CASRIP Newsletter - Fall 1995, Volume 2, Issue 3
ATRIP 1995 by Toshiko Takenaka
From July 19 through July 21, 1995, CASRIP hosted the 1995 annual meeting of the International Association for the Advancement of Teaching and Research in Intellectual Property (ATRIP). ATRIP is the largest international association for researchers and teachers specializing in intellectual property. In the past, their activities have been mainly in Europe. This is the second time ATRIP has held an annual meeting in the United States.
The meeting was a great success: it attracted about 100 professors and many other guests from 30 countries. (The number of the attendees is one of the best in the history of ATRIP.) Although most participants at ATRIP's annual meeting are usually from Europe, this year's annual meeting attracted a large group from the United States. Thanks to the diligent efforts of Ms. Morrison (CASRIP business administrator) and Ms. Morse (CASRIP Senior JD research associate), the conference went smoothly. The participants were deeply impressed with the conference's cozy atmosphere and I had never felt so proud of being part of CASRIP.
To welcome participants from outside the United States, CASRIP sponsored a mock patent infringement trial on the day before the meeting. Attorneys from the law firm of Morrison & Forester, who actually litigated the original case, played representatives for the parties. Professor Janicke from the University of Houston Law Center played the judge and Professor Chisum played an inventor who was also a witness in the case. CASRIP JD students, Mrs. Chisum and Ms. Morrison played jurors. Interestingly, the jury reached a verdict different from that of the real case. It was particularly fun to watch jury deliberation which was video taped and televised to the audience in the court room.
The annual meeting opened with a welcome speech by Professor Straus, ATRIP's president for 1994 and 1995. The afternoon of the first day was dedicated to problems in multimedia. Mr. Van Arsdale from Microsoft was the first speaker and addressed the needs and problems of multimedia producers. His talk was followed by a presentation of Microsoft products. The second speaker was Professor Loewenheim from the University of Frankfurt. He addressed the topic of "multimedia and European copyright law." The session concluded with panel discussions conducted by Professor Francon from France, Professor Gendreau from Canada, and Professor Strowel from Belgium.
On the evening of the first day, CASRIP and the Seattle law firm Christensen, O'Connor, Johnson & Kindness hosted a reception in honor of the ATRIP participants at the Columbia Tower Club, located at the top of the tallest skyscraper in Seattle. To add a perfect finishing touch to the warm reception, the sight of sunset over Puget Sound, seen from the Columbia Tower Club, was spectacular.
The second day of the annual meeting covered legal issues in intellectual property protection for biotechnology. The third day was dedicated to a discussion of parallel importation in which a recent Japanese case decision attracted the participants' interest. Reports on those two discussions were prepared by students and are included on page twelve. After the parallel importation discussion, I spoke about current and future projects at CASRIP. After the presentation, many participants expressed interest in our proposal to create a new intellectual property LL.M. program at the University of Washington School of Law.
Outside the official meeting, attendees enjoyed a blues performance, a traditional music in the United States, at the top jazz restaurant in Seattle. The meeting was concluded with big applause at the farewell dinner held at Blake Island. At the island, ATRIP participants enjoyed native Americans' traditional dance and smoked salmon dinner.
For CASRIP, hosting an international conference of this scale was a first time experience. Although we spent a significant amount of time planning the event, we encountered some unexpected circumstances, and learned a lot in the process. Nevertheless, the three-day program had enough of everything to keep everyone busy and happy. After completing the big event, we feel almost like professional conference organizers. We hope to have an international conference of this scale at CASRIP once every two or three years. If you are planning an international conference on intellectual property, please consider CASRIP as a possible host.
ATRIP Proceedings, July 20, 1995.
Report by Loraine Morse
Dr. Leroy Hood
Chair, Molecular Biology Department,
University of Washington
Dr. Leroy Hood spoke on "Biotechnology and the Human Genome Project: Challenges for Intellectual Property." He briefly explained the basic concepts of genetics; reviewed the Human Genome Project and discussed his views on appropriate intellectual property protection for biotechnological patents, which would still allow academic and scientific freedom for future development.
Basic Genetic Concepts
Biological information is contained in genes which are located on chromosomes. There are one hundred thousand (100,000) units of information (genes) in the entire genetic makeup (genome) of human beings.
The language of the DNA genetic code resembles the binary language of computers; combinations of "letters" result in different codes. Genetic language contains four letters, while computer language contains two letters. Messenger RNA (mRNA) is a nucleic acid which aids in the translation of genetic information into the actual proteins coded by the DNA. Like DNA, mRNA is a nucleic acid with a four letter language. Proteins, long recognized as patentable subject matter, possess a twenty letter language. Chromosomal language is more complex than genetic language. Chromosomes have a multiplicity of languages which provide many types of information in various forms: genes; regulation of individual/gene expression; regulation of body patterns; segregation of the centromeres in meiosis and mitosis (cell replication); and replication at many sites.
