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Contrasting European and U.S. Patent Laws: Issues for the Pharmaceutical Industry
Decision Resources, Inc., Dec 2005, Pages: 15
Patents are the lifeblood of the biopharmaceutical industry, which depends heavily on intellectual property (IP) protection (especially patents and trade secrets) to justify and support its investment in R&D. Although the fundamentals of IP law in the United States and Europe are similar, there are key differences with regard to issues of special concern to the pharmaceutical and biotechnology industries.
In this report, we present overviews of U.S. and European patent law, discuss key differences between them, and examine patent issues relating to the biopharmaceutical industry.
Business Implications
- The European Patent Convention (EPC) serves as a single patent- granting system, but patents granted under the EPC do not become Europe-wide patents; instead, they become a bundle of national patents to be enforced by individual national governments. Because there is no EU-wide patent-harmonizing mechanism, conflict can occur when courts in different countries in parallel cases differ in their interpretations of patents granted by the EPC.
- Key differences exist between U.S. and European patent law that may have repercussions for the biopharmaceutical industry. For example, the issues of ordre public and morality in Europe mean that the European Patent Office (EPO) must assess whether an invention is contrary to morality before granting a patent, nor can the EPO grant patents for new plant or animal 'varieties' or for an essentially biological process for the production of plants or animals.
- Recent changes in patent law and proposed and pending changes will alter the landscape of pharmaceutical intellectual property (IP).
Europe recently introduced a Bolar-like provision, which should simplify the landscape for generic drug companies. The U.S. Supreme Court has taken an expansive view of the equivalent provision, exempting drug companies from U.S. patent infringement charges if their work is related to the FDA regulatory process. In addition, there are proposals for a Community Patent in Europe and for adding EPO opposition-like provisions to U.S. patent law. These provisions, if enacted, will greatly change the patent prosecution landscape on both sides of the Atlantic.
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