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.

How to File a Patent Application

Haven’t you ever wondered why a light bulb appears over a cartoon’s head when they get an idea? Well it’s no coincidence that an idea and a light bulb are so closely related: the inventor of the light bulb, Thomas Edison, is probably one of the most famous idea makers in history. Well, he inspired a wave of invention that’s just getting bigger today. When an invention is made, though, there are many opportunities for the public to try to reproduce it and earn money by selling it. If you’re the inventor of a product, chances are, you don’t want that to happen. That’s why getting a patent is useful to the inventor. A patent will consider an invention to be the sole intellectual property of the inventor or anyone who may have purchased the idea from the inventor.

Patents are filed through a government organization called the US Patent and Trademark Office (USPTO). The USPTO has developed many rules and regulations to determine if an invention qualifies for a patent. They require that a formal application is filed before a patent is considered for an invention.

Unlike other government applications that may be familiar to the average American, this is no simple one-word-answer-oriented application. The application will ask the inventor to describe the application using the codes and regulations found in a number of documents, including the US Patent Classification System, the Manual of Patent Examining Procedures, the United States Code (title 35), and Rules of Practice in Patent Cases (37CFR). The USPTO offers guides for filling out a patent application and offers some limited live help.

The application will require a number of things, the most important of which are listed. First of all, it will ask for the background of the invention, particularly how and why it was generated. The purpose of the invention is important to list in this section. It will require you to elaborate how exactly the product works in a summary and a detailed description of the invention. The description must be concise and accurate and include instructions about how an average human not familiar with the invention characteristics would go about developing one of their own. The claims part of the application will be where you describe what exactly you want the patent to protect. The rules and regulations of the USPTO are to be used very carefully here, because any lawsuits related to your invention will revolve around the protections you describe here. Finally, if you are inventing a device, you’ll need to include drawings of the device. The drawings must be completed in india ink and must show every feature of the invention.

The above requirements are for a utility patent, which is what most inventions are. If you’re not creating a non-live physical entity, you will fill out an application for a utility patent. There are two other types of patents: a design patent and a plant patent. A design patent, which is granted to creative changes to an already existing object, requires a much more visual-oriented application. Rules require there to be drawings of the decorative changes made to the object and possibly photographs. Similar to the utility patent application, a claim must be made on the invention. Keep in mind that in this case, only one claim is allowed.

A plant patent is given to plants or seedlings that have either been discovered by an individual or genetically engineered. The application, in this case, is much more similar to the utility patent application. The background and description of the plant are described similar to the way a utility invention is, except biological terminology must be used. In addition, the inventor must be able to argue that the plant is stable and safe to propagate. Drawings of the plant can be included, but there is no need to illustrate the plant’s use.

The application must be turned into the USPTO in full with an application fee which varies based on the nature of the application. The USPTO website contains up-to-date fee schedules for inventors to review. Due to the complicated nature of the application, many people choose to have a patent attorney examine their application and suggest alterations. In any case, without a good patent application, you may not get a patent that recognizes your hard work.