Thursday, September 03, 2015

PTAB declines to institute IPR against Biogen's US 8,399,514 related to the MS drug Tecfidera

In a decision written by FRED E. McKELVEY, former Chief Administrative patent Judge, Board of Patent Appeals and Interferences [BPAI, the predecessor to PTAB], denying institution of inter partes review of Biogen's US Patent 8,399,514, related to the drug Tecfidera for treating relapsing remitting multiple sclerosis [RRMS], there is great emphasis on the "MS treatment" portion of the challenged claims, e.g.,

A method of treating a subject in need of treatment
for multiple sclerosis

a therapeutically effective amount of dimethyl
fumarate, monomethyl fumarate, or a combination

The Kappos reference cited against the Biogen patent in the submitted IPR challenge included the text:

An open-label pilot study
demonstrated that a product containing a mixture of
fumaric acid esters significantly reduced the number and
volume of gadolinium-enhancing (Gd+) lesions in
patients with RRMS. BG00012 is being investigated for
the treatment of psoriasis and other autoimmune diseases,
including MS [multiple sclerosis].

The decision by Judge McKelvey of PTAB includes the text

Petitioner has not
established the precise nature of the [Kappos] study and whether researchers were
determining a therapeutically effective amount. The Pilot Study is not 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.

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]

A separate PTAB argument is that the Kappos reference did not explicitly name the compounds
of claim 1 which were -- dimethyl fumarate, monomethyl fumarate, or a combination
thereof, -- which are species of the genus disclosed by Kappos, fumaric acid esters.
That is, dimethyl fumarate IS a fumaric acid ester.

The following paragraph from the PTAB decision is puzzling, and perhaps overly defensive:

We wish to make clear that we are not engrafting into the § 103(a)
obviousness evaluation whether DMF as a drug is effective. In re Anthony,
414 F.2d 1383 (CCPA 1969) (FDA, not USPTO, is responsible for safety of
drugs which are sought to be patented); In re Watson, 517 F.2d 465 (CCPA
1975) (Congress has given responsibility to FDA, not USPTO, to determine
in the first instance whether drugs are safe); Purdue Pharma L.P. v. Endo
Pharmaceuticals Inc., 438 F.3d 1123, 1134 (Fed. Cir. 2006) (quantum of
proof necessary for FDA approval is significantly higher than the proof
required in the USPTO). Nevertheless, Petitioner has bottomed its case on a
publication describing potential FDA phase I and II testing and we have
considered the content of Kappos to determine if it describes DMF as being
known to be useful in treating MS. We are unable, consistent with the
“description” requirement of § 102(b), to find a reasonable likelihood that
Kappos teaches that DMF was known to be useful in treating MS.

If this is an obviousness case under 103, then one wonders about the text

Consistent with In re Hughes, 345 F.2d 184 (CCPA 1965) (if a
reference is subject to two interpretations, then it will not support an
anticipation rejection), we are unable to find that “a fumaric acid ester” as
described by Kappos is DMF or MMF.

Gene Quinn of IPWatchdog savaged the decision in the post
With dubious logic and inaccurate statements of law,
PTAB denies another Kyle Bass IPR petition

The decision is paper 23 of the case IPR2015-01136 .

Bloomberg discussed the reaction of Kyle Bass:

“They threw Acorda out on a technicality; they threw Biogen out by ignoring the law,” Bass said. “They’re acting like a kangaroo court and we are not going to stand for it.”


Bass accused patent office Director Michelle Lee of directing the judges to find ways to not institute any reviews. “What Michelle Lee and the PTAB need to do is call balls and strikes and not try to change the rules of the game that were legislated to them by Congress,” Bass he said.


***The Boston Globe wrote

The America Invents Act of 2012 included a process meant to help companies fight so-called patent trolls holding them up in court. Trolls often acquire dubious intellectual property, claim the products of established companies infringe on their patents, and demand payments.

The new law gives third parties the ability to request a review of any unexpired patent by the Patent and Trademark Office, avoiding a lengthy court challenge in the process. It’s an express lane for patent challenges, a process that typically runs up big bills and takes years to resolve in lawsuits.

This statement overlooked the fact that "inter partes re-examination," which existed prior to IPRs, gave third parties the ability to request a review of issued patents.

Boston Globe post Hedge fund loses challenge of patent for Biogen’s MS drug


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