Patent Infringement Special Report: Part III, the Future of Drug Development

Part Three of our Special Report analyzes what may be one of the first ‘test cases’ of the new patent infringement precedent. We discuss this case within the backdrop of a past ruling that yielded surprising, perhaps contradictory interpretation, and question the future of intellectual property and drug development.

If you missed Part One or Part Two, follow the links.

The same day the Supreme Court remanded the Myriad case, Columbia University’s trustees sued the biotechnology analysis company Illumina Inc. (NASDAQ: ILMN), accusing it of infringement upon five U.S. patents for gene sequencing used in medical research. The institution claimed Illumina is wrongly using the protected technology in a March 26 complaint filed in DE federal court. Columbia filed its complaint hours after Swiss drugmaker Roche Holding AG extended a hostile $5.7B takeover bid for Illumina, according to a Reuters story.

The patents cover NGS technologies that allow rapid and precise DNA sequencing, which are particularly important in using genomic DNA in the emerging paradigm of personalized medicine. This approach “seeks to use a patient’s own genomic DNA sequence information as the basis for individualized health care,” according to the lawsuit.

In 2010, the US Federal Circuit Court of Appeals threw out the decision in Ariad Pharmaceuticals, Inc et. al v. Eli-Lilly, a patent infringement lawsuit brought against Eli-Lilly (NYSE: LLY) over its use of NF-κB inhibitors in two drugs for osteoporosis and sepsis. The appellate court determined the Ariad (NYSE: ARIA) patent to the inhibitor to be invalid because the company had failed to adequately describe the invention or explain proper replication methods.

The original 2006 decision had alarmed the drug development world, as the ruling stoked fears that broad patent claims on biological pathways would stifle drug development, according to Nature Magazine.

 The broad patent, granted in 2002 to several universities and licensed to Cambridge-based Ariad, hypothesized that three classes of molecules had the capability to reduce NF-kappa B activity. NF-κB is known to be involved in expression of proteins that are associated with many different processes, including the inflammatory response and regulation of the immune system.

However, Ariad’s patent did not detail the substances that have such action. The final US Federal Court decision reaffirmed the requirement of a ‘written description’ showing that the inventor possessed the claimed invention at the time of filing.

Ariad v. Eli-Lilly brought speculation that honoring broad patents such as Ariad’s would have a stifling effect on medical development. Meanwhile, Columbia, Prometheus, and Myriad claim that their patents are vital to discovery, innovation and incentive. Still, the Courts have defined ‘the law of nature,’ and determined the scrutiny of discoveries and hypotheses to be of utmost importance.

Is it now the Courts’ job to define the exact inclusive scope of a patent? Where does one draw the line between “nature” and “man-made invention?” Or is a paradigm shift at hand, in which the relationship between capital gain and integrity is brought to reexamination?

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