Once scientists have broken particular pieces of genetic codes, they create libraries of information. There are two types of genetic libraries: 1) Genomic Libraries (determined from chromosomes), and 2) Complementary DNA (cDNA) Libraries (determined from mRNAs).
Although scientists have made tremendous progress in ascertaining bits and pieces of biological information, complex living systems defy complete understanding. The sheer magnitude of biological systems presents a formidable challenge. For example, a typical human brain contains 10^12 cells and 10^15 connections amongst the cells. This entire cerebral network gives rise to consciousness, memories and other complexities. Grasping the complete nature of acquired biological information presents great difficulty since emergent properties can only be understood by understanding the system as a whole.
Dr. Hood commented that intellectual property laws will soon have to address the operation of biologically complex systems. Determining how to protect systems information will challenge patent law in the future.
The Human Genome Project
The Human Genome Project seeks to decipher heredity. A human cell contains twenty-three pairs of chromosomes, but there are twenty-four different types of chromosomes because of an additional sex chromosome. In development, chromosomal information dictates the specified processes for a cell to evolve into one of three major tissue layer cells that comprise a complete human organism. An "encyclopedia for constructing a human" would require the following:
= 3 x 10^9 nucleotides
= 500 volumes of instruction, each volume comprised of 1,000 pages and 1,000 words/page and 6 letters/word
Because numerical computation is essential to understanding the complexity of genetics, a "new theoretical biology" has arisen. Many applied mathematicians and computer scientists focus their attention on computations regarding genetic information.
Scientists decipher and manipulate biological information. DNA is a one-dimensional code. Proteins have three-dimensional codes embedded within them. Complex systems and networks are four- dimensional codes. In manipulation of biological products, gene products are generated for commercial or scientific use.
Once the Human Genome Project is completed, it will revolutionize medical technology. Patients with a predisposition to certain diseases can be identified at early stages, and perhaps some treatment can be made available before the disease progresses to an advanced stage. Also, scientists will be able to map multigenic traits (for example, Alzheimer's Disease, which actually results from a combination of defective genes on a number of different chromosomes). Genome-wide genetic mapping and clinical features will play key roles in the stratification of major human diseases. Molecular therapies -- antisense gene therapy to correct for defective genetic coding and protein engineering to produce properly functioning proteins -- will also be likely as a result of genomic mapping.
The Genome Project is concerned with two types of DNA: 1) twenty-three pairs of chromosomes (genomic DNA), and 2) mRNA of cells (cDNA sequencing). Biological scientists will have to develop tools and strategies to accurately determine the protein functions coded by the gene sequences.
Intellectual Property Laws Can Protect Biotechnological Inventions without Unduly Restricting the Realm of Scientific Research in the Future.
Unlike antibiotics, where function was a trivial concern and the structure difficult to ascertain, gene function is difficult to ascertain while gene structure is relatively simple to determine. Consequently, Dr. Hood suggested the following criteria to be the basis for granting a patent on a biotechnological invention: 1) patentee knows the complete structure of the gene; and 2) patentee must clearly understand at least one function of the gene. Since genes can have more than one function, another patentee could conceivably obtain a patent on another function of the same gene sequence already protected by a patent; Dr. Hood noted that this view differs from the current patent law which grants the initial patentee rights to everything.
Dr. Hood highlighted several issues of interest to patent law. Patenting fragments of genes would provide too broad a scope of protection and would cause a chilling effect on further useful scientific and academic research. Patenting discrete genes requires some consideration of biologically complex systems and networks. How does the prior art of defining individual components affect the whole system and network (parts versus whole)? Also, because chromosomes have a multiplicity of languages with many types of information, what will be the scope of patent protection for biotechnological inventions?
Professor Donald S. Chisum
CASRIP Director and Professor
University of Washington School of Law
After Dr. Hood's presentation, Professor Donald Chisum discussed "The Scope of Intellectual Property Protection of Biotechnology." While the United States has been criticized as having an antiquated patent system, the U.S. is the leader in providing patent protection for biotechnological inventions. Consequently, billions of dollars are invested for even just a kernel of research promise in the field of biotechnology in America. In determining the scope of biotechnology patents, Professor Chisum reviewed a few key cases. He also examined the scope of the biotechnology patents granted by the United States Patent and Trademark Office over the years.
Key Cases in Determining the Scope for Intellectual Property Protection of Biotechnology
The United States Supreme Court proclaimed living organisms patentable subject matter in the 1980 landmark decision of Diamond v. Chakrabarty. The justices allowed the patenting of microorganisms particularly effective at cleaning up oil spills. The Court made clear that ethical and other policy considerations were within the jurisdiction of the legislature; the justices merely had jurisdiction to interpret the law.
