While it may not be thought of first, another company's IP is almost as important as your own. Depending on its scope, another company’s IP could limit your innovations and growth. Being aware of how others' patents affect you is very important for a startup.
Knowing what competitors have in their own ‘IP toolbox’ will help you succeed and innovate without infringing upon anyone’s patents.
Intellectual property (IP) is very important for a growing life science company. IP allows a company protection and assurance that their product will not be copied or stolen.
For a life science company, a patent strategy will help you on your journey to achieving your business goals. The first step of this journey is generally to protect your product or service. This is essentially securing the patent and its protection for your product/service. This protection could be broad, intermediate, or specific, depending on the way the patent is worded.
The second step of formalizing your IP is analyzing your patent’s landscape. This is Freedom to Operate (FTO). FTO is important for potential investors because it gives them a glimpse of your IP scope. Maintaining an effective patent strategy will help biotech startups find funding and have a smoother exit.
Requirements for Patentability
Four requirements must be met for your invention to qualify as a patentable invention. Some are more straightforward, and others require more thought and research.
- Subject matter eligibility
- Inventive or non-obviousness
- Satisfactory Detail
Subject Matter Eligibility and Satisfactory Detail
This article will not focus on subject matter eligibility as much as the other requirements. Subject matter eligibility is a basic question of whether or not the idea is patentable. In many cases, if a patent fulfills the novelty and inventive requirements, it will fill the subject matter eligibility requirement. There are certain judicial exceptions to what can and cannot be patented. For example, one can not patent a law of nature.
In addition to subject matter eligibility, an awarded patent requires satisfactory detail. The patent should be comprehensive enough that a skilled person in your field could recreate it themselves.
Novelty and non-obviousness are the main focuses of this article. These are also the 2 most important requirements when trying to determine your FTO.
The novelty requirement is put in place so that one can not patent prior art. Prior art is the evidence that shows the public already knows of your invention. An invention is not new/novel, if the public has knowledge of the technology before the filing date. If you want to read more about filing dates and how to navigate them, click here.
A great metaphor for patent novelty is puzzle pieces. Suppose a previous patent has 4 claim elements, each of which is a puzzle piece. If you completely copy all 4 puzzle pieces, your patented claim will be considered invalid. But, if you add a puzzle piece, it may be considered new and novel. Another way to have novelty is to remove a puzzle piece from the previous claim.
However, adding and removing claim elements is not a surefire way of approving a patent. For each element you add, you need to complete additional research to ensure that there is not prior art that has claim to that element.
To be obvious, references must have every element of an invention, plus some reasoned basis for combining the references. References are evidence that a patent examiner will use to determine if your patent meets the non-obvious requirement.
If the examiner can find proof that prior art and evidence point to the existence and knowledgeability of the patent material, it is obvious. This proof can be from one or more sources, as long as they date before the application date. In simpler words, if someone of average skill in the subject is able to consider the patent material already known, then it is obvious.
Obviousness is arguably one of the most difficult parts of filing a patent. You will need to do your own research, or hire a researcher to look for current patents and patent applications. Beyond that, you need to research articles and journal entries in your field to make sure that your patent is truly inventive and unknown.
For more information on how to apply for patents and trademarks, check out this article.
What About After Rejection?
Your patent may be rejected because the examiner has found a journal article or a past patent with aspirational language pertaining to your patent. But, there are ways to get past a rejected application.
Showing original data is a great way to show that you are novel and non-obvious. For example, your patent may be for a certain drug combination that has been alluded to in previous works. This could be language like ‘this combination could work’ (key word being 'could'). This language shows a previous work that has a claim to your potential patent. But, a way to show that you are original and non-obvious is to present findings catered to your specific dose etc. This works best with significant results, which are often easier said than done. The drug combination example is specifically for pharmaceuticals, but it is relevant to all patent filings.
Also, keep in mind the US Patent and Trademark Office (USPTO) patent examiners might not find an exhaustive list of works that have a claim to your potential patent. The examiners need to only show one example of prior art to reject your application. It is up to you to verify and continue monitoring past works that could be a threat to your patentability.
