About Patented Tests
In order to run a patented test, the laboratory has to be licensed by the patent holder. In some cases, the patent holder will not license it and therefore, they have exclusive rights to the test. This enables them to charge exorbitant fees to the client. There are ways around patents though, thanks to new legislation. This enables Heli-Gen to offer sequencing of the region around and including the mutation whereby the client can have the results of patented tests at greatly reduced fees. Since you are looking directly at the unadulterated DNA sequence, the sequencing results are also more accurate than many other types of testing. The following are the legal reasons we can offer sequencing for these patented tests:
1. Specific genes (or "raw DNA sequences") cannot be patented. See AMP v. Myriad.
2. Raw-data DNA sequencing and PCR are some of a category of known techniques that are either not patent eligible or are covered by expired patents.
3. The area of patent law related to methods of utilizing the testing of specific gene mutations to diagnose diseases is evolving and unsettled. For instance, the Supreme Court has held that diagnostic correlation claims are not patent eligible (see Mayo v. Prometheus), and the Federal Circuit has just recently held that neither DNA primers nor methods of comparing specific DNA sequences are patent eligible (see Ambry v. Myriad). However, the courts have yet to decide on the patentability of a more complex method of tying a specific gene mutation to a specific disease diagnosis, and have specifically commented that methods drawn to "applications of knowledge" of specific genes are likely patent eligible. The test for making such a determination can be found in Alice v. CLS.
Heli-Gen is absolutely able to practice general testing techniques, which includes utilizing PCR and sequencing to yield raw genetic data. Heli-Gen may also perform comparisons of specific sequences to determine the existence of publically known alterations.
However, when it comes to "applying the knowledge" of said sequencing, for instance, to diagnose an animal as being genetically normal, a carrier of, or predisposed to having a disease by performing the above known techniques to determine the known information might be considered as infringement.
It is noted that nothing prohibits Heli-Gen from performing routine DNA sequencing, and providing the raw data to a customer, wherein the client could, on his/her own, use that information to determine whether their animal is predisposed to disease (see, e.g. the combination of 23andme.com and promethease.com). However, any direct facilitation towards that end (e.g. by providing a database for the customer to enter the information, or by providing instructions to the customer on how to use the raw DNA data) might be seen by a court as infringement. There are many ways that clients can obtain this information though.
Genes themselves, and simple methods of comparing gene sequences, are not patentable. However, a more-comprehensive method of diagnosing a specific disease by looking at a specific gene sequence/mutation is potentially patentable, that is, telling the client that the animal is positive for the disease and therefore is making a diagnostic statement. The client has many resources with which to determine the diagnostic relevance of the mutations or lack thereof in raw sequence, including the published papers on each disease which are referenced on this website or by contacting local universities with programs in genetics, and having them interpret the results as referred to in the scientific paper. Breed registries may also post keys to interpretation for their members to use. We're certain that breeders will soon follow suit.
Depending on the continued prosecution of patent laws, Heli-Gen hopes to be able to furnish interpretation of the patented tests in the near future.
Note: Older patented tests may not fall under this category since some of them patented the technique used for the test and not the interpretation of the findings. In these cases, Heli-Gen will be able to furnish the interpretation of the results.
NOTE: Diagnostic analysis of some older patented tests is perfectly legal due to the language in their claims. Only patented tests that are sequence only without diagnostic analysis are marked with an asterisk.