As reported by the NY Times.
A Delaware jury found Genzyme liable for inducing infringement of U.S. Patent 7,011,831, assigned to Shelbyzyme LLC. The jury rejected Genzyme’s inadequate written description, non-enablement, and anticipation defenses, and awarded Shelbyzyme $50M, calculated from a 6% royalty rate.
The ‘831 patent claims a method of treatment of a α-galactosidase A deficiency disease using “recombinant enzymatically-active α-galactosidase A or enzymatically-active fragment thereof” and in a dependent claim, “wherein the disease is Fabry disease.” The Fabrazyme® package insert describes its indication for use thus: “Fabrazyme® (agalsidase beta) is indicated for use in patients with Fabry disease.”
Fabry disease is a rare genetic lysosomal storage disease, which causes a wide range of systemic symptoms affecting the GI tract, kidneys, heart, and skin. Fabrazyme® is essentially an enzyme replacement therapy for the metabolic enzyme that is defective in Fabry patients.
There will be a one-day bench trial in September to address Genzyme’s inequitable conduct allegations and other equitable defenses. Because those defenses seldom prevail, and assuming the parties don't settle, Genzyme will probably appeal the decision early next year, with a decision from the Federal Circuit in 2014.
Given the breadth of claims and their congruence with the Fabrazyme® label, one imagines that any appeal will focus on attacking the validity of the '831 patent. In its trial brief, among other arguments, Genzyme focused on the fact that the examples of the '831 patent concern production of α-galactosidase A in insect cells, whereas the claims cover any active glycosylated α-galactosidase A. The argument is poignant, since the commercially useful drug is made in mammalian cells, which glycosylate proteins differently than insect cells. Genzyme argues that insect cell-produced drug as described in the patent would not even be an effective treatment. Nor, in Genzyme's view, would an ordinarily skilled artisan at the time have been able to use the patent's teaching to make the drug in mammalian cells without engaging in undue experimentation. In contrast to Genzyme's anticipation and inadequate written description defenses, which are issues of fact to which the court of appeals will give great deference to the jury, this non-enablement defense is an issue of law and may be more susceptible to appellate scrutiny.
Genzyme has not publicly commented about the verdict.
After an order from the Supreme Court to reconsider the case in light of its decision in Mayo v. Prometheus, a panel of the Federal Circuit Court of Appeals heard arguments in Association for Molecular Pathology v. Myriad Friday.
The issue is whether the Supreme Court's ruling in Mayo, which found method claims utilizing natural laws to be unpatentable, should apply to product claims for DNA isolated from living organisms.
On the case's first pass before this appellate panel, the Court held, 2-1, that isolated DNA claims were patentable subject matter because the claimed molecules have "a distinctive chemical identity" from their counterparts in the organism's genome. Myriad argues that the original decision is correct because Mayo addressed only process claims, and relied only on process claim precedent. AMP argues that the rationale behind Mayo should be broad enough to prevent patenting of naturally occuring molecules which have been "trivially" modified from their native state.
According to most of the commentaries we've seen, during oral argument the panel seemed entrenched in their original positions. There was little to suggest that either of the majority (Lourie and Moore) were inclined to extend Mayo. Indeed, given the tens of thousands of isolated DNA patents in force, it would be hard to imagine this panel upsetting the industry's settled expectations. Of course, the panel could surprise, or either the Federal Circuit en banc or the Supreme Court could decide to wade in.
Remember the Myriad case, where a number of Medical Associations and individual doctors — assisted by the American Civil Liberties Union and the Public Patent Foundation — sued Myriad for a declaration that Myriad’s BRCA diagnostic testing patents were invalid because they were directed to unpatentable subject matter under § 101 of the Patent Code? If not, see our July 29, 2011 post to refresh your recollection.
