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Last November, as the Corona virus was triggering a COVID-19 pandemic that made the need for reliable digital communication more crucial than it has ever been, the Federal Circuit issued a boon to the telecommunication industry by ruling in Koninklijke KPN NV v. Gemalto N2M GmBH et al. that sufficiently […]

So much effort is devoted to patent drafting and its associated prosecution to produce strong, broad claims that bring value to the client, that it’s a bit disconcerting when agreements governing the rights in such Intellectual Property are interpreted in a way as to undercut those rights.  However, one such […]

In OSI Pharmaceuticals, LLC v. Apotex Inc.[1] the Federal Circuit reversed the Patent Trial and Appeal Board’s inter partes review decision that claims 44-46 and 53 of OSI’s patent U.S. 6,900,221 (‘221 Patent) were unpatentable as obvious.[2]  It is a noteworthy case because it squarely addresses obviousness and reasonable expectation […]

As patent practitioners, so much of what we do is managing deadlines, devising strategy within those deadlines and evaluating the impact of delay.  The importance of this is illustrated in Intra-Cellular Therapies, Inc. v. Andrei Iancu[1] where the Federal Circuit upheld a decision by the District Court for the Eastern District of Virginia on patent term adjustment (PTA).[2]  It serves as a reminder to practitioners that in addition to other tactical considerations involved in replying to a Final Office Action, they must also account for its effect on PTA.

In Henny Penny Corp. v. Frymaster LLC[1] the Federal Circuit upheld the Patent Trial and Appeal Board’s inter partes review decision that claims 1-3, 5-12, 17-21, and 23 of Frymaster’s patent U.S. 8,497,691 (‘691 Patent) were not unpatentable as obvious.[2]  It is an interesting case because it illustrates a finding of nonobviousness where the Board not only held that there was no motivation to combine, but endorsed a showing of secondary considerations.

In Nuvo Pharmaceuticals v. Dr. Reddy’s Laboratories (Fed. Cir. 2019), the Federal Circuit held that a patent on a claimed pharmaceutical formulation was invalid for having an inadequate written description, even though the patent disclosed, in sufficient detail, effective formulations.

The ‘209 Patent includes method claims where folic acid and a methylmalonic acid lowering agent (e.g., vitamin B12) are administered prior to treatment with the antifolate pemetrexed disodium, a chemotherapy agent.[3]  The folic acid and methylmalonic acid are used to ameliorate the toxic effects of the pemetrexed.[4]  The heart of the Board’s conclusion was that although it was known to use folic acid to reduce the toxicity of antifolates such as pemetrexed, there was no reason to pretreat with vitamin B12 and folic acid prior to treatment with pemetrexed for cancer.[5]  On appeal, the Petitioner’s obviousness arguments related to the EP005 reference, which taught use of folic acid in conjunction with vitamin B12 to reduce homocysteine levels for all purposes.[6]  Homocysteine is an amino acid, and when present in high levels is predictive of pemetrexed toxicity.[7]  On its face this appears to be a solid case for obviousness.  Indeed, those arguing against motivation to combine during patent prosecution have almost certainly encountered an Examiner’s response referencing MPEP 2144IV at one time or the other:

In Endo Pharmaceuticals Inc. v. Teva[1] the Federal Circuit has further clarified the patent eligibility of treatment methods which include natural elements.  The Opinion, which includes comparisons with other cases such as Vanda[2], CellzDirect[3] and Ariosa Diagnostics[4], leaves one crafting such claims on ground that is fairly firm.

There is a scene in the Big Lebowski where the Dude complains about the lousy day he just had as he tosses down some snacks at a bowling alley bar.  In answer, the Stranger (played by Sam Elliot) offers the above advice as to the Dude’s existential situation.  It didn’t help.  One can almost imagine a similar response from Apple following the Federal Circuit’s decision in Personal Web Technologies, LLC, v. Apple, Inc., 2018-1599 (Fed. Cir. March 8, 2019), since it marked the second time in two years they had won at the Board, only to be disappointed at the Federal Circuit on the same patent, PWT’s 7,802,310 (‘310 Patent)[1].  While the Federal Circuit’s analysis in both cases was nominally different, the underlying theme in both was the need for a proper motivation-to-combine analysis.

Lead compound analysis (LCA) has been used in the evaluation of chemical compound Obviousness for the past 20 years.[1]  This approach supplemented the historic formulation of In re Dillon.[2]  While the Dillon analysis pivots about the structural similarity of the cited compound to that claimed and any motivation to make the claimed compound, LCA involves selection of a lead compound that is the most promising candidate for modification to improve its activity.  As such, it represents a somewhat more difficult standard than in Dillon.