News & Analysis as of

Pharmaceutical Patents

Biosimilar Uptake and Patent Litigation in Japan

Biosimilar uptake in Japan has been a bit mixed, but according to experts the volume shares of biosimilars suggests it could be a key market in years to come. The Pharmaceuticals and Medical Devices Agency (PMDA), which is...more

Pharma and Biologics Disputes in Canada—Big Changes for Big and Small Molecule Litigation

by Bennett Jones LLP on

The patent litigation that propels generic and biosimilar products to market will soon change dramatically. July 15, 2017, marked the release of long-awaited proposed amendments to the Patented Medicines (Notice of...more

Sandoz Files Two Petitions for IPR of Two AbbVie Patents Related to Humira

by Goodwin on

Sandoz has filed a petition for inter partes review of AbbVie’s U.S. Patent No. 8,802,100 (IPR2017-01823), which claims stable formulations of an anti-TNFa antibody identified in the petition as Humira® (adalimumab). Sandoz...more

Coherus Challenges One AbbVie Humira Patent In Four PTAB Proceedings

by Foley & Lardner LLP on

I’ve written previously about sequential PTAB challenges to the same patent, but the dispute between Coherus Biosciences Inc. and AbbVie Biotechnology Ltd. has engendered six Inter Partes Review proceedings against the same...more

Federal Circuit Patent Updates - July 2017

by WilmerHale on

Millennium Pharmaceuticals v. Sandoz Inc. (No. 2015-2006, 7/17/17) (Newman, Mayer, O'Malley) - Newman, J.Reversing and vacating judgments of invalidity for obviousness in consolidated appeals. ...more

UK Supreme Court Breathes New Life to the Doctrine of Equivalents

by Dorsey & Whitney LLP on

In what is perhaps the most important development in English law of the last decade in this area of interpretation of patent claims and patent infringement, the UK Supreme Court gave new life to the doctrine of equivalents in...more

The Federal Court Reverses a Hindsight Reconstruction of An Important Pharmaceutical Invention

by BakerHostetler on

In Millennium Pharmaceuticals v. Sandoz, the Federal Circuit reversed the district court’s holding of obviousness of certain claims of Millennium-owned U.S. Patent No. 6,713,446 (the ‘446 patent), finding that the district...more

Millennium Pharm. v. Sandoz, Inc. – Revenge of the Chemical Judges

In the 2003 panel decision in Schering Corp. v. Geneva Pharm., Inc., the panel rejected “the contention that inherent anticipation requires recognition [of the claim element not found] in the prior art.” The claims were...more

Settling the Discoverability of Settlement Agreements

by McDermott Will & Emery on

Settlement agreement between a co-defendant and plaintiff in a Hatch-Waxman patent litigation matter is discoverable, ruled Judge Bryson in Allergan, Inc. v. Teva Pharmaceuticals, Inc. et al., Case No. 15-1455 (E.D. Tex.,...more

UK widens the scope of patent protection

by DLA Piper on

On 12 July, the English Supreme Court introduced a major change to English patent law, extending the potential scope of protection of a patent beyond the interpretation of its claims to variants which achieve substantially...more

Amgen Withdraws Its Motion For Preliminary Injunction Against Hospira

by Goodwin on

On July 12, 2017, Amgen filed a Notice of Withdrawal of its Motion for Preliminary Injunction. As we previously reported, Amgen had filed an amended opening brief in support of its motion for preliminary injunction because of...more

German Federal Court: Permission granted - HIV/AIDS drug distribution continued

by Hogan Lovells on

The X. Civil Senate of the German Federal Court of Justice has granted a motion by three companies of the Merck Sharp & Dohme group (Merck) for a preliminary permission for the continued distribution of Isentress®, a drug...more

First U.S. Avastin and Herceptin Biosimilars

On Thursday, July 13, 2017, FDA’s Oncological Drugs Advisory Committee (ODAC) unanimously recommended approval of biosimilars of two blockbuster cancer drugs. The first, Amgen and Allergan’s ABP-215, is a proposed biosimilar...more

