Several emerging companies are building platforms around the concept of systems biology, which is premised on the idea that drug and diagnostic discovery require studying the ways in which the various elements of biological systems-including, but not limited to, genes and proteins-integrate and interact within an organism or function. This ambitious undertaking requires an arsenal of high-throughput technology and expertise drawn from a myriad of disciplines including chemistry, bioanalysis, molecular and cell biology, medicine, and informatics. The immediate challenge facing aspiring systems biology companies is to sustain themselves by creating sufficient value from their expansive technologies during the years it will take to come up with a novel diagnostic or therapeutic. Along with traditional discovery deals, as well as deals to resurrect partners' projects which have failed for lack of understanding about their proper use, several players are proposing interim steps to create product businesses, like using their technologies to find undervalued in-licensing candidates.

As of November 29, 2000, virtually everything changed for patent holders and patent challengers, the latter gaining the upper hand after the Federal Appeals Court rendered a decision, now called Festo. This decision has widespread implications for the patent-dependent pharmaceutical and biotechnology industries.

Cell Pathways began as the pet project of a man suffering a rare inherited disease causing colon polyps. He'd heard an anti-inflammatory from Merck might help, and when it did, he asked the prescribing physician to research it further. Hopes that Merck would take up the work were dismissed, so the founders decided to develop a metabolite of the original drug on their own. They got some money from angel investors and set to. The small firm came to believe its compound triggered cell death by a novel mechanism-and decided utter secrecy was necessary to protect the discovery. That choice meant Cell Pathways built no scientific credibility and found no partners. A new CEO has attracted some investors, taken the firm public and expanded its focus to cancer treatment. He too sought partners at first, before deciding the company had more to gain by keeping all rights to the product. Cell Pathways' credibility problem--compounded by a Phase III failure early in 1999--could be greatly healed if, as management now hopes, a revised data package convinces FDA to approve Aptosyn after all. The company insists it is not a one-trick pony, and says Aptosyn is in fact the first in a new class of compounds with the power to treat and even prevent some cancers. But before it can argue for a platform, it must prove the product works.

Like Banquo's ghost at Macbeth's table, Pfizer Inc. haunts the new collaboration between Merck & Co. Inc. and Schering-Plough Corp. Indeed, without Pfizer, these companies may never have gotten together at all in this innovative co-development and co-promotion alliance which serves both as a patent-extension strategy and an alternative to mergers.