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Patent Baristas

Reuters announced that the American Heart Association journal Circulation published an article showing Pfizer Inc.?s Bextra, a COX-2 inhibitor, can triple the risk of heart attack and stroke in certain patients.

In the study, the researchers studied mice genetically prone to hardening of the arteries or atherosclerosis and found that a compound called thromboxane or TxA2, produced by COX-1, accelerates atherosclerosis.  While low-dose aspirin prevents heart attack and stroke by blocking COX-1 formation of TxA2 in platelets, the addition of a COX-2 inhibitor caused changes that would result in a loss of stability of the plaque, making it more likely to rupture and activate clotting, causing heart attack or stroke.

Merck & Co. Inc. pulled its COX-2 inhibitor Vioxx from the market after clear evidence its use could raise the risk of heart attacks and in December, the National Institutes of Health halted a study involving Pfizer?s COX-2 inhibitor Celebrex.

See more here.

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In honor of Martin Luther King Day, I went with my daughter’s school class on a trip to see the National Underground Railroad Freedom Center in Cincinnati.  It was quite moving, even for second-graders, to see a slave pen, a two-story structure rescued and preserved inside the Center.  The movie on slave escapes across the river was a bit intense (and loud) but the kids came away with a deeper understanding of our history.  I recommend visiting the Center when you get a chance.

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Harold Wegner, a partner at Foley & Lardner has an interesting article pondering the upcoming possible changes to Japanese Patent Law.  The Japanese "Article 35" has become in the news for the astonomical awards of money to employed inventors possible independent of any employment contract. Legislation has been approved by the Cabinet that is now under consideration and may be enacted in the April-May 2004 session that would change in the law so that employers and workers are encouraged to reach an agreement on the framework for compensation.

But, in Japan any such agreement does not block imposition of a judicial award for compensation under Article 35 if the award is "unreasonable".

If enacted, the new law would have no effect on inventions that have been previously commercialized which are now in litigation ? or which may be litigated in the coming years, subject to the ten year statute of limitations to bring suit.

The current Japanese patent law states that "[t]he employee shall have the right to a reasonable remuneration when he has enabled the right to obtain a patent or the patent right with respect to an employee’s invention to pass to the employer or has given the employer an exclusive right to such invention in accordance with the contract, service regulations or other stipulations." Japanese Patent Law ? 35(3); emphasis added.  The proposed law makes no change in this provision.

The determination of the amount of reasonable remuneration is given in Art. 35(5) and is just like the old method of Art. 35(4) of the current law, except for the preamble concerning an employment contract: "In a case where there are no provisions such as [an employment] contract *** [under Art. 35(4)], or otherwise the paying remuneration in accordance such provisions is considered unreasonable according to the preceding section, the amount of the remuneration under the preceding section shall be determined by reference: "To the amount of profits to be realized by the Employer from the invention; and "To burdens that come along with the invention on the Employer contribution by the Employer and compensation and benefits given to the employee, etc by the Employer".  This is essentially the same as the current law.

Left unanswered are questions such as:

What happens if the patent life unexpectedly becomes devalued due to noninfringing product or shortened due to invalidity.

Can an inventor get remuneration for an invention that has never been the basis for any licensing but is used to exclude others?

What if there is no license but a covenant not to compete?

Does it matter whether the license generating income is for an "invention" or for a "patent"?

Is an invention made by a Japanese national covered by Art. 35 or only if the person makes the invention in Japan? What happens if the inventor works for a foreign company? Does the location of the research facility matter?

Is there a right to remuneration for this invention that is not commercialized?

What about co-inventors who did not invent the technology where there are different inventors of different claims in a patent and that the critical technology that is licensed is in claims with less than all of the named inventors?

What to do with post-grant inventorship changes and disputes?

May an employer avoid compensation altogether by refraining from filing a patent application or by abandoning or forfeiting the application or patent?

As you can see, there are lots of questions that will need to be answered through some expensive litigation to work out the details of just how inventor compensation will work.  While it is expected to pass, there could be changes to the law given the publicity of the Shuji Nakamura case against Nichia.  In addition, it will be difficult for Japan to harmonize with U.S. and European laws if they continue down a path with their own provincial reward system.

See the entire article here.

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GenoMed announced today that it has filed a patent application on two genes linked to common cancers.  These are the first new disease genes the company has filed on since its multiple patent applications on ACE, a "master" disease gene.

The first gene, involved in copying DNA, was linked specifically to pancreatic and ovarian cancers, which are notoriously hard to diagnose at an early stage.  It could help in the early diagnosis of patients at high risk for these cancers, as well as serve as a possible drug target for treatment of these poorly treatable diseases.

The second gene codes for a scaffolding protein involved in building protein networks inside the cell.  It was linked to all six common cancers (lung, colon, breast, prostate, ovarian, and pancreatic), and may lead to new broad-spectrum chemotherapeutic agents.

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Although an FDA advisory panel voted 20-3 Friday to recommend against allowing Merck to sell over-the-counter (OTC) Mevacor, a cholesterol-lowering statin drug, Bristol-Myers Squibb is seeking approval of a 20-milligram OTC version of Pravachol. "We are continuing a robust program to provide the FDA with the information it needs," company spokesman Rob Hutchison says. "Our own studies are underway."  Panel members said Merck’s "actual use" study, which simulated pharmacies selling OTC Mevacor, failed to show that consumers could properly decide on their own whether to take the statin.

Nearly six out of 10 study participants who used OTC Mevacor still ended up consulting a doctor. And even so, nine out of 10 failed to meet at least one of the criteria set forth on the drug’s label.

By switching a drug to OTC status, manufacturers hope to boost sagging sales resulting from generic competition. When a drug is switched, its manufacturer gets exclusive rights to sell it OTC for three years. Prescription Mevacor already is off patent, so it faces competition from generic lovastatin. Pravachol’s patent expires in April 2006.  OTC Mevacor would have been the first non-prescription drug to treat a symptomless chronic condition.  The FDA has until Feb. 24 to reach a decision about OTC Mevacor.

See more here.

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St. Jude Medical settled a 2000 patent infringement suit with heart-valve technology company Edwards Lifesciences Corp.  Edwards will receive a $5.5 million payment, and St. Jude Medical will get paid-up licenses for certain of its heart valve therapy products.

In the suit, Edwards claimed St. Jude Medical infringed on three of Edwards’ patents, two relating to annuloplasty rings and one relating to manufacturing methods used to make tissue heart valves.

See more here.

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Force Field Wireless claims to have developed a solution to the international menace of marauding geek wardrivers – DefendAir paint "laced with copper and aluminum fibers that form an electromagnetic shield, blocking most radio waves and protecting wireless networks". According to a South Florida Sun Sentinel article, one coat of the water-based paint "shields Wi-Fi, WiMax and Bluetooth networks operating at frequencies from 100 megahertz to 2.4 gigahertz", while two or three applications are "good for networks operating at up to five gigahertz".

There are some downsides as Force Field Wireless admits that "radio waves find leaks" andthe company asks users to be aware that the product "must be applied selectively" otherwise it "might hinder the performance of radios, televisions and cell phones". Although DefendAir is available only in grey, it can be used as a primer, so those who require wireless peace of mind plus bold fashion statement can cover it up quite nicely.  And I thought the aluminum foil I have all over my house would be enough.  Hmmmmm.

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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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