Vanda Pharma v. West-Ward Pharma Int'l: Tips for Life Sciences

Vanda Pharma, Inc., v. West-Ward Pharma Int'l, Ltd., was decided in 2018 and it includes some important tips for those seeking a patent in the life sciences. Despite being an excellent source of review for ANDA and generic patents, it also includes information regarding how to help a life sciences patent pass scrutiny under 35 USC § 101 (i.e., patent subject matter eligibility). For example, below is a list of tips gleaned from the case. Doubtless there are more hidden gems in there, but these are among the most valuable: 

Tips: 

1. A method of treatment is more likely to be patent eligible than a diagnostic method. 
2. A technique that is based purely on relationships within a biological system (e.g., concentrations of a drug within the body) and likely outcomes based on those relationships (e.g., likelihood a dosage concentration would produce harm) is less likely to be patent eligible. 
3. A specific method of application, administration, or treatment using a specific compound at a specific dose to achieve a specific outcome is likely to be patent eligible. 
• Tip number three may hold true even if the specific compound is an already existing drug, as long as there is a new way of using the existing drug (e.g., refined treatment) that produces an unexpected result. For example, a new administration of an existing drug that is safer because it reduces the chances of a negative side effect is likely to be patent eligible. 
4. Naturally occurring traits, characteristics, or parts of a biological system, even if slightly modified, are unlikely to be patent eligible (e.g., DNA or cDNA). 
5. A method or technique that is phrased in a patent claim so broadly that it prevents additional improvements to the drug, its use, or its administration is unlikely to be patent eligible because it "preempts" the field and hinders the progress of science. 
   

Significantly, passing scrutiny under 35 USC § 101 does not mean that the other statutory bars will be passed (e.g., 35 USC §§ 102, 103, and 112). Each of the other statutory bars must be properly addressed for the patent to issue. However, passing § 101 is a significant achievement, especially in the life sciences. 

As previously mentioned, there are additional legal gems within this case, including a few tips on Federal Subject Matter Jurisdiction in cases involving the Hatch-Waxman Act, Paragraph IV certification, and ANDA filings for generic pharmaceuticals. However, hopefully you will find the above-mentioned tips useful in directing your research and your efforts to protect it.