IP in Movies: Extraordinary Measures (2010)

As Jean-Luc Godard said, “Every film is the result of the society that produced it”. Cinema is a mirror of society. When the art of motion picture makes direct or indirect reference to a diversity of intellectual property (IP) issues — such as access to knowledge and social justice, freedom of creation and freedom of enterprise, counterfeiting or infringement, negotiation and settlement agreement —, this ascertains that IP has become tremendously important in our societies.

Extraordinary Measures (2010)

Tom Vaughan

Based on Geeta Anand’s (Pulitzer Prize 2003) book The Cure: How a Father Raised $ 100 Million — and Bucked the Medical Establishment — in a Quest to Save His Children (Harper Collins, December 23, 2009, ISBN 978-0-06-073439-8), Extraordinary Measures tells the story of a father (John F. Crowley) confronted with the disease from which his children are affected, the Pompe disease. Rare diseases are very often orphaned due to the economic difficulty of developing therapies for a very small number of patients. The Dutch researcher, Dr. Arnold Reuser (Erasmus University, and Pharming Intellectual Property B.V.) “spent several years trying in vain to find a company willing to invest the millions of dollars required to produce the enzyme for a disease with five thousand patients, at best. The financial incentive didn’t seem to match the enormity of the up-front investment needed—and John, with his Harvard business degree, could understand the awful logic of the financial decision.” (Geeta Anand, The Cure). The film highlights the financial and scientific hardships that John Crowley (Brendan Fraser) and Dr. Robert Stonehill (Harrison Ford) face in their quest for medical treatment that can stabilize Pompe disease.

“I don’t have the money to make my theory into a useable medicine” (Tom Vaughan, Extraordinary Measures, 2010) © Director: Tom Vaughan • Producers: Michael Shamberg, Stacey Sher, and Carla Santos • Screenplay: Robert Nelson Jacobs.

“Giving them the patents to my ideas” (Tom Vaughan, Extraordinary Measures, 2010) © Director: Tom Vaughan • Producers: Michael Shamberg, Stacey Sher, and Carla Santos • Screenplay: Robert Nelson Jacobs.

The patent race

William Canfield was credited as inventor in several patents filed on behalf of Novazyme Pharmacuticals, Inc. between 2001 and 2004 (see Patentscope, wipo.int). It is also true that Yuan-Tsong Chen is credited as the inventor for many patents filed on behalf of Duke University between 2000 and 2010 (ibid.). To be complete, it should be added that the patents filed by Genzyme Corporation on the same period of time show that several of its researchers were also working on a treatment dedicated to lysosomal diseases, including the various forms of Pompe disease. These researchers are Yunxiang Zhu, and Johannes Bernardus Mathias Marie Van Bree (who worked for Pharming Intellectual Property B.V.) (ibid.). The table below shows, without being exhaustive, that several teams of researchers were working simultaneously on a method of treating lysosomal diseases.

DatePublication #InventorOwnerTitle
2003.07.03US20030124653William CANFIELDNovazyme Pharmaceuticals, Inc.Method of producing glycoproteins having reduced complex carbohydrates in mammalian cells
2003.07.03US20030124652William CANFIELDNovazyme Pharmaceuticals, Inc.Methods of producing high mannose glycoproteins in complex carbohydrate deficient cells
2005.01.06US20050003486William CANFIELD and Stuart KORNFELDNovazyme Pharmaceuticals, Inc.Expression of lysosomal hydrolase in cells expressing pro-N-acetylglucosamine-1-phosphodiester α-N-acetyl glucosimanidase
2003.07.17US20030133924William CANFIELDNovazyme Pharmaceuticals, Inc.Highly phosphorylated acid beta-glucocerebrosidase and methods of treating gaucher’s disease
2002.01.24WO/2002/005841Yuan-Tsong CHENDuke UniversityTreatment of glycogen storage disease type II
2011.05.05US20110104187Yuan-Tsong CHEN, Priya KISHNANI, and Baodong SUNDuke UniversityMethod of treating glycogen storage disease type III with human acid α-glucosidase
2010.01.14WO/2010/005565Yuan-Tsong CHEN, Priya KISHNANI, and Baodong SUNDuke UniversityMethod of treatment of glycogen storage disease
2010.10.07US20100254966Yuan-Tsong CHENDuke UniversityTreatment of glycogen storage disease type II
2005.06.09US20050123531Yuan-Tsong CHENDuke UniversityTreatment of glycogen storage disease type II
2002.08.15US20020110551Yuan-Tsong CHENDuke UniversityTreatment of glycogen storage disease type II
2008.07.24US20080175833Yuan-Tsong CHENDuke UniversityTreatment of glycogen storage disease type II
2003.10.23WO/2003/086452Yunxiang ZHU and Seng CHENGGenzyme CorporationMethods of enhancing lysosomal storage disease therapy
2001.01.04EP1137762Johannes Bernardus Mathias Marie VAN BREE, Edna Henriette Germaine VENNEKER, David P MEEKERGenzyme CorporationTreatment of Pompe’s disease
2009.02.04EP2020438Johannes Bernardus Mathias Marie VAN BREE, Edna Henriette Germaine VENNEKER, David P MEEKERGenzyme CorporationTreatment of Pompe’s disease
2000.06.15WO/2000/034451Johannes Bernardus Mathias Marie VAN BREE, Edna Henriette Germaine VENNEKER, David P MEEKERPharming Intellectual Property B.V.Treatment of Pompe’s disease
2004.02.12US20040029779Yunxiang ZHU and Seng H. CHENGGenzyme CorporationMethods of enhancing lysosomal storage disease therapy by modulation of cell surface receptor density

Don’t put all your eggs in one basket

Geeta Anand’s investigation shows that Genzime had invested both in Pharming and in the research program of Yuan-Tsong Chen (Duke University) prior to the acquisition of Novazyme: “Genzyme had paid $ 17 million for Pharming and $ 20 million for Chen’s program. [The company’s head lawyer and senior business development executive] knew Novazyme’s own investors had valued the company at $ 35 million before the latest round of financing.” (Geeta Anand, The Cure).

Priya Kishnani, an insider

Thereafter, the Food and Drug Administration and the European Commission approved Genzyme’s medicines (alglucosidase alfa) for the treatment of patients with infantile-onset Pompe disease. Priya Kishnani, a member of Chen’s team, told her experience in research against Pompe disease at Duke University.

Funding research

Extraordinary Measures focuses on the obstacles of researchers in the search for drugs intended to fight rare diseases. These barriers are not only scientific. 80% of rare diseases are of genetic origin. However, in the field of genetics, training, skills, and technologies exist and progress rapidly and indefinitely. The difficulties are mainly financial: given the number of patients, profitability is not promised. In many cases, research is based on funds raised by non-governmental associations created by families confronted with rare diseases. In many cases, too, the pharmaceutical industry has no choice but to sell the drug at a very high price to make the investment in research profitable.

Fortunately, there are initiatives aimed at improving research funding and facilitating access to medicines. In countries with a health system built under the welfare state theory, the cost of treatment is borne by the state or, in the worst case, significantly reduced. Also, some insurance companies have created foundations whose purpose is to finance scientific research dedicated to the fight against rare diseases.

Above all, since January 2019, there has been an inspiring program: the European Joint Program on Rare Diseases (ejprarediseases.org), which is co-funded by the European Commission and the member states, is coordinated by the French National Institute of Health and Medical Research (Inserm, a French public entity). This program brings together research partners, funding agencies, hospitals, foundations, and associations of patients from 35 countries. It aims to create an extremely favorable environment for research, to coordinate work, and accelerate the development of drugs for people with rare diseases.

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