The Cabilly patents are two US patents issued to Genentech and City of Hope which relate to the "fundamental technology required for the artificial synthesis of antibody molecules." [1] The name refers to lead inventor Shmuel Cabilly, who was awarded the patent while working at City of Hope in the 1980s. [2] There was ongoing legal controversy surrounding these patents since their original filing in 1983. In 2008, the litigation that was pending before the U.S. District Court for the Central District of California, was fully resolved and dismissed.
An interference between U.S. Patent 4,816,567 (the original "Cabilly patent") co-issued to Genentech and City of Hope and U.S. Patent 4,816,397 (the "Boss" patent) issued to Celltech resulted in the issuance of a second "Cabilly patent" to Genentech in 2001. This new patent would extend into 2018, an effective term of 29 years.
A lawsuit filed by MedImmune, a licensee of the Cabilly patent, resulted in the United States Supreme Court case MedImmune, Inc. v. Genentech, Inc. which was decided in favor of MedImmune. Following the supreme court decision, the United States Patent and Trademark Office (USPTO) declared Genentech's patent invalid, but Genentech appealed that decision to the USPTO. The patent remained valid and enforceable until the process was completed. Genentech's "Cabilly II" patent 6,331,415 was then found, after USPTO reexamination, to be enforceable. MedImmune and Centocor have settled with Genentech. [3] Currently, two other challenges are in the courts. GlaxoSmithKline and Human Genome Sciences both are challenging the patent under antitrust law. [3] This is based on the settlement between Genentech and Celltech and their dispute over the original Cabilly patent 4,816,567 and the Celltech's patent 4,816,397.
An important implication of this case is the affirmation that a licensee retains the right to challenge a licensed patent. The controversy has also called attention to the amount of time the USPTO takes to resolve Interference proceedings, and has been cited in arguments for changing to a First to file patent system.
As with all utility patents in the United States, a biological patent provides the patent holder with the right to exclude others from making, using, selling, or importing the claimed invention or discovery in biology for a limited period of time - for patents filed after 1998, 20 years from the filing date.
A declaratory judgment, also called a declaration, is the legal determination of a court that resolves legal uncertainty for the litigants. It is a form of legally binding preventive by which a party involved in an actual or possible legal matter can ask a court to conclusively rule on and affirm the rights, duties, or obligations of one or more parties in a civil dispute. The declaratory judgment is generally considered a statutory remedy and not an equitable remedy in the United States, and is thus not subject to equitable requirements, though there are analogies that can be found in the remedies granted by courts of equity. A declaratory judgment does not by itself order any action by a party, or imply damages or an injunction, although it may be accompanied by one or more other remedies.
Diamond v. Chakrabarty, 447 U.S. 303 (1980), was a United States Supreme Court case dealing with whether living organisms can be patented. Writing for a five-justice majority, Chief Justice Warren E. Burger held that human-made bacteria could be patented under the patent laws of the United States because such an invention constituted a "manufacture" or "composition of matter". Justice William J. Brennan Jr., along with Justices Byron White, Thurgood Marshall, and Lewis F. Powell Jr., dissented from the Court's ruling, arguing that because Congress had not expressly authorized the patenting of biological organisms, the Court should not extend patent law to cover them.
Under United States law, a patent is a right granted to the inventor of a (1) process, machine, article of manufacture, or composition of matter, (2) that is new, useful, and non-obvious. A patent is the right to exclude others, for a limited time from profiting of a patented technology without the consent of the patent-holder. Specifically, it is the right to exclude others from: making, using, selling, offering for sale, importing, inducing others to infringe, applying for an FDA approval, and/or offering a product specially adapted for practice of the patent.
Patentable, statutory or patent-eligible subject matter is subject matter which is susceptible of patent protection. The laws or patent practices of many countries provide that certain subject-matter is excluded from patentability, even if the invention is novel and non-obvious. Together with criteria such as novelty, inventive step or nonobviousness, utility, and industrial applicability, which differ from country to country, the question of whether a particular subject matter is patentable is one of the substantive requirements for patentability.
The Board of Patent Appeals and Interferences (BPAI) was an administrative law body of the United States Patent and Trademark Office (USPTO) which decided issues of patentability. Under the America Invents Act, the BPAI was replaced with the Patent Trial and Appeal Board (PTAB), effective September 16, 2012.
In United States patent law, a reexamination is a process whereby anyone—third party or inventor—can have a U.S. patent reexamined by a patent examiner to verify that the subject matter it claims is patentable. To have a patent reexamined, an interested party must submit prior art, in the form of patents or printed publications, that raises a "substantial new question of patentability". The Leahy-Smith America Invents Act makes substantial changes to the U.S. patent system, including new mechanisms for challenging patents at the U.S. Patent and Trademark Office. One of the new mechanisms is a post-grant review proceeding, which will provide patent challengers expanded bases on which to attack patents.
