Category Archives: Federal Circuit Decisions

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No Nexus For Novartis Gilenya Patent

In Novartis AG v. Torrent Pharmaceuticals Ltd., the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) invalidating all claims of U.S. Patent 8,324,283, which is one of four Orange Book-listed patents for GILENYA. Among other issues, the court affirmed the PTAB’s finding that the asserted objective indicia of non-obviousness lacked sufficient … Continue reading this entry

Angiomax Patents Limited To Example

In The Medicines Co. v. Mylan, Inc., the Federal Circuit construed composition claims of two Angiomax patents as requiring the recited “batches” to be made by a specific “efficient mixing” process illustrated in one of the examples. While doing so may have preserved the validity of the patents, it required reversal of the district court’s … Continue reading this entry

PTAB Not Bound By Prior Court Decisions Upholding Exelon Patents

In Novartis v. Noven Pharmaceuticals, Inc., the Federal Circuit affirmed the USPTO Patent Trial and Appeal Board (PTAB) decisions invalidating certain claims of two Orange Book-listed Exelon patents. This decision has garnered attention because the patents previously were upheld by the U.S. District Court for the District of Delaware in a decision that also was … Continue reading this entry

Federal Circuit Finds "Consisting Of" Requires Reversing Infringement Of Shire Lialda Patent

The Federal Circuit focused on the “consisting of” language in the claims at issue when it reversed the district court’s finding that Watson’s ANDA product would infringe the only Orange Book-listed Shire Lialda patent. In so doing, the court emphasized the narrow scope of the Norian exception to the “closed” nature of “consisting of” language that … Continue reading this entry

Court Rejects Theory Of Derivation Based On FDA Requirement

The Federal Circuit decision in Cumberland Pharmaceuticals Inc. v. Mylan Institutional LLC may be more interesting for what Mylan argued than for what the Federal Circuit decided. However, it could be an important decision for pharmaceutical companies who need to innovate in order to satisfy FDA requirements.… Continue reading this entry

Federal Circuit Finds Infringement Under Akamai Of Two-Step Method Of Treatment

In Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., the Federal Circuit affirmed the district court decision finding infringement under Akamai of a two-step method of treatment when the prescribing information for the prescription drug component required coadministration of the other active agent. The appeal arose from ANDA litigation surrounding Eli Lilly’s ALIMTA® product, … Continue reading this entry

Inherent Disclosure Supports Priority Claim

In Yeda Research and Development Co. v. Abbott GmbH and Co., the Federal Circuit invoked the doctrine of inherent disclosure to uphold a priority claim to a German priority application that only partly described the claimed protein. Although the patent owner prevailed in this case, the fact pattern underscores the importance of including a robust disclosure in … Continue reading this entry

CAFC Says Functional Claim Language Does Not Create Divided Infringement

In LifeNet Health v. LifeCell Corporation, one of the many issues the Federal Circuit decided was that functional claim language did not create a divided infringement situation, even though an independent actor could impact whether the functional limitation was met. Under the court’s decision, since the limitation was a negative one, an independent actor could negate infringement, but his … Continue reading this entry

Federal Circuit Affirms Tygacil Formulation Patent

In a non-precedential decision in Apotex, Inc. v. Wyeth LLC, the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) finding that Apotex had failed to show that claims directed to a specific formulation of tigecycline were invalid as obvious. Both the PTAB and Federal Circuit decisions show that while the … Continue reading this entry

Construing Markush Group Claims

In Multilayer Stretch Cling Film v. Berry Plastics, the Federal Circuit provided a detailed discussion of the construction of claims that use Markush group language. The decision emphasizes the closed nature of the “consisting of” terminology, and underscores the care that should be used with Markush group claim language.… Continue reading this entry

En Banc CAFC Requires UCC Sale For On Sale Bar

In an en banc decision issued in The Medicines Company v. Hospira, Inc., the Federal Circuit determined that in order for a commercial transaction to trigger the on-sale bar of § 35 USC 102(b), it must “bear the general hallmarks of a sale pursuant to Section 2-106 of the Uniform Commercial Code.” Unlike the three-judge panel … Continue reading this entry

CAFC Finds Cryopreservation Method Patent Eligible

The Federal Circuit ruled that the cryopreservation methods at issue in Rapid Litigation Mgmt. Ltd. v. CellzDirect Inc., are patent eligible under 35 USC § 101. It therefore vacated and remanded the decision of the U.S. District Court for the Northern District of Illinois that held the claims invalid on summary judgment. The Federal Circuit distinguished … Continue reading this entry

Federal Circuit Requires 180 Day Notice For All Biosimilars, Even After Patent Dance

