An Approach to Pharma Life Cycle Management

August 12, 2019

Every innovative pharma company faces the same challenge, how to delay the patent cliff. The existence of the "skinny viii" (21 U.S.C. § 355(j)(2)(A)(viii)) makes developing additional FDA approved indications unattractive from an LCM viewpoint. Such additional indications may allow for market expansion during the life of the patents protecting the original indication but offer no protection once those patents have expired. With a skinny viii the generic seeks approval only for indication with the earliest patent expiration. Formulation patents often provide scant protection because of the possibility of design arounds and being more easily challenged for invalidity since often the original patents are available as prior art... Read more

ATHENA DIAGNOSTICS - THE FEDERAL CIRCUIT AGAIN ABDICATES ITS RESPONSIBILITY

July 15, 2019

In denying the petition for rehearing en banc the majority of the Federal Circuit abdicated its responsibility to define the limits of the Supreme Court's Mayo decision. Judge Dyk on the 25th birthday of the Federal Circuit noted that: Frequently, the Supreme Court in patent cases articulates a general principle and leaves it to our court to both administer the rule and apply it to the individual case.... Read more

Commercial Success of Claimed Product over Non-Infringing Competitive Products as Evidence of Non-Obviousness

June 17, 2019

During litigation or contested proceeding the patentee can point to commercial success of a product as evidence of non-obviousness of the claimed product. Although some work is necessary to show the nexus between the success in the market and the claimed invention, the evidence showing, for example, the product taking sales from competitive products could help the patentee's case.... Read more

What You Say Can Hurt You

May 21, 2019

Often in writing applications there is a tendency to denigrate prior art techniques. This is not risk free as the patentee in Nuvo Pharmaceuticals (Ireland) v. Dr. Reddy's Laboratories, Inc. (Fed. Cir. May 15, 2019) discovered.... Read more


Category: Patent Eligibility

Cleveland Clinic - Another Black Eye for the Federal Circuit and Dissing the USPTO

April 3, 2019

In the April 1 Cleveland Clinic Foundation v. True Health Diagnostics LLC decision, the Federal Circuit has once again given itself a black eye in finding a new diagnostic procedure to be patent ineligible and with the same punch dissed the USPTO.... Read more

Natural Alternatives - Claim Construction Defeats A 101 Challenge On The Pleadings

March 26, 2019

The Federal Circuit on March 19 in Natural Alternatives Intl. v Creative Compounds LLC. reversed a district court's opinion finding Natural's patent claims to be patent ineligible. The district court's decision arose out of a motion for judgment on the pleadings filed by Creative.... Read more


Category: Federal Circuit

The Federal Circuit Still Doesn't Get Diagnostic Claims

December 12, 2018

In Roche Diagnostics the Federal Circuit continued its failure to recognize that diagnostic claims were not patent ineligible because they used a natural law. Roche involved claims detecting the Mycobacterium tuberculosis strains (MTB) quickly and accurately. Prior to the invention delays often occurred in diagnosing tuberculosis because of the time necessary to detect its presence involved a three to eight week cell culture. Roche discovered that the MTB strains could be quickly identified by identifying the presence of specific nucleotide sequence which functioned as a signature for the MTB. The technique used to identify the presence or absence of the signature nucleotide was conventional PCR analysis. The Federal Circuit affirmed a finding the diagnostic claims to be patent ineligible because the PCR technique was conventional and nucleotides naturally occurring.... Read more

Will Rite-Hite Be Next?

October 12, 2018

In Rite-Hite v. Kelley Co., 56 F.3d 1538 (Fed. Cir. 1995) the Federal Circuit refused to award damages for the goods which were regularly sold as part of a package including patented goods.... Read more

WesternGeco – Impacts Lost Profits Beyond 35 U.S.C. 271(f) Infringement

August 6, 2018

The Supreme Court found Ion Geophysical Corp. (Ion) responsible for profits WesternGeco LLC. lost as a result of Ion's supplying to foreign buyers the parts necessary to assemble the patented ocean floor surveying equipment. WesternGeco's damages claim included a request for the lost profits of its foreign surveying business caused by Ion's 35 U.S.C. § 271(f) infringement. The Federal Circuit has denied these profits because, in its opinion, it would extend U.S. patent protection to foreign activities. The Supreme Court disagreed not with the concept that U.S. patent laws did not extend to foreign activities but because of the patent damages statute, 35 U.S.C. § 284 which provided:... Read more

The POPR and Expert Declarations

June 4, 2018

The PTAB in the past year has loosened rules governing IPR practice. In most cases the changes have been good for the process. However, some of the changes while introducing a greater degree of fairness into the system have created traps for the unwary. One such trap is allowing patentees to submit declarations with the POPR (Patent Owner's Preliminary Response). Contrary to what many practitioners expect, the submission of a declaration actually increases the probability of the petition being instituted. Indeed, it might even guarantee institution.... Read more

Federal Circuit Rules in Favor of Patent Eligibility

April 16, 2018

On April 13 the Federal Circuit affirmed the lower court decision in Vanda Pharm. Inc. v. West-Ward Pharm. Int'l. Ltd., appeal Nos. 2016-2707 and 2016-2708. The opinion addresses a number of concerns in ANDA litigation including whether jurisdiction exists under 35 U.S.C. § 271(e)(2) for a "late listed" Orange Book patent (it does), the availability of an injunction to prevent inducement of infringement by a label (it is available), and the patent eligibility of a claim to using a drug based upon the results of a diagnostic technique. It is this latter point which is of significant importance. Claim 1 of the patent (USP 8,586,610 (‘610)):... Read more

MPEP § 706.03(y) – Improper Markush Groups Unpatentable

April 2, 2018

As others have observed, the January 2018 MPEP revision instructs the examiners to reject Markush claims. It asserts that "this is a rejection on the merits and may be appealed to the Patent Trial and Appeal Board." Page 700-110. In form ¶ 8.40 it asserts as authority In re Harnisch, 631 F.2d 716, 721-2(CCPA 1980) and Ex Parte Hozumi, 3 USPQ2d 1050, 160 (Bd. Pat. App. & Int. 1984). No statutory authority exists since it has been held the restriction statute, 35 USC § 121 does not provide a basis for a substantive rejection of a claim. In re Weber, 580 F.2d 455 (CCPA 1978) and In re Haas, 580 F.2d 461 (CCPA 1978).... Read more