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.
However, the patent claims specified “immediate and sustained relief from pain.” Brigham’s problem arose when it was revealed that the time intervals for the relief were described differently in the patent than they were on the label for the product. In the end, the generic version was not found to infringe.
Could they have avoided this loss?
Perhaps they should have put a little extra care and effort into drafting their claims with a commercial product label in mind. You might be tempted to blame the patent attorney, but the ultimate responsibility falls on the applicant.
The moral of the story
Get some internal advice and have a strategy for your patent applications.
*Brigham and Women’s Hospital, Inc. v. Perrigo Co (Fed. Cir. Feb. 28, 2019)
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.
A recent post of mine on LinkedIn was a simple invitation to enroll in the Patent & IP Searching Class in the UCSD Extension IP Law Certificate Program. The post received a significant number of reads, making me think that posting some searching tips might be helpful, without your having to enroll and commit to a class.
How many of you go straight to Google and start typing key words?
To you I say, “STOP THAT!”
You need a structured, reproducible approach with a structured reproducible search engine.
Experience shows that Google patent searches are not always reproducible and, in many cases, can be dependent on your other searching behaviors. You should choose a search engine that is specifically designed for patent searches. And you should have documentation to be able to repeat the search when the client needs an update.
There are many commercially available engines as well as free ones. They all use essentially the same data sets but you can get some nice workflow features if you pay for the database.
Searching is both a structured skill and a skillful art. And, while learning the skillful art can take time and practice, the structured skill is easily taught.
Here’s my proven 10-step recipe for a good search. (You’ll notice that the actual searching doesn’t come until step 5 – and for good reasons.)
1. Determine purpose of search
Answer these questions:
What kind of search do you need to perform?
What is the purpose of the search?
What will the results be used for?
Who will get the results?
How much time, effort, and money should be allocated to the effort?
2. Gather the necessary data to conduct the search
3. Determine which databases need to be searched
4. Develop a search strategy
5. Perform a search
6. Evaluate the results
7. Modify the strategy
8. Repeat the search
9. Analyze and Summarize
10. Report the results
For more complete descriptions of each of these steps, links to search engines, and for some useful forms to help you document what you did, download the [download id=”12103″]. There’s no obligation. Just send me a note if you find it helpful.
It’s that time of the year. You know, the one where we promise ourselves we will go to the gym, eat healthier meals, etc., etc.
So, I’m here to help you check off one important resolution for your business this year; execute an IP strategy. It’s not as tiring as going to the gym, and will make your company healthier.
A quick story…
I was at a holiday networking event last week and the CEO of a startup company asked me about a large impending charge from her outside counsel. She had no idea what it was for, but it had something to do with a patent application they had filed.
It turns out it was a related to foreign filing costs for an application entering national phase, but she didn’t understand. And no one else at the company did, either. And, to make things worse, the company had completely skipped the national phase filing on an earlier application and is potentially going to lose all protection for that subject matter.