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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...more

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...more

Will The Avastin Biosimilar Patent Dance Go On?

Judge Sleet of the U.S. District Court for the District of Delaware has dismissed Genentech’s complaint against Amgen for allegedly failing to comply with the the Biologics Price Competition and Innovation Act (BPCIA), but...more

PTAB Puts Method Of Treatment Patents Under The 101 Knife

While the Supreme Court decisions in Myriad and Mayo have been applied to diagnostic-type claims, method of treatment patents were thought to be safe from the recent judicial expansion of the patent-(in)eligibility doctrine....more

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...more

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...more

Supreme Court Will Judge Biosimilar Patent Dance

The U.S. Supreme Court has agreed to review some of the patent dispute resolution provisions of the Biologics Price Competition and Innovation Act (BPCIA). The Court granted certiorari in the dispute between Amgen and Sandoz,...more

District Court Dismisses USPTO December 2015 Holidays Case

On December 2, 2016, Judge O’Grady of the U.S. District Court for the Eastern District of Virginia granted the USPTO’s motion to dismiss the complaint brought by Elm 3DS Innovations, LLC over the “holidays” declared December...more

Solicitor General Sides With Sandoz On Interpretation Of Biosimilar Statute

The Solicitor General of the United States has filed an amicus brief in Sandoz Inc. v. Amgen Inc., asking the Supreme Court to grant certiorari and reverse the Federal Circuit’s interpretation of one of the “patent dance”...more

PTAB Holds Oral Hearings In Tecfidera Patent IPR and Interference

On November 30, 2016, the USPTO Patent Trial and Appeal Board (PTAB) held oral hearings in two different inter partes proceedings involving the Biogen Tecfidera® patent with the latest expiation date. First, it heard...more

Swearing Behind A Reference With Reasonably Continuous Diligence

In Perfect Surgical Techniques, Inc. v. Olympus America, Inc., the Federal Circuit vacated and remanded a USPTO Patent Trial and Appeal Board decision in an Inter Partes Review proceeding, finding that the PTAB imposed too...more

USPTO Examination Time Goals -- How Much Time Should Examiners Have To Examine A Patent Application?

As part of its ongoing efforts to improve patent quality, the USPTO is reevaluating its examination time goals and seeking public feedback on how much time examiners should have to examine a patent application. Examination...more

District Court Denies Extra Patent Term Adjustment When National Stage Entry Date Falls On A Holiday

Some patent term adjustment (PTA) cases have broad impact–like Wyeth v. Kappos and Novartis v. Lee–but Acetelion Pharmaceuticals, Inc. v. Lee addresses a more esoteric issue: when does the 14-month clock start to run in a...more

Biogen TYSABRI Patents Spared Inter Partes Review

The USPTO Patent Trial and Appeals Board (PTAB) declined to institute Inter Partes Review (IPR) proceedings against three Biogen Idec TYSABRI patents. The IPR petitions were filed by Swiss Pharma International, and asserted...more

Higher US Patent Fees On The Horizon

The USPTO has published a proposed fee schedule for patent fees likely to take effect October 1, 2017–the start of the USPTO’s next fiscal year. The proposed fee schedule makes “slight” changes to many fees, and more...more

PTAB Upholds Lialda Patent Over Kyle Bass IPR Challenge

The USPTO Patent Trial and Appeal Board (PTAB) has issued a final written decision upholding Shire’s Lialda® patent over the Inter Partes Review (IPR) challenge brought by Kyle Bass and his Coalition for Affordable Drugs. The...more

Judge Grants Gilead Motion To Invalidate Remicade Patent For Obviousness-Type Double Patenting

The FDA approved Inflectra–Celltrion’s biosimilar version of Janssen’s Remicade® (infliximab) product–in April 2016, but according to Pfizer’s press release it’s commercial launch still “depend[s] on a number of factors”...more

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...more

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...more

Magistrate Judge Nixes TB Test Kit Claims

In a “Report and Recommendation on Defendants’ Joint Motion To Dismiss,” U.S. Magistrate Judge Cabell of the U.S. District Court for the District of Massachusetts determined that TB test kit claims do not satisfy the patent...more

Apotex Biosimilar Cleared Of Infringement But Pre-Marketing Notice Still Required

In what may be the first decision on the merits in a patent infringement suit brought under the Biologics Price Competition and Innovation Act (BPCIA), the U.S. District Court for Southern District of Florida has found that...more

District Court Upholds Eligibility Of Personalized Medicine Method Claims For FANAPT

In Vanda Pharmaceuticals Inc. v. Roxane Labs., Inc., Judge Stark of the U.S. District Court for the District of Delaware upheld the patent eligibility of personalized medicine method claims related to Vanda’s FANAPT®...more

Federal Circuit Affirms Tygacil Formulation Patent

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...more

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...more

USPTO Launches Patents 4 Patients

To support the National Cancer Moonshot initiative, the USPTO has launched the Patents 4 Patients program, also known as the Cancer Immunotherapy Pilot Program. Under this program, applicants can obtain expedited examination...more

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