The issue in this case is whether generic drug manufacturers can, under the antitrust laws, enter into exclusion payment agreements with companies that hold drug patents.
The AMA believes that patents should not be used to hinder the development of improved medical treatment.
Under “exclusion payment” agreements, patent holders pay generic manufacturers not to challenge their patents’ validity. As a result, the introduction of generic medications is delayed.
In this case, Bayer AG, which holds the patent on ciproflaxin hydrochloride, paid Barr Laboratories, a generic drug manufacturer, not to challenge its patent. A number of unions and drug stores sued to challenge the validity of the exclusion payment agreement under the antitrust laws.
A panel of the Second Circuit questioned whether it was sound public policy or consistent with Congressional intent to honor such exclusion payment agreements, but it found itself bound by existing precedent to do so. The plaintiffs petitioned for rehearing en banc, in order to change the court’s established precedent. However, the petition for rehearing was denied.
The AMA, along with the American Association for Retired Persons, filed an amicus curiae brief in support of the rehearing petition.
132 S. Ct. 1794 (2012), 689 F.3d 1303 (Fed. Cir. 2012), 653 F.3d 1329 (Fed. Cir. 2011)
702 F.Supp.2d 181 (S.D.N.Y. 2010)
669 F.Supp.2d 365 (S.D.N.Y. 2009)
The issue in this case is whether human genes can be patented.
The AMA believes that patents should not be used to hinder the development of improved medical treatment and technologies.
The American College of Medical Genetics, American Society for Clinical Pathology, College of American Pathologists, three other health care organizations, and several individuals sued the United States Patent and Trademark Office, Myriad Genetics, and the Directors of the University of Utah Research Foundation in the United States District Court for the Southern District of New York. The suit challenged the validity of the patents on the BRCA1 and BRCA2 genes, which can be examined to determine whether a woman is at risk for breast and/or ovarian cancer. The suit asserted that the patent claims are overbroad and also in conflict with constitutionally and statutorily based policies that prohibit the patenting of natural phenomena and basic human knowledge and thought.
The defendants asserted that although the underlying genes are found in nature, the patents cover isolated and purified gene molecules, which do not exist in nature. The plaintiffs and the patentees cross-moved for summary judgment, and the Patent and Trademark Office moved for judgment on the pleadings.
The trial court found that seven of the patent claims relating to the BRCA1 and BRCA2 genes were unpatentable subject matter and therefore invalid. The court observed that substances derived from products of nature can be the basis for patent protection only if the patented substances are fundamentally new or markedly different from the natural products. While some organic compounds may be patentable if they simply represent an isolated and purified form of a naturally occurring chemical, DNA is distinctive. Unlike other organic chemicals, DNA carries genetic information. Since the chemicals covered by the BRCA1 and BRCA2 gene patents merely replicate, rather than change, the information transcribed in the naturally occurring genes, the patent claims do not concern a fundamentally new or markedly different product. However, the court dismissed the United States Patent and Trademark Office from the suit, based on the doctrine of "constitutional avoidance."
The patentees appealed to the United States Court of Appeals for the Federal Circuit, which specializes in hearing appeals of patent cases. The Federal Circuit then found that an isolated DNA sequence is markedly different from the same DNA sequence incorporated naturally within the genome. Because the covalent chemical bonds between the isolated sequence and the rest of the genome have been broken, the isolated DNA has different chemical properties from the naturally occurring DNA. Moreover, because accepted practice, including procedures set forth within the Patent Office regulations, deems isolated DNA to be patentable, any change in such practice would upset settled economic expectations and should come from Congress, rather than the courts. Accordingly, the Federal Circuit reversed the principal holding of the trial court – which had found isolated DNA to be inherently unpatentable subject matter. The Federal Circuit affirmed some of the less consequential trial court holdings. The Federal Circuit affirmed some of the less consequential trial court holdings.
On November 30, 2012, the Supreme Court granted certiorari, with the certified question being: "Are human genes patentable?" Oral argument was heard on April 15, 2013.
Litigation Center involvement
The Litigation Center, along with the Medical Society of the State of New York and several other health care organizations, filed numerous amicus curiae briefs supporting the plaintiffs in the trial court, the Federal Circuit, and the Supreme Court.
545 F.3d 943 (2008)
The issue in this case was whether a computer program designed to help commodities traders hedge their risks was patentable.
