- Pipeline Watch: SPC expiry opens up olmesartan brands
Merck wins US$2.5 billion patent infringement suit
Gilead has been ordered by the US District Court for the District of Delaware to pay US$2.54 billion worth of damages to Merck, after a jury found that the hepatitis C blockbuster drugs Harvoni® (Sofosbuvir in combination with Ledipasvir) and Sovaldi® (Sofosbuvir) infringed Merck’s US patent US7608597. Harvoni was the highest selling drug product of 2015, with a global market worth US$18.1 billion, while Sovaldi made US$6.5 billion.
Patent Term Extensions in Taiwan, Province of China
The Patent Act Amendments have allowed pharmaceutical companies to apply for patent term extensions to increase the life span of a patent. The extension of product protection prevents generic versions of the drug from entering the national market for an additional period of time. Patent term extension periods vary from country to country, with Taiwan, Province of China (Taiwan) having its own specific calculation system.
- Pipeline Watch: Glivec SPC extensions are set to expire
- Drug In Focus: Abiraterone
New CJEU referral on interpretation of Article 3(b) of the SPC Regulation
Contributor article written by Mark Ness, UK and European Patent Attorney and Patent Director, HGF.
On March 3, 2016, the ECJ rendered a decision confirming the position of the European Medicines Agency, which has refused to grant a marketing authorization for a generic drug of an orphan drug whose market exclusivity had expired, but which concerned a pathology for which a similar orphan drug had market exclusivity (See Case C-138/15).
European General Court dismisses Lundbeck’s appeal against the Commission’s fine for delaying market entry of generic
Contributor article written by Elena Martini, UK and European Patent Attorney and Partner of Martini Manna.
By decision of 8 September 2016 in T-472/13, the European General Court dismissed Lundbeck’s appeal against the European Commission’s decision to fine it – and a number of generic companies – for delaying market entry of generic versions of Lundbeck’s anti-depressant citalopram product.
- Pipeline Watch: Six-month countdown starts for Cancidas
Calculating Standard Patent Expiry Dates and Data Exclusivity in Key Territories
Information in this document will help you apply the correct patent term, depending on when the patent was filed, and in which country. Data exclusivity laws vary among countries and have changed over time and this guide will help you understand laws in key territories.
Calculating US Expiry Dates
This document provides you with the key details in changes to US patent law including patent term adjustments and terminal disclaimers. It also provides examples to demonstrate different scenarios.
- Pipeline Watch: SPC expiries hit two agalsidase brands
- Drug In Focus: Pegfilgrastim
- Pipeline Watch: Vfend loses its paediatric protection
- Drug in Focus: Glatiramer Acetate
- Pipeline Watch: European certificates end for Aranesp
- Pipeline Watch: Rilpivirine surrenders its exclusivity in US
- Pipeline Watch: Seattle ruling affects bexarotene’s term
- Drug In Focus: Olmesartan
- Pipeline Watch: Spiriva SPCs expire throughout Europe
- Pipeline Watch: Valsartan combinations lose SPC benefit
Litigation News: US District Court Grants MorphoSys’ Request to Add a Second Patent in the Lawsuit Against Janssen and Genmab
On 15 February 2017, MorphoSys announced in a Press Release that the District Court has granted its request to add a second patent, US9200061, to the infringement lawsuit against Janssen and Genmab.
Written by: Shruti Mehta, Ark Patent Intelligence
Drug Approval News: The US FDA approves Amgen's Parsabiv™ (Etelcalcetide) – the first new treatment in more than a decade for secondary hyperparathyroidism
On 7 February 2017, Amgen announced that the US Food and Drug Administration has approved its Parsabiv™ (Etelcalcetide) product. Parsabiv is the second drug to be approved for the treatment of secondary hyperthyroidism in the US.
Written By: Hong Pham, Ark Patent Intelligence
Litigation News: US Court of Appeals for the Federal Circuit Grants Regeneron and Sanofi’s Request to Stay the District Court’s Permanent Injunction Order
On 8 February 2017, the US Court of Appeals for the Federal Circuit granted Sanofi and Regeneron’s request to stay the District Court’s permanent injunction order regarding Praluent®, which was to take effect on 21 February 2017.
Written by: Wai Fong Chan, Ark Patent Intelligence
Drug Approval News: The US FDA Approves Sunovion’s Supplemental New Drug Application for Latuda®
Sunovion issued a Press Release on 28 January 2017 that the US Food and Drug Administration has approved its supplemental New Drug Application for Latuda® (Lurasidone Hydrochloride) for the treatment of schizophrenia in adolescents aged thirteen to seventeen years.
Written by: Swetha Saikumar, Ark Patent Intelligence
Market Exclusivity and Drug Approval News: The US FDA has Granted Six Months of Paediatric Exclusivity to AstraZeneca’s Symbicort® Inhalation Aerosol
On 26 January 2017, AstraZeneca announced in a Press Release that the US Food and Drug Administration (“FDA”) has granted six months of paediatric exclusivity for its Symbicort® inhalation aerosol for the treatment of asthma.
