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

Patenting in India and Year 2007

Year 2007-08 was a landmark year in the history of Indian patents. This was the first year of India's 11th five year plan. This year Indian patent office was in limelight as only in 2005, India has amended its patent laws to allow product patents. A reasonable time has passed since opening of mail box (or black box) and it was a matter of curiosity to every one that how many patents would be granted as Patent office was under sever work pressure.

In this regard, I came across with an interesting article from EE times, which is as follows:

Concerned by the fact that India lags far behind the world average in patent filings per population, the Indian government pointed to an upswing in the number of patents granted since the launch of a major effort to modernize the patent process here.

The Indian Patent Office granted a record 15,262 patents during 2007-08, the government said, more than double the 7,539 granted the previous year (2006-07) and nearly eight times more than the 1,911 patents granted three years ago, in 2004-05. Historically, the total number of patent filings by residents of India is just three per million population, against a world average of 250.

According to the federal Ministry of Industry and Commerce, the number of patents granted in 2007-08, the first year of India's 11th five-year plan, compares well with the total number awarded during the entire period of the 10th five-year plan, which was just 17,618. The number of patent filings also crossed the 35,000 mark during 2007-08.

The rise is linked to the modernization of the patent and other intellectual-property offices. The Indian government spent more than $35 million in the first phase of the modernization effort, which included setting up integrated intellectual-property offices in four major cities and launching electronic filing of applications.

Another $75 million is to be spent to establish a Trade Marks Registry and Intellectual Property Archives and allied activities. The government has also begun work on a National Institute of Intellectual Property Management to handle training, education, research and think tank functions in intellectual-property rights.

Last October, the World Intellectual Property Organization recognized the Indian Patent Office as an International Searching Authority and an International Preliminary Examining Authority under the Patent Cooperation Treaty.

European Patent Office announces 24 X 7 access to European Patent Register

The much awaited 24 hours online access for European Patent Register including Public File Inspection is now available to all.

Here is the News
EN_____________ Register Plus now available 24/7

We are pleased to announce that Register Plus, comprising the Online European Patent Register and the Online Public File Inspection service, is now available round the clock. The database is updated on a 24-hour cycle. At any one time, the visible content will be as at 19.00 hrs the previous evening. Whilst there will be a short break for maintenance between 05.00 and 05.30 hrs CET daily, we will endeavour to keep all other outages to a minimum, and to inform you in advance of any planned downtime. If you have any queries about Register Plus, write to support@epo.org.

Teva to appeal U.S. District Courts decision over Quetipine

AstraZeneca PLC has won the initial battle over its antipsychotic drug Seroquel, removing the threat of generic competition for the company's second-best-selling product with $4 billion in sales in 2007 after Nexium.

In addition to this AstraZeneca PLC has also sued Sandoz for filing ANDA. Both Teva and Sandoz are in race for generic version of Seroquel and seek approval to market generic versions of SEROQUEL® (quetiapine fumarate tablets) in the US before SEROQUEL's US patent 4879288 expires in Sep. 2011.

For further details refer Wall Street journal and CNN money at
http://online.wsj.com/article/SB121495435431321131.html?mod=googlenews_wsj
http://money.cnn.com/news/newsfeeds/articles/apwire/851476d46341f0e43802c566ca32b121.htm

Patent Auction – Future of IP Trading?

Recently, the auctions arm of Ocean Tomo, LLC, announced the results of its 2008 European Live IP Auction held on 26th June at the NH Grand Hotel Krasnapolsky. Cumulative sales, including buyer’s premium, totaled $12.6 M, with an average sale price per lot of $437,036, with further transactions anticipated to close in the coming weeks. Further according to press release, for the first time the auction was viewed by several hundred people in closed-circuit locally-hosted events in Singapore, Tokyo, Bangalore, and Seoul. (http://www.businesswire.com/)

This kept me wondering about future of IP trade. Undoubtedly, “The value of an Idea lies in the art of using it”. So are we at the advent of patent auction as a tool for IP trade and business?

Almost 98% of the issued patents (almost 150,000 every year in US itself) are never commercialized. The one reason for this is that patent comes before the sale or commercialization. In today’s market driven world the interest of the patentee also changes with the time and more often patentee do not commercialize their patents as they often give priority to other inventions. This eventually leaves large number of patent files in one’s portfolio as fish files.

Patent auction is a fast way to sell or license such patents. The nature of the patent right creates a big imbalance in terms of knowledge between owner of the patent and the purchaser or licensee; the latter party can minimize the risk of purchasing or licensing a "zero" or low value patent by receiving sufficient time to investigate the patents.

Apart from above-mentioned Ocean Tomo, LLC, there are several other websites, which also provide opportunity to auction the patents. These are http://www.freepatentauction.com/, http://www.ipauctions.com/, http://www.ipmarket.com/, and http://www.shop4patents.com/.
Many companies might believe that patent auction is a swift and effective way to find a purchaser or a licensee for their IP rights. After all, intellectual property is an indispensable asset to companies.

However, though the patent auction has potential to become an effective way for inventors and companies to market and monetize their patents, some critics fear that the auction would only fuel patent trolls, who have no plans to practice the patent, but rather make all their money from licensing, often under threat of litigation. It would be evident from recent Blackberry case that companies are very sensitive to patent trolls. The other blocking aspect for patent auction is that inventors are often attached to their inventions and expect relatively big bucks for their invention.

Notwithstanding the pros and cons of the patent auction, I indeed believe that this could be the wave of the future for monetizing intellectual property, a mechanism for bringing more tangible value and a lucrative market to intellectual property.

Section 25 (1) of Indian Patent Act utilized for the first time by an overseas body

Signalling mounting global resistance to patenting of drugs in India, a Brazilian public health group has filed an opposition in India against US drug maker Gilead Sciences Inc.’s patent filing for their anti-AIDS drug, Viread.
This is the first pre-grant opposition filed by an overseas body against a patent grant in India and reflects a growing concern about ensuring that the supply of cheaper, non-patented drugs from India is not blocked.
Gilead faces the first pre-grant opposition to an application seeking a patent in India. Brazilian Interdisciplinary AIDS Association and the Indian non-governmental organization SAHARA, or Centre for Residential Care and Rehabilitation, on Thursday submitted their opposition in the Delhi patent office citing the implications the patent grant will have in restricting Brazil’s ability “to produce and access affordable generic versions of the drug”.
The drug is crucial for Brazil, which has a large patient population living with HIV. Brazil accounted for roughly 40% infected people in Latin America, which had a HIV-positive population of 1.6 million in 2007. The government there intends providing 31,000 people with tenofovir disoproxil fumarate, sold as Viread, and declared it a drug of “public interest” in April.
By procuring the drug from India, the South American country estimates it can save $38 million (Rs162.26 crore) on the drug.

The opposition is on the grounds that tenofovir consists of a previously known compound and hence not sufficiently inventive to qualify for a patent under section 3(d) of India patent law. This provision bars patenting of tweaked versions of existing drugs unless the modification leads to a substantial improvement in efficacy. Mumbai-based Cipla Ltd and patient groups, such as the Indian Network of Positive People and Delhi Network of Positive People, had previously filed opposition in the Delhi patent office in 2006. The drug patent filing is facing similar oppositions in Brazil as well from civil society groups.

In 2006, Gilead had signed a spate of voluntary licensing agreements with 11 Indian non-patented, or generic drug makers, allowing them to make copies of the anti-HIV drug and selling it in 95 low-income countries including India, in a bid to take the sting out of the patent oppositions.