Top 10 Considerations for Medtech Inventors
If you or your employer is interested in protecting an invention, then filing a patent application may be the way to go.
Whether you work in a contract manufacturing facility or for an original equipment manufacturer (OEM), you may have invented something. The invention could be an apparatus, a manufacturing method, an algorithm, or even a chemical compound. If you or your employer is interested in protecting the invention, then filing a patent application may be the way to go. Following are the top 10 items an inventor should consider when pursuing a patent.
1. Document your invention: Once you come up with an invention, it’s always a good idea to document your invention in a laboratory notebook or use the company’s standard invention disclosure form. Documenting the invention will help prove when it was conceived if potential future disputes require a conception date. Try to describe the invention in words and figures in enough detail that it is enabled (i.e., a person of skill in the art could read your description, understand it, and then duplicate the invention without undue experimentation). Many companies also reward employees for inventing and require an inventor to submit the invention in writing to an intellectual property committee, so writing things down will facilitate employee recognition programs.
2. Conduct searches: Preparing and filing a patent application can take a significant amount of time and can also be expensive. Therefore, time and budget permitting, before spending resources on a patent application, conduct prior art searches to see what the closest art is to your invention. This will give you a better picture of how likely you are to get a patent granted and also what the scope of protection provided by any patents you obtain are likely to cover. Additionally, searching may also identify relevant patents that represent freedom-to-operate (FTO) issues that could block you from practicing your invention. Therefore, searches are generally a good idea.
3. Obligations to an employer: Just because you invented something does not necessarily mean you own the invention. Most inventors are employees of a company and, if you look carefully at the forms you signed when you first started working for your company, chances are you signed an employment agreement that obligates you to assign any inventions you develop as a part of your job to your employer. Even if you did not sign anything obligating you to assign your invention to your employer, if you used your employer’s resources to come up with the invention, the employer may still have rights to your invention. Each state has its own laws regarding ownership of inventions so it is important to understand what your obligations to your employer are.
4. Work with a professional: Many inventors try to prepare and file their own patent applications. Unless you have done a lot of this in your career or had formal training, it is generally not a good idea for an individual to file his/her own patent application. A patent application is a legal document that has to withstand examination and scrutinization by the U.S. Patent and Trademark Office (USPTO). Additionally, once issued, the patent may have to survive challenges in court, and thus, it must be understandable to a judge and a jury, while also being technically accurate. Therefore, it must be robust enough to survive many challenges during its 20-year life. You would not perform a medical procedure on yourself, so don’t prepare your own patent application unless you really know what you are doing.
Seek out professional assistance from a registered patent agent or attorney. Patent agents are licensed to prepare and file patents with the USPTO, but are not attorneys. Similarly, a patent attorney is licensed to practice before the USPTO, but is also a lawyer licensed to practice law. These professionals may charge anywhere from $100 or $200 an hour or as much as more than $1,000 an hour, so it pays to do your homework and find a patent agent or attorney with expertise related to your invention.
5. Sign documents promptly: During the patent process, your patent attorney will send you various documents such as a patent assignment, an oath or declaration, and possibly other forms. There may be hard deadlines for filing some of these documents while others (e.g., an assignment) does not have as rigid of a deadline.
Nevertheless, it’s generally a good idea to promptly sign documents provided to you by your patent attorney and return them so they may be filed or recorded with the USPTO. In some cases, failure to sign a document can result in abandonment of a patent application, or may create problems with ownership. Given the fact some employees change jobs quite frequently, it can be hard to track down inventors once they move on, therefore, try to sign documents promptly.
6. Provide timely feedback to your patent practitioner: Timing can be critical in filing a patent application. Delays in filing can lead to loss of rights, interfere with a product launch, or affect advertising of the product. Therefore, it is critical to keep the patent application process moving forward. Your patent attorney or agent will send drafts of the patent application for review and comment. It is very important for you to review and give feedback in a timely manner. Your attorney or agent will know how to handle the legal aspects of the patent application, but there is no substitute for your technical expertise. Your attorney or agent will want to ensure your invention is described in a manner with which you are comfortable and is technically accurate. The fewer delays caused by review will result in a streamlined drafting process.
7. Mark your products with appropriate patent language: After filing a patent application, you are likely to have to wait several years until an issued patent is in-hand. If you produce any products that would be covered under your pending patent application, however, you are allowed to mark your product with “patent pending.”
Marking a product with “patent pending” does not confer any rights to the patent application owner. It can, however, offer advantages such as alerting potential competitors that if they do copy the invention, they may be subject to a lawsuit in the future. Additionally, some consumers may find it appealing to see that a product has a patent pending. If your patent application is no longer pending (e.g., it becomes issued or is abandoned), it is wise to remove the “patent pending” label from your product.
Once a patent is granted, the product can be marked with the number of the patent that covers it. Marking the product can allow you to collect damages for infringement for a time period before you actually file a lawsuit against an infringer. Current patent laws further allow products to be virtually marked with a website address that refers to the patent. If your patent lapses or expires, you must remove the markings or you may be liable for “false marking.”
8. Consider filing new patent applications for improvements: As stated previously, after filing your patent application, you are likely to have to wait several years until you have an issued patent in-hand. During that time, you might improve your invention. It is to your benefit to keep track of these improvements so you can continue to file patent applications to protect these improvements in subsequent patent applications. You may be able to take advantage of your existing patent application and weave the improvements into that application, or the improvements may require new patent applications. Your patent practitioner can provide guidance on how best to handle improvements.
9. Be realistic about timing and budgets: The timing and costs associated with filing a patent can vary. It is good to have a discussion at the outset with your attorney or agent to devise a budget. Keep in mind that beyond the fees for drafting and filing the patent itself, there may be further fees associated with prosecuting the patent before the USPTO where your attorney or agent will be arguing for the patentability of your claims. Also, you may want to file your patent application internationally. Each country has its own filing fees and attorneys in individual countries will also have their own fees. It may be good to determine, to the extent possible, how many countries you want to file in ahead of time so you can budget properly. Some countries have a variable fee scale depending on a company’s size where smaller companies pay reduced fees. Be sure to let your attorney or agent know what your company’s size is ahead of filing and if the size changes during prosecution of the patent.
10. Avoid public disclosure of your invention: Once you invent something, it’s generally a good idea to avoid publicly disclosing the invention. Examples of public disclosure may include presenting the invention at a conference, showing a prototype at a trade show, or publishing a paper about the invention. Public disclosure of your invention before filing a patent application may preclude your ability to obtain a patent on the invention since the public disclosure occurred before you filed your patent application. Some countries provide a grace period (e.g., the U.S.) that allows a patent to be issued even if you publicly disclosed the invention before filing the application, while other countries do not provide any grace period. Therefore, if you publicly disclose your invention before filing a patent application, you may be giving up your international rights. So it’s prudent to file a patent application before publicly disclosing the invention.
These are only a few of the considerations to balance when deciding whether or not to pursue a patent. There are naturally more issues that can arise during the process and different inventions can require different drafting strategies. Always remember there is no substitute for good communication between you and your attorney or agent; patent drafting is a highly collaborative process.
This article was originally published in MPO (Medical Product Outsourcing) Magazine. Re-published with permission.