Gene protection: how much is too much? Comparing the scope of patent protection for gene sequences between the United States and Germany.

AuthorBryan, Erin

Cite as 9 J. HIGH TECH. L. 52 (2009)

  1. Introduction

    The drive to map the human genome and identify genes led to the establishment of the Human Genome Project ("HGP"). (1) The HGP estimates that the human genome consists of 20,000 to 25,000 genes. (2) The U.S. Patent and Trademark Office ("USPTO") issues thousands of patents for human genes identified by HGP and it is reasonable to believe that this trend will continue as the HGP isolates and identifies more human genes. (3) This increase in intellectual property protection for human genes is not only evident in the United States, but also is found in many other countries, and in the European Union ("EU"). (4) In the EU, disputes arise as to the extent of protection given for human genes mainly due to the belief that living matter does not qualify for patent protection. (5)

    This Note explores the patentability requirements for human genes in the United States, the EU, and Germany. The first part of this Note sets forth background information on deoxyribonucleic acid ("DNA") and human genes.

    The second part examines the relevant patent laws of the United States, the EU, and Germany. The final two parts of this Note explore the differences between Germany and the United States regarding general and limited protection of DNA sequences, and present arguments for why Germany's national law presents a better model to follow when providing intellectual property protection based on the extent of patent protection provided for genes.

    11. DNA Background

    Understanding how DNA functions is essential for understanding the human genome and applying that knowledge to the study of various human afflictions. DNA forms the shape of a double helix, which is comprised of chains of sugars and phosphates and the bases adenine, thymine, cytosine, and guanine. (6) Particular DNA sequences form genes, which then code for a unique protein. (7) The process for making proteins from genes is known as gene transcription. (8)

    Gene transcription occurs when the double helix of the DNA is unwound and one strand makes messenger RNA ("mRNA"). (9) The genes that encode for the proteins copy onto the mRNA strand, which allows for the production of the proteins after a translation process. (10) There are one start and three stop codons that turn translation on and off, and there are an additional sixty-four possible codons that exist, representing a total of twenty amino acids bound together to make proteins. (11)

    Along a strand of DNA, the coding regions for genes, called exons, may be spread out and not connected with one another. (12) The areas in between the exon regions are areas of non-coding material called introns. (13) Because the coding regions are spread out along the DNA strand, the actual identification of genes is very difficult. (14) To combat this difficulty, new developments use Expressed Sequence Tags ("ESTs") in the identification of genes. (15)

    ESTs are DNA sequences that contain only exons--the regions that express genes--and do not contain any introns. (16) They are portions of complementary DNA ("cDNA") produced from mRNA. (17) Multiple options exist to utilize these portions of cDNA. One option is that a scientist may place the cDNA in a public library for other researchers to use to produce certain genes. (18) Alternatively, a scientist may manipulate the cDNA so that it binds back onto the original DNA strand and matches the complementary location where that specific gene is located, thereby identifying the location on the DNA strand of the gene. (19)

    Once a gene is known and characterized, researchers utilize functional genomics to try to determine the function of that gene. (20) There are various ways that researchers may attempt to derive the function, one being comparing the gene sequence to genes that are similar whose functions are already known. (21) Another possible way is to turn off specific genes in mice and observe the mice for resultant changes in their health and activities. (22)

    Currently there is a race in the biotechnology industry to identify and patent a gene's basic sequence. (23) Some in the industry believe that patents should not be granted for mere knowledge of the gene's sequence. Rather, the applicant also must identify a specific function. (24) The scope of patent protection in both Europe and the United States has favored the view that patents may be awarded for identifying DNA sequences for different genes, so long as some possible function is known. (25)

  2. History

    Various legal issues exist regarding the patentability of DNA sequences, which the United States, Germany, and the EU confront in different ways. Both the United States and Germany have their own legal frameworks for reviewing and granting gene patents on a national level, while the EU has distinct policies that individual countries within the EU implement. In addition, international agreements exist between the parties that also play a role in what is patentable for biotechnology. (26)

