‘Sheer ridiculousness’ or fair play? USPTO turns down patent challenge
Hedge fund manager Kyle Bass, who also runs the Coalition for Affordable Drugs, filed a review for two patents on Acorda’s 10mg Ampyra (dalfampridine) extended release tablets for multiple sclerosis.
Patents 8,663,685 and 8,007,826 are due to expire in 2025 and 2027 respectively.
Bass had asked the USPTO to assess the Ampyra patents along with more than 20 others held by other drug companies under inter partes review, which evaluates patent claims on the basis of prior art and is a cheaper alternative to judicial challenges.
Acorda’s ’685 and ’826 patents are for “Sustained Release Aminopyridine Composition” and describe a method of improving walking in multiple sclerosis patients, including PK parameters and dosing regimens for the oral formulation.
But Bass, the founder of Hayman Capital Management, challenged the patents, saying in his February 2015 filing they claim no new ground and were “obvious”.
Acorda does not contend it invented dalfampridine, nor to have been the first to use it in MS, nor to have original dosing, said Bass. “Instead, the ’685 patent simply attempts to claim a method of 4-AP twice a day for at least two weeks.
“Not only was that specific dosing regimen known in the prior art at the time of the alleged invention, but the prior art also taught that administering 10 mg twice per day was effective at improving walking in MS patients, while avoiding side effects attendant to higher daily doses.”
Bass claimed it would have been “obvious” to any doctor to extend treatment to 10mg twice a day every two weeks to treat MS.
In a letter to Congress earlier this year, Bass said he intends to challenge the patents of less than one per cent of existing branded pharmaceuticals “in order to police the abusive patent tactics used by the worst offending drug companies.”
He said inter partes review was designed to overturn “a small minority of patents that are particularly vague or lack novelty”: the “few ‘bad apples’” which drive up drug prices: “A small number of companies in the pharmaceutical industry have engaged in abusive practices by acquiring and enforcing weak patents.”
He added “the sheer ridiculousness of simple concepts that are claimed to be ‘novel’ in certain pharmaceutical patents” includes “siliconized rubber stoppers” or taking an already approved drug for “at least two weeks.”
“Abusive” patents like these allow drug companies to extend monopolies on old products, said Bass.
He said a hedge fund like his was a better challenger of pharma patents than generics companies which are willing to drop law suits in “pay-for-delay” settlements.
Acorda declined to comment on the patent office’s decision.
Bass and Hayman Capital have been pursuing other pharma companies’ patents, including those of Celgene and Pharmacyclics. In July, Celgene asked the USPTO to censor Bass, and claimed his real motivation was short-selling pharma shares.