Patent Pending: Session 2
By: Sam Sakells
Did you know that not all patents are equal? You might assume that simply having a patent for your invention is good enough to build a company (and it very well might be), but did you know that the quality of your patent can also play a crucial role in your success?
In "Session 2: Patenting with Purpose", we discussed the characteristics of a strong patent and how patents may (or may not) hold up in court during patent litigation. We concluded the session with a discussion of when we should patent our invention and how we as scientists can help IP professionals draft a strong patent application on our behalf.
As always, get comfortable and join me as I review this course session with you!
Session 2: Patenting with Purpose (Content Review)
Discussed Topics
Understanding Patent Litigation
Patent Prosecution for Strong Patents
Timeline Considerations for Patents
Understanding Patent Litigation
Why is a patent useful?
Patents can be useful for a variety of reasons. Here I've listed some of the common ways that patents can be useful when founding a biotech company. You might have guessed a few of these reasons already, but before this session, I didn't fully appreciate all the different reasons why you might want a patent on your invention.
- By patenting your invention, you earn the right to exclude others from making, selling, using, or importing your product. This essentially gives you a temporary monopoly over your invention, and it can be useful in preventing competitors from profiting from your invention and reducing your market.
- Patents can help you generate revenue for your company. Investors may be more likely to fund you if they know your invention has been patented.
- Patents are intangible assets. Patents can have monetary value and even be used as collateral for loans. This also means that in the event of bankruptcy, patents are viewed as valuable assets to either sell, auction, or license.
- Patents can help with your marketing image. Once you file for a patent, you should mark all your products with "Patent Pending" or eventually, "Patented", if you are granted the patent. This could help with your overall image.
What is the difference between patent prosecution and patent litigation?
While patent prosecution and litigation may sound like intimidating legal jargon, don't worry; these are both easy concepts to understand. Patent prosecution is the process of filing for a patent with the United States Patent and Trademark Office (USPTO). Patent litigation is the process in which one party sues another party for patent infringement.
Thus, patent prosecution comes first to issue a patent, and then patent litigation may come later if someone has infringed on the patent.
How do you enforce your patent?
Patents are not self-enforcing. This means that you need to sue another person or company for patent infringement to enforce your patent.
Are all patents litigated?
This section of the course really shocked me. Not all patents are litigated. In fact, it's actually very rare for a patent to be litigated. Out of the 375,000 U.S. patents issued each year, only about 4,000-6,000 new litigation cases occur each year.
The main reason for this discrepancy is likely because patent litigation is VERY expensive. For reference, if everything in the case goes relatively smoothly, it will likely still cost over $4 million.
Furthermore, patent litigation is unpredictable. Even with a strong argument, you could still end up losing the case, which would result in millions or billions of dollars wasted.
To better understand patent litigation, we went over a few example cases in class, so I decided to summarize one of the cases below for your reference.
Patent litigation case study: Idenix Pharmaceuticals LLC v. Gilead Sciences Inc. (2016)
Case Details:
Idenix and Gilead were both developing drugs for treating hepatitis C virus (HCV).
Idenix alleged that Gilead's drug, sofosbuvir, infringed Idenix's patent.
Gilead stipulated infringement but argued that Idenix's patent was invalid because it did not demonstrate enablement.
Basically, Gilead said that if Idenix's patent is valid, then they infringed. However, Idenix's patent should not be valid because there is not enough detail in their patent so that someone in the field could make or use their invention without undue experimentation.
Outcome:
The jury sided with Idenix and awarded ~$2.5 billion in damages.
Gilead filed a JMOL motion (Judgment as a Matter of Law) after losing the trial.
Basically, Gilead continued to argue that Idenix's patent was invalid due to lack of enablement, and the judge should review this case because it is a matter of whether Idenix's patent met the legal requirements for enablement. Because this is a legal question, rather than a factual question, the judge can make this decision.
The judge overturned the jury's verdict and found Idenix's patent to be invalid due to lack of enablement, thus also removing the ~$2.5 billion in damages.
Conclusion: Even though Idenix was the entity suing Gilead for patent infringement, Idenix ended up losing their patent altogether along with all the money they spent during the patent litigation case.
Patent Prosecution for Strong Patents
What makes a strong patent?
As I mentioned in the last blog post, the most important parts of a patent are the claims. A strong patent will have claims that are broad enough that you prevent people from making similar technologies, but not so broad that the patent is invalid.
It is generally a good idea to first draft a patent with broad claims and slowly narrow the claims until the patent becomes valid. You don't want the claims to be too broad or too narrow!
However, don't worry if you're not sure what details for your patent are too narrow or broad to be included in the patent application. Patent attorneys are paid to navigate this gray area, so they can provide you with suggestions and advice.
What support is available to scientists who want to file for a patent?
You should work closely with your university tech transfer office throughout this entire process. The tech transfer office is there to support scientists at the university and ensure that inventions with commercial potential are patented.
At UT Southwestern, we have the Office for Technology Development (OTD) and the Innovation Hub available to help scientists at the university navigate intellectual property (IP) protections and commercialization of their inventions. Be sure to check out their websites to learn more about OTD and the Innovation Hub.
Outside of OTD and the Innovation Hub, you would also likely work closely with a patent attorney. Again, OTD would streamline this process, but be sure to provide OTD and the patent attorneys with all details of your invention to help them prepare the best patent possible.
What is an Intellectual Property Questionnaire (IPQ)?
If OTD is interested in patenting your invention, you will likely be asked to complete an Intellectual Property Questionnaire (IPQ). An IPQ is basically just an information sheet that allows the inventor to provide as much information as possible to OTD and the patent attorneys. This course session stressed the importance of including as much detail as possible in this form. This is the time to list anything and everything about your invention including:
Technology use
Anything unique about your invention
Description of why your invention is better or different from previous technologies
Problem solved by your invention
Timeline Considerations for Patents
What is the ideal stage of product development to file for a patent?
I don't think there's one specific stage that's perfect for everyone, but there are some considerations for determining when it might be good for you to file for a patent. The optimal time is when you have enough information to support your patent, but you have not yet made a public disclosure.
You want to have as many details about your invention as possible before filing for a patent because it can help ensure that the patent is representative of the invention. Imagine a scenario where you file for a patent too early, and then your invention changes after further optimization. The original patent wouldn't be an accurate representation of your invention, and you might even need to file another patent application.
However, you also don't want to wait until after you've made a public disclosure because this could prevent you from being able to secure a patent for your invention altogether.
How long does it take to get a patent?
The exact timing can vary, but most patents take at least 2-3 years after the nonprovisional filing.
Conclusion
I hope this session has shown you that patent law can have major impacts on our science and its ability to be translated into real-world applications that help patients. I don't necessarily think we all need to be patent law experts; however, I think it's important that we at least learn the basics of patent law. Knowing the basics can at least help us understand how to work with the tech transfer office and patent attorneys to get our inventions patented. Keep in mind that the strongest patents typically result from clear communication between the inventor(s), tech transfer office, and patent attorneys.
In the next blog post, we will be diving deeper into the commercialization side of things as I review how patents impact business development. Stay tuned to learn more!
Acknowledgements
I would like to thank everyone at Norton Rose Fulbright, the UT Southwestern Office for Technology Development, the Innovation Hub, and my teammates in the Biotech Club. Each of you inspires me every day, and it is an honor to work with you all on this course and blog series. Today, I'd like to give a special shoutout to Talbot Hansum for leading this course session and providing us with insights into patent litigation!
Lastly, I'd like to thank you for reading today's blog post and learning about patent law. I'll see you in the next post!