Pharmaceutical Patent Application Specifics

In your laboratory, you and your colleagues have developed a novel new drug that has shown promise in some clinical trials. Chances are you’ve burned through many millions of dollars of venture capital in order to get this compound on the market. You know you’ve got quite a bit of steps left to convince the Food and Drug Administration (FDA) that your compound is viable, and that can quite easily saturate your mind. What you don’t want to forget about is that once your compound is approved by the FDA, it’ll be open for reproduction. Generic companies will want to sell it for cheap. Since they didn’t put the work into discovering the compound, they shouldn’t reap the initial revenue from selling it. Therefore, you’ll need to get a patent on that compound.

When it comes to inventing a drug, the regular rules of patent protection are slightly more complicated. First of all, a patent on a drug lasts 20 years. The 20 years is guaranteed so you can replenish your company’s resources, please shareholders and potentially explore another drug paradigm. After the 20 years has expired, generic companies can easily get hold of your compound and sell the compound to consumers at a greatly reduced price. You won’t be able to capitalize on your invention nearly as much.

Unlike other inventions, novel chemical entities (NCEs) as drugs must be characterized in a patent application by particular chemical properties. Describing the NCE’s purpose is not necessary, as it is in the FDA approval process. Instead, the US Patent and Trademark Office (USPTO) is more interested about what makes it novel. There are particular characteristics of the compound that it is most interested in:

1) If it is an analog of a previously patented compound: particularly if it is an isomeric, enantiomeric or crystalized version.

2) If its solubility and particle size is conducive to its bioavailability. Smaller, more soluble compounds are considered favorably by the USPTO.

3) If the compound can be separated into ‘selection patents’, where a particular group of atoms – or a selection – of a compound can be considered novel. In many cases where compounds are developed using combinatorial chemistry, ‘selection patents’ may be applicable.

4) If the compound produces particular metabolites in the body. If it does, and the metabolite has not yet been characterized by the USPTO, there may be an opportunity to both patent the compound and the metabolite it forms.

5) If it requires a prodrug. Prodrugs are active compounds in an organism that can work with a compound to produce a therapeutic response. If a prodrug is involved, then many inventors choose to include it on the patent application.

In addition to clarifying these chemical properties, inventors of NCEs may be able to patent already-existing drugs by changing certain characteristics of them. For instance, a dosage change on an already existing drug may treat another malady. Or, perhaps an inventor discovered an easier, more cost-effective way to produce a natural product artificially. In any case, these method changes, dosage changes or any other changes must be properly described on the patent application. It’s always good measure to be very fluent in describing chemical properties and formulation terminologies before you attack a patent application. It may be beneficial when going after that drug patent to contact a pharmaceutical patent lawyer to make sure you’ve covered all bases. Your investors will most likely celebrate that decision.