University exclusively licensed to Enzo. Initially, the District Court had on a motion for summary judgment ruled the patent invalid as anticipated by prior art, and indefinite based on the use of the claim language “covalently attached directly or through a linkage group that does not substantially interfere with the characteristic ability of the oligo- or polynucleotide to hybridize with a nucleic acid and does not substantially interfere with formation of the signalling moiety or detection of the detectable signal.”
However, in Enzo Biochem v. Applera, 599 F.3d 1325 (Fed. Cir. 2010) the Federal Circuit reversed, holding that with respect to anticipation Enzo had raised a genuine issue of material fact sufficient to survive a motion for summary judgment, and with respect to indefiniteness that the challenged claim language is not indefinite, and more particularly that the terms "hybridize" and “not interfering substantially” are not indefinite. This decision gained a lot of attention, with many people taking the position that the functional language used in the claim did not adequately apprise the public of the scope of these claims directed towards chemical compounds. It was thought that this case might be a good vehicle for the en banc Federal Circuit, or even the Supreme Court, to clarify the standard for satisfying the indefiniteness requirement, and perhaps raise the bar.
However, the petition for en banc rehearing and certiorari were both denied, and the case was sent back to the District Court for the jury to assess the validity and infringement of the patent. The jury found the claims not only to be infringed, but also rejected the anticipation and other validity challenges to Enzos patent.
Available link for download
Jury Finds Scruggs Willfully Infringed Monsanto Patents Award at Least 9 Million in Damages
Jury Finds Scruggs Willfully Infringed Monsanto Patents Award at Least 9 Million in Damages
10 years ago Monsanto sued farmers Mitchell and Eddie Scruggs (collectively referred to as "Scruggs") for infringing patents relating to genetically modified Roundup Ready soybean seeds and Bollgard-containing cotton seeds. The case has resulted in numerous judicial decisions, including three Federal Circuit decisions, most notably Monsanto v. Scruggs, 459 F.3d 1328 (Fed. Cir. 2006). Scruggs raised numerous arguments against Monsanto, including first sale/patent exhaustion, implied license, lack of sufficient written description and enablement, as well as allegations of patent misuse and antitrust violations.
Nonetheless, Monsanto has prevailed, and on September 21 a jury in the Northern District of Mississippi found that Monsanto is entitled to $2.6 million for Scruggs unauthorized planting of saved crop seeds contain the patented genes, and $6.3 million for their sale of saved soybean seeds containing the Roundup Ready gene (a practice referred to as "brown bagging"). Not only that, the jury found that the infringement was willful, which means that the court can enhance the damages up to triple the amount found by the jury, or close to $30 million. Based on history, I would not be surprised if Scruggs continues to appeal, perhaps stretching this out a few more years.
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