    1. U.S. Law

      U.S. patent law arises from the U.S. Constitution, Article I, section 8, clause 8. (27) Further, the Patent Act of 1952 (28) provides that certain requirements must be met in order to obtain a patent. (29) The item for which the patent is being sought must meet stated levels of novelty, utility, and nonobviousness. (30) In Diamond v. Diehr, (31) the Supreme Court looked to the legislative history of the 1952 Patent Act to determine how extensive patent protection was and found that "Congress intended statutory subject matter to 'include anything under the sun that is made by man."' (32) The Court, however, stated that it will apply certain subject matter restrictions under section 101. (33)

      The statutory patentability requirements are applied to biotechnology, including DNA sequences, in the same way as they are to any invention. (34) The courts have allowed, based on Diamond v. Chakrabarty, the patenting of DNA sequences corresponding to certain genes when the sequences are purified, meaning that the sequence has been isolated from how it would otherwise exist in nature, showing some characteristic that is different from the natural sequence. (35) In addition to DNA sequences, patent protection is also extended to Expressed Sequence Tags and Single Nucleotide Polymorphisms ("SNPs"). (36)

    2. EU Law

      The European Patent Convention ("EPC"), (37) national laws, and EU directives govern intellectual property rights in the EU. (38) The European Patent Organisation currently consists of thirty-four member countries. (39) The European Patent Office ("EPO") established an independent application and examination process for the granting of patents. (40) After a patent is granted through the EPO it is nationalized in individual countries designated by the applicant. (41) The enforcement of a patent in each individual country is governed by national law. (42)

      Each country has its own national patent laws and once a patent is granted through the EPO and nationalized in an individual country, it is then subject to that country's individual laws. (43) Because each country has individual patent laws and enforcement mechanisms, there is a lack of uniformity among the countries. (44) The EU sets minimum standards for patent protection by issuing directives that member states must implement into their national law. (45)

      The European Parliament and the Council of the European Union together approve EU directives that address certain patentability requirements. (46) In 1998, the European Union issued a directive on the patentability requirements of biotechnology. (47) The EPO readily adopted the biotechnology patentability requirements specified in the Biotech Directive. (48) The Biotech Directive is important because it clarifies that biotechnological inventions are considered for patent protection based on the standards applied to any other area of technology. (49) In addition, the Biotech Directive specifies what is considered patentable, such as biological material that has been isolated from its environment, and what is not patentable, such as plants and animals or processes that would produce plants or animals. (50) The Biotech Directive also provides a morality exception stating that any invention that contravenes public policy or morality is not patentable. (51)

      Member states were required to implement the Biotech Directive into their national law by July 30, 2000. (52) Some countries delayed implementation and the European Court of Justice ("ECJ") subsequently found them in violation of their obligations under EU law. (53) Norway, the Netherlands, and Italy filed a collective action at the ECJ to have the Biotech Directive invalidated, but the ECJ dismissed the action and used the opportunity to restate the underlying principles of the Biotech Directive, specifically to unify biotechnology patent law. (54)

    3. German Law

      Each state in the EU has its own national patent laws separate from EU policies, which interact with and sometimes conflict with EU laws. (55) German intellectual property law is governed by both national legislation, the German Patent Act ("PatG"), (56) as well as any directives issued by the EU, such as the Biotech Directive. (57) When Germany finally implemented the Biotech Directive into the PatG, the resulting legislation was more restrictive than the terms of the Directive, particularly with regard to DNA sequences. (58)

      The amended PatG contained a new paragraph in its first section describing which inventions would gain protection. (59) In addition, a section la was added after section 1, which specified that sequences or partial sequences of genes constitute patentable subject matter even if the structure is the same as that existing in nature. (60) Finally, section la also clearly states that if the invention is a sequence or partial sequence of a gene, the use of that sequence must be clearly identified. (61)

      Germany's amendment to the PatG with implementation...

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