Friday, 31 October, 2008

Court Of Appeal for Federal Circuit (CAFC) declined business model patents

In a significant decision today, CAFC in hearing en banc decision thwarted attempt to patent business model patents, a request by applicant Bilski et al. In the hearing en banc decision 3 judges (Judge Newman, Radar, Mayer) opposed the decison.

The court upheld Board of Patent Appeals (BPAI) decision that Bilski et al’s claimed invention (a method of hedging risks in commodities trading) does not satisfy the patentable subject matter requirementsas per 35 U.S.C. § 101.

Court also concluded that a claimed process is patentable under § 101 if:

(A) it is tied to a particular machine or apparatus, or

(B) it transforms a particular article into a different state or thing.

(As per earlier ruling of supreme court)

Court concluded that claimed invention In Re Bilski fails in above tests, hence, not patantable

Opinion of court

Impact on Indian industry

Although, the above decision was hailed by many software companies in US but in India, which is a major outsourcing hub for IT related work, the companies are not happy with the court's decision. Economic times has reviewed the impact of this decision on Indian IT industry Here

Dorzolamide Hydrochloride-Timolol Maleate (COSOPT and TRUSOPT): Prasco ready to launch generic form, Hi-Tech Pharma lose 180 days exclusivity

Prasco has begun shipping generic forms of Dorzolamide Hydrochloride-Timolol Maleate and Dorzolamide Hydrochloride Ophthalmic Solutions, comparable to Merck’s COSOPT® and TRUSOPT®.
Trusopt (Dorzolamide hydrochloride ophthalmic solution) is a carbonic anhydrase inhibitor formulated for topical ophthalmic use. Trusopt is used to lower increased intraocular pressure in open-angle glaucoma and ocular hypertension.
Cosopt (Dorzolamide hydrochloride & Timolol maleate) is a drug for lowering pressure in the eye to normal levels, and a treatment for glaucoma.
(Source: Prasco press release)
Also, Hitech and apotex has got final approval to market on October 28, 2008.
Cosopt 180 days exclusivity
The USFDA has denied Hitech pharma 180 days exclusivity for Cosopt (Dorzolamide hydrochloride & Timolol maleate) FDA law blog has reviewed the Hitech’s forfeiture of 180 days exclusivity due to failure to market in details Here
Earlier news of IPPharmadoc on this litigation here

Vfend 50 mg and 200 mgTablets (Voriconazole):Matrix won 180 days exclusivity without any opposition from innovator Pfizer, Matrix can file DJ action

Mylan today announced that its Indian subsidiary Matrix Lab has challenged Pfizer Inc.'s patents for its Vfend Tablets (Voriconazole: (2R,3S)-2-(2,4-difluorophenyl)-3- (5-fluoropyrimidin-4-yl)-1- (1H-1,2,4-triazol-1-yl) butan-2- ol), 50 mg and 200 mg, with the filing of its Abbreviated New Drug Application (ANDA). Importantly, Pfizer did not file a lawsuit against Matrix within the 45-day time period provided by the Hatch-Waxman Act to initiate an automatic stay of regulatory approval. Consequently, Matrix's ANDA will be eligible for final approval as soon as regulatory review by USFDA is complete.
US5116844 (Expiry: Aug 11, 2009): Link (Covers composition)
US5364938 (Expiry: Nov 15, 2011): Link (Covers Voriconazole generically)
US5567817 (Expiry: May 24, 2016): Link (Covers Voriconazole specifically)
US5773443 (Expiry: Jan 25, 2011): Link (Covers Voriconazole generically)
Matrix submitted its ANDA on April 14, 2008, and believes it is the first company to submit a substantially complete ANDA containing a Paragraph IV certification, and will be entitled for 180 days generic exclusivity.
Vfend Tablets, a triazole antifungal agent was approved by USFDA on May 24, 2002, had annual U.S. sales of approximately $157 million for the 12 months ending June 30, 2008, for the noted strengths, according to IMS Health.
Currently, Mylan has 112 ANDAs pending FDA approval, 23 of which are potential first-to-file opportunities.
Ippharmadoc believes that Mylan will now file Declaratory Judgment (DJ) against the listed patents. (Biomedicine news Link)

