PatentTalk: All about Patents

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

noreply@blogger.com (Prashant K. Bhavar) — Fri, 29 Aug 2008 10:14:00 +0000

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?

noreply@blogger.com (Prashant K. Bhavar) — Tue, 12 Aug 2008 07:59:00 +0000

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

noreply@blogger.com (Anonymous) — Fri, 18 Jul 2008 08:27:00 +0000

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

noreply@blogger.com (Prashant K. Bhavar) — Thu, 03 Jul 2008 11:00:00 +0000

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

noreply@blogger.com (Prashant K. Bhavar) — Wed, 02 Jul 2008 04:54:00 +0000

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?

noreply@blogger.com (Anonymous) — Tue, 01 Jul 2008 12:24:00 +0000

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

noreply@blogger.com (Anonymous) — Fri, 27 Jun 2008 10:44:00 +0000

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.

Para-IV challenge for Pramipexole 2 HCl: U.S. District Court favors Barr Pharma.

noreply@blogger.com (Prashant K. Bhavar) — Fri, 27 Jun 2008 08:21:00 +0000

June 26, 2008 : Barr Pharmaceuticals have announced favorable opinion by U.S. District Court for Delaware in it’s favor pertaining to a Para-IV challenge filed for Mirapex (R) i.e. Pramipexole dihydrochloride, the court have ruled the OB listed patents US 4,886,812 as Invalid on the grounds of nonstatutory double patenting.

Pramipexole (INN, trade names Mirapex and Sifrol) is a medication indicated for treating Parkinson's disease and restless legs syndrome (RLS). It is also sometimes used off-label as a treatment for cluster headache or to counteract the problems with low libido experienced by some users of SSRI antidepressant drugs. Pramipexole has shown robust effects on pilot studies in a placebo-controlled proof of concept study in bipolar disorder[1]. Pramipexole is classified as a non-ergoline dopamine agonist.

Source: http://www.rxtimes.com/?p=1633
http://www.bloomberg.com/

It’s Second in row for Boryung Pharmaceutical Co. South Korea

noreply@blogger.com (Prashant K. Bhavar) — Thu, 26 Jun 2008 10:47:00 +0000

Boryung Pharmaceutical Co. and other 4 generic pharmaceuticals firms prevail against Pfizer in an infringement suit brought by Pfizer for the generic version of cholesterol medicine Lipitor (Atorvastatin).

This is a second patent victory for Boryung Pharmaceutical Co in a month. Earlier it had won the a patent litigation against Sanofi-Aventis for generic version of Oxaliplatin (earlier post dated June 10, 2008 )

The news is as below
PFIZER LOSES RULING IN PATENT DISPUTE IN S. KOREA
Thursday, June 26, 2008; Posted: 04:08 AM
SEOUL, Jun 26, 2008 (AsiaPulse via COMTEX) --

A South Korean judge today dismissed claims brought by Pfizer Inc., the world's largest drug maker, in a patent lawsuit against five local pharmaceutical firms over their generic version of cholesterol medicine, according to the South Korean companies.
The Patent Court of Korea Judge Lee Tae-jong upheld its earlier ruling in favor of Dong-A Pharmaceutical Co. (KSE:000640), Boryung Pharmaceutical Co. and three other South Korean companies, saying their generic drug for cholesterol treatment didn't infringe on a Pfizer patent.
New York-based Pfizer filed the lawsuit with the South Korean patent court, claiming the five South Korean companies allegedly infringed its patent related to its cholesterol medicine "Lipitor."
Although the original patent for the drug expired on May 29 last year, Pfizer extended the patent to 2013 by modifying it, which critics say is an "evergreen" patent protection system, a typical tactic for brand-name companies to extend patent protection and fend off competition with generic drugmakers.
"It's another victory for local drugmakers against 'evergreen' patent tactics by multinational companies," said Ahn So-young, a patent attorney representing the South Korean firms. It wasn't immediately known whether Pfizer will appeal.
A public relations official in Pfizer's Korean unit wasn't immediately available for comment.
It was the second victory in a month for South Korean drugmakers in patent disputes with multinational drug manufacturers. On June 9, French drugmaker Sanofi-Aventis SA lost a patent lawsuit against Boryung Pharmaceutical over its treatment for colorectal cancer.