Written by: Himanshu Kashyap, Ark Patent Intelligence
Litigation News: US Court of Appeals Rules in Favour of Eli Lilly on Alimta® Vitamin Regimen Patent
On 12 January 2017, Eli Lilly announced in a Press Release that the US Court of Appeals for the Federal Circuit has affirmed the District Court’s decision, which held the Alimta® vitamin regimen patent to be valid and infringed by Teva’s proposed generic Pemetrexed products.
Written by: Shruti Mehta, Ark Patent Intelligence
Drug Approval News: The EMA and US FDA have Accepted to Review Boehringer Ingelheim’s Application for a Biosimilar Version of Humira®
On 18 January 2017, Boehringer Ingelheim announced in a Press Release that both the FDA and the EMA have accepted to review its biosimilar application for Adalimumab.
Written by: Neelima Sharma, Ark Patent Intelligence
Drug Approval News: Debiopharm Group’s Triptorelin 6-month Formulations Receive Approval for the Treatment of Central Precocious Puberty in Europe
Debiopharm announced in a Press Release on 9 January 2017 that it has received approval for its Triptorelin six-month sustained-release formulations marketed under the trade names Decapeptyl® and Pamorelin®, for the treatment of central precocious puberty.
Written by: Sadhees Devadoss, Ark Patent Intelligence
Drug Approval News: US FDA Accepts a BLA for Mylan and Biocon’s Proposed Biosimilar Trastuzumab
The US Food and Drug Administration has accepted a biologics licence application (BLA) for Mylan and Biocon’s proposed biosimilar Trastuzumab. If approved, MYL-1401O has the potential to be the first biosimilar Trastuzumab in the US.
Written by: Johny Trinh, Ark Patent Intelligence
Drug Approval News: FDA Accepts for Review a Supplemental New Drug Application for Allergan’s Liletta®
Allergan and Medicines360 announced on 4 January 2017 that the US Food and Drug Administration has accepted for review their supplemental New Drug Application for Liletta®.
Written by: Archana Ravishankar, Ark Patent Intelligence
Litigation News: US District Court Grants Amgen’s Request for a Permanent Injunction against Sanofi and Regeneron Regarding Praluent (Alirocumab)
On 5 January 2017, Amgen announced in a press release that the District Court has granted its requests for a permanent injunction against Sanofi and Regeneron, prohibiting them from importing, manufacturing, using and/or selling Praluent® until US patents US8829165 and US8859741 have expired. The injunction has been stayed for 45 days to allow the defendants the opportunity to appeal the decision to the US Court of Appeals for the Federal Circuit.
Litigation News: Vanda Pharmaceuticals Settles Fanapt Infringement Suit with Apotex
On 7 December 2016, Vanda announced that it has settled its dispute with Apotex and has granted Apotex with a non-exclusive licence agreement to manufacture and commercialise a generic version of Fanapt in the US.
Drug Approval News: Amgen and Allergan File Biosimilar Application for Bevacizumab
On 2 December 2016, Amgen and Allergan announced in a press release that they have submitted a biosimilar application to the European Medicines Agency for ABP 215, which is a biosimilar candidate to Roche’s Avastin® (Bevacizumab).
Drug Approval News: ANDA approvals for Breckenridge Pharma and Lannett Company
On 28 November 2016, Breckenridge Pharma announced that it has launched its ANDA for Armodafinil tablets (a generic version of Cephalon’s Nuvigil®) in 50 mg, 150 mg and 250 mg dosage strengths, and Lannett Company also announced that it has received approval from the US FDA for 800 mg Metaxalone tablets (a generic version of King Pharma’s Skelaxin®).
Drug Approval News: FDA Approved Sanofi’s Soliqua®
Sanofi announced on 21 November 2016 that they have received FDA approval for Soliqua®, which comprises 100 U/ml of Insulin Glargine and 33 µg/ml of Lixisenatide in a single pre-filled pen.
Litigation News: The Patent Trial and Appeal Board Denied Coherus Biosciences’ Inter Partes Review Petition
On 7 November 2016, Coherus Biosciences announced in a press release that the PTAB has denied its petition for an inter partes review of the US9114166 patent relating to AbbVie’s Humira (Adalimumab) formulation.
Amgen Inc. v Sandoz Inc. – Zarxio® litigation in the US
On 23 March 2010, the US Congress enacted the Biologics Price Competition and Innovation Act 2009 (“BPCIA”) as part of the Patient Protection and Affordable Care Act. The BPCIA established an abbreviated pathway for regulatory approval of biosimilars, biologic products that are “highly similar” and with “no clinically meaningful differences” in terms of the “safety, purity and potency” from the reference biologic drug products (42 U.S.C § 262(i)(2)).
- Litigation News: US District Court Grants MorphoSys’ Request to Add a Second Patent in the Lawsuit Against Janssen and Genmab