Barr Invalidates Galantamine Method of Use patent: Planning for an “AT RISK” launch

Barr Invalidates Galantamine Method of Use patent: Planning for an “AT RISK” launch

CNN Money reported

Barr says court voids Alzheimer's drug patent
Barr says Delaware court overturns patent on Johnson & Johnson's Razadyne ER
August 28, 2008: 11:56 AM EST
NEW YORK (Associated Press) - Barr Pharmaceuticals Inc. said Thursday a U.S. District Court voided a patent on the drug Razadyne, a drug used to treat dementia related to Alzheimer's disease, which would allow Barr to sell a generic version.

Barr said Judge Sue Robinson of the U.S. District Court for the District of Delaware sided with Barr. The company said Robinson cited a lack of enablement, or a description of how to make and use Razadyne and Razadyne ER, in ruling that the patent is not valid.

Barr said it is considering its options and plans to launch the generic as soon as it receives final approval from the Food and Drug Administration. The company is preparing to sell the drug before its patents expire, in what is known as an "at-risk" launch.

Robinson also denied a request from Ortho-McNeil Neurologics, a subsidiary of Johnson & Johnson, to issue a restraining order to prevent Barr from selling the drug. Ortho-McNeil said it will appeal the ruling.

According to Barr, sales of Razadyne extended-release capsules reached $112 million in the 12 months ended June 2008, while total sales of Razadyne tablets were $102 million.

Patent 4,664,318 concerns the 8 milligram, 16 milligram and 24 milligram extended release capsules of Razadyne, also called galantamine hydrobromide. Razadyne ER was scheduled to lose patent protection in December.

Tarceva (Erlotinib) Patent Challenge: Can Cipla prevail?

CNBC reported today that Cipla’s Tarceva (Erlotinib) Patent Challenge Resumes in Delhi High Court.

This is one of its kinds of patent challenge, which will define the enforcement of IP rights for Pharmaceutical Product Patents in India.
Facts:
Roche has a granted Indian Patent IN 196774 for Tarceva:

• Application NO 537/Del/1996 Filed on 13.03.1996
• Joint patent owner along with Pfizer
• Indian Patent IN 196774 Granted on 23.02.2007

Roche has already been denied a permanent injunction and damages sought to stop Cipla from selling Tarceva.
Delhi High Court on March 19, 2008 held that :

• On a conspectus of all the factors, the defendant's (Cipla’s) contention does not appear implausible. This is not to say that there is merit in its contentions; it is, not also meant to be reflective of the strength of such contentions.
• Any comment by the court, in that regard would be unfair to the plaintiff (Roche) and the court should refrain from conducting a mini trial as to the strength of the parties, at the interlocutory stage.
• All that can be therefore said is that the plaintiff's case (Roche) though arguable and though disclosing prima facie merit, has to answer a credible challenge to the patent, raised by the defendant (Cipla)
• In India, once granted the patent is not presumed to be valid, unless and until the said patent sufficiently and successfully passes through major phases of patent challenges including pre/post grant opposition and revocation stages, which the court in other word described as a SIX year Rule. i.e., the patent would be presumed to be valid if it survives more then Six years from the date of grant.
• Therefore, keeping in mind the therapeutic and life saving potential of Tarceva the court has denied permanent injunction.
• The courts decision was based solely on the humanitarian ground indicating that human suffering is prime and intangible in comparison to financial loss if any to Roche, which can always be compensated but not the human loss if injunction is granted.

Accordingly, now the patent trial has begun in Delhi High Court and Interestingly for the first time Delhi High Court would be evaluating the Patent laws for Pharmaceutical Product Patents and in general the IP enforcement.

It is note worthy to mention that the said patent has already withered through a pre-grant opposition by Natco and emerged Valid. Even the fine print of the same courts ruling, hearing the Injunction favors Roche with respect to Inventive merit of Tarceva and thereby the Patent Validity.

As per the facts put forth, earlier in the court there is every chance for Roche to survive based on Patent laws, however the question is Can Cipla prevail?

Source http://www.moneycontrol.com/india/news/business/cipla-roche-patent-battle-to-resume-at-delhi-hc/16/20/351515