AIDS Drug Patent and Indian Patent Office

noreply@blogger.com (Anonymous) — Mon, 23 Jun 2008 11:02:00 +0000

Indian Patent Office on Thursday rejected a patent application filed by multinational pharma company Boehringer Ingelheim on paediatric form of anti-AIDS drug nevirapine. The company was trying to claim a patent on the syrup form of nevirapine, which is particularly important for children living with HIV who are unable to swallow tablets. This is the first decision from the Patent Office on the 13 patent oppositions filed by public health groups against AIDS drugs, and will set an important precedent for the pending patent applications, industry expert pointed out. If the patent had been granted, price would have increased for children suffering from AIDS. In May 2006, the Indian Network of People Living with HIV/AIDS (INP+) and the Positive Women's Network (PWN) had filed a pre-grant opposition against the company's application. "We opposed the patent application on nevirapine hemihydrate (syrup) to ensure that it remains available for our children and to make sure that the government doesnt say it is too expensive to provide," said, P Kousalya, president of PWN. Nevirapine is an important anti-retroviral drug, invented in 1989, and was not patentable in India. "Accessing appropriate paediatric formulations of AIDS drugs has been a particular problem around the world, and we hope that this decision can be a step towards making them more available," she added. The Indian Patents Act contains some important safeguards designed to ensure that "frivolous patent applications are not granted at the cost of public health. These include section 3(d) of the Patents Act, which prevents many "new forms" of known substances from being patented unless there is a significant improvement in efficacy, and section 3(e) of the Act, which prevents "mere admixtures" of substances from being patented.
Other AIDS drugs for which Indian patent oppositon have been filed includes Atazanavir, Combivir, Valganciclovir, Efavirenz, Tenofovir and Amprenavir.

Siurce: http://www.blackenterprise.com/yb/ybopen.asp?section=ybaa&story_id=118464621&ID=blackenterprise

Another Patent litigation over Xyzal....

noreply@blogger.com (Anonymous) — Tue, 17 Jun 2008 05:35:00 +0000

Sepracor Inc. and Brussels-based pharmaceutical company UCB SA sued Sandoz Inc., a generic arm of Novartis, in North Carolina on Thursday, marking the third suit the two have filed recently over allergy drug Xyzal. The same plaintiffs sued Sun Pharmaceutical Industries Ltd. over Xyzal.

Xyzal (levocetirizine), a once-daily oral antihistamine, was co-developed by UCB and Sepracor as a follow-on product for the market leader Zyrtec (cetirizine), which will lose patent protection in the US in December 2007. Xyzal, indicated for the relief of symptoms associated with allergic rhinitis (seasonal and perennial) and the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children six years of age and older, was launched in Europe in 2001.

Under a licensing agreement relating to the antihistamine levocetirizine, Sepracor has exclusively licensed to UCB all of Sepracor’s patents and patent applications in the United States regarding levocetirizine.

Abraxis to Appeal Jury Ruling on Elan Patent Infringement Claim of US 5,399,363

noreply@blogger.com (Anonymous) — Sat, 14 Jun 2008 09:14:00 +0000

Abraxis BioScience, Inc. a fully integrated, global biotechnology company, today announced that it intends to appeal the jury ruling in the U.S. District Court for the District of Delaware that Abraxis has infringed upon a patent owned by Elan. In the suit, Elan claimed that Abraxis infringed upon two of Elan's patents, 5,834,025 and 5,399,363, asserting ABRAXANE(R) (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) uses technology protected by Elan-owned patents. Elan withdrew its claim that Abraxis infringed on its 025 patent. The jury ruled that Abraxis has infringed upon Elan's 363 patent, which runs until 2011, and awarded Elan $55 million in damages for sales of Abraxane(R) to date. The company said it is disappointed by the jury ruling in this complex patent litigation and feels confident as it proceeds to appeal in this matter. Abraxis will pursue post-trial motions and appeal the judgment of the District Court.

SOURCE: Abraxis BioScience, Inc.

