It’s still January and there’s still time to start on your IP resolution.
Step 1: Make A Plan.
An IP plan aligns your IP strategy with your Business and R&D Strategy. Aligning strategies requires understanding how the timelines match up. And, depending on the industry you are in, this alignment may look quite different.
Consider a product with a rapid lifecycle. By the time you have an issued US patent, you may already be launching the next generation of your product, or a completely different one. In this scenario, depicted below, you should think about protecting your core technologies more intensely than ancillary features that may become obsolete.
Perhaps you are in a company with a very long development timeline, like pharmaceuticals.
In this second scenario, patent protection is critical for more aspects of the product because of the long timeline, significant investment, and exposure of the product before it is commercialized.
But in this second scenario, there are many opportunities for the patent strategy to become misaligned with the R&D activities or the marketing plans. After all, those activities rarely progress on a straight line as planned. Yet, the patent process is fairly linear with distinct deadlines. Delays in development may require changes in your patent filing plans. These things need to be communicated to your IP folks!
Your business may fall somewhere in between these two extremes.
Nonetheless, it should be evident that along the way from concept to product, you should compare the IP activities and the product development activities. This is done by gathering information and holding an IP review.
The information you need is not held by any one individual
In the IP world, everyone in the value chain for a product plays a specific role according to their needs and view of the world. Here are some examples.
Research and Development: Your scientists and engineers are often so busy with their work that once the invention disclosure is filed it’s the last you’ll see or hear from them on the topic. And, there may be related or follow-on inventions that haven’t been disclosed but are being incorporated into the product.
Regulatory: Your company will work hard to overcome many regulatory hurdles. In the pharmaceutical and medical device industries, these “hurdles” may lead to label claims. You will want to be sure they are covered in your patents. You will also want to have a plan in place to maximize your regulatory extensions, such as those provided by the FDA Orange Book.
Project Management: This group may come the closest to knowing how the pieces are fitting together. They should have the timelines and delays well in hand.
In-house or outside counsel: Patent attorneys who prepare and prosecute applications are usually focused on defining the scope of the patent claims. In-house counsel may have a feel for the business activities, but may not always be up to date. Remember that most groups run when they see legal coming! Outside counsel will only be aware of what you are thinking or doing if you tell them. They can’t read your minds.
Marketing: This group is defining the features, attributes, and commercial claims associated with the product. Will the patents actually cover them? Many of the patents were likely drafted at the start of development and not looked at since. Periodic IP reviews will keep you on track.
Once you overlay the timelines, understand the needs of each group, and have gathered information along the way, it’s time to bring the groups together to share and validate the assumptions. This is where you bring in your IP folks to facilitate a review in conjunction with the project management group. It’s not as hard as you think and, it will save you time, money, and heartache in the long run.
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The next piece of the strategy is to set a plan for the global scope of your patent filings.
Brigham and Women’s Hospital owned a patent (US 5,229,137) directed to “Methods and pharmaceutical compositions for treating episodic heartburn.” They licensed the patent to Johnson and Johnson and it became one of the Orange Book listed patents protecting Pepcid Complete®. When Perrigo launched its generic version, Brigham sued Perrigo* for patent infringement. After all, the generic version had all of the same ingredients listed in the patent claims, a combination of a histamine H2-receptor antagonist (famotidine) and an antacid.
