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
Friday, June 13, 2008
Wednesday, June 11, 2008
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.
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
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
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.
Tuesday, June 10, 2008
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.
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
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
Thursday, June 5, 2008
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
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
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