December 24, 2014
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Drug giant Pfizer is being subject to widespread derision Wednesday, after it sent a note to British doctors warning them that they face possible patent infringement if they dare to prescribe a generic version of anti-epilepsy drug pregabalin to treat a secondary approved usage for pain management, as opposed to their name brand blockbuster, Lyrica.
Doctors in the U.K. who received the letter have been blogging about it all week, with many reacting to the over-reaching legal decree with increasing amounts of scorn.
“This is a weird circumstance: Pfizer‘s secondary patent is on a specific use of a drug that’s in the public domain. They want doctors writing neuropathic pain scrips to specify that the patient must take Lyrica, their name-brand version of pregabalin, even though it costs much more than generic pregabalin, and even though the two drugs are identical,” wrote blogger Cory Doctorow on Boing Boing.
“Weirder still is that Pfizer wants to make their stupid problem into everyone else’s stupid problem. The fact that it’s hard to enforce this kind of secondary patent is Pfizer‘s business, not doctors’. Doctors’ duty is to science and health, not Pfizer‘s profit-margins. Scientifically, there’s no difference between the two compounds. Doctors who prescribe generics leave their patients (or possibly the NHS) with more money to pursue their other health goals,” it continued.
“If your dumb government monopoly is hard to enforce, maybe you shouldn’t be banking on it. But in the world of corporatist sociopathy, where externalising your costs on others isn’t just a good idea, it’s your fiduciary duty to your shareholders, Pfizer‘s actions are practically inevitable,” concluded the post.
The text of the letter is reproduced in part below; read the full copy of it here.
“[Date]
[CCG Address]
Dear [NAME]
Re. Lyrica (R) (pregabalin) pain patent
I am writing to you to ensure you are informed about the relatively unusual issues surrounding the loss of exclusivity situation for the Pfizer product Lyrica (pregabalin) and so that you can take necessary action to prevent patent infringement by your organisation.
An appendix is attached describing the factual aspects of the situation in detail to ensure that you have the full information available. You will see that, whilst the basic patent for pregabalin has expired and regulatory data protection for Lyrica expired in July 2014, Pfizer has a second medical use patent protecting pregabalin’s use in pain which extends to July 2017. Pfizer conducted further research and development on pregabalin leading to the invention of its use in pain and hence was granted a second medical use patent for this indication. This patent does not extend to pregabalin’s other indications for generalized anxiety disorder (GAD) or epilepsy.
As a result of the pain patent, we expect that generic manufacturers will only seek authorisation of their pregabalin products for use in epilepsy and generalised anxiety disorder and not for pain, whilst Pfizer‘s pain patent is in place. Generic pregabalin products therefore are expected not to have the relevant information regarding the use of the product in pain in the PIL (Patient Information Leaflet) and SmPC (Summary of Product Characteristics). In other words, the generic pregabalin products are expected to carry so-called “skinny labels” and will not be licensed for use in pain. In the circumstances described above, Pfizer believes the supply of generic pregabalin for use in the treatment of pain whilst the pain patent remains in force in the UK would infringe Pfizer‘s patent rights. This would not be the case with supply or dispensing of generic pregabalin for the non-pain indications, but we believe it is incumbent on those involved to ensure that skinny labeled generic products are not dispensed and used for pain.
In this regard, we believe the patent may be infringed, even potentially unwittingly, by pharmacists and others in the supply chain, if they supply generic pregabalin for the pain indication. Without information, guidance and practical solutions from the authorities, Pfizer believes that multiple stakeholders, possibly without realizing, may contribute to patent infringement which would be an unlawful act. This runs contrary to the government’s established policy of rewarding additional research by the granting of a second medical use patent.
We also note that, by issuing guidance, your CCG is able to influence patterns of prescribing and dispensing in your area. We believe these powers must be exercised responsibly and with a view to avoiding the infringement of Pfizer‘s pain patent.
In view of the above, Pfizer requests that you issue appropriate guidance to prescribing clinicians within your CCG to help to ensure that our pain patent is respected and that all prescribing clinicians are aware of the pain patent situation.There are a number of ways in which this might be achieved, but the simplest solution, we believe, is for clinicians to be advised to prescribe Lyrica (R) by brand when prescribing pregabalin to treat neuropathic pain. Pharmacists will then be able to dispense Lyrica (R) against such prescriptions and this will ensure that they do not infringe the pain patent. In addition this will mean that patients with pain will be provided with a PIL that describes the use of pregabalin in pain.
Your CCG may also consider reviewing patient records retrospectively (in advance of the availability of generic drugs) and use prescribing decision support mechanisms such as Scriptswitch to support appropriate ongoing prescribing. We are willing to discuss, or assist CCGs with, the development of other solutions.
We should also note that, in our view, (i) CCG guidance instructing or encouraging the usage of generic pregabalin in pain would amount to procurement of patent infringement (an unlawful act); and (ii) your CCG is under an obligation to address the risk of wide scale infringement of Pfizer‘s patent rights. Pfizer therefore formally reserves all of its legal rights in this regard. If you have any questions in relation to the above please contact Pfizer Ltd on 01304 616161.
Yours sincerely
Ruth Coles
Legal Director”
