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.

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

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

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

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....

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

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

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

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

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.

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!!

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

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

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