Policy

The "Genomic Research and Accessibility Act" was introduced in the U.S. House of Representatives in February to prohibit the patenting of human genetic material. The bill has been referred to the House Committee on the Judiciary.
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U.S.

The framers of the U.S. Constitution realized over two centuries ago that it was important to create incentives for technological innovation.¹ The drafters of the Constitution, Article 1, section 8, clause 8 sought to promote the widespread distribution of knowledge by giving Congress the power "To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries;..." In return for full disclosure of an invention, federal patent law rewards inventors with a 20-year monopoly that forbids anyone else from making, using or selling their invention in order to assure that novel , non-obvious and useful technologies get developed that otherwise might not have been created.²

Under patent law, scientific principles -- such as E=mc 2 -- are not patentable so everyone will have access to them. Products of nature are also not patentable because the public would not be gaining anything new if an individual was allowed to, say, patent air and charge us each a licensing fee whenever we breathed.³ Yet genes, the arrangement of the chemical letters C, A, T, and G, seem to be both.⁴

There has not yet been a direct attack on patents alleging that genes are nonpatentable subject matter because they are a product of nature. Applicants who seek human gene patents assert that they have isolated and purified a gene or genetic material, having manipulated it to eliminate the non-coding regions of the gene, while apparently still performing the same function as a naturally-occurring gene.⁵ They argue that the genetic materials they are claiming are isolated and purified natural substances, which have been held patentable subject matter by various courts.⁶ However, the useful properties of a gene -- such as its ability to bind to another complementary strand of DNA for diagnosis or its ability to code for a particular protein -- are not ones that the scientist has invented (or created through isolation or purification), but rather are natural, inherent properties of genes themselves.

Under the U.S. federal patent statute, 35 U.S.C. §101 et seq., an applicant must satisfy a number of requirements in order to be issued a patent. When patent examiners are reviewing patent applications, they judge them on a claim by claim basis, where a finding that a particular claim does not meet the legal standards of patentability does not mean that the entire application is void. Only the individual claims that fail to meet the requirements of patentability will be refused by the United States Patent & Trademark Office (USPTO). Accordingly, a given patent application may have some claims which are rejected and some which are permitted. When a patent is issued, the patent holder gains the right to exclude others from making, using, selling, offering to sell, or importing the claimed invention for twenty years, measured from the date of the filing of the original patent application.⁷ The claims of the patent are what control the scope of the patentee's ability to exclude others. To assess the scope of a patent, therefore, requires assessment of each and every claim in the patent.

The disclosure provisions require that an applicant satisfy four basic requirements in the patent specification: written description, enablement, best mode, and definiteness.⁸ These disclosure obligations guarantee that, in exchange for the patentee's exclusive rights, the public obtains all of the information needed to practice the invention, enhancing the level of knowledge available in the public domain. Specifically, the law requires that the patent application "contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention."⁹ These disclosure obligations are generally satisfied by the patent's specification, which is the full description of the invention provided by the inventor including a background of the invention, brief description of any drawings, and both a summary and a detailed description of the invention.

The written description requirement relates to whether the applicant has adequately disclosed the invention in a way to demonstrate that she was in possession of the invention at the time she filed her application. The applicant must provide a written description of the invention in the patent application, demonstrating that she indeed has created the invention at the time she files her application for the patent.¹⁰ The U.S. Supreme Court, for example, has said that a patent is not a "hunting license"; nor a "reward for the search, but compensation for its successful conclusion."¹¹ Recent USPTO guidelines regarding written description designed to assist patent examiners in analyzing claimed subject matter for compliance with substantive law further clarify this requirement.¹²

The patent application must also be adequately "enabled," describing the invention fully, so that it would be technically feasible for another person skilled in that field to make and use the invention.¹³ This requirement assures that the public gets information back in exchange for the exclusive rights granted to the patent holder.¹⁴ When a patent is granted, the information in it becomes public. But others cannot make, use, sell, offer to sell, or import the patented invention itself without the permission of the patent holder. The patent holder can refuse to give anyone else permission to use the invention or can charge any price for the right to use the invention.

