Delaying grant of a competitor's patent – strategic or nonsense?
Livemint reported late last week that the association of innovator pharmaceutical companies in India (‘OPPI‘), has recently reiterated its demand for removal of the pre-grant patent opposition provisions from India’s Patent Law.
The argument is that it has been widely misused by interested parties to unnecessarily delay the patent application process.
So, when is it strategically useful to delay the grant of a competitor’s patent? Here are some thoughts, what would you add?
- Eliminate the opponent’s ability to obtain an injunction using the patent in question. (Damages will still be available in most countries from the date of publication.)
- In the United States (Pharmaceutical) Orange Book context, delaying grant of an opponent’s patent (eg. with Rule 99) would mean the patent is not listed in the Orange Book and you don’t have to file against it.
- To decrease the value of the competitor’s IP portfolio. (Don’t even think of doing this unless you have very good reason to.)
- etc
6 Comments on “Delaying grant of a competitor's patent – strategic or nonsense?”
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Duncan
Delaying the grant of a competitor’s patent could also cause them to miss the opportuinty to obtain an SPC or other patent term extension.
Note that in most jurisdictions, the sponsor of a new drug application – who has been granted market authorization, is given a very limited amount of time to apply for a patent term extension (SPC or otherwise). In the EU for instance – the time to apply for an SPC is six months from the date of approval – in the US the application time is compressed into 30 days. One can easily imagine a scenario whereby a delay in the grant of a patent that covers a commercial pharmaceutical product results in a forfeiture of an additional patent term (as much as five years).
.pete – thanks and welcome.This is a great point, for the benefit of other readers, ‘pete’ is referring to patent term extensions in the US under 35 USC 156.In Europe (and in some other countries), you can apply for the SPC (or extension as the case may be) within 6 months of (a) product authorization or (b) grant of the patent – paragraph 2 of Article 7 of Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning
the creation of a supplementary protection certificate for medicinal
products.
I wonder how they determine eligibility for the OPPI given the increasing focus on NCE’s by former generic companies?
Anyway, to reflect on Pete’s point, the only time delaying grant of a patent would prevent filing of an SPC would be if the patent was granted after expiry (which does happen in Europe, albeit rarely), due to the option that Duncan mentioned of filing an SPC app within 6 months of Grant of the patent. Even then, I’m not sure if the SPC could be applied for and granted with retropsecitve force? I guess we’ll never know.
To take the scenario on step further, what if an interested but technically unrelated party were to oppose and appeal the grant of a patent to maintain uncertainty of the scope of the final claims and keep potential entrants at bay. If the interested party was, in fact another division of the patentee company, would this interference be allowable, sure it would be unethical, but until it happens it is a strategy that is open to any patentee to prolong the life of their own patent.
Leighton – these are very interesting points.I totally agree wit your point about blurring of the line between innovator and generic companies.In relation to standing to bring the opposition proceedings, I am pretty sure that in most countries which have an opposition procedure, any other party may oppose the grant of a patent. So even a related company could theoretically do this. (Though as you suggest, there would be quite a few frowns from the Patent Office.)In relation to prolonging the life of the patent – it is of course
possible that by delaying grant, a company may become eligible for an
SPC or have its SPC period extended. Which is presumably what you’re
referring to. It seems like quite a risky thing to do to orchestrate an opposition to one’s own patent. Once the process is started, it is open to the Patent Office in many countries to go even further and invalidate the claims based on prior art not cited by the opponent.Also – I guess another scenario which might fit your set of facts is where there is prior art that is likely to narrow the claims in any event. In other words – uncertainty about claim scope is the next best thing that the patentee can hope for. In that scenario, it seems to be that the patentee is hoping that other companies (such as those interested in marketing a generic pharmaceutical), would be hesitant because of the uncertainty, and therefore not launch their product. This usually just triggers a race to see who will invalidate the patent first.
I can’t think of a case where the SPC expiry date would change if the patent grant was delayed, only the eligibility for application if the patent had expired. I guess if we are talking about pre-1995 applications in the US, or similar in Spain where the expiry date is calculated from issue/grant date then there would be some effect, but the likelihood is slim for all the reasons you mention.
The use of uncertainty is a tool we have all seen used in the industry. A raft of late filings for Paroxetine pre-expiry was timed to create much confusion by SKB and may have scared some generics from launching…unfortuntely it is late, broad filings by generics that is causing the same problem for most other drugs.
Thanks LeightonProbably no surprise that there’s a market advantage to any company launching a generic version who can create uncertainty and hesitation amongst other generic launchers. Case in point is Teva’s Carvedilol strategy.