The Leahy-Smith America Invents Act, H.R. 1249, which passed the House in June by 304-117 in June, contains a provision to amend 35 U.S.C. 156, the statute governing patent term extensions.

Specifically, a section of HR1249 would insert the following clause:

‘For purposes of determining the date on which a product receives permission under the second sentence of this paragraph, if such permission is transmitted after 4:30 P.M., Eastern Time, on a business day, or is transmitted on a day that is not a business day, the product shall be deemed to receive such permission on the next business day. For purposes of the preceding sentence, the term ‘business day’ means any Monday, Tuesday, Wednesday, Thursday, or Friday, excluding any legal holiday under section 6103 of title 5.’

Known as the “Dog Ate My Homework Act”, the provision has been bounced around for several years now, and is intended (very specifically) to help Massachusetts-based The Medicines Company, which submitted its PTE application for U.S. Pat. No. 5,196,404 for ANGIOMAX (bivalirudin) 61 days after FDA approved its New Drug Application (NDA) .

In case you haven’t already guessed, the patent term extension law requires the submission within 60-days of the date of NDA approval. There are no exceptions to that window, so patent officials rejected the application for extension.  The above clause would put the Medicines Company’s application within the window of time.

The Medicines Co. wants its patent to be extended 1,773 days, giving it exclusive rights to the drug until Dec. 15, 2014. This is a high-stakes game of chance as the Medicines Co. expects Angiomax to generate more than $500 million in sales in the United States by 2010.

The NY Times ponders whether this could be viewed as a bailout of a specific lawfirm since the provision could get  the law firm WilmerHale off the hook for a possible $214 million malpractice payment.

Senator Jeff Sessions, R-AL, has proposed an amendment that would remove the provision from the bill.  However, Senate leaders want to pass the House version of the bill, which contains that provision, without any amendments, saying any changes could jeopardize the entire legislation.

While some would say that “deadlines are deadlines” and it’s just tough luck for those who miss them, it doesn’t make sense to deny any kind of equity.  I think the standard should be the same reviving an application that becomes abandoned because of failure to timely pay the issue fee or respond to a Patent Office deadline, that is, when the abandonment was unavoidable and unintentional. Both require a fee where the fee for unintentional is a huge fee compared with unavoidable since fault is admitted on the part of the applicant.

For both unavoidable and unintentional revival there is no time limit, but the applicant must state that the entire delay between abandonment and the filing of the revival petition was unavoidable or unintentional. For equity’s sake, a terminal disclaimer would then be filed equal to the time that the application was abandoned. Why should patent term extensions receive different treatment than other types of patent term “oops”?  The effect is the same for both.

It is worth noting that without the extension, the Medicines Co. stands to lose an estimated $500 million to $1 billion in profits.

What a Diff’rence a Day Makes!

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2 Comments

  1. I enjoyed your artical,question If I may?What are the chances of receiving a patent using a ” Peer-to-Patent process” in regards to Amarin corporation patent on the use of AMR101,especially after U.S. patent examiners issued a final rejection notice on the AMR101 patent, but a previous “non-final” rejection issued in June said the claims in the AMR101 patent overlapped similar claims made in an existing patent issued for Epadel, another fish-oil derived EPA drug sold by the Japanese drug firm Mochida.?

  2. [...] “The dog ate my homework” component of Patent Reform (HR 1249) (IPBiz) (Patent Baristas) [...]