Best mode requires the applicant to disclose what she believes is the best way of practicing the invention, if there is such a best way. It is the only disclosure obligation that is subjective: it depends on what the inventor believes is the best mode at the time of filing of the patent application. There is no best mode violation if what the inventor believes to be the best in fact is not.

Definiteness relates to the way the claim is written: the claim must "particularly point out and distinctly claim the subject matter which the applicant regards as his invention."¹⁵

Not every innovation is patent eligible. An invention must be of eligible subject matter and have utility, or some benefit to the public. The substantive provisions of the federal patent statute provide that there must be eligible subject matter, evincing utility, novelty and nonobviousness.¹⁶ Any "new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement" is eligible patent subject matter.¹⁷ The USPTO has interpreted this to allow patents on genetic sequences. However, the identified human genetic material must also have a beneficial utility to society that is "substantial, specific, and credible" in order to be afforded patent protection.¹⁸ Clarifications to the revised utility guidelines adopted by the USPTO in 2001 provide that if an application discloses only the nucleic acid molecular structure for a newly isolated gene, and no utility, the claimed invention is unpatentable subject matter.¹⁹ But where a patent application also discloses "how to use the purified gene isolated from its natural state," it satisfies the utility requirement.²⁰

An invention must also be new or "unanticipated" by knowledge already in the public domain (also known as prior art) to satisfy the novelty requirement.²¹ In order for a patent claim covering the invention to be anticipated, and thus unpatentable subject matter, each and every aspect of the claim must be present in a single prior art reference.

In addition, where an invention is "obvious," or a trivial change to the present state of the art, it is unpatentable.²² The manner in which the invention is made is irrelevant to the obviousness determination, which focuses instead on whether the differences between the subject matter in the patent application 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."²³

Unlike other countries, such as Japan and the United Kingdom, the U.S. does not have a general patent exception that allows research related to the patented invention.

There is a narrow, judge-made common law experimental use exception, developed as a defense to claims of patent infringement that is reserved only for endeavors that are "solely for amusement, to satisfy idle curiosity, or for strictly philosophical inquiry."²⁴ A Federal Circuit case recently reiterated that the experimental use exception is "very narrow" and "strictly limited" by holding that a non-profit university could not invoke the exception.²⁵ The Court determined that the focus is on whether the act of infringement is in furtherance of legitimate business or merely for amusement, curiosity, or philosophical inquiry.²⁶

International

Biotechnology is a global industry and biotechnology firms seek to protect their inventions in as many nations as possible to ensure the greatest possible benefit. Although most countries have their own independent patent systems, several agreements have been developed to provide a more consistent level of global intellectual property protection. Patent rights are dealt with as trade issues across international boundaries, so one such agreement, the Trade-Related Intellectual Property Rights Agreement (TRIPS), was created by the World Trade Organization (WTO).

The WTO and TRIPS were both established in 1995, replacing the General Agreement on Tariffs and Trade (GATT). Although the WTO has only been around since 1995, GATT had been around since 1948, overseeing international trading rights.²⁷ The WTO provides a forum where its 147 member countries can negotiate or settle trade agreement disputes.²⁸ TRIPS established a minimum level of intellectual property protection to be provided by signatory nations and remedies for the enforcement of intellectual property rights.

Under TRIPS, several options exist for dealing with the patenting of genes. First, if gene patents are viewed as having an adverse affect on public health, TRIPS permits its members to alter or regulate their patent laws to protect public health by giving public health greater weight than the commercial concerns of patentees.²⁹ Next, one can argue that the patenting of genes commodifies humans, thereby raising moral concerns. TRIPS also allows its members to deny a patent application if its commercial exploitation would be contrary to "ordre public or morality."³⁰ Finally, if a gene patent prevents a nation from combating an urgent situation, article 31 of TRIPS allows its members to ignore health care patents and grant compulsory licenses to third parties to produce generic versions of the product.³¹

In Europe, the European Patent Convention (EPC) established the European Patent Organization (EPO) in 1973 and it currently includes twenty-eight nations.³² The EPC allows a patent applicant to obtain patent rights in any EPO member state listed in the application by filing a single patent application.³³ Similar to TRIPS, the EPC contains exceptions to patentability for inventions whose commercial exploitation would be "contrary to ordre public or morality."³⁴ Although morality can be considered in the patent granting process, its implementation has proven to be rather rare. The EPO Opposition Division has decided that this morality provision may only be used on a very limited basis when there is "an overwhelming consensus that the exploitation or publication of an invention would be immoral."³⁵

