Patent landscape of telomerase

The patent documents discussed in this report are divided into four categories depending on the protected subject matter:

Wild-type telomerase

This section presents patents that claim aspects of nucleic acid sequences encoding wild-type[1] telomerase. What is “wild-type” telomerase? For this landscape analysis it is defined as the catalytic protein containing 1132 amino acids in human and homologues in other species. This definition, prevalent in scientific literature and in patents, has been arrived at somewhat arbitrarily. It came about from the first publications describing the cloning of human telomerase (Meyerson et al. 1997e; Nakamura et al. 1997) in which two sequences of telomerase were found, but only one of which had an open reading frame encoding the known motifs of telomerase.

Variants of telomerase

This section presents patents directed to variants (alternate forms) of wild-type human telomerase. Variants come in many different flavors, including: mutations, insertions, deletions, polymorphisms, and RNA splice variants. The first set of patents presented in this section is about RNA splice variants. Two groups initially described RNA splice variants: CAMBIA[1] and Bayer. In the United States, CAMBIA obtained two granted patents, while Bayer appears to have largely abandoned their effort to obtain protection for splice variants, possibly because their disclosure of splice variants was later in time than CAMBIA’s.

Diagnostics

Long before the gene encoding telomerase catalytic protein was isolated, telomerase was recognized as a key regulator of the replicative lifespan of cells. It is fairly obvious that diagnostics for telomerase activity would therefore be of interest for proliferative diseases such as cancer. Diagnostic assays are currently the subject of some interesting patent court cases. For example, in Innogenetics, N.V v. Abbott Laboratories, Fed. Cir. App. 2007-1145, 2007 U.S. Dist. LEXIS 3148 (W.D.Wis. 2007)(Crabb, J.), the accused infringer, the pharmaceutical company Abbott, appeals from an injunction in a challenge to recent court decisions concerning E-Bay and willingness to license.

Stem cells

Stem cell biology is both a fascinating area of research and a controversial one. When hearing the term “stem cell”, most people think of embryonic stem cells, cells that are immortal and also have the potential to differentiate into any of the specialized cells that make up the body. For this reason, it is hypothesized that stem cells may become the basis for treating a variety of diseases, including Parkinson’s disease, traumatic spinal cord injury, Alzheimer’s disease, heart disease, diabetes, and muscular dystrophy.

The selected patents and patent applications were chosen as those with the broadest claims in the area.