File too early (no. 9 in our list of IP mistakes)

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”.

Put another way, the early bird can arrive too early and leave itself exposed while it waits on the worm.

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]

17 Comments on “File too early (no. 9 in our list of IP mistakes)

  1. In the States, the pressure to file early is enhanced by the risk of malpractice liability to the attorney. If something goes wrong as a result of a recommendation to delay filing in order to allow the commercial aspects of the invention to “bake” a bit more, attorneys expect that they will be blamed because their expert advice was followed to result in the poor outcome. Also, I think it is an almost universal problem that if patent professionals are paid only for a volume of work product produced and advice to wait to file does not create a profitable volume, it is less likely that the professional will provide advice that creates value for the client but not for her.

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    • Very true Jackie. Patent attorneys wouldn’t want to put their careers and credibility at risk by delaying the application unless there are express instructions by the client to do so. I believe the writer has fallen short of explaining away his reasons for delaying certain patent applications. Unfortunately, when you are challenging or finding exceptions to a universally accepted practice, you need to be very clear and persuasive in your arguments. This article, in my mind, has failed to do so.

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      • Safdar – I think you may not have fully appreciated the points – see my other comment and thanks for your thoughts!

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      • Thank you all for the interesting comments.

        Safdar – I have tried to address the issue of the “what if you are scooped” scenario by saying that “this is a decision for senior management, with full knowledge of the benefits and risks clearly communicated by the patent attorney”. That point could have been emphasised. Also note that I have many examples from direct experience where the decision was to abandon and refile a priority/provisional application because it wasn’t “baked” enough (to use Jackie’s words). These decisions aren’t taken lightly, but they are taken in given circumstances. It’s more common in the pharma world than you might think.

        Jackie – It seems a bit sad, if true, that an attorney might not recommend a course of action that was best for a client based on it affecting their personal loss of filing income. The liability issue re. outside counsel is well taken, but again I refer to the comments I made above to Safdar noting the decision is for senior management with full knowledge of risks and benefits.

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      • I just want to emphasize that “full knowledge of the benefits and risks clearly communicated by the patent attorney” is a phrase not easily implementable today in patent intensive technologies. You need to study the issues from various development angles; research, market, competition, production and IP at the very least.

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      • Exactly Naim – this is why this decision in my experience is recommended during a patent review committee process attended by senior members of all of the groups you mention i.e. R&D, Commercial, IP, BD. They each need to be aware of the implications and understand the somtimes contrary points of view before a decision is taken.

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      • The other point I’d emphasise is that, so often, the default position is to wait until about 10 months of convention priority has expired and then only decide where to file and not whether it is appropriate to do so. Tracking progress throughout the priority period and, if necessary, having the conviction to recommend to a patent review committee or similar body to abandon and refile should always be a consideration. It’s an easy option to onlyconsider where to file at the 12M anniversary, but not necessarily the correct one.

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    • To get around this issue, an attorney or an in-house professional needs a study that intersects IP filing strategy in the technology space with technological and market developments related to the inventive disclosure to look for a signal whether the market as a whole is ripe to absorb this invention. After this evaluation, it would be difficult to prove malpractice. The senior management ought to establish processes to generate these studies that may involve R&D, marketing and IP collaborating with each other.

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  2. Safdar Mahmood made the following comments over at Facebook (http://www.facebook.com/profile.php?id=547503280)

    #
    Safdar Mahmood Interesting and contrary to the conventional understanding. I wonder what situations we are talking about !
    32 minutes ago · LikeUnlike
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    Duncan Bucknell thanks Safdar – check out the post and let me know what you think
    31 minutes ago · LikeUnlike
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    Safdar Mahmood Sure Duncan. Thanks for sharing.
    30 minutes ago · LikeUnlike
    #
    Safdar Mahmood
    Just had a brief overview. I can understand the lack of sufficient support reason but I wonder what he means by “The issue is that one is often not much closer at the convention deadline to knowing the real value of a pharmaceutical inventi…on’. As far as I am aware, patent valuation is not a part of patent application or registration. Also, some patents have unforeseen subsequent side-benefits and this is particularly the case with pharma patents. For instance, Minoxidil was patented as a blood pressure lowering drug but subsequent use revealed its hair growing properties as well. I wonder how these accidental can be covered in an application without waiting for too long. Still a good piece and thanks for sharing :).See More
    18 minutes ago ·
    #
    Safdar Mahmood Another flaw is that he’s using the word ‘IP’ which is a very broad term covering everything from trademarks to copyright but he’s strictly talking about patents and that too only ‘pharmaceutical patents’. So the semantics have also gone wrong a bit.
    11 minutes ago ·
    #
    Duncan Bucknell thanks so much Safdar – I’ll post this on the site so that others can discuss too
    10 minutes ago ·
    #
    Safdar Mahmood Pleasure Duncan
    9 minutes ago ·

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    • Safdar – he means that a drug candidate is not very far through the 10 year approval process at the point 12 months after the priority date. The accidents you speak of would be covered in subsequent filings. Also, it does apply to trademarks in certain situations as well.

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      • If he’s talking about the 12 month priority period, then he has a point.

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  3. One of the things relevant here is to consider the impact of the “velocity of a potential inventive idea”. This is similar to the velocity of money; how fast a note is exchanged in the economy. So if an important main idea in technology space is public then patentability of associative important ideas that can be potentially patentable, depends upon the velocity of the main public idea; how fast the main idea exchanges (depends on the technology and its state of the art) and mutates. For this you need to follow not just prior art but all related technology clusters in the globe

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    • Thanks Naim – which is time consuming and expensive… I think you also need to take a step back from time to time and think well ahead of what’s going on out there at the frenetic pace you mention…

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      • You are right. It is time consuming but it need not be expensive if it is an in-house solution. You can distribute time needed over a period in which you create an extended technology map and keep adding small increments to it. As the tech map grows, specially the non patent literature portion, you will be able to assess the velocity aspect with increasing clarity. Let patience be your guide specially if you are to patent a lot. Example Qualcomm.

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      • I see what you mean, Naim – but time consuming is still expensive, even if in-house – just costs are more hidden 🙂

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  4. Pingback: Develop IP that no one wants (no. 33 in our list of IP mistakes)

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