Takeda Pharmaceutical Co. (4502), Asia’s largest drugmaker, sued to block Impax Laboratories Inc. (IPXL:US) and Novartis AG (NOVN)’s Sandoz unit from selling generic versions of the acid-reflux drug Dexilant.
Impax and Sandoz are seeking U.S. Food and Drug Administration approval to sell copies of Dexilant, according to separate lawsuits filed May 29 in federal court in San Francisco. Takeda, based in Osaka, Japan, alleges the generic versions would infringe a patent that expires in 2030, according to the complaints. Takeda filed a similar lawsuit against TWI Pharmaceuticals Inc. (4180)
The complaints seek a court order declaring patent infringement and delaying approval for the generics until the patent expires.
The cases are Takeda Pharmaceutical Co. v. Impax Laboratories Inc., 13-cv-02416, and Takeda Pharmaceutical Co. v. Sandoz Inc., 13-cv-02418, U.S. District Court, Northern District of California (San Francisco).
Biogen MS Pill Delayed in Europe as Patent Extended to 2028
Biogen Idec Inc. (BIIB:US), the world’s biggest maker of multiple sclerosis drugs, said a European regulatory decision on its new pill will be delayed until the second half of the year after a patent on the medicine was extended.
Biogen said it’s seeking to clarify Tecfidera’s regulatory exclusivity status in Europe. A European patent on the pill was extended May 29 until 2028 and covers the expected 480-milligram dose planned for sale, the Weston, Massachusetts-based company said in a regulatory filing.
Tecfidera cleared U.S. regulators on March 27, propelling Biogen shares to a 31 percent gain from the approval through yesterday. The drug followed Novartis AG’s Gilenya and Sanofi (SAN)’s Aubagio to the market as oral options for MS, a central nervous system disease otherwise treated by injection or infusion. The illness affects 2.1 million worldwide, according to the National Multiple Sclerosis Society.
Biogen is working to make Tecfidera’s regulatory data protection clearer to all parties, Kate Niazi-Sai, a Biogen spokeswoman, said in an e-mail. “We originally anticipated that the dialogue would be completed by now, but it is not,” she said.
Initial U.S. sales of Biogen’s pill, formerly known as BG-12, were greater than those of Gilenya and Aubagio, suggesting revenue may be more than analysts’ initial estimates of $240 million to $300 million this year, according to a Wells Fargo & Co. report on April 29. The medicine may have sales of $3.4 billion by 2017, according to the average of eight analysts’ estimates compiled by Bloomberg.
“We have been encouraged by early signs of physician and patient interest in this product,” Tony Kingsley, Biogen’s head of commercial operations, said April 25 on a conference call after the company released first-quarter earnings. “U.S. physician awareness of Tecfidera is high and perceptions are strong.”
Biogen also sells Avonex, an injection, and Tysabri, an infusion.
Article One Hands Out More Than $4 Million to Patent Searchers
Article One Partners, a New York-based company that conducts crowd-sourced searches for information that could potentially invalidate a patent, said it has paid out more than $4 million to people who conducted searches on its behalf.
In a statement yesterday, the company said it has more than 27,000 researchers working in more than 160 countries. It conducts research on behalf of clients who typically are targets of patent-infringement suits brought by patent owners who don’t themselves make products covered by their patents.
Marshall Phelps, the former head of patents and licensing at both International Business Machines Corp. (IBM:US) and Microsoft Corp. (MSFT:US), is chairman of Article One Partners’ board. The company said in its statement that it is a partner to seven of the top U.S. patent filers.
Future Hepatitis C Blockbusters May Spawn Compulsory Generics
Hepatitis C drugs like Gilead Sciences Inc. (GILD:US)’s sofosbuvir, which analysts forecast will become the company’s top seller, may spawn compulsory generics in countries that can’t afford them, according to a report backed by billionaire Richard Branson.
While health officials are negotiating with drugmakers including Gilead over the price of new medicines for the deadly liver virus, developing nations should issue compulsory licenses for the therapies if price reductions aren’t sufficient, according to the report by the Global Commission on Drug Policy, of which Branson and former Federal Reserve Chairman Paul Volcker are members.
Under a World Trade Organization agreement known as trade-related aspects of intellectual property rights, or TRIPS, member countries can give licenses to generic-drug makers to make low-cost copies of treatments protected by patents that are needed to address a public health emergency.
“If the prices were to be unaffordable once more in history, it would be one more scandal around inequity of access to health care,” Michel Kazatchkine, the United Nations Secretary General’s Special Envoy on HIV/AIDS in Eastern Europe and Central Asia, said at a briefing in Geneva yesterday. “There’s no reason why a country like Ukraine wouldn’t go for this and declare a public emergency.”
About 170 million people are infected with hepatitis C, which is transmitted commonly among drug users who share contaminated needles, and can cause liver damage and cancer. Of 16 million people estimated to inject drugs globally, about 10 million have hepatitis C, according to today’s report, which didn’t specifically name sofosbuvir.
Spokeswomen for Gilead didn’t immediately respond to a call and e-mail requesting comment sent outside regular business hours.
Gilead applied for U.S. regulatory approval of sofosbuvir last month, and the drug may cost as much as $100,000 per patient, according to Mark Schoenebaum, an analyst at ISI Group in New York. The Foster City, California-based company gained the drug with its $11.1 billion acquisition of Pharmasset Inc. last year.
The pill may earn Gilead almost $4 billion in 2015 and $6.3 billion the following year, according to the average analyst estimates (GILD:US) compiled by Bloomberg.
Johnson & Johnson (JNJ:US), AbbVie Inc. (ABBV:US), Merck & Co., Bristol-Myers Squibb Co. (BMY:US) and Vertex Pharmaceuticals Inc. (VRTX:US) are among other companies developing new hepatitis C treatments.
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ICANN to Study Security of New Domain Names, Dotless Names
The Internet Corporation for Assigned Names and Numbers, the nonprofit organization that controls the Internet’s domain-name system, said in a statement that it is looking at the potential security issues related to the new top-level domain names.
This would be related to potential collisions between the applications for these names with private name spaces that are already in use.
ICANN will also look at the issue of what are known as “dotless domain names.” These are domain names that consist of a single label. ICANN says that while the use of dotless domain names could provide potential innovations, “their use also raises usability, functionality, security and stability concerns.”
The organization said it has commissioned a report on these issues, including options about how to mitigate potential risks and the pros and cons of the options. ICANN said it plans to deliver the results of the study before its meeting in Durban, South Africa, in mid-July.
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Ukraine Singled Out by Trade Report for IP Rights Violations
Ukraine is listed as a priority foreign country for IP rights violations in a report issued by the Office of the U.S. Trade Representative.
The country was the only one to receive this designation in the report, which was issued this month. According to the report, Ukraine’s IP environment is flawed.
Among the reasons listed are the unfair, nontransparent administration of the system for collecting societies, the widespread and admitted use of illegal software by Ukrainian government agencies, and the failure to implement an effective means to combat the widespread online infringement of copyright and related rights.
Ukraine has recognized that it has illegal “rogue” collecting societies that collect royalties by falsely claiming they have to right to do so, according to the report. These organizations “rarely disburse sufficient funds that they collect to the rights-holders entitled to the royalties.”
The report notes that while the Ukrainian government budgeted $12.3 million for software legalization in state institutions for 2013, the money has not been spent. In 2012, there was not one single conviction in Ukraine for online piracy, according to the report.
Ten nations are listed on the report’s priority watch list. They are Algeria, Argentina, Chile, China India, Indonesia, Pakistan, Russia, Thailand and Venezuela.
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