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TRENDSPOTTER: Pushing a Patent to the Limit

YOU AND your company have discovered a new gene or protein and you want a patent, the question is, how far can that patent extend? Certainly you can claim the isolated gene or protein. You might even be able to claim a protein encoded by a gene. If your gene or protein can be plugged into a standard assay and you describe how to do this, some assay claims may also be possible. But, wouldn't it be great if you could also claim things discovered using that assay!

A number of inventors have tried to do just that, and a few have even succeeded in securing patents with such claims, known in industry parlance as “reach-through claims.”  However, recent remarks by the Patent and Trademark Office make clear that patents with reach-through claims are unlikely to be issued, throwing into question the validity of any previously issued patents offering reach-through rights.

For Patent and Trademark Office purposes, a “reach-through” claim is one that claims a product or a compound identified using a screening assay for a particular activity, including binding to an identified or an orphan receptor or binding to a protein or nucleic acid.

Generally, no specific products or compounds have been explicitly identified.  

For example, one type of reach-through claim involves combinatorial libraries. Because each claimed library or claim to an individual member must have a specific, substantial, and credible utility under the PTO's new utility guidelines (“TRENDSPOTTER: What the PTO Means by ‘Utility,’” March 23, 2001) a claim to the library as a whole may be supported, but claims to individual members of the library may not be.

Additionally, because the PTO's new written description requirements make clear that possession of a genus does not necessarily imply possession of individual species of that genus, claims to individual species may fail to meet that requirement as well.

Therefore, an application that only discloses a combinatorial library is entitled only to claims that will prevent others from making, using, or selling the library itself, not its individual members.

If protection is desired for individual members or a sub-genus of the library, such members must be specifically identified and described. Otherwise, a claim to the individual member or sub-genus is a reach-through claim and will not be allowed.

Similarly, disclosure of a receptor does not entitle an inventor to claims for a drug that may be identified using the receptor in a screening assay unless the application also includes a specific description of the drug itself.  However, claims to the receptor allow the inventor to prevent use of the receptor itself in such a screening assay and, therefore, give the inventor some leverage for obtaining compensation for drugs developed using the receptor.

The disclosure of a receptor likewise fails to support claims to a receptor agonist.  If claims to an agonist or a drug are desired, some definite description of the physical characteristics of the agonist or drug must be included to satisfy the written description requirements.  

Additionally, the application should provide adequate teaching of how to make and use the full scope of receptor agonists or the drug, and also at least the structure or physical or chemical characteristics of a representative number of receptor agonists or the drug. Such requirements are rarely met by a disclosure intended to describe a receptor. Absent a very thorough description of the agonists or drugs discovered using a particular receptor, claims to these drugs or agonists may not be patentable.

There are numerous other examples of reach-through claims based upon genomics inventions. As a rule of thumb, inventors should not expect to obtain claims to anything that does not include the newly discovered gene or protein. The primary exception is in the rare cases when the type of biological molecule or chemical likely to bind to the gene or protein is readily apparent based upon examination of the gene or protein itself and can be described in some detail.

Rochelle K. Seide is a partner at the law firm of Baker Botts, where she specializes in biotechnology, intellectual property, and patent issues. She also has a PhD in human genetics. Michelle LeCointe is an associate at Baker Botts and a registered patent agent. They can be reached at [email protected]  and [email protected] .

TrendSpotter is a weekly column that focuses on how trends in politics, patent law, and the US and European markets will affect the genomics industry. The column appears every Friday. 

To access previous columns just enter the word "Trendspotter" in the archive search window on the homepage.     

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