Amgen Inc. has added a warning to its anemia drug Aranesp after studies showed high doses of similar drugs can cause blood clots and death.  Aranesp is widely used to treat anemia in adult cancer patients as well as chronic kidney disease.  Some researchers had thought elevating hemoglobin might boost the effectiveness of chemotherapy and radiation to fight cancer.  The company said in a Jan. 11 letter to health professionals that two clinical studies revealed the complications when similar drugs were used to raise hemoglobin levels above recommended levels.  A Food and Drug Administration panel of outside experts last year called for more study of the risks of the anemia drugs, including faster tumor growth and more blood clots.  The company said it would not change its dosage recommendations.  Story here.

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InPharma reported that the European Commission, the biotech industry and Chinese government are funding a project aimed at safety in nanobiotechnology. As Philips and GE Healthcare are working on the development of nanomaterials for use in patients, a portion of the $15.6 million will be directed towards studies of the in vitro and in vivo toxicology of nanomaterials, and also whether the size of the particles affects their toxicity, in the same way that asbestos is safe when encountered in a sheet, but causes cancer when inhaled as a dust.

Last year, one study was reported showing that inhaled nano-sized particles accumulate in the nasal cavities, lungs and brains of rats, raising concerns that this build-up could lead to harmful inflammation and a risk of brain damage or other central nervous system disorders. And it is known that carbon “buckyballs,” a spherical form of the element that has properties attractive for drug delivery, are toxic to cells.  See the article here.

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The World Intellectual Property Organization (WIPO) marked the filing of the one millionth international patent application under the Patent Cooperation Treaty (PCT) in the 26-year history of the PCT.  The Director General observed "While it took 22 years to receive the first half million PCT patent applications, it took only 4 years to top the one million mark, reflecting an astonishing acceleration in the pace of technological development and unprecedented use of the international patent system."  The PCT facilitates the process of obtaining patent protection in more than 120 countries through the filing of a single international application.

The largest users of the PCT system have originated from the United States of America, Japan, Germany, the UK and France. That said, the numbers of PCT applications from several developing country members continue to show a marked increase, most notably in India and the Republic of Korea which enjoyed double-digit growth in 2003.

See the entire press release here.

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The inventor of an LED technology has reluctantly agreed to a record settlement from his former employer in a dispute. Shuji Nakamura, now a professor at the University of California, Santa Barbara, will receive 840 million yen ($8.1 million) from his former employer, the Nichia Corporation, for inventing blue-light-emitting diodes. Nichia secured lucrative patents for Mr. Nakamura’s invention, which allowed the creation of more vibrant video billboards and traffic signal lights and helped lead to the development of blue lasers, which are used in the latest DVD players. His invention was also useful in creating white-light-emitting diodes, which may someday replace incandescent bulbs as a source of indoor lighting.

The case goes against the tradition that employees should sacrifice everything for their companies. Traditionally, in Japan, corporate engineers and scientists are treated just like less-skilled employees. It is unusual for Japanese companies to sign contracts with their researchers that specify how profits from their inventions will be shared, as is often the practice in American companies.

The amount of the settlement was significantly smaller than the $190 million the Tokyo District Court awarded inventor Shuji Nakamura in January as reasonable compensation.

By mandating that employee-inventors receive fair compensation for the value their inventions provide to their employer, Japanese patent law stands in stark contrast to its American counterpart. Japan’s fair compensation provisions have been on the books since 1959, but employee-inventors have only recently started to sue under these statutes.

Mr. Nakamura sued his former employer four years ago, seeking a share of the royalties from his invention after the company gave him an award of 20,000 yen, or less than $200, for his work.  See the entire article here.

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In a Forbes article, Matthew Herper lays out his ideas for five ways we could improve the FDA.

Fix 1: Pay Up

How do we expect to police a $216 billion industry on $300 million per year?

FDA Fix 2: Power Up The FDA

Give the FDA powerful sticks and carrots to compel drug companies to test their medicines more thoroughly.

FDA Fix 3: Track Side Effects

In order to make sure that medicines are safe, we need to find new ways to track existing drugs.

FDA Fix 4: Fund Drug Studies

Right now, we depend entirely on companies to test the drugs they sell us. That’s not smart medicine, and it’s bad economics too.

FDA Fix No. 5: Forget Labels

Adding warnings to drugs has a limited effect. Does the FDA need its own ad agency?

As the author points out, this is only an agency that regulates products that make up a quarter of every dollar Americans spend annually–some $1 trillion in total.

More here.

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For those who always appreciate that "extra" day to get a filing in, the USPTO will be closed on Monday, 17 January (Martin Luther King Day) and again on Thursday, 20 January (Inaugural Day).

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Health and Human Services today announced steps HHS can take to advance medical innovations and move products more quickly from the lab bench to the bedside.  The recommendations were outlined in a new report: "Moving Medical Innovations Forward — New Initiatives from HHS."

The HHS task force examined internal procedures at agencies across the department, including the Centers for Disease Control and Prevention (CDC), the Centers for Medicare & Medicaid Services (CMS), the Food and Drug Administration (FDA) and the National Institutes of Health (NIH).

The report made several specific recommendations:

      Improving cooperation with other federal agencies that play a role in medical technology development.

      Creating a forum that will serve as a sounding board for investigators and manufacturers to communicate with HHS agencies.

      Supporting the ongoing development of standard formats for electronic clinical trial data.

      Improving collaboration between CMS and FDA.

      Supporting new inter-agency scientific education and cross-training efforts to identify knowledge gaps among those serving in the technology transfer functions in HHS.

The report is available here.

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This topic has been kicked around so long it seems like it, like trickle-down economics, is an ideal that is always just out of our grasp.  But, I will at least pass along that the "Committee Oversight Plan 108th Congress" website for the U.S. House of Representative’s Subcommittee on Courts, the Internet, and Intellectual Property describes plans to consider a world patent.  Under Article III, U.S. Patent and Trademark Systems, the document describes:

"Single, Low-Cost World Patent. The cost to U.S. companies and inventors of applying for and obtaining separate patents in each of 150 or more countries is prohibitive. In developing countries and even in Europe, patent fees are at such high levels that they constitute a tax on innovation. European government fees to obtain and maintain a patent are more than ten times the fees in the U.S. In addition, the expense of retaining separate patent attorneys or agents in each foreign country is burdensome and expensive. The United States could take a leadership role in negotiating an agreement under which countries would give full faith and credit to patents granted by an international organization or one of the three largest patent offices in the world- the U.S. Patent Office, the European Patent Office, or the Japanese Patent Office. Countries giving full faith and credit would charge a minimal fee for patenting in that country, and it would be unnecessary to retain separate patent attorneys or agents to obtain a patent in that country. The obstacles to negotiating and implementing such an arrangement would be formidable, but a single low-cost world patent is the best long-term approach to obtaining effective world-wide patent protection for U.S. companies and inventors. "

Starting with the Big Three (USPTO, EPO and JPO) makes a lot of sense, though.

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