Rader Steps Down – Prost Steps Up

Judge Randall Rader will step down as Chief Judge of the Fed. Cir. on May 30th, and Judge Sharon Prost will replace him. Judge Rader will remain active as a “Circuit Court Judge.”

As Chief Judge, Rader bought sheer intelligence and coherence to a number of difficult decisions. Although I have criticized his Bilski dissent – which bought the cult of the abstract idea to prominence, he also was among  the last of the defenders of a limited role for the written description requirement – a  legal battle eventually lost (See his concurrence in Novozyme v. DuPont Nutrition this year).

I guess I would have hoped for a Chief Justice with some scientific background – Judge Prost is an expert on Labor Relations, but I certainly wish her well as she prepares to lead the court into uncharted waters, with the Supreme Court poised to be the Neptune to her Ulysses.

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USPTO Subject Matter Eligibility Guidance – 9th May Forum – Outcome and Opportunities

Guest Post from Paul Cole, Lucas & Co., UK

As noted in postings in this and other blogs, controversy has been generated by the publication of new USPTO patent eligibility guidance for laws of nature, natural products and natural phenomena (Andrew Hirshfeld, 4th March). A forum hosted by the Office on 9th May provided an opportunity for feedback from organizations and individuals. Some 80 people attended in person and some 350 people watched via webcast. A replay is available via the USPTO’s webpage (https://www.uspto.gov/patents/announce/myriad-mayo.jsp) and slides from the presentations by the USPTO and by 9 of the 10 invited speakers are also available.

Perhaps the most important take-away message was that although the Office is unwilling to withdraw the guidance or to depart from the basic principles contained in it, it is recognised that development must be an iterative process. Until the end of June the public still has the opportunity to submit comments, suggest alternative interpretations and submit additional training examples. Andrew Hirshfeld went out of his way to say that he would love to see additional examples.

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PTO s. 101 Forum – Thumbs Down on Practitioners

The USPTO held a four hour public forum on the new, disruptive s. 101 examination guidelines on Friday afternoon. The forum featured ten speakers from the patent bar, including Hans Sauer of BIO, Leslie Fishcher from Novartis, Barbara Fiacco (for the AIPLA), Greg Cox (speaking for the ABA IPL Section) and your truly (speaking out for justice, of course – my slides are attached). There were also three break periods where the studio audience or webinar participants asked questions.

There were brief opening remarks by Deputy Director, Michelle Lee, but the Forum was presided over by Drew Hirshfeld, who is Deputy Commissioner for Patent Examination Policy (He has Steve Kunin’s old job) and who signed off on the Guidelines. Jerry Lorengo, the relatively new Director of 1600 was present, but did not have a big role in the proceedings. Mr. Hirshfeld’s Legal Advisor, Raul Tamayo, made the PTO’s position on compound and composition claims clear: “The Supreme Court has never held that a claim reciting a natural product eligible unless it was structurally different from what occurs in nature.” The PTO clearly intends to fill that gap in jurisprudence, and has taken the position that a functional difference cannot per se meet the requirement for a structural difference.

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Dolly Led to Slaughter – Part II

As I read and re-read In re Roslin, App. No.  2013-1407 (Fed. Cir., May 8, 2014), before going across the street to “testify” at the PTO 101 Forum, I was struck by how the logical pathway chosen by the panel to deny claims to the famous cloned sheep could have gone the other way.

The panel followed the pathway: a) no naturally-occurring organism is patentable, b) Dolly’s DNA donor “parent” was not patentable, c) Dolly was identical to the donor parent in genetic make-up and d) Dolly is patent-ineligible under s. 101, since she exhibited no marked difference from the donor sheep.

This analysis let the panel sidestep  the fact that Dolly is “man-made”. An alternative analytic pathway is a) no naturally occurring organism is patentable, b) Dolly is a product of the hand of man and her difference from naturally occurring organisms is her “sameness”, e.g. her very existence is not a natural phenomenon, and c) Dolly meets the requirements of s. 101 and Chakrabarty as a patent-eligible product of human creativity. (I know Dolly is no more – I am just using the present tense for clarity.)

Of course, my alternative analysis was not adopted by the panel, but at least they did not refer to Dolly as a “product of nature” but rather ruled that she was unpatentable subject matter under s. 101. Maybe the Supreme Court will see it my way. It really should grant cert. if only to endorse the “markedly different” dictum in Chakrabarty that is currently the law of the land at both the Fed. Cir. and the PTO.

Another issue that needs resolution is whether or not the effort required to obtain a pure culture of cells (as in Bergy) or a purified natural product as in Parke-Davis is “creative” enough to avoid the curse of Funk Bros. But that’s now a story for another day.

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