EP Vantage Interview – Medicines Company vows to carry on fighting patent decision

For most companies a fourth knock-back from the US Patent and Trademark Organisation (PTO) over extending the lifespan of your most valuable drug would be the signal to give up and start thinking about what to do next. Not so for The Medicines Company, who yesterday could have witnessed the expiry of the main patent for Angiomax, their anti-clotting treatment.

Instead Clive Meanwell, TMC's chief executive, is undaunted and has vowed to continue to fight on, determined to take the matter back to the courts again. Speaking to EP Vantage he says: “This is far from over. As far as we are concerned it’s just getting started. We are extremely disappointed by the PTO’s 60-hour turn around of the judge’s ruling. We are surprised that after the judge spent so long carefully deliberating they can turn that back in 60 hours and be clear.”

It was indeed a very swift ruling, after TMC managed last week to get a district court ruling forcing the patent agency to not only reconsider its decision to refuse Angiomax a patent term extension because the filing deadline was missed by two days, but also ensure that the main patent on Angiomax held while the PTO revisited its decision. This temporary stay of execution caused shares in the group to rise by 20% on March 17, as optimistic investors speculated that the court ruling could make the PTO change its stance. Since then however with the PTO confirming its rejection of patent term extension on March 19, the stock has lost all those gains.

Hope over experience

This always looked like an overly confident view, given the previous hardline stance taken by the PTO and what it could mean for future disputes. Haydn Evans, a vice president at IP management specialists CPA Global, said it was highly unlikely the organisation would bend on the matter, as it would set a precedent. “If they did overturn it could have serious implications for timeliness and would become case law,” he said.

Despite what is increasingly looking like the end of the road for Angiomax the extra revenues that would flow if the patent is extended to December 15, 2014, make the group’s dogged determination, even stubbornness in fighting on, look justified (Court ruling sparks share rally for The Medicines Company, March 17, 2010). Last year, Angiomax accounted for $401m of the group’s total revenues of $404m.

TMC now has until May 23 to file another legal challenge, thanks to the PTO agreeing to extend the patent date another 61 days while it considered its decision, which in the end took it all of 60 hours.

Deadlines, deadlines, deadlines

Interestingly, the extension granted by the PTO neatly demonstrates the pitfalls of meeting deadlines. The organisaton itself ironically miscalculated the number of days involved in granting the two-month extension, originally stating it to be 60 days but later correcting the period to 61 days.

The extension, however, raises its own difficulties as it is still not certain when TMC’s additional six month paediatric extension to the patent will kick in.  If the original March 23 expiry date is taken then the group could face the threat of generic challenges as early as September, but if the new May 23 date is used then the group will get two months grace until November. It may not be much, but TMC will be grateful for any delay to potential generic entry.

TMC will be basing its next legal challenge on the fact that in other parts of patent law, outside of the Hatch-Waxman Act, filing a day or two late either carries no penalty or a minor fine. Describing the current system as draconian Mr Meanwell says: “The punishment and the crime here are completely misaligned. If you miss your mortgage payment by one day you generally do not lose your house.”

Do as I say, not as I do

However, the rather scathing reply given by the PTO to TMC’s latest legal efforts appears to leave little room for manoeuvre. The organisation said: “Because 60 days is not the same as two months in all instances due to the varying number of days in a month, MDCO’s docketing mistake lead [sic] to its missed deadline.”

TMC is not alone in missing patent term extension deadlines. In August 2003 Procter & Gamble missed a deadline for filing an extension for Prilosec OTC by one day while AstraZeneca's Symbicort had its patent extension denied, both because it is a combination of already approved products and because it missed its filing by a day, back in September 2006. AstraZeneca has appealed the PTO's decision and is seeking almost a three-year extension on the current patent, from October 2014 to July 2017.

Furthermore, an article by Nature Biotechnologyin June 2009, highlighted that it is not just pharma companies that have problems with defining the 60 day rule and that of the 100 approved extension applications they looked at, 78 incorrectly identified the 60th day of the filing period.

However, it could be argued, and perhaps rightly, that companies should file well within the 60 day period to avoid the potential loss of millions or billions of dollars. As the PTO also highlighted in its latest rejection, leaving a filing until the last possible moment does not offer any advantage to the application being approved or the length of the patent term extension granted.

The blame game

In terms of its late filing TMC is laying the blame firmly at the door of its lawyers. “We had prepared our patent extension application long in advance of the so called 60 day deadline, we filed it via two extremely reputable law firms, who themselves chose to leave it to the last minute and if there was a mistake made it was by the law firms and not us. That is not talked about much.”

Intriguingly however the group has decided against suing its lawyers. While suing might have been a natural reaction, Mr Meanwell says that for TMC the critical factor is the loss of five years of extra research and development time that could have allowed the drug to be extended into other indications, including cardiac surgery, stroke and peripheral arterial disease.

“Our law firms could not give me back that time, even if I sued them. On the financial side there is no way on heaven’s earth that we could recoup the lost money. Angiomax’s revenue is in excess of $400m a year worldwide and four and a half or five years of that is not going to be paid back to me by any law firm. They will simply refer to their insurance firms and there will be a limit on the policies.”

Future moves

While TMC is not interested in suing its lawyers, some in the market have raised the question of whether the group’s licensing partner, Biogen Idec, will resort to the law to recoup the revenues it stands to lose if the patent does expire this year. In 2002 Biogen out-licensed the drug to TMC and receives royalties on worldwide sales. Mr Meanwell is sure that this is a situation that will not arise. “Biogen is as deeply concerned as we are and I am quite confident we can figure a way forward with Biogen.”

What might provide some comfort to Biogen is that the drug still has patent protection in Europe, albeit a much smaller market, where the patents are valid until 2015. Here TMC is continuing with its strategy of expanding use of the drug and recently gained approval in heart attack.  

Mr Meanwell also intends to stay in the market and try to compete with any generic companies who are challenging the remaining patents on the drug that expire in 2028. At present Teva Pharmaceutical Industries and APP Pharmaceuticals are circling.

With so much to lose it is not surprising that TMC is taking this as far down the line as it can, a sentiment underlined by Mr Meanwell’s last comment: “We are not going to go quietly into the night even if we do not prevail in Washington.”

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