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The UK High Court Revokes MSD’s SPC for HIV anti-retroviral drug, Atripla®
On 21 March 2017, the UK High Court of Justice (Chancery Division) Patents Court held Merck Sharp & Dohme’s combination SPC based on EP0582455 covering the anti-retroviral medication, Atripla®, to be invalid.
- Drug In Focus: Bendamustine
- Pipeline Watch: Tamiflu SPCs expiries clear path in Europe
- Pipeline Watch: SPC expiries for travosprost are in sight
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Copaxone® Litigation in the US: Generics soon to be launched?
Glatiramer Acetate is a $4.13 billion USD revenue generating drug and Teva earns 96% of that revenue. District Court has found all the asserted claims of US8232250, US8399413, US8969302 and US9155776 relating to Teva’s Copaxone to be invalid for obviousness. Teva has appealed the District Court's decision to the US Court of Appeals for the Federal Circuit.
- Drug In Focus: Lanreotide
- Pipeline Watch: Melatonin SPC questions are put to bed
- Pipeline Watch: Lumigan SPCs expire but barriers remain
- Pipeline Watch: SPC expiry opens up olmesartan brands
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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.
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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
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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
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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.
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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
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The UK High Court Revokes MSD’s SPC for HIV anti-retroviral drug, Atripla®
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Drug Withdrawal News: FDA Requests the Removal of Opana ER® Due to Abuse Concerns
On 8 June 2017, the US Food and Drug Administration requested Endo Pharmaceuticals to remove its opioid pain medication, reformulated Opana ER® (Oxymorphone Hydrochloride) from the market.
Written by: Swetha Saikumar, Ark Patent Intelligence
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Drug Filing News: US FDA and EMA Have Accepted Regulatory Submissions for Sutent® (Sunitinib) for Adjuvant Treatment of Patients at High Risk of Recurrent Renal Cell Carcinoma After Surgery
The US FDA and the EMA have recently accepted new drug indication applications from Pfizer for the new use of Sutent in an adjuvant treatment of recurrent renal cell carcinoma (“RCC”). If approved, the new indications will likely help to extend the lifecycle of Sutent in RCC for Pfizer.
Written by: John Chong Ho, Ark Patent Intelligence
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Litigation News: Janssen Files a Patent Infringement Suit Against Samsung Bioepis Concerning Renflexis®, a Biosimilar Infliximab product
On 17 May 2017, Janssen, a subsidiary of Johnson and Johnson, filed a patent infringement suit in the US District Court for the District of New Jersey against Samsung Bioepis, a joint venture between Samsung Biologics and Biogen, alleging that Samsung Bioepis’ filing of an abbreviated biologics license application for Renflexis® (Infliximab), a biosimilar version of Janssen’s Remicade®, constituted an infringement of three US patents: US6773600, US6900056 and US7598083.
Written by: Neelima Sharma, Ark Patent Intelligence
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Drug Approval and Drug Launch News: First Generic Versions of Strattera Have Been Approved by the FDA and are Being Launched in the US
On 30 May 2017, the US Food and Drug Administration approved the first generic versions of Strattera (Atomoxetine). The following day, Aceto announced that its generic subsidiary, Rising Pharmaceuticals, has launched generic Atomoxetine capsules, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg for the treatment of attention-deficit/hyperactivity disorder.
Written by: Himanshu Kashyap, Ark Patent Intelligence
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Litigation News: UK High Court Held that the SPC Protecting Prezista® (Darunavir) is Valid
On 3 May 2017, the High Court held that the SPC for Prezista® (Darunavir) complied with Article 3(a) of the SPC Regulation and thus, generic companies are not able to market a generic version of Prezista in the UK until 23 February 2019.
Written by: Shruti Mehta, Ark Patent Intelligence
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Drug Launch News: Launch of Teva’s Generic Version of Glumetza® in the US
In late May 2017, Teva launched a generic version of Glumetza® extended-release tablets for the treatment of high blood sugar in adults with type 2 diabetes mellitus in the US. The launch is expected to affect both the sales of Salix’s Glumetza and sales of other generic versions of Glumetza currently available on the market.
Written by: Himanshu Kashyap, Ark Patent Intelligence
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Drug Approval News: Bristol-Myers Squibb's Opdivo® (Nivolumab) Received Approval from the European Commission, the Taiwan Food and Drug Administration and Health Canada
In late April 2017, Opdivo® received approval from the European Commission for the treatment of squamous cell cancer and from the Taiwan Food and Drug Administration for the indication of advanced renal cell carcinoma. Just last week, Opdivo also obtained approval from Health Canada for the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck in adults progressing on or after platinum-based therapy.
Written by: Swetha Saikumar, Ark Patent Intelligence
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Drug Approval News: Cipher Received Health Canada Approval of Ozanex™ for the treatment of impetigo
On 8 May 2017, Cipher announced that the Health Canada has approved its Ozanex™ (Ozenoxacin cream, 1%) for the treatment of impetigo in patients aged 2 months and older. Ozenoxacin is a novel non-fluorinated quinolone topical antibiotic developed for the treatment of impetigo. Ozenoxacin is the first topical antibiotic that has been shown to be effective against antibiotic-resistant bacteria such as Methicillin-resistant Staphylococcus aureus.
Written by: Mudita Jain, Ark Patent Intelligence
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Drug Approval News: The US FDA Approves Ravicti® sNDA for Uric Cycle Disorders in Patients Two Months and Older
Horizon announced in a Press Release that it has received approval from the US FDA for its supplemental New Drug Application for Ravicti® oral liquid, which expanded the age range of the patients to include patients aged two months and older who are suffering from urea cycle disorders and are not able to manage their disorder by dietary protein restriction and/or amino acid supplementation alone.