The Federal Circuit clarified the scope of intellectual property protection of biotechnology in Amgen v. Chugai and Genentech v. Wellcome Foundation. In Amgen, genetic sequences which were "purified and isolated" (in other words, not the substance in its natural form) and which specifically indicated "a DNA sequence encoding..." received patent protection. However, the Amgen patentee could not receive protection for the broad claim of a purified and isolated genetic sequence which encoded "a polypeptide encoding anything."
In Genentech, the plaintiffs had obtained method and product patents on producing natural tissue plasminogen activator (t-PA), a protein found in the human body. The defendants had created a non-naturally occurring product, FE1X, which was structurally different from t-PA. The accused product lacked approximately 15% of the structure found in natural t-PA. The court adopted the "narrow structural definition" recited in the patents; that is, to produce t-PA through recombinant DNA technology with the same structure as natural t-PA. The court found that the defendants did not infringe the plaintiffs' patents because the patentee could not reasonably contemplate FE1X at the time of filing their patents.
As Amgen and Genentech illustrate, courts have granted protection to claims which state that particular DNA sequences encode for particular proteins.
U.S.P.T.O. View on Scope of Intellectual Property Protection for Biotechnology
Professor Chisum cited some research done by Diana Scheiness, a recent graduate of the University of Washington School of Law. Scheiness surveyed the language in granted biotechnology patents, especially from 1983 when a large number of patents were granted claiming nucleic acid sequences.
Three categories for cloned genes were determined: 1) Narrow: strictly limited to precise DNA sequence; 2) Intermediate: DNA sequence encoded to direct protein (like Amgen and Genentech); and 3) Broad: any DNA sequence that hybridized with the cloned sequence. The U.S.P.T.O. granted patents mostly to applications with the narrow claims, although a considerable number of patents were also issued to applications with the intermediate claims. Since legal research addresses the past rather than the future the U.S.P.T.O.'s position may be different from its previous stance.
Professor Dr. Joseph Straus
Chair, ATRIP Biotechnology Committee
Max Planck Institute
Panelists: Professors Martin Adelman (U.S.A.), Andre Bercovitz (Spain), Donald Chisum (U.S.A.), Leroy Hood (U.S.A.), Kamal Puri (Australia), Horatio Rangel-Ortiz (Mexico), and Joseph Straus (Germany)
The panel discussion raised several issues in intellectual property protection of biotechnology. Ethical and moral questions about the propriety of patenting biotechnological inventions dominated the discussion among the panelists. Professor Dr. Straus and Dr. Hood cautioned that one must first define exactly what is meant by "ethics" in order to effectively discuss whether biotechnology patents violated the public order or not. Professor Chisum noted that almost everyone wanted the benefit of biotechnological inventions, but not everyone was comfortable with allowing intellectual property protection for them. Professor Bercovitz stated that he had a fundamental objection to product patents in biotechnology, because the subject matter was not created so should not be protected. He also believed that interests other than the inventors' rights should be taken into account in patent protection.
As introduced by Professor Adelman, the panelists recognized that structure/function and product/process issues are particularly relevant to biotechnology patents. Professor Chisum commented that they have traditionally been major issues in chemical patents as well.
Regarding activity in South and Central America and Australia, Professor Rangel-Ortiz briefly reported that South and Central American countries were seeking to introduce legislation providing for "an equitable allocation of benefits derived from genetic resources." Professor Puri explained that Australia's system for protection of biotechnology patents resembled the U.S. system more than the European system. Australia distinguishes between structure and function, and is willing to grant patent protection for biotechnological inventions.
ATRIP Proceedings, July 21, 1995.
Report by Wei-Fu Hsu
Panel Discussion - Exhaustion and Parallel Importation after GATT- TRIPs
Chair: Professor Alberto Bercovitz
Panelists: Professors Bercovitz (Spain), Shoukang Guo (China), Joanna Schmidt (France), Bojan Pretnar (Slovenia), Vito Mangini (Italy), Edmund Kitch (U.S.), Bernt Hugenholtz (Netherland), Christopher Heath (Germany), William Cornish (U.K.)
In his introductory remarks, Professor Bercovitz first discussed the possibility of legalizing the practice of parallel importation. He briefly reviewed the GATT agreement and then went on to discuss the relationship between protection for intellectual property and protection for the environment.
Professor Bercovitz noted that there was no clear interface between these two issues before 1992. However, after the 1992 Rio Conference, these two issues seemed to be in direct conflict. There could be two primary modes of interface. The first mode is compulsory licensing of environmental technology. The second mode is the sharing of genetic resources.
