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Pharma clients normally ask for product identification. Product identification is an elaborate process and one needs to go stepwise, whether identification is for generic dosage form or active pharmaceutical ingredient (API). Identification process starts with understanding client’s objectives, current portfolio, current capabilities (both from R&D and Marketing penetration perspective), budget & strategic goals. Next step […]

After a patent has been issued, the owner has the power to enforce the patent. However, Patents are territorial rights, their scope, enforcement, and validity may vary from country to country. Differences in governing laws/rules applied to various aspects of patent litigation like claim construction; recovery of damages; availability of interim remedies to provide emergency […]

What’s your game? Most of the businesses are becoming global and technology-driven, companies everywhere are facing pressures to be on the cutting edge. And this is not just true for the small pharma companies even the largest pharmaceutical companies are facing the same issues. Additionally, During the last decade, Pricing and early access to promising […]

Commercial success of pharmaceutical products is subject to several risks, like reliance on third parties, regulatory compliance, failure to gain market and patient acceptance, ability to provide adequate supply, competitive challenges, legal and regulatory requirements, and intellectual property and regulatory challenges. The commercial success depends, in part, on company’s ability to obtain patents and/or maintain […]

Dec 4th, 2020, in Neurim Pharmaceuticals (1991) Ltd & Anor v Generics UK Ltd (t\a MYLAN) [2020] the England and Wales High Court (Patents Court) rejected all the claims of Mylan for the invalidity of the EP1,441,702. The case has been in headlines, since June 2020 when the UK appeals court refused the grant of […]

On Nov. 30, 2020, the US District Court for the District of Delaware on remand upheld the validity of various patents of Tris Pharma relating to Quillivant XR® (methylphenidate HCl aqueous extended release oral suspension) and found Actavis’s product infringing. Court found all the asserted patents/claims valid, and Actavis directly infringe, contributorily infringe, and induce […]

Nov 2020, the European Commission (EC) has fined Teva and its now subsidiary Cephalon 60.5 million euros for agreeing to delay the generic version of Modafinil. A series of EU antitrust investigations begun in the year 2009 into ‘pay-for-delay’ drug deals. The drugs involved were Citalopram of Lundbeck, Fentanyl of Johnson & Johnson, Perindopril of […]

The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) established a framework for FDA approval of biosimilars. It also provided a system for litigation of patent disputes involving those products. Recently on November 19, 2020, FDA issued guidance entitled, “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the Biologics Price Competition […]

Most of the companies obtain an agreement from employee to assign any patents developed while working on the employer’s business at the beginning of employment itself. And later make the inventors sign invention-specific confirmatory assignments with each potentially patentable invention.  Even if that is not the case, the employer still may compel the employee to […]

The introduction of modified versions of original products, is used as a strategy by pharmaceutical companies to switch patients from an original product to a follow-on product that benefits from further patent protection or new product exclusivity and may help circumvent Medicaid rebates on established products.  The Innovator pharmaceutical companies take advantage of their market […]