Posts Tagged: "Gene Patents"

Bio-Pharma at the U.S. Supreme Court

Since my last article here on IPWatchdog.com, the pharmaceutical industry has been simply overflowing with interesting developments, including the US Supreme Court hearing arguments concerning three significant cases. The first case argued at the Supreme Court will determine whether generic drugmakers can be sued for alleged flaws in the design of their medications. Another argument before the Supreme Court was about pay-to-delay deals in which a brand-name drugmaker agrees to pay a settlement to a generic rival in exchange for ending patent litigation and launching a copycat medicine at a future date. The Court also heard arguments about a case that raises crucial questions about whether human genes can be patented. And the outcome may well reset the boundaries and direction of medical research in the US, which of course has tremendous implications for investments made by the biopharmaceutical industry and the battle against many diseases, notably cancer.

Supreme Court Hears Myriad Gene Patent Challenge

If cDNA is patent eligible subject matter, as it seems likely based on the tone of the oral argument, that should be very good news for Myriad. As Justice Breyer recognized during questioning of Mr. Hansen (representing AMP), the Myriad claim says they want “the isolated DNA of claim 1 wherein said DNA has the nucleotide sequence set forth in SEQ ID No. 1.” If you look at SEQ ID No. 1 clearly states that the molecule type is cDNA, thus cDNA seems to be a part of the claim, not to mention that the cDNA used by Myriad was a consensus sequence made from hundreds of different patients. Thus, if cDNA is patent eligible then the Supreme Court must find that at least some genes are patent eligible and must also find the Myriad claims patent eligible. Whether the Supreme Court Justices really captured that nuance remains in doubt. It seemed at times that Justices Sotomayor and Kagan were openly arguing the AMP/ACLU case. Sadly, at times it was apparent that the Supreme Court doesn’t understand even the most basic and fundamental patent law concepts.

Forward Looking Personalized Medicine, Patent Law and Science

Social policy concerns have influenced the AMP v Myriad debate. The Supreme Court, to the extent it must make a ruling for our times, informed by societal context, should dispassionately consider all the available empirical evidence, from the academic work cited here, to the claim scope limits resulting from massive sequence publication projects and recent court cases, and the thriving innovation ecosystem in personalized medicine at and among for profit and not for profits, and render a clear forward compatible decision for us all.

Patent Pending: Corporations, the Constitution, and the Human Gene

The Honorable Alex Kozinski immediately posed the question—by way of an analogy to scientists who stare at the stars—of why should someone be able to get a gene patent just because there was a significant amount of effort put in to discover that gene. Throughout the event, Judge Kozinski took on the role of the generalist judge, who would need to be convinced that the invention in the lab is anything other than a product of nature. Professor David Winickoff of UC Berkeley followed that question up by discussing James Watson’s amicus brief and the idea that genes are both symbolic in our culture and shared by all humans, thus making them a unique item in our world.

Emerging Patent Law Policy Issues for in 2013

From implementation of sections of the Leahy-Smith America Invents Act to anticipated decisions from the Supreme Court, we can expect changes to the patent system that will affect the high tech and biotechnology industries, start up companies and established businesses of all sizes. Just some of the developments we can expect to see include a determination of whether genes are patentable, proposed legislation addressing the litigation strategies of non practicing entities, and harmonization of the US with much of the world through the implementation of the first-to-file patent application system and the introduction of an international design patent application process.