Friday, 24 October, 2008

Clarithromycin Extended Release Tablets: CAFC Upholds Preliminary Injunction

Court of appeal for federal circuit court ruled that Sandoz could not start marketing its generic version of Clarithromycin Extended Release Tablets before the resolution of the patent trial with innovator Abbot.
The dispute was on preliminary injunction granted by district court in favor of innovator Abbot. preliminary injunction in equity, is an injunction entered by a court prior to a determination of the merits of a legal case, in order to restrain a party from going forward with a course of conduct until the case has been decided. If the case is decided against the party that has been enjoined, then the injunction will usually be made permanent. If the case is decided in favor of the party that has been enjoined, the injunction will usually be dissolved or dismissed. In most courts in the United States, the party seeking the preliminary injunction must demonstrate all four things together:
1) That there is a substantial likelihood of success on the merits of the case,
2) That they face a substantial threat of irreparable damage or injury if the injunction is not granted,
3) That the balance of harms weighs in favor of the party seeking the preliminary injunction
4) That the grant of an injunction would disserve the public interest. (Source: wikipedia)
The dispute was w.r.t factor 1 of preliminary injunction i.e substantial likelihood of success on the merits of the case. While the defendant (Sandoz) did raise a substantial question of the vulnerability of the patent, it did not provide any clear and convincing evidence of invalidity.
The presentation of sufficient evidence to show the likelihood of prevailing on the merits is quite different from the presentation of substantial evidence to show vulnerability
It is pertinent to mention here that obviousness grounds based on 3 prior art documents provided by Sandoz were sound and based on this one judge was against preliminary injunction. IPPharmdoc believe that there are chances of hearing en banc on the said issue.

Opinion of court

Wednesday, 22 October, 2008

Para IV filings: Mylan (Cyclobenzaprine Hydrochloride ER Capsules), Barr (oxymorphone hydrochloride ER tablets) and Par (Sumatriptan/Naproxen)

Mylan (Cyclobenzaprine Hydrochloride ER Capsules)
Innovator Cephalon and Eurand has confirmed the receipt of a Paragraph IV Certification Notice Letter on October 20, 2008 regarding an Abbreviated New Drug Application (ANDA) submitted to the USFDA by Mylan Pharma, requesting approval to market and sell a generic version of the 15 mg and 30 mg strengths of AMRIX (Cyclobenzaprine Hydrochloride Extended-Release Capsules).

Barr (oxymorphone hydrochloride ER tablets)
Barr Pharma confirmed that it has initiated a challenge of the patents listed by Endo Pharmaceuticals Inc. in connection with its Opana(R) ER (Oxymorphone hydrochloride) extended-release tablets, 5 mg, 10 mg, 20 mg and 40 mg.

Par (Sumatriptan 85 mg/Naproxen sodium 500 mg tablets)
Innovator Pozen and GlaxoSmithKline (GSK) has confirmed that they received a Para IV letter from Par Pharma on Treximet (Sumatriptan 85 mg/Naproxen sodium 500 mg). Par's letter advised POZEN and GSK that it intended to market a generic version of Treximet tablets before the expiration of following Orange Book listed patents, with following starategy:
US5037845: (Expiry: Aug 6, 2008)- Para III
US6060499 (Expiry: Aug 14, 2017)- Para IV
US6586458 (Expiry: Aug 14, 2017)- Para IV
US7332183. (Expiry: Oct 2, 2025)- Para IV
Earlier, innovator got approval on this combination on Apr 15, 2008. The New combination exclusivity on this product will expire on Apr 15, 2011.

Ciprofloxacin: The US court approved settlement between generic and innovator to be lawful

The U.S. Court of Appeals for the Federal Circuit (CAFC) has upheld the 2005 decision of the U.S. District Court of New York, which rejected a challenge to the lawfulness of a 1997 patent litigation settlement between Barr Labs and The Rugby Group (which has since been acquired by Watson Pharmaceuticals). and Bayer Corporation related to the antibiotic Ciprofloxacin. CAFC affirmed the grant of summary judgment by the District Court and concluded that Agreements were not in violation of section 1 of the Sherman Act because any anti-competitive effects caused by the Agreements were within the exclusionary zone of the patent. The CAFC affirmed the court's dismissal of antitrust claims.
(Opinion of the court here)
Earlier news of IPPharmdoc on Ciprofloxacin antitrust issues Here

