Aventis v. Hospira – How to Meet the Therasense Standards

Posted on April 10, 2012 by Warren Woessner

On April 9, 2012, The Fed. Cir. affirmed a holding by the district court that rendered two (then) Sanofi add-on patents on infusion vehicles for docetaxel unenforceable due to inequitable conduct. The inventors, particularly inventor/project manager Fabre, were found to have intentionally decided not to submit two material pieces of prior art to the PTO.

“Materiality” was not an issue on appeal, since the district court had invalidated the patents using the disclosures of the uncited references. Since the references were material under the “clear and convincing standard”, they had to be material under the PTO’s lower “preponderance of the evidence” standard.

The section on intent is more interesting. The references were not “knock-out” s. 102(b) disclosures of the invention, but rather were used to support invalidation based on s. 103. This left the contemporary relevance of the reference open to some debate, and both the district court and the Fed. Cir. relied heavily on the testimony of inventor Fabre who, unfortunately, testified in detail about his reasons for not submitting the references.

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Posted in Inequitable Conduct/Rule 56 | Tagged , , , , , | 2 Comments

USPTO Encourages Prosecution After Final – Sort of

Posted on April 4, 2012 by Warren Woessner

Although entry of any amendments after final rejection has always be discretionary with Examiners, for pretty much my entire career, I have had good luck continuing prosecution after final rejection – sometimes filing multiple Rule 116 amendments or making multiple calls – not really interviews – to the Examiner. I have found most Examiners willing to “continue talking” after final, and even to grant formal interviews – particularly if it is the first one in the application.

Now the PTO has formalized “Let’s Make A Deal” which is a set of guidelines that, cautiously, encourages Examiners to continue to consider post-final amendment, even if it requires some – but not too much – further consideration. Let’s hope this will lead to a more productive, less adversarial relationship, between prosecutors and Examiners, so that applicants feel less “forced” to simply give up and file an RCE.  I continue to believe that the backlog would noticeably shrink if Examiners were required to pick up the phone after receiving a Rule 116 Amendment, and not just print out the “standard” Advisory Action refusing to enter the amendment.

 

USPTO Press Release

Posted in USPTO Practice and Policy | Tagged , , , | 1 Comment

Mayo v. Prometheus – A European View

Posted on March 29, 2012 by Warren Woessner

A Guest Post from Paul Cole, European Patent Attorney, Lucas & Co; Professor of IP law, Bournemouth University.

Is a claim to an assay patent-eligible when all its features are known save for how it should be interpreted? The interpretation is clinically significant because it allows a family of drugs to be administered safely even though a minority of patients are at risk of significant and in some instances fatal side-effects. Before the invention knowledge was available to enable the practical steps in the assay to be carried out and measurements had been made but their clinical interpretation was not understood.

A European answer is to be found partly in the “any hardware” approach first set out in T 931/95 PBS PARTNERSHIP/Controlling pension benefits system and approved by the Enlarged Appeal Board in in G 3/08 PRESIDENT’S REFERENCE. It was pointed out that a computer-readable data storage medium had the technical effects of being computer-readable and of being capable of storing data and is patent-eligible under EPC arts 52(2) and (3). On that basis it could not become ineligible merely because it was storing computer program X, any more than a cup which was a technical article could become ineligible merely because it was decorated with picture X. There was no case-law to support the view that a claim to “a computer-readable storage medium with program X written on it” should lose its technical character merely because it was too generic or functionally defined.

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Posted in Patent Eligible Subject Matter | Tagged , , , , , , , , , , | 3 Comments

Legal Challenge To “ObamaCare” Threatens Generic Biologicals

Posted on March 29, 2012 by Warren Woessner

What should not be lost on pharma/biotech patent attorneys or their clients, amidst all the attention given to the Supreme Court’s review of the “Patient Protection and Affordable Health Care Act” – public law 111-48, is that it contains the entirety of the legal and regulatory approval process for “biosimilars” or generic biological products. As I wrote here on March 26, 2010, Title IV of the law is “Improving Access to Innovative Medicial Therapies” – Subtitle A and is referred to as the “Biologics Price Competition and Innovation Act of 2009.” It can be most easily be followed by printing (roughly) pages 1827-1869 of the PDF of H.R. 3590. The Act amends section 351 of 42 USC 262 and 35 USC 271(e). In my March 26th post I reviewed many of its Hatch-Waxman-like features.

Since enactment, there have been many seminars, workshops and symposia about how best to implement these procedures at the FDA/USPTO, and the FDA has finally begun to work with the stakeholders to provide a regulatory pathway for generic biologicals. Without such a pathway –as currently – a generic biological has to endure the same NDA route to approval as any other new drug. Questions of what degree of “biosimilarity” should be required and what the market exclusivity period should be for the first generic biological to be approved have been hotly debated.

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Posted in Follow-On Biologics | Tagged , , , , | 1 Comment