Posts Tagged ‘Warren Woessner’

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Supreme Court Reverses In Caraco Appeal

Tuesday, April 17th, 2012

Today, in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk, in an opinion authored by Justice Kagan (a copy can be found at the end of this post), the Court reversed the Fed. Cir.’s divided 2010 decision that an ANDA filer (a “generic drug company”) sued in para. IV litigation cannot assert a counterclaim that the NDA holder (“the innovator”) listed a use code in the FDA Orange Book that is overly broad. This question is important because during litigation, Novo had broadened its use code to cover uses Caraco alleged were not within the claims of the listed patents, but which Caraco wanted to be able to include in its labeling. So the question presented was:

“Whether an ANDA applicant may assert a counterclaim under Section 355(j)(5)(C)(ii)(I) by alleging that the brand name manufacturer’s patent information [the use code] does not accurately and precisely describe the method of use claimed by its patent.”

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Posted in Hatch-Waxman | 1 Comment »

Aventis v. Hospira – How to Meet the Therasense Standards

Tuesday, April 10th, 2012

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 | 2 Comments »

USPTO Encourages Prosecution After Final – Sort of

Wednesday, April 4th, 2012

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

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Posted in USPTO Practice and Policy | 1 Comment »

Mayo v. Prometheus – A European View

Thursday, March 29th, 2012

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 Patentable Subject Matter | 1 Comment »

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