Chapter 9 - The longest patent extension battle in history


    A pharmaceutical company named The Medicines Company (MDCO) made news in 2015 when it lost a court battle for the rights to its patented drug.  This is a warning story that has been told many times before by patent lawyers regarding inventions, even serving as a punch line in books such as “Don’t File a Patent!”  The saga began way back in December 2000 when MDCO filed a patent term extension (PTE) request for its anticoagulant drug Angiomax (bilvalirudin) U.S. Patent No. 5,196,404

    The right to file a PTE is codified under the Hatch-Waxman Act of 1984 to help companies retain market exclusivity for their products because of time lost in the early years developing and testing a new drug as well as time taken at the end of drug development waiting for NDA review approval.  Since a patent only lasts 20 years and it takes up to 15 years to bring a drug to the market, companies often require patent extensions to remain competitive.  Under the patent term extension rules of the US Patent and Trademark Office (USPTO) 35 USC 156, a company can file a PTE within 60 days of receiving FDA approval for a drug.  However, MDCO’s PTE request arrived at the USPTO on the 61st day (Feb 2001) by a stroke of bad luck.  After many years of appeal to the District Courts for the recognition of the PTE, MDCO repeatedly got denied.

    In 2010, when MDCO’s patent expired, they found themselves in an infringement lawsuit with a generic company named APP who filed an ANDA for the generic version of bilvarudin.  The US Court of Appeals heard the motion from APP and decided finally to settle the case in favor of MDCO, giving them the PTE for 1728 days.  This meant their patent was now extended from 2010 to December 2014. MDCO went on to sue its intellectual property consultants, Fish & Neave LLP and Ropes & Gray LLP for legal malpractice because they did not carefully calculate the PTE request deadline and made MDCO miss out on the crucial 60-day deadline.  MDCO won a summary judgment against the law firm and settled all its cases in 2012.  This was all well and good for the company at the time.

    However, MDCO was embroiled in another lawsuit, a few years later, against a company named Hospira, who were ready to market its generic version of bilalvirudin.  Hospira was in charge of Ben Venue Laboratory, subcontracted by MDCO to manufacture bilvalirudin for many years.  Ben Venue Laboratories had used the patented methods, “adding a pH-adjusting solution during the compounding process minimize the Asp9-bivalirudin impurity to less than 0.6%” filed under US Patent 7,582,727 and 7,598,343 by MDCO. MDCO filed suit claiming that Ben Venue Laboratories used this method of manufacturing bivalrudin before the patent expiration and exploited the drug for marketing, committing a commercial violation.  When the case was reviewed by the District Court this time, they found that Ben Venue did not violate patent infringement and that MDCO’s claims were invalid under on-sale bar.  Thus MDCO went on to face a recurring situation where its pioneer drug was threatened in the market by a generic.  After the Hospira challenge, the company was not able to appeal for further patent extensions because its extra 1728 days also expired.  Later in 2016, the case was brought to the Court of Appeals for the Federal Circuit and two years later, they affirmed the District Court’s non-infringement findings.  However, the Federal Circuit overturned the on-sale bar determining that a distribution agreement constituted a commercial offer-for sale, since the product did pass hands.

    The moral of the story is to respect filing deadlines when submitting a patent and to choose your intellectual property lawyers wisely.  When filing a patent for the first time in preparation for marketing a product it is advisable to do some research in order to keep track of the filing dates and to keep ahead of the game.


    The Medicines Company v APP and initial PTE denial

    The Medicines company v Hospira

    When can you file a Patent Term Extension

    Lawsuit against IP law firm

    On-sale bar