Arthur Dale Riggs was an American geneticist who worked with Genentech to express the first artificial gene in bacteria. His work was critical to the modern biotechnology industry because it was the first use of molecular techniques in commercial production of drugs and enabled the large-scale manufacturing of protein drugs, including insulin. He was also a major factor in the origin of epigenetics.
Tanox was a biopharmaceutical company based in Houston, Texas. The company was founded by two biomedical research scientists, Nancy T. Chang and Tse Wen Chang in March 1986 with $250,000, which was a large part of their family savings at that time. Both Changs grew up and received college education in chemistry in National Tsing Hua University in Taiwan and obtained Ph.D. degrees from Harvard University. For postdoctoral training, Tse Wen shifted to immunology and did research with Herman N. Eisen at the Center for Cancer Research, M.I.T. The two Changs successively became research managers and worked with a range of monoclonal antibody projects in Centocor, Inc. based in Malvern, Pennsylvania, from 1981 to 1985. The Changs were recruited by Baylor College of Medicine toward the end of 1985 and offered faculty positions in the Division of Molecular Virology. Soon after their arrival, they were encouraged by a high-ranking Baylor official and local business leaders to start a biotech venture in Houston. This was in a period of time when the economy of Houston was in slump as the result of the collapse of the oil industry.
MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118 (2007), was a decision by the Supreme Court of the United States involving patent law. It arose from a lawsuit filed by MedImmune which challenged one of the Cabilly patents issued to Genentech. One of the central issues was whether a licensee retained the right to challenge a licensed patent, or whether this right was forfeited upon signing of the license agreement. The case related indirectly to past debate over whether the US should change to a first to file patent system - in 2011, President Obama signed the Leahy-Smith America Invents Act, which shifted the United States to a first-inventor-to-file patent system.
H. Michael Shepard is an American cancer researcher who was awarded the 2019 Lasker Clinical research award, which he shared with Dennis Slamon and Axel Ullrich for their development of Herceptin
Altvater v. Freeman, 319 U.S. 359 (1943), was a decision by the Supreme Court of the United States which held that, although a licensee had maintained payments of royalties, a Declaratory Judgment Act claim of invalidity of the licensed patent still presented a justiciable case or controversy.
Cambridge Antibody Technology was a biotechnology company headquartered in Cambridge, England, United Kingdom. Its core focus was on antibody therapeutics, primarily using Phage Display and Ribosome Display technology.
The Leahy–Smith America Invents Act (AIA) is a United States federal statute that was passed by Congress and was signed into law by President Barack Obama on September 16, 2011. The law represents the most significant legislative change to the U.S. patent system since the Patent Act of 1952 and closely resembles previously proposed legislation in the Senate in its previous session.
Mayo v. Prometheus, 566 U.S. 66 (2012), was a case decided by the Supreme Court of the United States that unanimously held that claims directed to a method of giving a drug to a patient, measuring metabolites of that drug, and with a known threshold for efficacy in mind, deciding whether to increase or decrease the dosage of the drug, were not patent-eligible subject matter. The decision was controversial, with proponents claiming it frees clinical pathologists to practice their medical discipline, and critics claiming that it destabilizes patent law and will stunt investment in the field of personalized medicine, preventing new products and services from emerging in that field.
The Patent Trial and Appeal Board (PTAB) is an administrative law body of the United States Patent and Trademark Office (USPTO) which decides issues of patentability. It was formed on September 16, 2012, as one part of the America Invents Act. Prior to its formation, the main judicial body in the USPTO was the Board of Patent Appeals and Interferences (BPAI).
Alice Corp. v. CLS Bank International, 573 U.S. 208 (2014), was a 2014 United States Supreme Court decision about patent eligibility. The issue in the case was whether certain patent claims for a computer-implemented, electronic escrow service covered abstract ideas, which would make the claims ineligible for patent protection. The patents were held to be invalid because the claims were drawn to an abstract idea, and implementing those claims on a computer was not enough to transform that abstract idea into patentable subject matter.
Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), was a Supreme Court case that challenged the validity of gene patents in the United States, specifically questioning certain claims in issued patents owned or controlled by Myriad Genetics that cover isolated DNA sequences, methods to diagnose propensity to cancer by looking for mutated DNA sequences, and methods to identify drugs using isolated DNA sequences. Prior to the case, the U.S. Patent Office accepted patents on isolated DNA sequences as a composition of matter. Diagnostic claims were already under question through the Supreme Court's prior holdings in Bilski v. Kappos and Mayo v. Prometheus. Drug screening claims were not seriously questioned prior to this case.
Peter v. NantKwest Inc., 589 U.S. ___ (2019), was a United States Supreme Court case from the October 2019 term.