Sanofi-Aventis Seeks Injunction for Low Cost Generic Uroxatral (Alfuzosin) against Sun Pharma

noreply@blogger.com (Prashant K. Bhavar) — Fri, 13 Jun 2008 03:55:00 +0000

13 June, 2008

Sanofi has alleged infringement of U.S. 4,661,491 patent for Method of Use of Uroxatral, used to treat an enlarged prostate gland which expires in early 2011 and is seeking to have injuction for low cost generic Uroxatral

There is yet another composition patent U.S. 6,149,940 listed in OB, which claims a tablet with controlled release of alfuzosin hydrochloride which expires in second half of 2017.
For details refer the link on Bloomberg.com by Phil Milford by clicking on the title

Doctrine of Patent Exhaustion: Review of Two Recent Supreme Court Decisions

noreply@blogger.com (Anonymous) — Wed, 11 Jun 2008 13:48:00 +0000

Long-lasting, 150-year old Doctrine of Patent Exhaustion limiting the patent rights that survive the initial authorized sale of a patented item was at issue in two totally unrelated cases, which occurred miles away from each other. In these cases, the two Supreme Courts reached to a totally opposite verdict for application of Doctrine of Patent Exhaustion.

In a landmark case of QUANTA COMPUTER INC V LG ELECTRONICS the US Supreme Court applied thes Doctrine of Exhaustion to method patents and prevented LG Electronics from further asserting its patent rights with respect to the patents substantially embodied by those products.

However, in another landmark decision, RECYCLE ASSIST CO LTD V CANON CO LTD, the First Petty Bench of the Supreme Court of Japan held that a recycled product violates the patent right of the original product if the recycled product can be recognized as a “new manufacture” of the patent product.

According to the Exhaustion Doctrine, “when a patented item is once lawfully made and sold, there is no restriction on its use to be implied for the benefit of the patentee.” Therefore, US Supreme Court found that there right of LG Electronics exhausted when it licensed Intel to practice any of its patent and to sell products practicing those patents. Intel authorized sale to Quanta of products made by practicing LG’s patent took its product outside the scope of the patent monopoly and as a result LG can no longer assert its patent rights against Quanta.

However, Japan Supreme Court found that, Recycle assists, a company based in Tokyo, when imported the used ink cartridges from China, which was sold by the patentee through existing trade channels to consumers and sold in Japan the recycled ink cartridges, violated patent rights for the original cartridges. The Court recognized the refilled product as a new manufacture of the patented product.

The Court stated that, “The function, structure, materials of the product, its purpose, its usable life and its manner of use should be considered regarding the attributes of the patented product, and the state of the patented product when it is manufactured, the method and degree of manufacture, the usable life of the replaced components, and the technological function and economic value of the components in the patented product should be considered regarding the manner of reconstruction or replacement of the components.”

Based on abovementioned various elements, the Court recognized recycling as manufacturing.

It would be interesting to see the approach of US Courts to the Doctrine of Exhaustion to the recycling cases.

Lansoprazole Patent Challenge

noreply@blogger.com (Prashant K. Bhavar) — Wed, 11 Jun 2008 06:41:00 +0000

Ethypharm, Takeda & TAP Pharmaceuticals together sue Barr Pharmaceuticals for Prevacid.
June 11, 2008

Barr Confirms Patent Challenge of Prevacid(R) SoluTab(TM) Delayed-Release Orally Disintegrating Tablets, 15mg and 30mg

MONTVALE, N.J., June 10 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL) today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patents listed by TAP Pharmaceuticals Inc. in connection with its Prevacid(R) SoluTab(TM) Delayed-Release Orally Disintegrating Tablets (lansoprazole), 15mg and 30mg.

Barr filed its Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic Prevacid SoluTab product with the U.S. Food & Drug Administration (FDA) in November 2007. Following receipt of the notice from the FDA that Barr's ANDA had been accepted for filing, Barr notified the New Drug Application (NDA) and patent holder.

On June 9, 2008, Ethypharm, S.A., Takeda Pharmaceutical Co., Ltd. and TAP Pharmaceuticals Inc. filed suits in the U.S. District Court for the District of Delaware to prevent Barr from proceeding with the commercialization of its product. This action formally initiates the patent challenge process under the Hatch-Waxman Act.