Under the EPC, varying degrees of patent protection can exist because each nation can interpret and modify a patent consistent with its national patent system.³⁶ In an effort to provide a more uniform level of patent protection for biotechnology inventions, the European Union drafted Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the Legal Protection of Biotechnological Inventions (Directive).³⁷ The Directive required all member nations to adopt the provisions contained in the Directive into their patent systems.³⁸ The Directive states that the simple discovery of an element of the human body, "including the sequence or partial sequence of a gene is not a patentable invention."³⁹ But, where the sequence is disclosed and is isolated from the human body or made by means of a technical process, it may be patentable even if it is identical to a natural element.⁴⁰ The Directive also considers certain subject matter to be absolutely unpatentable, including: "processes for cloning human beings; processes for modifying the germline genetic identity of human beings; uses of human embryos for industrial or commercial purposes; and processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes."⁴¹

n addition to multinational agreements, several nations have provisions within their own patent laws that would provide a basis for which gene patents could be challenged. For example, the United Kingdom,⁴² New Zealand⁴³ and Japan⁴⁴allow a patent application to be denied based on ethical and social considerations. However, a discussion paper on New Zealand 's Patent Act stated that the exception rarely, if ever, has been applied.⁴⁵

Alternatively, in Australia , the Patents Act does not explicitly allow a patent examiner to consider ethical concerns in assessing a patent application.⁴⁶ However, an indirect requirement may exist that would allow social and ethical considerations to be considered in granting a patent.⁴⁷ Under section 18 of the Patents Act, a patent may be granted for a "manner of manufacture" if it is within the meaning of section 6 of the Statute of Monopolies.⁴⁸ Section 6 states that an invention "be not contrary to the law, nor mischievous to the state, by raising prices of commodities, or hurt of trade, or generally inconvenient."⁴⁹ Therefore, a patent that could potentially issue under ³manner of manufacture² could be deemed to be contrary to the law or generally inconvenient.

A number of developed countries have a formalized research exemption built into in their statutory patent laws. For example, the United Kingdom law reads that "an act which, apart from this subsection, would constitute an infringement of a patent for an invention shall not do so if (a) it is done privately and for purposes which are not commercial; [or] (b) it is done for experimental purposes relating to the subject matter of the invention."⁵⁰ Japan's patent law states that "the effects of the patent right shall not extend to the working of the patent right for the purposes of experiment or research,"⁵¹ and Germany provides that "effects of patents shall not extend to ... acts done for experimental purposes relating to the subject matter of the patented invention."⁵²

In the U.S. , such a statutory exemption has been considered in Congress, however has not been passed into law. The Genomic Research and Diagnostic Accessibility Act of 2002 , HR 3967, introduced by Lynn Rivers (D-MI) and David Weldon (R-FL), would have amended U.S.C. §271 through the addition of a subsection allowing the use of genetic sequence information for noncommercial research purposes.⁵³ It also aimed to amend 35 U.S.C. §287(c)(2) to allow for the use of genetic sequence information for "performance of a genetic diagnosis, prognostic, or predictive test of a medical or surgical procedure."⁵⁴ Although it did not pass in the 107 th Congress, it has not been reintroduced.

