API and IP Newsletter
Contents
Development activities of Hetero.
General information.
Draft Patents (Amendment) Rules, 2021.
Fitch Affirms Teva at 'BB-'; Outlook Remains Negative.
Intellectual Property.
Development activities of Hetero
In our firm SIDVIM, we analyse development activities of various Pharmaceutical companies, especially in small molecules. We have analysed imports of Hetero Drugs and could derive interesting conclusions. Glimpses of our analysis is provided in the table below. A wealth of information is gathered based on imports and exports of Indian Generic Companies.
General information
Draft Patents (Amendment) Rules, 2021
New Patent Rules, regarded as Draft Patent Amendment Rules 2021 have now been published. Any suggestions or comments regarding the Draft amended rules must be provided within 30 days from the date of publication of the rules, i.e., 30 days from February 9, 2021 New Applicant Category of ‘Eligible Educational Institution’ has been introduced. (Read more)
Fitch Affirms Teva at 'BB-'; Outlook Remains Negative
Teva's litigation profile remains the single biggest constraint on Fitch's 'BB-' IDR and is the principal reason for the Negative Outlook despite improvements in Teva's credit profile compared to a year ago.(Read more)
Intellectual Property
GSK vs Teva on Skinny label or Carve-out issues
Section viii carve-outs
What is Section viii carve-outs in US?
The statute (21 U.S.C. § 355(j)(2)(A)(viii)) allows the generic sponsor to remove or “carve-out” the protected indication or other protected condition of use from the product labelling and submit a “section viii” statement explaining that the applicant does not seek approval for the protected use.
Though statute looks simple, the issues related to section viii carve-outs remain unresolved in the context of the small molecules. In February 2020, the FDA issued draft guidance which makes it explicitly clear that carve-outs are indeed permissible for biosimilars.
This is the case of Carvedilol and GSK’s patent reissued in 2008, related to treatment of congestive heart failure using Carvedilol.
In the lower court, Teva argued that it could not be found to have induce infringement because the patented use was carved out on the skinny label. The lower Court held that GSK failed to prove Teva caused the direct infringement.
GSK appealed. On appeal, GSK argued that Teva promotes its generic product as being the same as the branded product.
In October, a three-judge CAFC panel decided in favour of GSK.
Now, the appeals court will review the case "en banc," which means the court's entire complement of 12 judges will hear arguments.
This will be an interesting case to follow and it would show path for generics to carve out labels and subsequent marketing of their products. News here.
Disclaimer
Sidvim LifeSciences Private Ltd has taken due care and caution in developing this document. Since the data used for analysis in this document is based on the information available in the public domain, its adequacy or accuracy or completeness cannot be guaranteed. This document is for information only and Sidvim is not responsible for losses that may or may not arise due to any decisions made based on the same. No part of the document shall constitute or be represented as a legal opinion of any kind or nature. No warranties or guarantees, expressed or implied, are included in or intended by the document, except that it has been prepared in accordance with the current generally accepted practices and standards consistent with the level of care and skill exercised under similar circumstances by professional consultants or firms that perform the same or similar services.