In Myriad, a panel of the Federal Circuit Court of Appeals held that Myriad’s isolated BRCA DNA claims patentable under § 101, but its method claims for analyzing patients for mutations in these genes unpatentable. Having just found Prometheus’s claims to a different type of diagnostic test unpatentable under § 101, the Supreme Court has now remanded the Myriad case, which had been subject of a pending writ of certiorari, back to the Federal Circuit with instructions to reconsider in light of Mayo v. Prometheus.
It will be very interesting to see whether the Federal Circuit panel chooses to interpret Prometheus v. Mayo broadly enough to reverse its decision that claims to isolated DNA sequences are patentable. Judge Lourie’s opinion in Myriad held that isolated DNA sequences are patentable because “BRCA1 and BRCA2 in their isolated state are not the same molecules as DNA as it exists in the body; human intervention in cleaving or synthesizing a portion of a native chromosomal DNA imparts on that isolated DNA a distinctive chemical identity from that possessed by native DNA.” Slip Op. at 42. This “distinctive chemical identity” test seems a slender reed now that the Supreme Court rejected the Federal Circuit’s holding in Mayo that the human interventions of “administering” a drug and “determining” its levels in the body conferred patentability to Prometheus’s claims.
Tuesday the Supreme Court unanimously decided Mayo Collaborative Services v. Prometheus Labs, a decision of considerable significance to the diagnostics industry.
The Court reversed the Federal Circuit Court of Appeals, which had held that patent claims to “a method of optimizing therapeutic efficacy” for treatment of a specific disorder with the steps of (a) administering a specific drug; (b) determining the level of a metabolite of the drug in the patient; wherein the dosage of the drug should be increased or decreased if the level of the drug is outside of a specified range, were patentable under the §101 utility requirement.
September 22, 2011: Genetic Engineering and Biotechnology News published an article today entitled "Prometheus and Myriad Case Outcomes Will Help Shape the Future for MDx Businesses." The article addresses whether the outcome of the Myriad and Prometheus cases will affect the incentives for the development of DNA diagnostic tests and personalized medicine. The author quotes Jonathan Loeb concerning the availability of patent protection and proper claiming strategies for DNA diagnostics in light of the recent Myriad decision, and concludes "As Dr. Loeb correctly noted, the decisions in those cases will constitute a roadmap to patenting and ultimately commercializing molecular diagnostics tests and the genetic material to be used in them."
On July 29th, the Federal Circuit handed down its decision in the much-discussed Association for Molecular Pathology v. U.S. Patent and Trademark Office (commonly known as the “Myriad Genetics” case). The Federal Circuit split the baby — finding Myriad’s isolated BRCA DNA claims patentable, but its method claims for analyzing patients for mutations in these genes unpatentable.
Genentech’s Cabilly II patent, which is directed generally to co-expression of recombinant antibody heavy and light chains in a single host cell, has been subject to a series of lawsuits since it issued in 2001. The Cabilly patent is widely licensed in the industry and is thought to cover most, if not all therapeutic antibodies. A succession of pharmaceutical companies have filed actions seeking declarations that their therapeutic antibodies do not infringe Cabilly II, and/or that it is invalid and unenforceable: MedImmune (product: Synagis®; Centocor (ReoPro® and Remicade®); GlaxoSmithKline (Arzerra®); and Human Genome Sciences (“HGS”) (Benlysta®). MedImmune and Centocor have settled with Genentech for undisclosed terms. Medimmune’s suit went all the way to the Supreme Court on the issue of licensee estoppel, and to the Federal Circuit on MedImmune’s antitrust allegations. Genentech also prevailed on U.S. Patent Office reexamination of Cabilly II. GlaxoSmithKline’s and HGS’s suits are ongoing.
On March 7, 2011 the Federal Trade Commission released a 300-page report addressing the relationship between patent law and competition policy and offering recommendations for improving the patent system. The Evolving IP Marketplace: Aligning Patent Notice and Remedies with Competition (2011). Dechert’s Antitrust and Intellectual Property Groups have prepared a “Dechert OnPoint” entitled “FTC Recommends Improvements to Patent System” which analyzes the key points of the FTC’s observations and recommendations.