Today, we feature a white paper from Ulrich Storz, Ph.D., Esq., Senior Partner, Michalski Hüttermann & Partner, Germany. He will be presenting at the Antibody Engineering Therapeutics Conference. The event will take place December 2-6, 2012 in San Diego, California. For more information, download the agenda.Introduction:
Patent protection for most of the antibodies with large global markets will expire within the next three to seven years, thus exposing the respective drugs to competition by biosimilar manufacturers (Table 1). To protect their market leadership, numerous companies are therefore in a process of developing or already have on the market, second generation antibodies. An invention for which patent protection is sought has to pass particular tests, which are, among others, the novelty requirement, the inventive tep/nonobviousness requirement and the written description and enablement requirement.1 These requirements are, however, not absolute, but subject to constant changes.
The Moving Target:
Antibody engineering and design underwent substantial advancements in the past 20 years, including development of recombinant chimerization and humanization techniques and the creation of libraries, display methods and affinity maturation approaches. However, in a global knowledge society, a method that was cutting-edge technology yesterday may be an industry standard today, particularly with respect to technical disciplines that are strongly influenced by academic research, as is the case with therapeutic antibodies.
This situation is reflected in the increasing scrutiny patent authorities exhibit with respect to antibody-related patent applications. The hurdles are steadily set higher or, as the European Patent Office (EPO) puts it, “the bars are raised.”
Patent protection plays a crucial role in the pharmaceutical industry because of its reliance on rapidly changing technology. Because of high upfront disbursements for research and lengthy clinical development and approval procedures (with the respective outcomes by no means predictable), the industry depends on efficient patent protection to assure a sufficient return of investment. This phenomenon can be summed up in the phrase “no patent equals no product”. To ensure that the scientific development of new antibody drugs will continue in the future, it is thus important to co-develop suitable patent strategies.
Read the full paper here.
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