Fundamental Documents and Cases in Bioethics and Intellectual Property Law

I. Treaties and Statutes

United States Trademark Act

United States Copyright Act

United States Patent Act (28 U.S.C. §§1295, 1338)

Section 101.(1999) Inventions patentable
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title.

Section 102(1994): Conditions for patentability: Novelty 
A person shall be entitled to a patent unless-   
(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for patent, or
(b) the invention was patented or described in a printed publication in this or a foreign country of in public use or on sale in this country, more than one year prior to the date of the application for patent in the United States, or
(c) he has abandoned the invention, or
(d) the invention was first patented or caused to be patented, or was the subject of an inventor's certificate, by the applicant or his legal representative or assigns in a foreign country prior to the date of the application for patent in this country or an application for patent or inventor's certificate filed more than twelve months before the filing of the application in the United States, or
(e) the invention was described in a patent granted on an application for patent by another filed in the United States before the invention thereof by the applicant for patent, or on an international application by another who has fulfilled the requirements of paragraphs (1), (2), and (4) of section 371(c) of this title before the invention thereof by the applicant for patent, or 
(f) he did not himself invent the subject matter sought to be patented, or
(g) before the applicant's invention therefore the invention was made in this country by another who had not abandoned, suppressed, or concealed it.  In determining priority of invention there shall be considered not only the respective dates of conception and reduction to practice of the invention, but also the reasonable diligence of one who was first to conceive and last to reduce to practice, from a time prior to conception by the other.

Section 103 Requirements (Nonobviousness): 
A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains.

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Paris Convention for the Protection of Industrial Property March 20, 1883 (international agreement for Nationals of any country of the Union to enjoy in all the other countries of the Union the advantages that their respective laws now grant, or may hereafter grant, to nationals).

1998 Directive on the Legal Protection of Biotechnological Inventions (98/44/EC)

Convention on Jurisdiction and Enforcement of Judgments in Civil and Commercial Matters, dated Sept. 27, 1968, 1998 (the Brussels Convention) (Purpose of Convention is to establish process for determining proper court for litigation involving nationals from several States)

Community Patent Convention, dated Dec. 15, 1975 and amended (Establishing a common system of law for patents for invention is common to the Contracting States and European patents granted for the Contracting States shall be called Community patents)

European Patent Convention, dated Oct. 5, 1973, effective 1978 (A system of law, common to the Contracting States for the grant of patents for invention is established. Patents granted by virtue of the Convention shall be called European patents. The European patent shall, in each of the Contracting States for which it is granted, have the effect of and be subject to the same conditions as a national patent granted by that State)

Patent Cooperation Treaty, effective 1978, Done at Washington on June 19, 1970, amended on September 28, 1979, and modified on February 3, 1984 (The States party to the Treaty constitute a Union for cooperation in the filing, searching, and examination, of applications for the protection of inventions, and for rendering special technical services. The Union shall be known as the International Patent Cooperation Union)

Directive 98/44/EC of the European Parliament and of the Council  of 6 July 1998 on the legal protection of biotechnological inventions

Draft Hague Convention on Jurisdiction and Foreign Judgments, (a defendant may be sued in the courts of the State where that defendant is habitually resident)

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Agreement on Trade-Related Aspects of Intellectual Property Rights, Article 27 (TRIPS)

European Patent Litigation Protocol Concerning  European Patents (EPLP), initiated June 1999

World Intellectual Property Organization Meeting on intellectual property and genetic resources, Geneva, April 17 and 18, 2000

World Intellectual Property Organization, Working group on biotechnology, Geneva, November 8 and 9, 1999, Issues for proposed WIPO Work Program on Biotechnology

Council of Europe Treaties on Bioethics

President Clinton's apology to the Participants in the Tuskegee Syphilis Experiment

List of Available files to the U S President's Advisory Committee on Human RadiationExperiments        

Trilateral Project B33b Mutual Understanding in Search And Examination: Comparative Study on Biotechnology Patent Practices (JAPAN PATENT OFFICE)

Citizens' Rights and the New Technologies - A Europea Challenge

Group of Advisors to the European Commission on the Ethical Implications of Biotechnology (1997)

United Nation Convention On Biological Diversity
(The Convention on Biological Diversity's objectives are "the conservation of biological diversity, the sustainable use of its components and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources." The Convention is thus the first global, comprehensive agreement to address all aspects of biological diversity: genetic resources, species, and ecosystems. It recognizes - for the first time - that the conservation of biological diversity is "a common concern of humankind" and an integral part of the development process. To achieve its objectives, the Convention - in accordance with the spirit of the Rio Declaration on Environment and Development - promotes a renewed partnership among countries. Its provisions on scientific and technical cooperation, access to genetic resources, and the transfer of environmentally sound technologies form the foundations of this partnership.)