Prevacid SoluTab (lansoprazole) had annual sales of approximately $428 million in the U.S., based on IMS sales data for the 12-month period ending March 2008.

Mylan Prevails in Federal Circuit: Omeprazole DR Capsules Do Not Infringe Patents asserted against Mylan by AstraZeneca.

noreply@blogger.com (Prashant K. Bhavar) — Wed, 11 Jun 2008 03:58:00 +0000

June 10,2008
Here is the press release :SOURCE: Mylan
Mylan Wins Generic Prilosec® Patent Litigation: Court of Appeals Affirms No Infringement

PITTSBURGH, June 10 /PRNewswire-FirstCall/ -- Mylan Inc. (NYSE: MYL) announced today that the U.S. Court of Appeals for the Federal Circuit has affirmed a May 2007 District Court ruling stating that Mylan's 10 mg and 20 mg Omeprazole delayed-release capsules do not infringe patents asserted against Mylan by AstraZeneca. Omeprazole is the generic version of AstraZeneca LP's Prilosec®.

Mylan launched its Omeprazole products on August 4, 2003, despite the patent infringement litigation, which at the time was unprecedented in the generic pharmaceutical industry.

"Once again, we are pleased to have prevailed in court, and we believe that this decision ends the patent litigation surrounding this product for our company," said Mylan Vice Chairman and CEO Robert J. Coury. "Our original decision to launch this product means that consumers, the government and third-party payors have benefited significantly for nearly five years because they've had access to a lower-cost generic version of Prilosec."

Mylan Inc., with a presence in more than 90 countries, ranks among the leading diversified generic and specialty pharmaceutical companies in the world. The company maintains one of the industry's broadest -- and highest quality -- product portfolios, supported by a robust product pipeline; owns a controlling interest in the world's second largest active pharmaceutical ingredient manufacturer; and operates a specialty business focused on respiratory and allergy therapies.

Sanofi’s appeal fails ; Generic Oxaliplatin to stay in Korea!!

noreply@blogger.com (Prashant K. Bhavar) — Tue, 10 Jun 2008 03:45:00 +0000

The Patent Court of Korea upheld on June 4 its earlier ruling in favor of Boryung, saying the South Korean company's generic drug for colorectal cancer didn't infringe on a Sanofi patent related to the cancer drug, Boryung officials said.
It's a victory for Boryung against a "multinational pharmaceutical company trying to block access by a local company with a deceptive patent," an official at Boryung said.
Last October, Boryung introduced the generic drug called Oxaliplatin liquid medicine for the first time in the world after winning the lawsuit in July that year. Sanofi filed an appeal in October.
Generic drugs usually sell for lower prices than brand-name medicines as they can be made after patent protection of the original brand expires.
Multinational drugmakers such as Sanofi have allegedly been accused of trying to ban sales of generic drugs by winning new patents for their branded medicines.
Officials at Sanofi's Korean office weren't immediately available for comment.

European Patent Register, Online File Inspection available 24/7

noreply@blogger.com (Prashant K. Bhavar) — Tue, 10 Jun 2008 03:32:00 +0000

European Patent Register, Online File Inspection available 24/7

The European Patent Register and the Online File Inspection Facility, Register Plus, is now available 24/7.
The database is updated on a 24 hour cycle, and at any time the visible content will be as at 19.00 the previous evening.
The European Register and Online File Inspection will be unavailable from 05.00 to 05.30 for daily maintenance.
We will keep any other outages to a minimum and we will inform you in advance of any downtime.If you have any queries about Register Plus, you can send an e-mail to: support@epo.org
source: http://www.epo.org/patents/updates/2008/20080609.html

Matrix Labs Sued For AZOR –PARA-IV

noreply@blogger.com (Prashant K. Bhavar) — Thu, 05 Jun 2008 03:59:00 +0000

Daiichi Sankyo the innovator for AZOR has filed a lawsuit in the U.S. District Court for the District of New Jersey alleging infringement of the sole patent U.S. Patent No. 5,616,599 relating to Azor® listed in the "Orange Book". The said patent is set to expire by Apr 25, 2016.
Mylan has confirmed the said news and believes to have a FTF (first to file) Para-IV status. As per the FDA record the said ANDA was filed on 11th Feb, 2008. This if true would make Mylan eligible for 180 days of exclusivity in case Mylan prevails and Daichi fails to defend its IP.