¹ The Constitution gives Congress the power to "promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries." Article 1, Section 8, Clause 8.
²35 U.S.C. §154(a)(2).
³ See Diamond v. Chakrabarty , 447 U.S. 303 (1980). The court held that products of nature are "manifestations of...nature, free to all men and reserved exclusively to none." Id. at 309.
⁴ Sunny Bains, "Double Helix as Engineer," 279 Science 2043, 2043 (1998) (detailing that the letters C, G, A and T stand for the four different bases that make up human DNA: cytosine, thymine, adenine, and guanine).
⁵ Sheldon Krimsky, "The Profit of Scientific Discovery and Its Normative Implications" 75 Chi- Kent L. Rev . 15, 26 (1999).
⁶ Parke-Davis v. H. K. Mulford , 196 F.496 (2d Cir. 1912), upheld a patent on adrenaline, a natural hormone that was found in animal glands. The patent applicant identified, isolated, and purified the active ingredient ­ adrenaline, creating a product that did not exist in nature in that precise form and that could be used for medical treatment. The U. S. Supreme Court's subsequent Chakrabarty decision allowing the patent on genetically-engineered bacteria dealt with a new invention -- a genetically engineered life form invented by combining genes in ways that did not occur in nature. Diamond v. Chakrabarty , 447 U.S. 303 (1980).
⁷ 35 U.S. Code (USC) §154.
⁸ 35 U.S.C. §112.
⁹ 35 U.S.C. §112.
¹⁰ 35 U.S.C. §112.
¹¹ Brenner v. Manson, 383 U.S. 519, 536, 86 S. Ct. 1033, 1042 (1966).
¹² United States Patent & Trademark Office, Guidelines for Examination of Patent Applications Under the 35 USC §112, ¶1 "Written Description" Requirement, 66 Fed. Reg . 1099 (2001).
¹³ 35 U.S.C. §112.
¹⁴ R. Eisenberg, U. Chi. L. Rev . 56, 1017 (1989).
¹⁵ 35 U.S.C. §112.
¹⁶ 35 U.S.C. §§101-103.
¹⁷ 35 U.S.C. §101.
¹⁸ United States Patent & Trademark Office, Utility Examination Guidelines, 66 Fed. Reg . 1092 (2001).
¹⁹ United States Patent & Trademark Office, Utility Examination Guidelines, 66 Fed. Reg . 1092 (2001).
²⁰ United States Patent & Trademark Office, Utility Examination Guidelines, 66 Fed. Reg . 1092 (2001).
²¹ 35 U.S.C. §102.
²² 35 U.S.C. §103.
²³ 35 U.S.C. §103(a).
²⁴ Roche Products v. Bolar Pharmaceutical Company, 733 F.2d 858 (Fed. Cir. 1984), cert. denied, 469 U.S. 856 (1984).
²⁵ Madey v. Duke University , 307 F.3d 1351, 1362 (Fed. Cir. 2002).
²⁶ Madey v. Duke University , 307 F.3d 1351, 1362 (Fed. Cir. 2002).
²⁷ World Trade Organization, "What is the World Trade Organization?" available at http://www.wto.org/english/thewto_e/whatis_e/tif_e/fact1_e.htm, last visited July 28, 2004.
²⁸ World Trade Organization, "What is the World Trade Organization?" available at http://www.wto.org/english/thewto_e/whatis_e/tif_e/fact1_e.htm, last visited July 28, 2004.
²⁹ Agreement on Trade-Related Aspects of Intellectual Property Rights, April 15, 1994 , art. 8, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C Legal Instruments - Results of the Uruguay Round vol. 31; 33 I.L.M. 83-111, 87 (1994).
³⁰ Agreement on Trade-Related Aspects of Intellectual Property Rights, April 15, 1994 , art. 27, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C Legal Instruments - Results of the Uruguay Round vol. 31; 33 I.L.M. 83-111, 93-94 (1994).
³¹ Agreement on Trade-Related Aspects of Intellectual Property Rights, April 15, 1994 , art. 31, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C Legal Instruments - Results of the Uruguay Round vol. 31; 33 I.L.M. 83-111, 95-96 (1994).
³² European Patent Office, "EPO Member States," available at http://www.european-patent-office.org/epo/members.htm#extension_states, last visited July 26, 2004.
³³ Donna M. Gitter, "Led Astray by the Moral Compass: Incorporating Morality into European Union Biotechnology Patent Law," 19 Berkeley J. Int'l L. 1-43, 19 (2001).
³⁴ Convention on the Grant of European Patents, October 5, 1973 , art. 53, 13 I.L.M. 268-351, 286 (1974).