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The United States Senate Biotechnology Caucus' Hearing On The Positive Implications of Genome Research in Health Care          

S.2015 Stem Cell Research Act of 2000 (Introduced in the Senate)
Part of the federal government's efforts to amend a 1995 congressional ban on embryo research, which specifies that federal taxpayer money cannot be spent on biomedical research involving embryos outside the womb. Last December, the National Institutes of Health issued preliminary guidelines that would allow government-funded researchers to use stem cells from already destroyed embryos. If passed, S 2015 would allow researchers to use and destroy embryos under specific circumstances. 

II. Significant United States Cases

Brenner v. Manson, 383 U.S. 519, 533 (citing Story, Note on the Patent Laws, 3 Wheat. App. 13, 24). Also, see Justice Story's comments in the early case of Lowell v. Lewis, 15 F. Cas. 1018, 1019 (No. 8568) (C.C.D. Mass. 1817), that an invention would not be considered statutorily "useful" if it were "injurious to the well-being, good policy, or sound morals of society." (statutory requirement to show practical utility in order to receive patent)

Parke-Davis & Co. v. H.K.Mulford & Co., 196 F. 496 (2d Cir. 1942) (upholding a patent for adrenaline isolated from animal suprarenal glands)

Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948), (holding that a mixed bag of different bacteria, each with a certain function, does not satisfy the novelty requirement because no new bacteria was created, and each of the bacteria was functioning as nature originally provided).

Merck & Co. v. Olin Mathieson Chem. Corp., 253 F. 2d 156 (4th Cir. 1958)(upholding a patent for a vitamin B concentrate which had been extracted from its natural form and purified

Diamond v. Chakrabarty, 447 U.S. 303 (1980) (Section 101 is sufficiently broad to encompass a living microorganism that possesses a trait not found in naturally occurring organisms.  However, the Court invited Congress to amend Sec. 101 so as to exclude from patent protection organisms produced by genetic engineering)

Ex Parte Allen, 2 U.S.P.Q.2d (BNA) 1425 (1987) (patent claim for genetically engineered oysters is rejected but Bd of Patent Appeals rejects argument that subject matter is naturally occurring organism) 

Notice by the Patent and Trademark Office, Patent and Trademark office Notice: Animals-Patentability, 1077 Official Gazette U.S. Pat. and Trademark Off. 8 (Apr. 21, 1987). Patent Office announces that it now considers nonnaturally occurring non-human multicellular living organisms, including animals, to be patentable subject matter within the scope of 35 U.S.C. 101. A claim directed to or including within its scope a human being will not be considered to be patentable subject matter under 35 U.S. C. 101.

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Patent for the "Harvard Mouse", a genetically engineered mouse which is highly prone to breast cancer. U. S. Pat. No. 4,736,866 (Apr. 12, 1988) First animal patent in the United States.

Animal Legal Defense Fund v. Quigg, 932 F.2d 920 (Fed. Cir. 1991) (failing to reach actual issue of animal patenting because the PTO's rule is exempt from the notice-and-comment rule and because those bringing suit did not have standing to seek the desired declaration).

In re Deuel, 51 F.3d 1552 (Fed. Cir. 1995) (relaxing obvious standard by stating that general motivation to search for some gene that exists does not necessarily make obvious a specifically-defiend gene that is subsequently obtained as a result of that search)  Allows patents to be granted for DNA molecules even if the method of finding the DNA was obvious. (Note: 1995 amendment to 35 U.S. C. Sec. 103 seems to require that both the process and the molecule be nonobvious to satisfy the nonobviousness requirement.) Patent No. 5401504, USPTO, August 13, 1997 (withdrawal of patent for the use of turmeric powder as a wound healing agent on the grounds that the use of turmeric was known in India for centuries)

Bloodsaw v. Lawrence Berkeley Labs, 9th Circuit Court of Appeals, Feb . 3, 1998.(question whether a clerical or administrative worker who undergoes a general employee health examination may, without his knowledge, be tested for highly private and sensitive medical and genetic information such as syphilis, sickle cell trait, and pregnancy)

AFG Indus., Inc. v. Cardinal IG Co. ( February 6, 2001) 
("Composed of" Transition Term Is Treated Like "Consisting Essentially of"; Extrinsic Evidence Should Have Been Credited

III. Canadian Cases

Appeal filed against rejection of Harvard Mouse Application, BNA Pat. Trademark & Copyright L.Daily (Mar. 26, 1996). (Commissioner of Patents in Canada refuses to extend definition of invention to include nonhuman mammals primarily because of the inability to control reproduction)

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