Sources:
http://www.news-medical.net/?id=38944
http://www.financialexpress.com/news/Daiichi-Sankyo-sues-Matrix-Lab/318888/
http://www.fda.gov/cder/ogd/ppiv.htm

FDARA and “Chiral Switch”

noreply@blogger.com (Anonymous) — Mon, 16 Jul 2007 09:26:00 +0000

To date, one of the most interesting strategy to monopoloise the pharmaceutical market is a recourse to "chiral switch". Chiral Switch is a shift to an optically-active enantiomer from an optically-inactive racemate. AstraZeneca utilized this concept in retaining its share of the drug market for treating gastrointestinal diseases, by transferring doctors and patients from its blockbuster omeprazole (marketed as the drug product LOSEC) to omeprazole sodium (marketed as NEXIUM) before the original omeprazole patent expired. This particular move of chiral switch has done wonders for AstraZeneca and omeprazole remains to be one of the best selling molecule in their portfolio.

Another interesting case is that of Citalopram (racemate, Celexa) and escitalopram (enantiomer, Lexapro). In the future, one would not be srprised if chiral switch becomes main weapon to maintain the monopoly in the pharmaceutical market. Provigil (racemate) and Nuvigil (enantiomer), dextromethorphan, PLAVIX ((S)-clopidogrel are already on their way to follow the suit.

Chrial switches have highlighted the importance of chiral molecules. In fact, the focus of whole drug industry has been shifted to chiral molecules. For stastical consdieration, the nine out of first ten block bluster molecules in the year 2006 were chiral in nature.

A review by John Caldwell of the University of Liverpool and organic chemists Israel Agranat and Hava Caner at the Hebrew University of Jerusalem indicates that since 1990, the proportion of single-enantiomer drugs among approved new chemical entities worldwide has been consistently greater than that of racemates [Nat. Rev. Drug Discovery, 1, 753 (2002)]. Chiral effects in pharmaceuticals are being exploited in several ways: as mentioned above by chiral switching, by discovering distinct therapeutic uses for enantiomers of chiral drugs, and by creating non-racemic mixtures of enantiomers.

Probably, keeping in mind the importance of Chiral molecules, the US Senate on May 09, 2007 passed FDARA (Food and Drug Administration Revitalization Act)

The main feature of this act, is that, it provides an opportunity, to elect 5-year exclusivity under certain circumstances for enantiomers.

According to provision of this Act, Specifically, FDARA § 264, if an application is submitted under [§ 505(b)] for a non-racemic drug containing as an active ingredient a single enantiomer that is contained in a racemic drug approved in another application under [§ 505(b)], the applicant may, in the application for such non-racemic drug, elect to have the single enantiomer not be considered the same active ingredient as that contained in the approved racemic drug . . . .

Thus, if a single enantiomer is not considered to be the same active ingredient as that contained in the approved racemic drug, FDA may consider it to be a new chemical entity eligible for 5-year exclusivity. However, such an election of 5-year exclusivity can only be made if:

(A) (i) the single enantiomer has not been previously approved except in the approved racemic drug; and (ii) the application submitted under [§ 505(b)] for such non-racemic drug –
includes full reports of new clinical investigations (other than bioavailability studies) – (aa) necessary for the approval of the application under subsections (c) and (d); and (bb) conducted or sponsored by the applicant; and
does not rely on any investigations that are part of an application submitted under [§ 505(b)] for approval of the approved racemic drug; and
(B) the application submitted under [§ 505(b)] for such non-racemic drug is not submitted for approval of a condition of use— (i) in a therapeutic category [(as identified in the list referenced at42. USC § 1860D-4(b)(3)(C)(ii)

in which the approved racemic drug has been approved; or (ii) for which any other enantiomer of the racemic drug has been approved.

