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Section 101 Examples Example 16 (8): Antibodies This is an example provided by the U.S. Patent and Trademark Office for analyzing Section 101 patent subject matter eligibility issues. The example is one of the "Nature Based Product Examples" provided by the USPTO on December 16, 2014. The original PDF document is found here. The numbering of these examples is taken from Appendix 2 of the July ...

The bottom of Figure 2 and the text below set out the hypothetical claims provided by the USPTO for this example that focuses on antibody claims. For each of these claims, the figure shows the flow of the analysis leading to the final USPTO determination (i.e. the eligibility path). The analysis focuses on whether the claimed antibodies and antibodies found in nature is a marked difference ...

Many patent applicants currently face difficulty in obtaining antibody claims because of written description and enablement rejections under 35 U.S.C. §112(a). The USPTO routinely rejects claims ...

We examine approximately two decades worth of antibody patents to determine how the US Patent Office has dealt with them. Specifically, we examine a sample of every patent directed to an antibody composition of matter from 2001–present. We find that patent examiners have steadily increased the use of 35 U.S.C. § 112(a) enablement and written description rejections while slightly decreasing ...

The USPTO and EPO examine antibody claims for patent-eligibility, clarity, support and enablement, novelty and inventive step. However, despite the efforts of WIPO’s SCP, the USPTO and EPO significantly differ during examination of antibody patent applications in their determination whether or not an antibody claim meets these requirements.

Matter Eligibility Under 35USC § 101” PowerPoint of April 16, 2014, exacerbate the problem. F” in the personalized medicine, but the claim is not to a pure personalized medicine method. In essence, Example F instead addresses the patent eligibility of an “antibody XYZ”, which the Guidance

Antibody patent applications are subject to similar standards for patentability as chemical compound inventions. On a basic level, a patent application for an antibody needs to satisfy novelty, nonobviousness, written description and enablement requirements to be patentable.

The rise of antibody-based treatments in the pharmaceuticals market has been accompanied by developments in U.S. patent law that may adversely affect the scope of intellectual property protections available for such treatments. Some of those developments concern the basic patent eligibility requirement of 35 U.S.C. § 101.

Is the USPTO now stricter than the EPO on antibody claims? A consideration of recent developments from both sides of the pond. Patent protection for monoclonal antibodies, bispecific antibodies and nanobodies, as well as CAR-T and CAR-NK cells may represent an important aspect for a company’s intellectual property position. Companies seeking protection in the United States should consider ...

The USPTO in the Written Description Guidelines reasoned that further requiring patent applicants to structurally specify the claimed antibodies other than its specific binding affinity to a certain antigen would impose undue burden to innovators.

The memo notes that some of the USPTO’s written description guidance pertaining to antibody claims is therefore outdated and advises that additional written description examination guidance is forthcoming. The upshot is that innovators will now find it much more challenging to obtain broad protection for new antibodies.

Stringent patentability requirements present a challenge to obtaining broad-based antibody claims, so companies should develop a strategy based on multiple reinforcing layers of protection.

Overview of Patenting Antibodies in the EPO and USPTO Over the past 40 years, antibodies have become a significant class of therapeutics. Big molecule pharmaceuticals, such as antibody drugs, are associated with even greater costs in the drug discovery phase than small molecule pharmaceuticals. Therefore, if you are an SME looking to develop a novel antibody therapy, the stakes are particular...

Long gone are the days of the “newly characterized antigen” test which provided an exception to the general written description rules at the USPTO for antibody claims.

Many patent applicants currently face difficulty in obtaining antibody claims because of written description and enablement rejections under 35 U.S.C. §112 (a). The United States Patent & Trademark Office (USPTO) routinely rejects claims as too broad, arguing that such claims cover more antibodies than the specification discloses, or that undue experimentation would be needed to determine ...

The United States Patent and Trademark Office (USPTO) Patent Basics webpage provides a helpful overview to the Patent life cycle, including essential information you should do before, during, and after the patent application process.

Stringent patentability requirements present a challenge to obtaining broad-based antibody claims, so companies should develop a strategy based on multiple reinforcing layers of protection.

A powerful, flexible web-based patent search application that improves the overall patent searching process. It includes two user selected interfaces that provide enhanced access to prior art.

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