Should there be new intellectual property rights after the TRIPs Biotechnology Treaty? In Professor Bercovitz's view, this is a problem of the discoverer's rights versus the inventor's rights. The problem involves complex issues of intellectual property rights, contractual rights and sovereign rights. Rights of people in developing or underdeveloped countries should also be considered. Professor Bercovitz suggested that the approach of compulsory licensing should not be used.
Finally, Professor Bercovitz discussed the possible positive and negative effects of IP rights on biotechnology. He also discussed the prospect of utility patent and plant patent for biotechnology and mentioned the issue of ethics regarding biotechnology IP rights.
After Professor Bercovitz's introductory remark, the panel commented on the parallel importation problem in different countries. Professor Bercovitz made some remarks on the two modes of exhaustion, national exhaustion and regional exhaustion. He then talked about exhaustion in trademark and tradename.
The next speaker was the Professor Shoukang Guo from the People's Republic of China. He emphasized China's efforts to enforce intellectual property rights, especially in the field of copyright. Driven by price differential, piracy is still rather rampant in China and it poses a problem for both foreign and domestic goods. However, a newly enacted copyright law criminalizes some aggravated circumstances of piracy. Professor Guo then discussed the problem of parallel importation in China.
The next speaker was Professor Joanna Schmidt from the University of Lyon in France. Professor Schmidt first reviewed the influences of TRIPs on the problem of parallel importation. She then discussed the effects of TRIPs on national and international laws. She suggested that national laws should be kept intact. Therefore, she said, when applying these rules to any country we should ignore some rules due to the national or regional concerns. For example, an importation might not be considered infringement to the importing country but would be infringement to the European Community (EC) as a whole. She further discussed the two exceptions of Article 3 and 4, i.e., the treatment between members of TRIPs and the favored nations. She then discussed the impact of TRIPs on intellectual property rights for those unauthorized importers. She offered two possible solutions. First, we could block parallel importation on the basis of IP infringement but due to the exhaustion rule, it may or may not be infringement. Second, we could use a contract between the IP holders and licensees. But due to the complexity of laws, some practices of contract laws may have an impact on IP contracts in international commerce. In EC, the parallel contract is not valid.
Dr. Bojan Pretnar stressed that in Slovenia laws vary from region to region, especially in IP and trademark laws. He also emphasized some specific problems of small countries. For example, a small country would prefer the localization of producing goods because of the small market. Therefore, he stressed that there should be no uniform solution globally, instead, we should consider the special situation of different countries.
Professor Vito Mangini said that the concept of trademark is still developing in Italy. He talked about some Italian cases and stressed that any new problem would be important because of the EC market integration. He then talked about some aspects of national law and Article 6 of TRIPs. The European Community law does not limit the licensee's exclusive rights, and therefore there is no conflict with local sovereignty.
Professor Edmund Kitch said that Article 6 of GATT-TRIPs (trying to define what is or is not the legitimate notion of exhaustion) should be adopted. The U.S. approach is based on the notion of territorial safeguard, and therefore should have a separate doctrine of exhaustion. However, the doctrine of exhaustion is limited. It derived not from IP laws but from the principle of restrictive distribution in antitrust law. There is some law and economic debate on the desirability of such a distribution system. The goal is to give the lowest possible price to the consumers but the manufacturers also need some incentives to promote consumption education about products. Without a restrictive distribution system, the manufacturer might not get into the market in the first place. He then discussed the long term impact of parallel importation on the value of exclusive distribution system and the possible adoption of a doctrine of international exhaustion.
The final speaker was Professor Bernt Hugenholtz. He first commented that Microsoft and the proposed information superhighway network were the major driving force of software protection in parallel importation or exhaustion. But due to easy access of information on the Internet, it is hard to stop the informational transformation. For the purpose of European harmonization, the enabling right was not implemented. Some courts' decisions did not apply to the enabling right directly and applied the international exhaustion rules instead. However, in EC countries the domestic principle of exhaustion was favored in extending the notion of reproduction. He suggested that the exhaustion right should be applied to modern technology without worrying about the original right owner.
Professor Bercovitz then commented that Article 6 did not solve the problem and the international exhaustion principle was not recognized in several important jurisdictions. Christopher Heath commented on the application of the international exhaustion principle in Japanese and German courts. He noted that if an invention was not patented in both countries, the exhaustion principle will not apply. But the Japanese courts always uphold the exhaustion principle in trademark cases.
Professor William Cornish commented that the principles of exhaustion and parallel importation are not necessary the same. The principle of exhaustion is a problem of the initial scope of the right. This is especially true in trademark and copyright laws. When applying the exhaustion principle, it is not a problem of trademark or copyright, but rather a problem of the scope of protection.