In addition to these requirements, which essentially necessitate the submission of a “full” 505(b)(1) NDA, FDARA § 264 also includes two significant limitations that may offset the incentive for electing 5-year exclusivity.

First, FDA may not approve a single enantiomer of a previously approved racemate granted 5-year exclusivity for any condition of use in the therapeutic category in which the racemic drug has been approved “[u]ntil the date that is 10 years after the date of approval of a non-racemic drug described in [proposed FDC Act § 505(t)(1)].”
Second, “the labeling of a non-racemic drug described in [proposed FDC Act § 505(t)(1)] and with respect to which the applicant has made the election provided for by such paragraph shall include a statement that the non-racemic drug is not approved, and has not been shown to be safe and effective, for any condition of use of the racemic drug.”

Thus, a mere reading of this act suggest that USFDA wants pharmaceutical companies to develop the single enantiomers for new therapeutic indication and not for the same therapeutic indication, in which the chiral drug is approved.

Therfore, whether the implemenation of FDARA would limit the strategy of Chiral swithes and enhance the use of single enantiomer for new therapeutic indications need to be seen.

Patent Battles: The Way Ahead -II

noreply@blogger.com (Anonymous) — Mon, 02 Jul 2007 12:46:00 +0000

In continuation to my previous post related to patent battle, herein the effort is made to review the situation in India. The patent scenario in India is also changing to be at par with other so called advanced or highly regulated market, especially in pharmaceutical sector.

With the implementation of Product patent regime and honoring the importance of adequate patent protection life, India is on track to see a major change in pharmaceutical scenario. Further, the efforts are being carried out to implement data protection, as outlined by Satwant reddy committee report. These developments are strong indicators of changing winds in Pharmaceutical sector in India. It’s only a matter of time, for Pharmaceutical Industry in India, to witness a high number of patent litigations.

The forecast of high number of patent litigation is based only on desire of pharmaceutical companies to capture the untapped market due to the pressure for ever increasing profits at pharmaceutical companies. The capability of Indian companies to capture lucrative markets of US and Europe is well proven. Therefore, this battle, when fought at their own backyard, i.e. in India, appears to be far more brutal. India, being a country of vast population and legislation offering or attempting to offer adequate Intellectual protection is certainly a big pharmaceutical market of future.

Once it is accepted that, even in India, which has moved a long way from process development, there would be a large number of patent litigations, the future pharmaceutical market would be governed by litigations, then obviously the next big question which comes in mind is that whether our judiciary system is capable of handling such a huge task?

In India, where normal civil and criminal cases take unwarranted time to dispose, the future of patent litigations, involving technical subject matter is ambiguous. The existing infra structure and corrupt system only adds to this ambiguity.

Therefore, whether Indian Legal System as well as Health Regulatory System would be able to cope with the demands of future would need to be seen.

If we look at China, a neighboring Country, the Pharmaceutical industry picture is clearly depicting a birth of another giant. China, similar to India, has huge population and therefore, remains to be a big Pharmaceutical market.

Chinese legal system has already shown to the world their preparedness about Health issues. The recent Judgment of Beijing court slamming the death penalty to Zheng Xiaoyu, who was found guilty for taking over $850,000 worth of bribes in the form of cash and gifts when inappropriately approving hundreds of drugs and medical devices, at least six of which proved to be fake is clear indicators of strong pharmaceutical environment.

Whether there would be any stringent and/or bold decision in Indian scenario would need to be wait and watched.

In an effort to mimic regulated countries atmosphere for IP issues, how far India, China or similar countries like Brazil could go would determine, which would be the Best Pharmaceutical market of twenty-first century.

noreply@blogger.com (Prashant K. Bhavar) — Fri, 29 Jun 2007 11:21:00 +0000

Biogenerics: Opportunity In Abundance

In The Midst of Thick Challenges

A number of factors are coinciding to make biogenerics a hot topic at the moment: Government agencies around the globe especially US and Europe are busy devising a balanced regulatory policy for biogenerics to address the rapid and a more urgent priority for governments and consumers healthcare spending on ageing populations.

As key patents on some of the early recombinant protein therapeutics have started to expire the generic companies are developing the capabilities to develop and create their own versions of these off-patent products while Innovators on the other side are trying there best to exert a much greater influence and slow down the reforms.

