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The Trials of Amgen IAM ISSUE 18_TEXT 26/5/06 17:40 Page 43 Feature Amgen The trials of Amgen It is a company that has become used to major patent litigation. But Amgen’s latest battle could turn out to be the most significant yet, especially at the end of a period when acquisitions and the establishment of a venture fund have marked a change in strategy The Lilly perspective By Victoria Slind-Flor Almost simultaneously with the patent’s issuance, Ariad filed suit against Lilly in A very big patent is threatening the world’s federal court in Boston. Ariad charged largest biotech company. Although Amgen infringement by two different Lilly drugs: Incorporated of Thousand Oaks, California, sits Evista, which treats osteoporosis; and on top of a powerhouse portfolio of rights and Xigris, which is used against toxic shock. produces bioengineered drugs for diseases According to members of the biotech patent affecting a broad swathe of the population, bar, Ariad also contacted Amgen and as many Amgen products could potentially be many as 50 other biotech and pharma infringing a patent assigned to a small companies, warning them they were Cambridge, Massachusetts, biotech company. potentially infringing the patent. If a jury verdict handed down in early May The case went to trial this year before against Eli Lilly and Company is any indication, US District Judge Rya Zobel and in early Amgen officials need to be very concerned. May, a jury awarded Ariad more than US$62 The patent in question relates to a million in royalties for past infringement and method of inhibiting a certain kind of human a 2.3% royalty on future sales of Lily’s two protein involved with cellular response to drugs up to 2019. The verdict is under stress. This technology was developed by two appeal, and the patent is also under re- Nobel prize-winners, David Baltimore – now examination at the US Patent and Trademark president of California Institute of Technology Office, but still, many observers of the – and Philip Sharp, of Massachusetts biotech scene anticipate that Amgen would Institute of Technology, together with Harvard be Ariad’s next planned target. University biologist Thomas Maniatis. This Ariad was represented by a team from particular protein, which is known as NF-κB, New York’s Kaye Scholer, led by veteran is implicated in many diseases, including biotech patent litigator Leora Ben Ami. Ariad rheumatoid arthritis, cancer and auto-immune Chairman and Chief Executive Officer Harvey disorders. Ironically, Baltimore, the lead J Berger has said he’s confident that the jury inventor, is also a member of Amgen’s board verdict will be upheld by the appeals court. of directors. Amgen makes a tempting potential deep- The ‘516 patent issued in June 2002 pocket defendant. The 26-year-old biotech and is licensed to Ariad Pharmaceuticals by company brought in US$12.4 billion revenues Harvard, MIT and the Whitehead Institute for in 2005, with US$2.57 billion coming from Biomedical Research. It is lengthy, with 203 Enbrel, which is used to treat rheumatoid separate claims around the reduction of arthritis. And Amgen’s pipeline of up-and- NF-κB in a variety of cells, including liver, coming drugs includes new treatments for lymphoid and immune cells. This reduction arthritis, cancer, lupus and asthma, all of is a pathway or drug target that is employed which are likely to work by reducing the NF-ÎB by a wide range of existing drugs and even protein as is outlined in the Ariad patent. such common substances as red wine, In an effort to head off a possible aspirin and garlic. infringement action, Amgen went to federal www.iam-magazine.com Intellectual Asset Management June/July 2006 43 IAM ISSUE 18_TEXT 26/5/06 17:40 Page 44 Amgen court in Delaware at the end of April, asking a Amgen R&D expenditures judge to rule that all of the claims in Ariad’s ‘516 patent are invalid and that several 2.5 products, including Enbrel, do not infringe. Ariad proved to be a challenging litigation 2.0 opponent in the Lilly case. As one senior biotech patent lawyer – who spoke on the 1.5 condition of anonymity – said: “When Ariad brings two Nobel laureates and an issued patent into court, jurors are unduly 1.0 US$ Billion impressed.” Plus, he continues, the science is so difficult to understand and the patent 0.5 so long and involved that jurors, and even the federal judges who hear patent cases, are easily daunted. 