Written by: Neelima Sharma, Ark Patent Intelligence
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Drug Filing News: Orexigen Files New Drug Submission for Contrave® in Canada
Orexigen announced that Health Canada has accepted for review its New Drug Submission (“NDS”) for marketing approval of Contrave® (Naltrexone Hydrochloride in combination with Bupropion Hydrochloride) for improving the health and lives of patients striving for weight loss.
Written by: Himanshu Kashyap, Ark Patent Intelligence
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Drug Approval News: The US FDA Approves Generic Versions of Benicar® Tablets and Benicar HCT® Tablets
On 24 April 2017, the US Food and Drug Administration approved Torrent’s, Alembic’s, Aurobindo’s, Macleods’s, Zydus’s, Jubilant’s, Alkem’s, Teva’s and Accord’s Olmesartan Medoxomil tablets, 5 mg, 20 mg and 40 mg, which are generic versions of Daiichi Sankyo’s Benicar®, and Teva’s, Alembic’s, Aurobindo’s and Prinston’s Olmesartan Medoxomil and Hydrochlorothiazide tablets, 20 mg/12.5 mg, 40 mg/12.5 mg and 40 mg/25 mg, which are generic versions of Daiichi Sankyo’s Benicar HCT®.
Written By: Anjali Akari, Ark Patent Intelligence
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Drug Launch News: Teva Launches AirDuo™ RespiClick® and its Authorised Generic in the US
Teva has launched two products for the treatment of asthma, AirDuoTM RespiClick® and its authorised generic in the US. Both of these products are expected to affect the sales of Glaxo’s top selling Advair Diskus®.
Written by: Archana Ravishankar, Ark Patent Intelligence
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Drug Launch News: George Steuart Health Partners with Celltrion to Launch First Ever Infliximab Biosimilar in Sri Lanka
Earlier this month, George Steuart Health launched Remsima®, the first ever Infliximab biosimilar in Sri Lanka. Remsima will be available in the form of a powder concentrate for solution and in the form of an infusion, for the management of a range of chronic inflammatory diseases.
Written by: Mudita Jain, Ark Patent Intelligence
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Drug Filing News: Amgen Submitted Applications to the US FDA and the European Medicines Agency for an Expansion of the Indication for Xgeva®
In early April, Amgen submitted a supplemental Biologics Licence Application to the US Food and Drug Administration and an application for a variation to its marketing authorisation to the European Medicines Agency in order to expand the indication for Xgeva® (Denosumab) for the prevention of skeletal-related events in solid tumours, to include patients with multiple myeloma.
Written by: Swetha Saikumar, Ark Patent Intelligence
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Litigation News: BioMarin Settles Sapropterin Patent Infringement Suit with Par
On 13 April 2017, BioMarin announced in a Press Release that it has settled its patent infringement suit with Par and that it has granted Par with a non-exclusive license to its Kuvan® patents, allowing Par to market a generic version of Kuvan in the US from 1 October 2020.
Written by: Shruti Mehta, Ark Patent Intelligence
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Drug Approval News: Japanese Approval of Toray’s Additional Formulation of Remitch® OD Tablets 2.5 µg, for Pruritus Treatment
On 30 March 2017, Toray announced in a press release that the Japanese Pharmaceuticals and Medical Devices Agency has approved its additional oral disintegrating tablet formulation, Remitch® OD 2.5 µg.
Written By: Anjali Akari, Ark Patent Intelligence
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Drug Launch News: Rising Pharmaceuticals Launches Capecitabine Tablets, 150 mg and 500 mg
On 28 March 2017, Aceto announced that its generic subsidiary, Rising Pharmaceuticals, has launched Capecitabine tablets, 150 mg and 500 mg, an AB-rated generic version of Roche’s Xeloda® tablets for treating metastatic breast cancer.
Written by: Himanshu Kashyap, Ark Patent Intelligence
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Drug Therapy News: Genentech's Rituxan® gets US FDA breakthrough therapy status for the treatment of pemphigus vulgaris
On 24 March 2017, Roche announced that the US Food and Drug Administration has granted its Rituxan® product for pemphigus vulgaris with breakthrough therapy designation status. This is the fifteenth breakthrough therapy designation granted to Roche drugs since 2013.
Written by: Hong Pham, Ark Patent Intelligence
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Drug Approval News: The US FDA Approves EMD Serono's Bavencio™ (Avelumab) – the First Treatment for Rare Form of Skin Cancer
On 23 March 2017, Pfizer announced in a Press Release that the US Food and Drug Administration (“FDA”) has approved its BavencioTM (Avelumab) product for the treatment of metastatic Merkel cell carcinoma.
Written by: Neelima Sharma, Ark Patent Intelligence
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Drug Launch News: Launch of Mylan’s Generic Desvenlafaxine Extended-release Tablets and Exemestane Tablets
At the beginning of March, Mylan announced in separate press releases that they have launched generic Desvenlafaxine extended-release tablets, 50 mg and 100 mg, and generic Exemestane Tablets, 25 mg, in the US.
Written By: Anjali Akari, Ark Patent Intelligence
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Drug Withdrawal News: FDA Requests the Removal of Opana ER® Due to Abuse Concerns
Featured Article
Drug In Focus: Bendamustine
Read a brief overview of Bendamustine’s molecule patent has long since expired, however, Cephalon and Teva patent protection of Treanda® has managed to knock back multiple attempts by generic developers to enter the US market before formulation patent expiry.