Let's say that your patent is approved because you demonstrated impressive statistical results. Does this mean that you can begin selling this drug combination therapy to the market? Not necessarily. After being awarded a patent, there is a separate and distinct part of owning a patent called Freedom to Operate (FTO).
Freedom To Operate (FTO)
Let’s continue on with the combination drug example. Even if you are awarded the patent for your combo, there are still ways to infringe upon another patent. The other company’s patent might claim parts of your invention (at an earlier date), like a certain chemical compound. This means if you were to use this compound, you could be opening yourself up for a lawsuit. The other company’s patent is a blocking patent. A blocking patent is present if practice of a later invention would infringe the earlier patent.
Blocking patents can become an issue even after you perform research as in this example. This is because of the ‘safe harbor exemption’. The exemption allows companies to research and test products that might otherwise be considered a patent infringement. This is especially relevant for drug and biotech companies. Simply performing the research will not constitute a lawsuit, but attempting to sell and market the combination might.
Getting Past a Blocking Patent
In order to get past a blocking patent, your company may want to consider a few options:
- If the patent owner is willing and able to license their patent to you, this route is generally the easiest. However, a big pharma company is less likely to allow this.
- Trying to invalidate the blocking patent could be an expensive and lengthy process.
- Wait for Expiration
- Depending on when the patent was first filed, your company could wait for the patent to expire. In many cases this is not a viable option; it could be depending on the filing date.
If these all sound like tough options, its because they are. Finding out that another patent might affect your work is hard, but there are options. You need to be patient and flexible.
Monitoring Pending Claims
When identifying FTO, focus primarily on the issued claims of a patent; pending claims are not as important as issued ones. A pending claim is a patent that has already been filed by the inventor with the USPTO. A patent can be pending from 1-3 years. If you come across a pending claim that could be a potential block, keep track of it. You want to make sure that it does not develop into an issue for your new patent.
When monitoring pending claims, it is important to keep in mind that they can be very broad. Many times, a pending claim will be far too broad, and then rejected by the USPTO. There is no reason to get worried or defensive about a claim that will most likely be rejected.
Many times, after being rejected, these patents will be amended to become more specific. Only then will you have to start investigating and researching whether or not this claim will affect your company. A quick way to determine whether or not a patent is valid is to look at the serial number. Current issued patent numbers are usually from 7,000,000 to 11,000,000.
When reading through these pending applications you should look for language like ‘comprising’. A claim with the word ‘comprising’ is indefinite. For example, a patent claim to a table comprising 3 legs covers a table that has 3 or more legs. The opposite of this word is ‘consisting’. For example a claim might outline a process that ‘consists’ of 3 steps. Those 3 steps would then be an exhaustive list. It is also in your best interest to monitor your competitors and their patent filings and applications.
When Do You Analyze Your FTO?
Patentability should be an ongoing process. Your company should constantly be researching new patent applications and implications of current claims. However, there are some instances in which a company should sit down and analyze their Freedom To Operate formally. The surefire and most important time to analyze your FTO is before and during a product launch. There is no safe harbor for a product launch, as opposed to solely research. Putting a product out in the market might expose your company to lawsuits if you do not analyze your FTO beforehand.
Another time to research your FTO is during fundraising. This will depend on the investor. Sometimes, investors will want proof of your FTO to ensure that they are investing in a worthwhile cause. If they do not ask for it, then you do not need to do it. It may be more harm than good in some cases; you might overthink pending claims or scare away investors for no reason. For more information about funding your startup, read Finding Funding for Your Biotech Startup.
In regards to pending claims, many investors look for a plan. Having a plan of what you will do to either license or 'blow up' the blocking patent is important for an investor. It shows that your company is prepared and will not be hindered by the pending claim.
Intellectual property is a very important part of a growing biotech or medtech business. Acknowledging and assessing your competition and your own shortcomings will help you better understand your company's possible scope. Before opening yourself up to a lawsuit, you need to do your research!
This content comes from a University Lab Partners webinar hosted in partnership with Wilson Sonsini presented by Maysam Pessian.
Maysam Pessian is an associate in the San Diego office of Wilson Sonsini Goodrich & Rosati. His practice focuses on patent prosecution and intellectual property counseling, serving clients in a wide range of technology fields, including the pharmaceuticals and biotechnology industries.