Does Dolly deserve defense? An analysis of the patentability of cloned livestock.

• Author: Clark, Andrew

1. Introduction

   "The real value of cloning ... lay in the potential to engineer animals to produce medications, and even transplantable organs, for use by human beings. Those prospects, too, have so far remained largely unrealized." Dr. Keith Campbell (1)

   Rapid developments in the biotechnology industry have made cloning a once futuristic idea a reality, leaving the United States Patent laws in a perplexing position: can the longstanding patent system adequately protect products of unforeseen technologies, or are the technologies themselves the only patentable subject matter? The term "clone" was first coined by J.B.S. Haldane, a British biologist, in a speech he gave in 1963. (2) The science of cloning has rapidly developed since the 19th century, with the first major advances occurring in the 1970s. (3) The biggest event in cloning history, the successful cloning of Dolly the sheep, was revealed in 1997. (4) Dr. Keith Campbell, (5) a cell biologist, and Dr. Ian Wilmut, (6) a developmental biologist, were responsible for cloning Dolly at the Roslin Institute in Scotland in 1996. (7) The field of cloning has continued to develop with other milestones along the way, including the cloning of fifty mice by scientists at the University of Hawaii and the successful cloning of an endangered guar (wild ox) by scientists at Advanced Cell Technology, Inc. (8)

   This note suggests that the United States Patent and Trademark Office should no longer deny patents to genetically cloned animals, in particular livestock. Patent laws should no longer consider cloned animals to be unpatentable subject matter, rather the laws should include animals that are not a product of natural reproduction. (9) Parts II and III describe the evolution of United States Patent laws. (10) Part IV will provide a background of the development and uses of the science of cloning. (11) Part V will propose facts that present unique considerations for patent law. (12) Part VI will propose an expanded application of Patents to incorporate products of animal cloning. (13)

   II.Current State of United States Patent Law

   The United States Congress has the right to develop and enact patent laws under Article I, [section] 8, cl. 8 of the United States Constitution. (14) The creation of patent laws, and the interpretation of patentable subject matter have drastically changed since the first patent statues were enacted. (15) The most recent modification of United States Patent Law was enacted on September 16, 2011. (16) The biggest change brought by the 2011 revision is the change to a first-to-file system rather than the first-to-invent system that was previously in place. (17) The Patent and Trademark Office made this change in order to "result in greater transparency, objectivity, predictability, and simplicity in patentability determinations." (18) This change to a first-to-file system puts the United States on a similar patent system as the rest of the world. (19) Using this system, a patent is granted to the first inventor to file a patent application in contrast to the old system that granted a patent to the first person to invent. (20) In the current patent system there are five requirements of patentability. (21) It is undisputed that a patent right is a property right. (22) The property right granted by patents is a negative right that allows the holder of a patent to exclude others from making the invention. (23) However, the negative property right does not ensure the right of inventor to make or sell his patented invention. (24) It is important to note that patent rights, like property rights, are transferrable. (25)

   1. Types of Patents

   The modern patent system has three main types of patents. (26) The three types of patents available to inventors in the United States are: 1. a utility patent; 2. a design patent; and 3. a plant patent. (27) This section discusses each type of patent in detail. The type of patent that an inventor files is dependent upon the subject matter or type of invention. (28)

   1. Utility Patent

      The most commonly filed patent type is the utility patent. (29) Approximately 90% of all patent applications that have been filed in the last few years have been utility patents. (30) A utility patent is granted to the inventor for the invention of "a new and useful process, machine, manufacture, or composition of matter." (31) There is also a grant of a utility patent for a sufficiently useful improvement of an existing patented invention. (32) The utility patents require various conditions of patentability, which are discussed below.

      1. Patentable Subject Matter

         The scope of patentable subject matter for a utility patent is defined by 35 U.S.C. [section] 101. (33) The patentable subject matter is described in broad terms as "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." (34) Therefore, patentable subject matter can be said to be any machine, manufacture, composition of matter and process. (35) In terms of patentable subject matter a machine is described as "the production of articles for use from raw or prepared materials by giving to these materials new forms, qualities, properties, or combinations, whether by hand-labor or by machinery." (36) It is important to note that manufacture implies a change to a product or item, but not every change is considered to be manufacture. (37) Therefore, manufacture should yield a new good, one that has been transformed with a distinctive character, name or use. (38) Composition of matter as specified in [section] 101 can simply be put as all "compositions [made up of] two or more substances." (39) An expansion of the interpretation of composition of matter occurred when the United States Supreme Court heard Diamond v. Chakrabarty. (40) The Chakrabarty Court held that a genetically manufactured bacterium was in fact patentable subject matter. (41) 35 U.S.C. [section] 100 clarifies the meaning of process by stating that "process, art or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material." (42) On occasion, the Supreme Court has been tasked to decide whether a new invention is sufficient subject matter to warrant a grant of a patent; yet after considering these various cases there is still no settled interpretation of [section] 101 and the subject matter it includes. (43) "The Supreme Court has determined that certain categories of invention or discovery exceed the statutory boundaries of patentable subject matters including laws of nature, products of nature, physical or natural phenomena, abstract ideas, and unapplied mathematical algorithms." (44)

      2. Usefulness

         Once it is determined that an invention is of a sufficient patentable subject matter another condition of patentability is usefulness. As stated in [section] 101 of the Patent Act, "Whoever, invents or discovers any new and useful process, machine, manufacture, or composition of matter, may obtain a patent therefore ..." (45) The standard of usefulness is a very low threshold. (46) Therefore, any invention that has a minimal degree of usefulness will sufficiently fulfill this requirement. (47) Inventions that lack any usefulness or are otherwise inoperable are inventions that are said to have not fulfilled the usefulness threshold. (48)

      3. Novelty

         In addition to an invention being useful and patentable subject matter, the invention must also satisfy a novelty requirement. The novelty requirement of patentability is governed by 35 U.S.C. [section] 102. (49) Section 102 statute states that:

         A person shall be entitled to a patent unless--

         (1) The claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention; or

         (2) The claimed invention was described in a patent issued under section 151 [35 USCS [section] 151], or in an application for patent published or deemed published under section 122(b) [35 USCS [section] 122(b)], in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.

         Section 102 focuses on the prior art of the invention that was in existence before the patent application filing date. (50) In the above quoted language subsection (1) of [section] 102 highlights that an invention lacks novelty if it was previously in public use or available to the public. (51) Courts examining patent eligibility disputes have defined disclosure in public by an inventor to occur when he discloses the invention in a printed document. (52) "To constitute a publication, within the meaning of the statute, the invention must be described sufficiently to impart to a person with ordinary skill and knowledge of the prior art the information needed to devise the invention without further genuine inspiration or undue experimentation." (53) Some examples of the applicable document have been held to include: "slides and drawings, (54) microfilm, (55) photographs, or [material published] in technical or popular journals." (56) There is a "critical date" one-year grace period that allows an inventor up to one year to file for a patent after he has engaged in public or commercial activity involving the invention. (57)

      4. Non-obviousness

         A third condition of patentability for a grant of a United States patent is the requirement that the nature of the subject matter of the invention is non-obvious. The condition for an invention to be non-obvious is found in 35 U.S.C. [section] 103, which provides: (58)

         A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior...