Nagendra Setty

An important new law went quietly into effect at the beginning of this year. It promises to have immense effects on the pharmaceutical industry: It will reshape one of the world's largest markets, make an important population of scientists and researchers more accessible to American companies, alter the infrastructure that supplies the developing world with drugs for AIDS and other diseases, and push a group of ferociously competitive companies away from generics and toward proprietary drugs.

Significantly, it wasn't passed either by the United States or the European Union, but rather, by India, the world's fourth-largest pharmaceutical market and the home of significant resources in pharma manufacturing and R&D.

Patent issues have moved to center stage in Washington. In June, the Supreme Court ruled unanimously that pharma companies can do research on patented materials without infringing on intellectual property rights. Patent-extension proposals continue to pop up as incentives for desirable new drug research. Congress has launched a serious effort to overhaul the current US patent system and policies. And, somewhat ironically, industry strategies for transferring valuable patent rights to overseas subsidiaries put pharma companies in a prime position to benefit from a one-time tax break for companies that bring some of those foreign profits back to this country. (See "Bringing It All Back Home.")

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Drug Delivery Executive: Dr. Joseph Mo, President and CEO of NexMed, explains how his company’s transdermal drug delivery system has been incorporated with existing drugs to develop new patient-friendly transdermal products, thereby extending patent lifespan and brand equity.

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How much of an impact does patent reform, real or imagined, have on biopharmaceutical stocks?

Plenty. Consider Pfizer as an example.

Brian O'Connell
The pharma giant sent shock waves up and down Wall Street in December '05 when it announced that third-quarter profits had plummeted by 52 percent. That in turn sent company stock down almost nine percent, reaching a 15-year-low.

While declining sales of linchpin drugs like Lipitor and Viagra had a lot to do with Pfizer's financial woes, analysts noted that many investors were jumping ship over the fact that the company has a slew of patents ending their run in 2006. Pfizer will have to battle it out with generic drug makers encroaching on its turf.

Investors spent 2005 nervous about Lipitor's patent, which seemed vulnerable after Ranbaxy Pharmaceuticals filed a patent infringement lawsuit. With $2.9 billion in Lipitor sales, Pfizer had a lot riding on the outcome of this patent case, which ended in Pfizer's favor.

Patents, trademarks, copyrights, and trade secrets constitute private intellectual property (IP), and the owners of such property, like owners of real property, are entitled to exclude trespassers.

Enforcing intellectual property (IP) rights need not involve litigation. Owners of IP who are not solely interested in exclusivity frequently work out private licenses with perceived infringers.1 Similarly, a carefully worded cease-and-desist letter might convince an infringer to halt the infringing activity without judicial intervention. Letters and licensing negotiations, however, often simply serve as preludes to litigation.

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Commercial embodiments of genetically modified inventions are protected in Canada.

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Biotech patent decisions before the Supreme Court and the Prime Minister's commitment to innovation will shape the future of life sciences protection in Canada.

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The Madrid Protocol offers companies another option for trademark registration o­n a global scale.

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The prospect of off-patent blockbuster biotechnology drugs is triggering a complex legal, policy, and scientific debate o­n a new type of generic. “What ‘same’ is.” That is the underlying enigma of the day, Ropes & Gray Senior Partner Alan Bennett told attendees of a July 2003 Food and Drug Law Institute conference in Washington, DC, entitled “Issues Raised by Follow-on Versions of Biologics.” Even though—as Bennett pointed out for laughs—this enigmatic query brings to mind President Bill Clinton’s infamous legalese, “It depends o­n what ‘is’ is,” the question of sameness as it relates to therapeutic recombinant proteins is more than just legal posturing.

When generic versions of Lilly's antidepressant Prozac (fluoxetine) were introduced in 2001, Prozac's volume fell precipitously—losing 73 percent of its share of new prescriptions within two weeks. Although that may be the most well -known example of the impact of generics, the Federal Trade Commission reports that between 1984 (when Congress passed the Hatch-Waxman Act) and 2002, generics' prescription share has risen from 19 to 47 percent. Today, the figure is widely reported to be more than 50 percent. Based o­n review of recent patent expiration data, such rapid losses of revenue for brand owners appear to be more common. Generic companies are stronger and more sophisticated, and payers are more effective in their efforts to influence the way prescriptions are written and filled.

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With some planning, you can use intellectual property laws to adequately protect the wealth of data stored in your databases. Those valuable data may not be copyrightable, but the software used to store them is.

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