³⁵ Donna M. Gitter, "Led Astray by the Moral Compass: Incorporating Morality into European Union Biotechnology Patent Law," 19 Berkeley J. Int'l L. 1-43, 26 (2001).
³⁶ Donna M. Gitter, "Led Astray by the Moral Compass: Incorporating Morality into European Union Biotechnology Patent Law," 19 Berkeley J. Int'l L. 1-43, 20 (2001).
³⁷ See Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the Legal Protection of Biotechnological Inventions, 1998 O.J. L213/13.
³⁸ Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the Legal Protection of Biotechnological Inventions, art. 15, 1998 O.J. L213/13, 20-21.
³⁹ Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the Legal Protection of Biotechnological Inventions, art. 5(1), 1998 O.J. L213/13, 18.
⁴⁰ Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the Legal Protection of Biotechnological Inventions, art. 5(3), 1998 O.J. L213/13, 18.
⁴¹ Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the Legal Protection of Biotechnological Inventions, art. 6, 1998 O.J. L213/13, 18-19.
⁴² Patents Act, 1977 § 1(3)(a) ( Eng. ).
⁴³ Patents Act, 1953 § 17(1) (N.Z.).
⁴⁴ Patent Law, 1999 § 32 ( Japan ).
⁴⁵ New Zealand Ministry of Economic Development, "A Review of the Patents Act 1953: Boundaries to Patentability: A Discussion Paper," 17 (2002) available at http://www.med.govt.nz/buslt/int_prop/patentsreview/discussion/patentsreview.pdf, last visited July 23, 2004.
⁴⁶ Australian Law Reform Commission, "Issue Paper 27: Gene Patenting and Human Health," 144 (2003) available at http://www.austlii.edu.au/au/other/alrc/publications/issues/27/, last visited July 21, 2004.
⁴⁷ Australian Law Reform Commission, "Issue Paper 27: Gene Patenting and Human Health," 144 (2003) available at http://www.austlii.edu.au/au/other/alrc/publications/issues/27/, last visited July 21, 2004.
⁴⁸ Patents Act, 1990 (Cth), § 18(1)(a) (standard patents); § 18(1A)(a) (innovation patents) (Austl.).
⁴⁹ Statute of Monopolies, 1623 21 Jam. 1 ch. 3 (Eng.); s ee, e.g. , Peter Drahos, "Biotechnology Patents, Markets and Morality," European Intellectual Property Review 441-49, 441 (1999) (the author states that ethical considerations are included in the "generally inconvenient" term of the statute); s ee generally Australian Law Reform Commission, "Issue Paper 27: Gene Patenting and Human Health," 144 (2003) available at http://www.austlii.edu.au/au/other/alrc/publications/issues/27/, last visited July 21, 2004 (citation omitted) (discussing that several decisions of the High Court and Federal Court, in obiter dicta , have suggested that the Œgenerally inconvenient' exception allows public policy considerations to be used as a basis for denying a patent application; however, Australian courts have not relied solely on public policy or ethics when denying a patent under the Œgenerally inconvenient' exception).
⁵⁰ Janice M. Mueller, "The Evanescent Experimental Use Exemption from United States Patent Infringement Liability: Implications for University and Nonprofit Research and Development," 56 Baylor L. Rev. 917, 970, citing Patents Act, 1977, c.37, 60(5)( Eng. ), available at htpp://www.wipo.int/clea/docs_new/en/gb/gb001en.html.
⁵¹ Janice M. Mueller, "The Evanescent Experimental Use Exemption from United States Patent Infringement Liability: Implications for University and Nonprofit Research and Development," 56 Baylor L. Rev. 917, 970, citing Japan Patent Law, Law No. 121, 1959, amended by Law No. 220, 1999, 69(1), available at http://www.wipo.int/clea/docs_new/en/jp/jp036en.html.
⁵² Janice M. Mueller, "The Evanescent Experimental Use Exemption from United States Patent Infringement Liability: Implications for University and Nonprofit Research and Development," 56 Baylor L. Rev. 917, 969, citing German Patent Act, 1980, 11.2, available at http://www.wipo.int/clea/docs_new/en/de/de081_en.html.
⁵³ Genomic Research and Diagnostic Accessibility Act of 2002, HR 3967, 107th Cong. (2002).
⁵⁴ Genomic Research and Diagnostic Accessibility Act of 2002, HR 3967, 107th Cong. (2002).