Monday, September 21, 2015

Did PTAB and the NLR analyze the facts of the Tecfidera petition properly?

A post in the National Law Review, dated 10 September 2015,

Clinical Trials As Prior Art: PTAB Denies Bass IPR Petition With Only A "Hope" of Efficacy includes the text:

The Board rejected the challenge based on Kappos for a variety of reasons. Notably, the Board explained that Kappos does not contain “a description that DMF is useful for treating MS; rather, at best it is a ‘hope’ that DMF will turn out to be useful for treating MS. A hope may or may not come true and does not establish that DMF is useful for treating MS.” IPR2015-01136, Paper 23 at 12-13. The Board went on to explain that a Phase 2 study was needed to demonstrate efficacy: “Phase II may or may not establish that DMF is useful for treating MS. However, prior to completion and evaluation of Phase II, one skilled in the art would not necessarily understand from Kappos that DMF is useful for treating MS.” IPR2015-01136, Paper 23 at 10-11

This NLR text ignores IPBiz text from 3 September 2015, a week earlier:

One notes that if a study showed a product containing a mixture of fumaric acid
esters reduced the number of gadolinium-enhancing (Gd+) lesions in
patients with RRMS , then therapeutic effectiveness
has been established. The Kappos people had already found --a therapeutically effective amount--.
Optimizing amounts when the effect is demonstrated is usually considered "obvious."
MRI measurements are standards used by the FDA to judge effectiveness for many
disease-modifying MS drugs. [note: the "gadolinum" refers to an MRI scan technique,
including paramagnetic gadolinium, which is sensitive to newly-formed lesions;
this is related to the NMR relaxation time T1, and is distinct from MRI measures
related to T2, which are not necessarily solely related to "newly-formed" lesions]

link to IPBiz post:

One notes that pre-clinical studies, which precede Phase II studies, are done to establish preliminary efficacy. A problem with the PTAB decision: are Phase II studies necessary to establish utility in the patent law context?

In the context of this case, the fumaric acid esters (which apparently were di-methyl and mono-methyl in the Kappos work) did show positive results in the gadolinium MRI.
One notes from a paper published in 1987: Gadolinium DTPA is a paramagnetic contrast agent that does not cross an intact blood–brain barrier. We studied 16 patients with multiple sclerosis, using magnetic resonance imaging, gadolinium-enhanced magnetic resonance imaging, and computed tomographic scans. Gadolinium enhancement of multiple sclerosis plaques correlated with the clinical activity of the disease and corresponded anatomically with the symptoms and signs.


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