In some situations, filing IP very early in the invention cycle can actually do harm and perhaps kill the potential commercial prospects for an invention.
Earlier blogs in this series have highlighted speed of action as a way to achieve competitive advantage. Speed to file IP, speed to publish, speed to invent. But to quote a well-known public vehicle information commercial “speed kills”.
Of course, those industries which rely on new products or product improvements every few years need to stay nimble and develop very fluid IP strategies, moving quickly to protect and publish and building IP positions for exclusivity, bartering and freedom to operate.
Other industries, however, have much longer life-cycles. In the pharmaceutical arena, we all know the rate of attrition is astonishingly high and becoming higher as regulatory bodies set higher approval standards. This is so despite the promise – now seen to be false – that combinatorial chemistry and the genomic revolution would provide a host of new targets and an infinite number of small molecules to test in a high throughput manner leading to new cures.
In both the small molecule and biotech fields, the approval process is long and arduous, with companies often having to change direction and even back a different horse as pre-clinical and clinical data are generated and analysed.
Now I’m not suggesting that one should wait until a product has cleared the regulatory hurdles before filing a patent application to protect against copying. Waiting does have its attractions since every day a patent is on file before the commercialization of a corresponding product is a day of patent term lost, subject of course to patent term extension, patent term adjustment and the like.
Waiting would be too risky for such a major product investment most of the time. The threat of being scooped by an earlier competitor patent, or a disclosure by a competitor or the undertaking and publishing of clinical trials negating patentable subject matter would be a very real concern, particularly in highly competitive areas. No, the base patent application needs to be filed early. But how early?
Conventional wisdom is to file as soon as some data is available, even in vitro data, using a single or multiple provisional filings of varying scope and exemplification, and make a decision at the 12 month convention date about how to proceed.
No problem there: I have recommended and followed that tactic successfully for close on 30 years. The issue is that one is often not much closer at the convention deadline to knowing the real value of a pharmaceutical invention and the tendency is to progress a convention filing rather than take any risk of being scooped.
This is where great communication between the IP team and senior management is critical. An attorney would never make the autonomous decision to abandon and refile, and middle management would be foolish to do the same. But that may be the best decision to take depending on a whole range of factors. The patent highway is littered with prior art, developed by a patentee, colliding with a patented invention of key value.
If the circumstances are such that refiling or even holding back a filing until more information is available on a product or product series is the best course of action, then this is a decision for senior management, with full knowledge of the benefits and risks clearly communicated by the patent attorney.
Another reason to consider delaying is that the invention may have very limited support, possibly resulting in no patent or a patent with very limited scope. This could be devastating from a self-collision perspective with the doomsday scenario of a broad disclosure providing no effective protection for a compound of interest and no ability to claim the compound of interest in a later selection patent in view of the earlier disclosure.
A third reason to consider deferring filing is that the early publication of your invention will alert competitors to the area of interest. You may then be in a foot-race with competition to file an application covering compounds of particular interest.
Another important reason for considering delaying filing is that the base patent may be the only effective patent protection the patentee can obtain. Secondary patents, especially on formulations and salts, are highly vulnerable to attack and may not even be granted with any meaningful scope of protection if at all. So to file the base patent early and rely on a patent life-cycle management strategy of later secondary patents is a strategy that is successful in only limited cases.
Also, in view of best mode requirements and other considerations, the secondary patents may often be filed such that their term expires before the base patent plus patent term extension. Companies would do well to consider what strategies might be employed to not only give secondary patents the very best chance of being upheld in court, but also to enable their filing at a time that will lead to an effective extension of the term of protection for the marketed product.
This leads us into a contentious area of allowable and unacceptable use of IP under competition and anti-trust laws. That is a blog for another day, although if you have any thoughts or comments on that particular matter in relation to secondary patents please do ad your thoughts.
(This is number 9 in our list of IP mistakes and how to avoid them.)
[Image credit: Flying Jenny]