In Amgen v. Apotex, the Federal Circuit rejected Apotex’s arguments that the 180-day pre-marketing notice requirement does not apply to biosimilar applicants who participated in the “patent dance” process of the Biologics Price Competition and Innovation Act (“BPCIA”), expanding on its decision in Amgen v. Sandoz that 42 USC § 262(l)(8)(A) is a mandatory, stand-alone requirement. … Continue reading this entry

CAFC Upholds Same Day Continuation Applications

The Federal Circuit decided not to disturb the “longstanding administrative construction” of 35 USC § 120 that permits the filing of a continuation application on the same day its parent application grants as a patent. The decision came in Immersion Corp. v. HTC Corp., where the district court held that the statute requires a continuation application to … Continue reading this entry

On Sale Bar Invalidates Safyral, Beyaz Folate Patent

In Merck & CIE v. Watson Laboratories, Inc., the Federal Circuit found communications between Merck and a potential joint venture partner amounted to a commercial offer to sell that invalidated the Orange Book-listed folate patent at issue. Despite the confidentiality agreement that was in place, a footnote in the court’s opinion indicates that it was … Continue reading this entry

CAFC Affirms Finacea Gel Infringement Under Doctrine Of Equivalents

In Intendis GmbH v. Glenmark Pharmaceuticals Inc., USA, the Federal Circuit affirmed the district court decision that found infringement under the doctrine of equivalents. This case shows that the doctrine of equivalents still lives, that not every claim amendment will give rise to prosecution history estoppel, and that formulation patents can provide valuable protection for … Continue reading this entry

Having A Bad Hair Day? The Federal Circuit Agrees That Method Of Cutting Hair Is Invalid Under 101

While I do not usually write about non-precedential decisions, In re: Brown caught my eye as an interesting patent eligibility case. It does not relate to diagnostics or computer programs, but rather to the art of cutting hair.… Continue reading this entry

Federal Circuit Finds Personal Jurisdiction Based On Plans To Market ANDA Product

In Acorda Therapeutics Inc. v. Mylan Pharmaceuticals Inc., the Federal Circuit held that the filing of an Abbreviated New Drug Application (ANDA) and intentions to market the product across the United States–including in the state at issue–were sufficient “personal contacts” to give rise to specific personal jurisdiction.… Continue reading this entry

Federal Circuit Recognizes Limited Patent Agent Privilege

In In re Queen’s University At Kingston, a divided panel of the Federal Circuit recognized a limited “attorney”-client privilege for patent agents. The majority’s decision to recognize a patent agent privilege is based largely on the statute permitting non-attorney patent agents to practice before the USPTO, and a Supreme Court decision ruling that prosecuting patent applications constitutes … Continue reading this entry

En Banc Federal Circuit Limits Patent Exhaustion

In Lexmark International, Inc., v. Impression Products, Inc., the en banc Federal Circuit upheld a patent holder’s rights against exhaustion under two circumstances: (1) where the patent holder had sold a patented article with “clearly communicated, otherwise-lawful restrictions” and (2) where the patent holder had sold a U.S.-patented article abroad without an express or implied license … Continue reading this entry

Federal Circuit Finds No "Way" To Support Doctrine Of Equivalents

In Akzo Nobel Coatings, Inc. v. Dow Chemical Co., the Federal Circuit upheld the district court’s grant of summary judgment of no infringement under the doctrine of equivalents because the patent holder had failed to establish a genuine issue of material fact under the function-way-result test. This case illustrates the scrutiny the court may apply … Continue reading this entry

Asset Transferee Cannot Appeal Reexamination

The Federal Circuit dismissed the appeal in Agilent Technologies, Inc. v. Waters Technologies Corp., because the appellant was not a “third-party requester” dissatisfied with the final decision in an inter partes reexamination proceeding, as required by 35 USC § 141. Although Agilent was a transferee of relevant assets, it had not shown that it was the successor-in-interest … Continue reading this entry

Purdue OxyContin Patents Invalid Despite Stemming From Discovery Of Source Of Toxic Impurity

In Purdue Pharma L.P. v. Epic Pharma LLC, the Federal Circuit affirmed the district court decision holding four OxyContin patents invalid as obvious. In so doing, the court rejected Purdue’s arguments that its discovery of the source of the toxic impurity that was minimized in the claimed products did not support patentability, because the solution to the … Continue reading this entry

Incomplete Restriction Requirement Stops Clock For Patent Term Adjustment

In Pfizer v. Lee, the Federal Circuit affirmed the decision of the U.S. District Court for the Eastern District of Virginia that upheld the USPTO’s Patent Term Adjustment (PTA) calculation that stopped the clock running against the USPTO when the examiner issued an incomplete Restriction Requirement. This decision is not surprising, but Applicants should remember that … Continue reading this entry