Diagnostic and Personalized Medicine Claims — Strategies for Navigating the §101 Minefield

In Cleveland Clinic Foundation v. True Health Diagnostic LLC, the Federal Circuit (CAFC) dealt another blow to the patent eligibility of diagnostic methods and the growing field of personalized medicine....more

Bioverativ Files ITC Complaint Against CSL’s Idelvion® Alongside District Court Infringement Suit

by Goodwin on

In an earlier post, we discussed the recent rise in Section 337 proceedings against pharmaceutical products and medical devices at the International Trade Commission. Last week, Bioverativ, which markets the recombinant...more

Supply and Purchase Agreement Triggers On-Sale Bar Provision of 35 USC § 102(b)

by McDermott Will & Emery on

The US Court of Appeals for the Federal Circuit reversed the district court and found that a Supply and Purchase Agreement between Helsinn and third-party MGI Pharma, Inc. (MGI) before the critical date of the asserted...more

Actavis v. Eli Lilly1: Back to the future - The UK Supreme Court changes the test for patent infringement

by WilmerHale on

The UK Supreme Court rarely hears patent cases, and will only hear cases that it considers to be fundamentally important. The court's July 12 judgment is most significant for changing the test for infringement in the United...more

Court Construes “Hydrate” to Require Crystalline Form Following Battle of the Experts

by McDermott Will & Emery on

Addressing the issue of the proper construction of claims to a trihydrate compound, the US District Court for the District of New Jersey concluded that a person of ordinary skill in the art (POSA) would understand “hydrate”...more

Hospira Opposes Amgen’s PI Motion in Amgen v. Hospira

by Goodwin on

On July 6, 2017, Hospira filed a publically available redacted version of its brief responding to Amgen’s motion for a preliminary injunction (PI). As we previously reported, following the Supreme Court’s decision in Sandoz...more

Pfizer Takes Aim at Herceptin® Patent at the PTAB

by Fish & Richardson on

Pfizer has shown its muscle in the biosimilars field, purchasing Hospira in 2015 and launching the second biosimilar on the U.S. market, Inflectra® (infliximab), a biosimilar of Johnson & Johnson’s Remicade®. Pfizer is now...more

UK Supreme Court hands down landmark ruling in favour of Eli Lilly

by Hogan Lovells on

Following last Friday’s (7 July 2017) unusual move of advance publication of the outcome of the case, the UK Supreme Court now published the reasons for its decision in the long-running Actavis v Eli Lilly case. The reasons...more

District Court Invalidates Dietary Supplement Patents On Motion To Dismiss

by Foley & Lardner LLP on

The U.S. District Court for the Southern District of California invalidated several dietary supplement product and method patents as being directed to ineligible subject matter, even though they claimed products providing a...more

Method-of-Treatment Claims That Did Not Require a Specific Level of Efficacy Held Unpatentable as Obvious in Light Of References...

The Patent Trial and Appeal Board (the “Board”) issued a final written decision in an inter partes review determining Claims 1-5 of U.S. Patent No. 8,889,135 owned by Abbvie Biotechnology Ltd. unpatentable as obvious...more

The Travails of the First U.S. EPO Biosimilar

Pfizer’s proposed biosimilar of Amgen’s Epogen® and Johnson & Johnson’s Procrit® (epoetin alfa) is poised to be the first erythropoietin (EPO) biosimilar in the U.S. FDA staff recommended approval of Pfizer’s product as a...more

Known Solution to General Problem Provides Sufficient Motivation to Modify Prior Art

by Jones Day on

In a final written decision in Bass, et al., v. Fresenius Kabi USA, LLC (IPR2016-00254), the PTAB found that the challenged claims of Fresenius’s U.S. Patent No. 8,476,010, directed to a sterile pharmaceutical composition of...more

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