16 PARTIAL REVISION OF SWISS PATENT LAW...BIOTECH PATENTS The economic and scientificsignificance of biotechnology has increased enormouslyand will continue to grow. Now that itspatent law is being revised, Switzerland will increasinglybenefit from the growing importance ofthis field.Heinz MüllerThe patenting of biological material or even of livingorganisms is not a new phenomenon. Although thenumber of patent applications has increased sharplyin the last few decades with the expansion of molecularbiology, a living organism was patented way backin 1873. This US patent was issued to Louis Pasteurand covers not only the method for preparing a sterileyeast culture for beer manufacture but also the yeastitself. The first patent applications for plants followedat the end of the 19th century, and the first patent applicationsfor genetically modified organisms werefiled in the early 1980s.PATENT PROTECTIONHIGHLY IMPORTANTSince that time, biotechnological inventions have beenthe subject of numerous international, European andnational patents, some of which have been filed by<strong>Swiss</strong> companies. Because the economic importanceof the biotech industry has grown enormously in theinterim, the significance of patenting biotech inventionshas also increased enormously and often representsone of the most important assets of a start-upcompany.Current <strong>Swiss</strong> patent law, however, does not sufficientlytake into account the fact that inventions inthe area of biotechnology involve biological material.Biological material is reproducible, often highly complex,and sometimes cannot be adequately describedso that specimens must be filed with a patent applicationin order to guarantee disclosure and reproducibility.For this reason, certain sections of the currentlaw must be revised and amended.The goal of these changes is to provide effective andappropriate protection for biotechnological inventions.A patent law revision focusing on the patenting ofbiotechnological inventions has therefore been set inmotion. The plan was to harmonise patent law withEU <strong>Biotech</strong>nology Directive No. 98/44/EC, which theEuropean Patent Office (EPO) has also made part ofits guidelines.The changes listed below are intended to guaranteepatent protection for biological material and methods– protection that is justifiable on social and ethicalgrounds and is also appropriate for the pharmaceuticaland biotech industries and for academic research.EFFECTIVE PROTECTIONA patent is a legal right granted by a governmentfor a limited period of time to prevent others frommaking, using or selling an invention. Patents areboth an incentive and a source of revenue for researchand development, in particular for thoseareas involving high-cost, high-risk inventions suchas for biotech inventions. Furthermore, patentprotection gives companies the competitive edgenecessary to survive in today’s fast-developingand continually changing marketplace.THREE NEWLYFORMULATED SECTIONSThree newly formulated sections covering the area ofbiotechnology will be explained below on the basisof the draft revision of patent law as adopted by theFederal Council in its legislative message of 23 November2005.a) Are genes patentable?According to Directive 98/44/EC, isolated genes assuch are patentable. In Switzerland, however, naturallyoccurring genes would be excluded from patentingunder the new law. This is a restriction of patentabilitythat goes substantially beyond the practice appliedby the EPO. However, it would continue to be possibleto patent “derived sequences” such as the cDNA producedby PCR, under the condition that at least onefunction of these sequences is known. This meansthat the properties and applications of sequences thatare derived from gene sequences must already bedescribed in the patent application. Adding them lateris no longer possible. This is intended to preventspeculative patent applications.b) Are human beings and their body parts patentable?Respect for human dignity shall be guaranteed inthat the human body as such, in any given phase ofits formation and development, is excluded frompatentability. This also corresponds to Directive98/44/EC. In addition, human physical components intheir natural environment shall also be excluded frompatenting, again in agreement with the EU directive.They are also excluded because they are only discoveriesand not patentable inventions.
...POSITIVE FOR BUSINESS AND RESEARCH17This applies to all living things in general: The subjectof a patent is not the living organism in its natural environmentbut a technical teaching as to how humanbeings can utilise nature in a new way for commercialpurposes. The technical beneficial effect makes thediscovery an invention under patent law. On the otherhand, isolated and perhaps technologically modifiedcomponents of the human body outside their naturalenvironment (such as isolated and possibly geneticallymodified blood cells) are patentable.c) Which ethical values are considered in patenting?Except for inventions whose exploitation wouldviolate public order or morality, patent law takes intoaccount generally binding moral and ethical valueswhen issuing patents. However, only violations of fundamentaland therefore permanent values justifydenial of a patent since there are often as many as 10years or more between the time the patent applicationis filed and the date the invention is first exploitedor used. Value systems and standards can changeduring that time. It would therefore be unfortunate orregrettable if a patent were denied for an inventionwhose exploitation becomes unproblematic duringthe potential protection period of 20 years due to achange in social or political values and standards.These fundamental values are not only mentioned inthe general clause quoted above but are also illustratedby explicit exclusion criteria in the new patentlaw. Examples are the cloning of human organisms,chimeras with human germ cells, modification ofhuman germ line cells or unmodified human embryonicstem cells. These exclusion criteria also correspondto Directive 98/44/EC.Professor Heinz Müller isan expert in patents andtechnology at the <strong>Swiss</strong>Federal Institute of IntellectualProperty and alecturer in Medical Biochemistryat the Universityof Basel.THE SWISS FEDERAL INSTITUTEOF INTELLECTUAL PROPERTY...…is the federal competence centre for all mattersdealing with patents, trademarks, designs andcopyrights. The broad range of services offered bythe institute can be divided into three areas: propertyrights, information products and training. Theissuance and administration of property rights isthe institute’s core business. Information productssuch as research into technological developments(novelty searches) and trademark searches are importantmarket-oriented services for our clients. Inaddition to these services, we offer training coursesin all areas of intellectual property rights.@For further information please visitwww.ige.ch