BOSTON CLUSTER


A clear picture is emerging, one that reveals a small life sciences hub where students, researchers and businesses all closely interact. One of the main benefits of having so many high quality institutions clustered together, Uhl says, is the opportunity to collaborate. “While the life science community in Boston is very small, it is one of the most active,” she says.


Barry Greene, president of Cambridge- based Alnylam Pharmaceuticals, says the main advantage of being at the hub’s centre is the partnership opportunities that


“INCIVEK WILL BATTLE AGAINST A VIRUS AFFECTING AROUND 170 MILLION PATIENTS WORLDWIDE BUT IT WILL PRODUCE DIVIDENDS OF HUNDREDS OF


MILLIONS OF DOLLARS. COULD IT BECOME THE BLOCKBUSTER DRUG?”


arise.


Tese partnerships foster collaboration and advancement in research and development (R&D). “For example, Alnylam has developed strategic collaborations


related to its novel


technology and product pipeline with local entities including MIT, Harvard,


Biogen,


Novartis and Cubist. In addition, the entire industry benefits from Boston’s world-renowned medical community, including hospitals and schools,” he says.


It is interesting to note that companies typically assess whether there is room to innovate before undertaking any R&D. Jennifer Camacho, shareholder at Greenberg Traurig LLP in Boston, says it is too expensive and too risky not to do things in this order. Large pharmaceutical companies will employ teams of people to assess the market, while smaller companies tend to collaborate, she says. Camacho, who refers to the “synergy” between these smaller companies, says that they are oſten the best innovators, “thinking outside of the box”.


All companies face challenges when trying to secure or protect IP. Aside from regulatory issues, Camacho says the volume of case law handed down by US courts, particularly covering the biotech industry, is large. “Tis gives rise to questions on how different cases affect biotech companies, and is narrowing the realm of patent eligibility,” she says. A final hurdle for life sciences companies is patent reform in the US. Te America Invents Act, passed in September 2011, lays down new rules for filing patents, known as ‘first-to-file’. Although it won’t replace the current ‘first-to- invent’ system until March 16, 2013, Camacho


16


says companies need to be incorporating these changes into their IP strategies.


While this legislation may be a challenge for life sciences companies, the government is keen to help Boston. As the Jones Lang Lasalle report notes, the cluster receives significant funding from the National Institute of Health, which has bankrolled Boston with at least $2.2 million to date. These handouts, along with further tax breaks for companies locating in the area, provide incentives for businesses to grow and thrive. But for all the money,


the


prestige and the additional praise from Jones Lang Lasalle, has a Boston institution made an outstanding discovery, one groundbreaking drug that has been important for treating an illness or disease?


“To my knowledge, there hasn’t been a blockbuster drug generated by a Boston life sciences company,” says Uhl. Te term blockbuster is, however, subjective and prevents us from understanding Boston’s notable successes. As Uhl herself notes, and others concur, there have been several important breakthroughs in the area.


For example, Doug Cole, general partner at Flagship Ventures in Cambridge, and George Xixis, a partner at Nutter, McClennen & Fish


Life Sciences Intellectual Property Review 2012


LLP in Boston, both argue that there have been positive advancements in the treatment of hepatitis C, an infectious disease primarily affecting the human liver. On May 23, 2012, the US Food and Drug Administration (FDA) announced its approval of a hepatitis C treatment called Incivek, which is produced by Vertex Pharmaceuticals, based in Cambridge. Only 10 days earlier, the regulator cleared a similar drug from pharmaceuticals company Merck, based in New Jersey, setting up an intriguing sub-plot to the Boston-New Jersey rivalry.


According to the FDA’s Debra Birnkrant, a drug cocktail that has been the standard hepatitis C therapy requires 48 weeks of in about half of


patients. But the new


developments, FDA commissioner Margaret Hamburg says, are “innovative” and represent a “new direction” in the treatment of hepatitis C, and a “significant improvement” over the current standard of care. Incivek, which costs $49,200 for a 12-week treatment course, works by blocking an enzyme used by hepatitis C to copy itself. Incivek will battle against a virus affecting around 170 million patients worldwide but, according to Xixis, it will produce dividends of hundreds of millions of dollars. Could it become the blockbuster drug?


Xixis expects another drug, called BG-12— produced by a Massachusetts company, Biogen—also to do “exceedingly well”. The drug, which is now under review by US and European regulators, treats multiple sclerosis (MS), the disabling disease that attacks the central nervous system. Shares in Biogen immediately soared back in October 2011 when it revealed positive results from clinical trials. The trials showed that over a two-year period, when given twice a day, BG-12 cut the annual relapse rate in patients with MS by 44 percent. When given three times a day, it cut the relapse rate by 51 percent. Biogen already produces MS drugs Avonex and Tysabri which are given by injection, but the new BG-12 pill could become the world’s leading treatment for the disease.


www.worldipreview.com


for the past decade treatment and fails


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