In this context the people’s representatives in US have taken a big leap forward to open the much debated market barrier for biogenrics. The bill passed by the Senate health, Education, Labor and Pension committee by a Voice vote is fairly assumed to be included in the broad FDA bill expected to be passed in the coming months is one such effort taken by US and being eagerly tracked by all the stake holders involved.

The authors who wrote the bill say "The bill reflects a balanced approach that enables patients to have safe, effective and affordable biological drugs, while preserving the incentives that have brought these life-saving advances to the American public,"

The major highlights being provision of a 12 years of marketing exclusivity for Biologic medicine to the Innovator against the traditional 5 years of marketing exclusivity for new chemical entities.

If this becomes law it could open doors for multibillion dollar biotech products such as Epogen (Amgen), Procit (Johnson & Johnson) since their patents have expired and have already enjoyed at least 12 years of monopoly.

So what this means to generic drug maker is an Opportunity in abundance: The big attraction in terms of market potential for biogenerics however in the midst of thick challenges in terms of massive barriers to entry.

Basic barriers to market entry in biogenerics are much higher than for any small molecule generics such as

¨ High development costs since the investment needed to put a biogeneric through the necessary clinical trials is considerable
¨ Greater time in development (due to required clinical testing)
¨ Quality requirements, as well as demanding and uncertain regulatory approval and not but the least
¨ Intellectual property issues in terms of Patent.

As a result, the situation demands the companies to move beyond typical generic company strengths and develop new skills in biotechnology, manufacturing, clinical trials, regulatory compliance, pharmacovigilance testing and marketing.

The investment needed to put a biogeneric through the necessary clinical trials is considerable and illustrates the great importance of strong financial backing and regulatory expertise.

All in all, generics companies will have to create an entirely new business model for biogenerics: in many ways closer to the branded biotech model.

Industry observers says that only a select bunch of top biogeneric players are expected to make use of this opportunity and have an initial impact on the market due to there present strength and capabilities. Five key players will be Novartis's Sandoz, Teva, BioPartners, BioGenerix a subsidiary of Ratiopharm and Stada through its affiliate Bioceuticals. However, based on the current outstanding success of Indian pharmaceuticals companies on follow on generics we can certainly look forward for Biotech Industries in India joining the race.

Patent Battles: The Way Ahead

noreply@blogger.com (Anonymous) — Thu, 28 Jun 2007 12:14:00 +0000

Intellectual property (IP) is a buzz word in today’s knowledge based era. The value of IP is enormous and ever increasing, especially in the field of pharmaceutical industry. Moreover, thanks to computers and internet, which make transfer of information even faster than speed of light. The advent of e-communications has brought everyone on global level and the competition in each filed of technology is fierce.

If we look at various patent related cases, which are filed in all Federal District Courts of USA, we would note that from June 01, 2007 to June 26, 2007, at least 224 new cases have been filed. The number is mind-boggling. Statistically it is approximately 10 new patent related litigations per day! A list of few of these cases, mainly related to Pharmaceutical field is given in Table – 1. By virtue of these litigations, multimillion-dollar molecules such as Oxaliplatin, Depakote are under generic attack. The battle of Sertraline is special as it involves fight of generic companies with each other.

The US generic market is definitely a lucrative option for generic companies and beyond any doubt, the provisions of Hatch-Waxman Act has catalyzed early generic entry. In fact all major life savings drugs have seen an early entry by the provisions of Hatch –Waxman in USA. Further, one should thank to the apex Court of USA, for raising the standard of obviousness in USA recently through a judgment in KSR case.

Therefore, patent battles would continue to drive pharmaceutical market in USA.

Patent Talk

noreply@blogger.com (Prashant K. Bhavar) — Mon, 25 Jun 2007 10:51:00 +0000

Every one of you out there! interested to know all about Intellectual Property : Especially Patents.

Welcome to this new blog PATENT TALK

This is our first attempt to write Interesting things about patents and hope you would enjoy reading the same

till then wait for OUR first writeup !!!!!!!!!!

We will be there

Nishid & Prashant