Archive for the ‘Patentable Subject Matter’ Category

FDA’s New Biosimilars Guidance

Monday, August 11th, 2014

The following has been posted with the permission of their authors James E. Valentine and James C. Shehan of Hyman, Phelps & McNamara as part of their FDA Law Blog.

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August 09, 2014

FDA’s New Biosimilars Guidance Has Sponsors Provide Information to Win Reference Product Exclusivity; Liberal Criteria Opens the Door to More Exclusivities Being Awarded

By James E. Valentine* & James C. Shehan

On August 5, 2014, FDA announced the availability of its most recent biosimilars guidance entitled, “Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act” (“FDA Draft Guidance”). The Draft Guidance puts some sponsors of BLAs past, present, and future, on notice that FDA wants them to submit certain information for their biologics to be considered for “reference product exclusivity.”  But that’s a burden that sponsors will likely gladly bear, because FDA’s proposed broad interpretation of structural modification, a key term in determining whether a related product differs enough from a sponsor’s structurally related product to merit its own exclusivity, makes more products eligible for exclusivity than is required under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”).

USPTO TRIPs over Myriad-Mayo guidance

Thursday, July 31st, 2014

Timothy W. Roberts, Chartered Patent Attorney; MA (Oxon); LL.D (honoris causa, Sheffield University)

Paul G. Cole,  Chartered Patent Attorney;  MA (Oxon); LLM, NottinghamTrent; Visiting Professor, Bournemouth University

The above UK-based European Practitioners have today filed comments at the USPTO arguing that the USPTO’s Myriad-Mayo Guidance is inconsistent with the provisions of Article 27 of the TRIPs Agreement.

They argue that the ruling of Justice Thomas in Myriad is TRIPs-compliant only on the narrow holding that mere isolation of a DNA sequence unaccompanied by new, improved or extended utility does not give rise to eligibility. Any broader interpretation of the ruling e.g. to exclude natural products selected or isolated by the hand of man and possessing new or improved utility would be inconsistent with the express provisions of the Agreement. It will be recollected that Justice Ginsburg during oral argument in Myriad was concerned that the US was at risk of adopting a rule quite different from that of other industrialised nations and would be placing itself in an isolated position. Only the suggested interpretation, they argue,  would avoid those concerns, and they submit that the Court had these considerations in mind when it handed down its limited and cautious opinion in Myriad.

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Myriad Guidance Comments

Thursday, July 10th, 2014

The USPTO is now publishing comments

http://www.uspto.gov/patents/law/comments/myriad-mayo_guidance_comments.jsp

 

More Questions Than Answers from the PTO

Wednesday, July 2nd, 2014

At the recent BIO International Convention, Deputy Commissioner Andrew Hirschfeld (who chaired the May PTO s.101 Forum) presented seven “Sample Claims” related to biotech/pharma inventions and invited “discussion and feedback” from the interested public. The claims have been posted on the PTO website (and can be found here). I will attempt some commentary on patent-eligibility under the new PTO Guidelines.

6. Antibiotic L, which is expressed by recombinant yeast. (Antibiotic L is secreted by a bacterial species and exhibits antibiotic properties when the bacteria functioning naturally)(Comments in parentheses are my slightly rewritten summaries of the background of the claims provided by the PTO in the slides.)

Patents4Life comments: We know that the Guidelines would require the Examiner to reject a claim to isolated antibiotic L or to a pure strain bacterial culture that would excrete the antibiotic into the medium–both are “natural products.” But in claim 6, a lot more of the hand of man is involved. But wait! This is a product-by-process claim and the PTO ignores process limitations when evaluating the patentability of a compound, and evaluates the compound per se. Now the “answer” turns on whether or not expression from yeast significantly alters the structure of antibiotic L, and we are not told whether or not it does. So the question is unanswerable at this point.

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