Recently in FDA Regulation Category

The court in Association for Molecular Pathology v. USPTO (popularly known as the ACLU v. Myriad case) issued a decision today declaring Myriad Genetic's patents-in-suit invalid.  The case addresses the much discussed patents covering the BRCA1/2 genes that are used to detect gene mutations associated with breast cancer, and it has stirred much emotion and public debate.  For that reason alone, the decision is likely gain much attention (NYT, WSJ, Patent Docs).  But from a legal perspective, what is dramatic about this decision (a copy of which can be downloaded from the ACLU website) is that U.S. District Court Judge Robert Sweet based his determination on a finding that claims drawn to purified DNA are mere products of nature that are not patentable.  If it were to stand on appeal, the decision would have a significant impact on the biotechnology industry, which has invested much in DNA patents.

Judge Sweet's opinion is quite thorough, extending 152 pages and containing a very detailed discussion of DNA technology.  It addresses cases from the 1800s as well as more recent ones and finds that no court has squarely held that purified molecules that are fundamentally the same as those that exist in nature are patentable.  The judge framed the issue succinctly:

The appropriate 101 inquiry is whether, considering the claimed invention as a whole, it is sufficiently distinct in its fundamental characteristics form natural phenomena to possess the required "distinctive name, character and use."

And later:

[T]he purified product must possess "markedly different characteristics" in order to satisfy the requirements of 101.

In addition to the DNA compound claims, the court found Myriad's method claims related to the BRCA-1/2 genes unpatentable as well.  In this case, Judge Sweet invoked In re Bilski to find that the claimed methods were mental steps that do not meet the criteria for patentable subject matter.

Interestingly, the court dismissed the constitutional aspects of the case on the basis that it was not necessary to tackle them given the invalidity determination.  These were the more creative arguments advanced by the ACLU and PubPat, so it is unfortunate that they were not discussed in detail.

One assumes that the decision will be appealed.  Thus, it is too early to say what effect it will have.  But it is a fascinating statement in the DNA patent debate. 

I wrote a short post about the demise of the "pay-for-delay" prohibition in the final health care bill amendments that appeared in today's Business Casual Blog on the Smeal Website.  Rather than repost it here, I thought it better to simply provide the link.

Speaking of the health care bill, one intellectual property part that did make it in is the new pathway for approving generic biologic drugs, or "biosimilars" (see report from Patent Docs).  That's a pretty significant move, as there is currently no abbreviated mechanism for approving generic biologic treatments similar to the Hatch-Waxman Act for drugs.  Notably, the term for relating the generic biologic compound to the innovator application is "biosimilar," which is different than the "bioequivalence" standard for drugs.

Major news outlets have been reporting over the last month about the public disclosure of a previously confidential study of the cholesterol drug Vytorin (see NY Times, Wall St. J.).  The so-called "Enhance" study apparently indicates that the drug, while effective in lowering cholesterol, provides few if any cardiac benefits over generic drugs.  Given the risks inherent in just about every medication on the market, a finding of reduced medical benefit could significantly alter the cost-benefit equation of treatment with Vytorin.  Today, the National Law Journal reports that a flood of lawsuits claiming fraud have been triggered by the alleged failure to publicly disclose the clinical studies (they were completed in 2006 and disclosed to the FDA).  Could such litigation have broader impacts than the individuals involved?

I wrote about this issue last year in an article published in the Indiana Law Journal.  Lawsuits of the type above seek to punish companies for withholding information.  While that seems like a very good idea, a rational company may react in a negative fashion.  Particularly, a company may decide to refrain from undertaking any study that is not absolutely required by the FDA.  Since the failure to undertake a study has almost never been successful as a cause of action, there is less liability risk for companies that study less.  Paradoxically, the forced disclosure of existing information may lead to the generation of less information.  Recent changes to FDA law as a result of the FDA Amendments Act of 2007 give the HHS Secretary the power to order new clinical studies after the drug is on the market (a power not previously available to the Agency), but this creates no incentive for a company to undertake a voluntary study.

The counter to disclosure-related litigation is FDA preemption — in other words, deciding that compliance with the federal government’s disclosure rules precludes any state action to the contrary.  The idea is to prevent conflicting disclosure policies.  To date, courts have been split on the application of preemption.  As future issues involving drug disclosure questions occur (and it seems inevitable that they will), the rules on preemption will need to become clearer.  The Supreme Court may decide this issue in 2008 in Wyeth v. Levine (see SCOTUSBlog for relevant filings).  The Court has also granted cert. to a similar case, Warner-Lambert v. Kent involving the question of fraud on the FDA.