Case summary and AMA involvement
At the request of the Minnesota Medical Association, the Association for Molecular Pathology, and the Mayo Clinic, the AMA joined in an amicus curiae brief. The brief was formally filed in support of the United States Patent and Trademark Office, but it said little about the issues in the Bilski case, the suit before the Court. Instead, it encouraged the Supreme Court to accept a contemplated petition for certiorari, which at that point had not yet been filed, in Prometheus Laboratories v. Mayo Collaborative Services.
By a split decision, the Supreme Court affirmed the decision of the Federal Circuit that the particular computer program at issue was unpatentable. It held that the program was an abstract idea, rather than a concrete application of the idea.
The issue in this case was whether a "correlation" between a laboratory finding of elevated levels of the amino acid homocysteine and deficiencies of certain vitamins is a patentable process.
Since such a correlation can be made in any way, including through a purely mental association, the AMA position is that it represents a scientific law, which is unpatentable.
The lower courts held that the patent claim was valid and that Laboratory Corporation of America Holdings (Lab Corp) was liable for inducing infringement of the claim when it encouraged doctors to order diagnostic tests for measuring homocysteine. Those courts assessed damages and enjoined Lab Corp from using any tests that would lead the doctors it served to find a vitamin deficiency by taking account of elevated homocysteine levels.
The United States Supreme Court initially granted certiorari to determine whether the patent claim was invalid as improperly seeking to claim a monopoly over a basic scientific relationship. The United States Supreme Court, however, without elaboration, dismissed its grant of certiorari as having been improvidently granted. Three of the justices dissented from that order, indicating that the Supreme Court should have reversed the lower court decisions and found the portion of the patent at issue invalid.
The AMA, along with the Association of American Medical Colleges and several specialty medical societies, submitted a brief as amici curiae to oppose the patent.
628 F.3d 1347 (Fed. Cir. 2010), 581 F.3d 1336 (Fed. Cir. 2009)
The issue in this case was whether a procedure for determining medically appropriate dosages of azathioprine (AZA) drugs is a potentially patentable process or whether it is inherently unpatentable because it is a manifestation of a law of nature and an application of a mental process.
The AMA condemns the patenting of medical and surgical procedures.
Prometheus Laboratories is the exclusive licensee of two patents. These patents measure the blood metabolites of patients taking AZA for treatment of autoimmune diseases, including Crohn's disease. The patents cover a three step process: (1) administration of the AZA drugs to the patient; (2) measurement of the metabolite levels; and (3) determination, based on the metabolite levels, of whether a change in drug dosage is appropriate. The patents further specify the metabolite levels at which an adjustment in dosage would be indicated.
Mayo Collaborative Services, an affiliate of the Mayo Clinic, developed its own test to measure the same metabolites, but using slightly different metabolite levels to indicate a modification in dosages. Prometheus sued Mayo for patent infringement, and the trial court granted summary judgment for Mayo, holding that the Prometheus patents described a law of nature and were thus invalid.
Prometheus appealed to the Federal Circuit Court of Appeals. The Court of Appeals reversed, holding that the Prometheus patents pass the first test of patentability - - description of patentable subject matter. The court found that a procedure involving the transformation of "a particular article into a different state or thing" may be patentable. Because the body's metabolic processes transform AZA into chemical byproducts, the Prometheus Laboratories patents involve such a transformation and are thus potentially valid. The court remanded to the trial court for a determination as to whether the patents satisfy the remaining criteria for validity under the Patent Act.
Mayo Collaborative Services petitioned for certiorari in the United States Supreme Court. The Supreme Court granted certiorari, summarily reversed, and remanded the case to the Federal Circuit for further consideration in light of its decision in Bilski v. Kappos. On remand, the Federal Circuit again held that the Prometheus patents cover patentable subject matter.
The Supreme Court again granted certiorari, but this time for a more substantive review. On March 20, 2012, in a unanimous opinion, the Supreme Court again reversed the holding of the Federal Circuit Court of Appeals. It found that the Prometheus patents merely described a naturally occurring process, rather than a practical application of that process. Therefore, the claimed patents were invalid.
AMA and Litigation Center involvement
The Litigation Center, along with various other medical associations, filed an amicus curiae brief in the Federal Circuit opposing the patent.
The AMA, along with several specialty medical societies filed an amicus brief in support of one of the Mayo Collaborative Services petitions for certiorari.
The Litigation Center filed an amicus brief, along with various other medical associations, in the Supreme Court, regarding the merits.