0 Not an open and shut case 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 But Charles Hoyng, a biotech partner at the Silicon Valley office of Los Angeles firm Robert Armitage, Lilly’s general counsel Latham & Watkins, points out that the and senior vice president, has equally harsh “learned judges” of the appeals court are less words about the patent. After the verdict likely to be swayed by Ariad’s marquee-name came down in May, Lilly issued a statement scientists. He anticipates the CAFC will in which Armitage said that Ariad’s dispose of the ‘516 patent as summarily as infringement charges are “equivalent to the court rejected the University of discovering that gravity is the force that Rochester’s ‘850 patent for a method of makes water run downhill and then screening for the COX-2 inhibitors used to treat demanding the owners of all the existing arthritis. In 2004 the appeals court found that hydroelectric plants begin to pay patent the university’s patent was invalid because it royalties on their use of gravity”. failed to demonstrate a method of treatment. However, if Ariad continues to prevail, In any case, Amgen had to proceed almost every pharmaceutical and biotech separately from the Lilly litigation because company could potentially be found to each dispute focuses on specific drugs infringe the patent. That is why every biotech proprietary to the companies. Members of the lawyer is watching the case so closely. patent bar estimate that the minimum cost Amgen will incur in challenging the Ariad A history of litigation patent is US$10 million. But that is a Amgen has faced bet-the-company litigation miniscule amount of money compared to before. Back in 1997, it charged Transkaryotic Amgen’s potential exposure. All in all, Therapies Inc (TKT) of Cambridge, challenging Ariad is bet the company litigation Massachusetts, with infringing five patents for on which Amgen’s very survival could depend. bioengineered erythropoietin, which is used to Warren Woessner of Minneapolis’s treat anaemia. Lawyers for TKT argued that Schwegman, Lundberg, Woessner & Kluth there was no infringement because the has read the ‘516 patent carefully and says company used the different process of “gene it contains “many ‘Hail Mary’ claims activation” to create erythropoietin. Lloyd because, like a[n American football] pass, “Rusty” Day of Cupertino, California’s Day it’s thrown as far and hard as you can and Casebeer Madrid & Batchelder served as you hope there will be someone who can Amgen’s lead counsel. catch it on the other end.” That case was also closely watched, with He anticipates that the patent may well armies of lawyers paid by investment-bank not survive the re-examination because, clients to sit in the courtroom every day and under US patent law, it fails to “enable” the monitor the process of the litigation. invention. It does not mention any specific Ultimately, US District Judge William G Young drugs that can be used to reduce the NF-ÎB found that TKT did infringe several of Amgen’s level. Additionally, if other drugs and patents and he was later affirmed by the US substances such as red wine and aspirin Court of Appeals for the Federal Circuit. have been operating against this protein for Amgen did not meet with the same years and years, then Woessner says the success overseas. In 2004 the UK’s House method the patent claims is already in the of Lords upheld an earlier Court of Appeal public domain. ruling that TKT did not infringe Amgen’s 44 Intellectual Asset Management June/July 2006 www.iam-magazine.com IAM ISSUE 18_TEXT 26/5/06 17:40 Page 45 Amgen Amgen employees biotech lawyer. “This could cover many, many drugs,” he says. “It’s the single most 15000 important biotech case at the moment.” 12000 Building a biotech behemoth Amgen started small back in 1980 and, early on, the company was without a strong 9000 focus. Indeed, one of the first patents that issued to Amgen was for bioengineered 6000 indigo dye and another was for a shipping unit to protect its contents from freezing. But Amgen employees 3000 the company hit the jackpot in 1983 when a company scientist successfully cloned a gene that affects red-blood cell production. 0 This discovery led to the development of erythropoietin, the anti-anaemia blockbuster 1980 1981 1982 1983 1984 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 drug that received approval from the US Food and Drug administration in 1989. In European patent of erythropoietin, because the same year, it was named “product of the TKT used a different method of producing year” by Forbes magazine. the drug. (TKT was acquired by the UK’s Neupogen, which stimulates white blood Shire Pharmaceutical Group in mid-2005.) cell production, was the company’s second Amgen is still involved in erythropoietin- big hit. Cancer patients undergoing related court battles. In November 2005, chemotherapy and others with impaired Amgen filed suit in Boston against Roche immune systems receive injections of Holding AG, in efforts to halt Roche’s Neupogen to help them fight off infection.
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