Patent Baristas

The USPTO’s Patent Application Information Retrieval (PAIR) sytem now lists expirations due to failure to pay maintenance fees. Expired patents now have a status of "Patent Expired Due to Non-Payment of Maintenance Fees Under 37 CFR 1.362".  Patents can, of course, expire in other ways.  If a patent is subject to a terminal disclaimer relative to a previous patent and they cease to be commonly owned, for example.

The U.S. Supreme Court agreed to review a lower ruling in which a patent held by Integra LifeSciences Holdings prevented Germany’s Merck KGaA from conducting conduct "head-start" exploratory research for future applications into a potential new anticancer drug, even if the drug could not feasibly be marketed until after the patent expired in 2006.

Under 35 U.S.C. 271(e)(1), it is generally not an act of infringement to use a patented invention "solely for uses reasonably related to the development and submission of information under a Federal law" regulating the manufacture, use, or sale of drugs. The question presented is whether the court of appeals erred in limiting that exemption to clinical studies designed to provide information for Food and Drug Administration approval of a new drug.

The government has argued that the Federal Circuit decision (see 331 F.3d 860, 66 USPQ2d 1865 (Fed. Cir. 2003)) incorrectly suggests that Section 271(e)(1) is limited to "clinical" research, which the FDA regards as trials on humans. However, in determining whether to permit clinical trials, the FDA considers pre-clinical research, including pharmacological and toxicological studies of the drug involving laboratory animals or in vitro.

To read the Federal Circuit opinion in this case, click here.

To read the government amicus brief, click here.

Update:

For more on Merck v. Integra, see Dennis Crouch’s Patently Obvious blog for an outstanding review of the case and the flood of amicus briefs pouring into the Supreme Court.

According to a January 9, 2004 article in the New York Times Magazine by Ted C. Fishman, what makes China so troubling for American and other foreign companies is that the country is both a potential rival, with an alternative legal approach to intellectual property that limits their prospects in China and weakens their competitive strength globally, and a haven for pirates and counterfeiters.  Fishman points out that China’s failure to police industry and to protect intellectual-property acts, in effect, like one of the greatest industrial subsidies in the world.  Chinese manufacturers and industries freely exploit foreign ideas and technologies.  This is particularly true with high-tech and pharmaceuticals.  For the most part, China fears no repercussions from its actions because the size and potential of its markets give China an undiminished (for now) power to lure the world’s most advanced technology to its shores.  Read the entire article here.

The Ohio Valley Affiliates for Life Sciences Group (OVALS) will host it’s regional conference  "The Promise of Innovation: OVALS Making It Happen" on March 7-8, 2005, at the Dayton Marriott Hotel in Dayton, Ohio. 

TOPICS INCLUDE:

• Policy to financing: emerging trends in life sciences
• Creating building blocks for university/industry agreements
• Moving from lab to market: what industry wants!
• The regional profile: OVALS as a national life sciences hub
• OVALS at the forefront of scientific discovery: BioDefense, Environmental Health, NanoTechnology and Cellular Biology
• Special interest sessions: contemporary issues in Bioethics and Venture Investment
• Current industry RFPs: real opportunities for universities

Register and see Agenda.

The OVALS Partnership developed in 2002 as a forum to discuss and stimulate economic development opportunities for Life Sciences within the "Ohio Valley" region.

Reuters reported that Medtronic Inc. lost a patent case over heart stents against rivals Guidant Corp. and Boston Scientific Corp. on Wednesday, but the company said it would appeal the decision.  A Delaware District Court ruled that two of Medtronic’s stent devices used to treat clogged heart arteries infringed a patent held by rival Guidant, and that stents offered by Guidant and Boston Scientific did not infringe Medtronic’s Boneau patents.  Heart stents are tiny wire-mesh tubes that prop open clogged heart arteries that have been cleared surgically.

The federal court judge found that Medtronics S7 and Driver coronary stents infringed one claim of Guidant’s Lau patent.  Medtronic’s Driver stent is central to the company’s efforts to develop a more advanced drug-coated stent that helps keep arteries from re-closing.  A drug-coated version of the Driver is currently in clinical trials.  Guidant agreed last month to be bought by Johnson & Johnson, another maker of the heart devices, for $25.4 billion.  Currently, J&J and Boston Scientific are the only two companies to sell a drug-coated stent in the United States.

An article by SiliconVally.com entitled "Loophole boosts biotech profits" describes the extension of patent term Amgen received for applications filed prior to June 8, 1995, the date that patent term was changed from 17 years after issuance to 20 years from the date of filing an application. The key patent covering the drug Epogen expired Oct. 27, 17 years from issuance.

Epogen and its chemical twin, Procrit, brought $6 billion in revenue last year, $19 billion worth of Epogen since 1989. Fortunately for Amgen, the revenue will continue since it won as many as 12 extra years of protection beyond that first patent, running until 2016.

While the article bemoans Amgen’s filings prior to the law change for extending patent protection and the fact that biotech generics are not available for approval by the FDA, it isn’t so clear that Amgen manipulated the system. Arguing that they took advantage of the law as it applied to everyone is a little like complaining that retirees born before 1960 are taking advantage of an earlier retirement age allowed over those born in 1960 or later.

With respect to generics, biotech and pharmaceutical industries argue that there can be small but important differences in different versions of biotech drugs and that generics should be subject to the same FDA studies as the original products. The FDA has put off considering any biotech generics until it completes a series of public workshops on the subject, set to continue next year.

See the entire article here.

In Law Technology News,  Attorney Laura Owen of Cisco Systems recommends steps that companies must take to adapt to the changing legal landscape in her article "The Tech Evolution: Change or Die." While I don’t agree that failure to adapt legal practices causes a lot of corporate carcasses, embracing advances in legal work can make any company more successful and more profitable.  She makes a good point about reigning in the cost of IP legal work, an area that typically commands the highest billing dollars.

3.  Move your legal work to low cost firms located in the Midwest, South or other regions away from high cost centers. Doesn’t sound like technology here, but it is. Extranets provide ways for companies to work with firms across the country (and the world ). Web-based worksites are always open, always on. Work flow tools — putting the right person in the right order at the right time — can dramatically improve productivity and reduce costs.

For example, patent prosecution works well for this model — and if the client uses an online patent application tool for its employees, connecting to the firms that do the work, clients improve the patent prosecution for the company and the firms make more money through an increase in patent filings.

We already do work with many coastal high-tech companies that like my firm’s low billing rates and personal service.  If you are interested in finding out about what we can offer, call me at: 513.651.6839 or send me a note at: salbainyjenei@fbtlaw.com.