Posts Tagged ‘IP law tools’

Revised 2014 Interim Guidance on Patent Subject Matter Eligibility Released by PTO

Tuesday, December 16th, 2014

On Monday, December 15th, the Patent Office released revised “Guidance” on the evaluation of subject matter patent-eligibility under s. 101. (A copy is available at the end of this post.) The “Guidance” is an attempt to unify the analyses that were set forth in earlier Guidelines post-Mayo and post-Alice, and apply to all classes of inventions. After stripping away the introductory material, and the case law summaries, there are only a few pages of substantive guidance.

The most important change to the notorious March 4th “Life Sciences Guidelines” is summarized in the Flowchart on page 9 and in section 3B. If a composition is a “nature-based product,” it is analyzed in step 2B to see if it is “markedly different” from “its naturally occurring counterpart in its natural state.” However, the revised Guidance pointedly drops the requirement that the product be structurally different. Now “markedly different characteristics can be expressed as the product’s structure, function and/or other properties and will be evaluated based on what is recited in the claim on a case-by-case basis.” That is a big “or”:

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Commil USA v. Cisco Systems – Induced Infringement In For Clarification

Monday, December 8th, 2014

Supreme Court granted cert. to resolve the question of whether or not a defendant’s belief that a patent is invalid is a defense against a charge of inducing infringement. The question appears to rest on Judge Newman’s characterization given in her dissent from the majority opinion (Proust, O’Malley). (A copy of this decision can be found at the end of this post.) However, the majority opinion appears more nuanced to me:

“Under our case law, it is clear that a good-faith belief of non-infringement is relevant evidence that ends to show that an accused infringer lacked the intent required to be held liable for induced infringement.”

I read this as simply stating that the belief can provide evidence of lack of specific intent to induce acts of infringement. The evidence may be “strong,” such as a competent opinion rendered before the offending acts, or “weak,” e.g. the opinion of a non-attorney or a just incompetent opinion. In fact, the majority makes an effort to “spank”‘ Judge Newman in footnote 1:

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FDA Accepts First Biosimilar Application for Review

Monday, July 28th, 2014

In an important step forward for the introduction of “generic biological,” the FDA announced that it has accepted Sandoz’s application to market a generic version of Amgen’s Neupogen®, which stimulates white blood cell production. As you may recall, about two years ago, the FDA was authorized to permit generic biologicals in a section of “Obamacare” (the Affordable Care Act), but final rules have not yet been promulgated. Since Neupogen is not “under patent” or NCE exclusivity in the U.S. this can roughly be analogized to a Para. III ANDA filing. With many other applications in progress, we will have to see how rough this gets.

Read more here.

Gone Judge – Judge Randall Rader To Resign

Monday, June 16th, 2014

Before stepping down as Chief Judge of the Fed. Cir. on May 30th, Judge Rader had sent a letter to his colleagues on the court apologizing for sending an email to an attorney who had appeared before the court a number of times, praising his work and encouraging him to circulate the email to his associates. (A copy of the letter is available at the end of this post.) The letter was dated May 23, 2014, and was clear about the error of his ways:

“I realize in retrospect that the email constituted a breach of the ethical obligation not to lend the prestige of the judicial office to advance the private interests of others. I apologize for that error, which may have led to the perception that the attorney in question was in a position to influence me in my performance of judicial duties….Working with the court, I have taken steps to remedy the breaches for which I was responsible by recusing in cases as to which a question might be raised as to my impartiality. I am committed to adhering carefully to the requirements of the Code of Conduct for United States judges in making any necessary recusal decisions. I am truly sorry for the lapse and will work diligently to ensure that it does not recur….”

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