Statements by KEI and others on NIH rejection of Fabrazyme March-In Request

For background on the Fabrazyme case, see: http://www.keionline.org/fabrazyme

The following statements were made today by civil society on the NIH rejection of the Fabrazyme March-in Request Petition. Contact Judit Rius at judit.rius@keionline.org if your organization would like to submit an statement.

Statement by James Love, Director of Knowledge Ecology International (KEI) (Contact: 1.202.361.3040)

KEI is disappointed but not entirely surprised the NIH has continued its 30 year tradition of rejecting petitions to use federal March-in rights to overcome abuses of patent rights. The Fabrazyme march-in petition was filed on August 2, 2010. A supporting petition was filed by the American Medical Student Association (AMSA), Knowledge Ecology International (KEI), Public Citizen, Universities Allied for Essential Medicines (UAEM), and U.S. PIRG (Public Interest Research Group) on August 27, 2010. The DHHS rejection, signed by NIH Director Francis Collins, was issued on December 1, 2010, and made public on December 7, 2010. The NIH has denied the patients suffering from shortages of Fabrazyme the opportunity to present their case at a hearing, but has left the door open to a new petition filed by a company that can prove it can market a product. The NIH has effectively created an inappropriate high barrier for using the march-in rights. The patients wanted to obtain the open license to the relevant NIH funded patents in order to negotiate with potential suppliers of generic/biosimiliar Fabrazyme, operating under the realistic assumption that suppliers would not invest in a generic version unless they have assurances they can overcome the patent monopoly. The NIH is denying the patients with Fabry disease the opportunity to seek self help remedies, in a case of clear abuses of the patent owners. It is shocking that the Obama Administration refuses to give persons who have Fabry's disease a hearing, and that they have issued a decision that reads as it had been written by lawyers for Genzyme Corporation, that includes a number of rebuttal assertions of fact, but no opportunity for the petitioners to make their case in a public hearing.

The NIH also has yet to respond to the August 27, 2010 supporting petition. The August 27 petition asked the NIH to expedite the proceeding and broaden the issues to include the possible use of the NIH royalty free license, and the pricing of Fabrazyme. The NIH decision did not address the issues raised by the AMSA, KEI, Public Citizen, UAEM, and U.S. PIRG.

KEI is pleased that the Fabry patients will appeal the NIH decision. The Congress should also undertake a review of the the NIH's longstanding failure to use the march-in rights to protect the public when patents on government funded inventions are abused. In 30 years, the NIH has yet to grant a march-in request. I don't think the taxpayers believe there have been no abuses of NIH funded invention patent rights over that 30 year period.

The NIH was asked to remove the patent barrier to competitive supplies of Fabrazyme. They said they would not remove the patent barrier, because there are other barriers. This is not the right way to approach the problem. All barriers should be removed. The NIH should focus on the barrier it controls, the NIH funded patents.

Statement by Judit Rius Sanjuan, Foreign Law Adviser of Knowledge Ecology International (KEI) (Contact: 1.212.222.5180):

I am outraged and disappointed over the Obama Administration's first decision on a petition to use the march-in provisions in the Bayh-Dole Act to address the failures of the patent owners to ensure patient access to a publicly funded drug. With no hearing or call for public comments, NIH has decided to side with a pharmaceutical company and defend their abuse of a legal monopoly on a government funded invention. US patients that are suffering from a shortage of supply of Fabrazyme over the past 18 months have experienced dosage rationing and are paying extraordinarily high prices for medicines that keeps them alive. The remedy they sought would not only deal with the present shortage, but provide the means to reduce the risk of future shortages. I wonder why do we have legal mechanisms to protect patients and consumers, if the US government is not willing to use them?

The NIH decision also raised an important issue about the current FDA rules to supply drugs when a firm with a legal monopoly fails to meet the needs of patients. The FDA should open an inquiry into mechanisms to overcome regulatory barriers to entry when there is an abuse of intellectual property rights or a failure by the incumbent to adequately supply a market.

Statement by Robert Weissman, President of Public Citizen (contact Angela Bradbery, 202-588-7741):

Why is NIH resorting to legal gymnastics to avoid exercising its legal authority to ensure an adequate supply of an important medicine? NIH agrees Genzyme is failing to produce an adequate supply of the important medicine Fabrazyme. It is plain that removing the patent monopoly on the drug is a necessary condition to enabling other potential manufacturers to enter the market. Yet NIH chooses to deny a request to issue open licenses for the Fabrazyme patents -- a request for which it has undisputed legal authority -- on the Alice-in-Wonderland, self-justifying grounds that there are as yet no competing suppliers. Of course there are no competing suppliers -- why would any firm try to enter a market it believed closed by a patent monopoly?

Statement by Ethan Guillen, Executive Director of UAEM (contact: 775 287 2553):

It is astounding that the NIH has once again refused to exercise its right to protect the public from abuse and negligence with a medicine discovered with taxpayer dollars. Universities, government and industry are currently celebrating the 30th anniversary of the Bayh-Dole Act that put in place public interest safeguards for medicines discovered with public money. The reason for the anniversary celebration must be that no matter what the corporate abuse whether it be exorbitantly high prices or lack of availability, Big Pharma has won 100% of the time. Because of this, Fabry patients continue to suffer needlessly. The NIH clearly needs to take requests to protect the public interest seriously and provide, at a minimum, an opportunity for public comment or better yet, a public hearing. I hope we have a full hearing of the issue on appeal, including input from public interest groups and those Fabry patients suffering due to the exorbitant prices and inadequate quantities of Fabryzyme.