Wednesday, 8 October, 2008

Entacapone (200mg) Tablets: Sun Pharma filed Para IV

Orion Corporation has confirmed that it has received Paragraph IV certification from SunPharma against Orange book listed patents for Comtan (Entacapone, 200mg tablets). USFDA approved this product on Oct 19, 1999. Patentee Orion Pharma has licensed this molecule to Novartis. Orion previously sued Sun Pharmaceutical Industries Ltd. for patent infringement when it challenged certain Orion U.S. patents as part of an earlier filed ANDA on a generic version of Orion's proprietary drug, Stalevo as reported earlier by IPPharmadoc Here . That action is pending in the District Court for the District of New Jersey.
US4963590 (Expiry: Nov 27, 2007): Claims Pharmaceutical composition and method of use of catechol-O-methyl transferase inhibitor
US5112861 (Expiry: May 12, 2009): Method of use with Entacapone and levodopa
US5135950 (Expiry: Oct 31, 2010): Crystallographically essentially pure polymorphic form A
US5446194 (Expiry: Oct 19, 2013): Covers Entacapone as product
US6599530 (Expiry: Sep 14, 2018): Covers an oral compacted composition in the form of a tablet, which comprises a pharmaceutically effective amount of entacapone, nitecapone, or pharmaceutically acceptable salt of entacapone or nitecapone, and croscarmellose sodium in an amount of at least 6% by weight of the composition.
Entacapone is a catechol-O-methyl transferase inhibitor for the treatment of Parkinson's disease. When administered in conjunction with dopaminergic agents such as L-DOPA, entacapone increases the bioavailability of these compounds by facilitating their passage across the blood-brain barrierFurthermore, Wockhardt is first Para IV filer on this product and innovator Orion sued Wockhardt for in the District Court of Delaware. Sun Pharma has challenged product patent ‘194 and formulation patent ‘530. Also, Sun has not challenged method of use patent ‘861 and crystalline polymorph patent ‘950. From this filing, it can be concluded that Sun pharma intend to enter into the market after the expiry of ‘950 patent on Oct 31, 2010

Generic Approvals: US market

Final approval
Primidone Tablets:
Dr. Reddy's Laboratories
Bromocriptine Mesylate Tablets: Paddock Lab
Galantamine Hydrobromide Extended-release Capsules: Barr Lab
Cyclobenzaprine Hydrochloride Tablets: Aurobindo
Promethazine Hydrochloride Injection: Wockhardt USA
Tramadol Hydrochloride and Acetaminophen Tablets: Alphapharm

Tentative Approval
Arsenic Trioxide Injection: Teva Parenteral
Olmesartan Medoxomil and Hydrochlorothiazide Tablets: Mylan Pharmaceuticals

Canadesartan+Hydrochlorthiazide: Paragraph IV filed

A generic company has filed Paragraph IV against Atacand HCT® (Candesartan and Hydrochlorothiazide) Tablets 16 mg/12.5mg and 32mg/12.5mg on June 25, 2008. The said combination was approved by USFDA on Sep 5, 2000 . Also, innovator got approval on another combination 32mg ;25 mg on May 16, 2008.

Following Orange Book patents are listed for this product:

US5705517 (Expiry: Apr 18, 2011): Covers candesartan as product
US5196444 (Expiry: Jun 4, 2012): Which covers A stable crystal of 1-(cyclohexyloxycarbonyloxy)ethyl 2-ethoxy-1-[[2'-(1H-tetrazol-5-yl)-biphenyl-4-yl]methyl]benzimidazole-7-ca rboxylate.
US5534534 (Expiry: Jul 9, 2013): A pharmaceutical composition of Candesartan
US5721263 (Expiry: Feb 24, 2015): Covers a pharmaceutical composition, which comprises (.+-.)-1-(cyclohexyloxycarbonyloxy)ethyl 2-ethoxy-1-[[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl]-1H-benzimidazole-7 -carboxylate or a pharmaceutically acceptable salt thereof in combination with hydrochlorothiazide (or diuretic)
US5958961 (Expiry: Jun 6, 2014): Covers pharmaceutical combination
Earlier, the monotherapy of Atacand received a Para IV filing back in 2006 from generic player Sandoz. The generic player filed its Para IV against polymorph and formulation patents and Paragraph III against product patent. Importantly, innovator did not sued the generic player.

Monday, 6 October, 2008

Riluzole 50 mg tablet (Rilutek): CAFC favored innovator sanofi Aventis, generic launch after expiry of product patent

CAFC favored innovator Sanofi Aventis in a patent dispute on generic form of Riluzole by Impax. Following is the only orange book listed patent for Riluzole:
US5527814 (Expiry: Jun 18, 2013): Which covers Riluzole as product
Impax tried to prove invalidation on the grounds that ‘814 patent is anticipated and obvious in light of prior art disclosure.
Also, Impax tried to prove inequitable conduct. However, CAFC upheld District court’s decision that selection of Riluzole is not anticipated by the prior art (Aventis’s patent US5236940). Court found that ‘940 patent although discloses Riluzole as a Markush structure, but do not discloses its effectiveness in treating RLS. Furthermore, court concluded that

Friday, 3 October, 2008

Clopidogrel Besylate: German Court ruled in favor of Generic companies

The Acino Group has won favorable German court ruling in the legal proceedings regarding Clopidogrel Besylate. In a significant decision by the German High Court (Oberverwaltungsgericht) Nordrhein-Westfalen, dismissed the objections against the immediate enforcement of the drug approval for clopidogrel, developed by Acino. The initial drug approval therefore remains in effect and the generic clopidogrel Besylate by Ratiopharm and Hexal for 75 mg tablets, which were launched in July 2008, will remain in the market. The generic oproduct is 25% Cheap in comparison to innovator product Clopidogrel Bisulfate.
Also, Swiss generics maker Schweizerhall had earlier received German approval for clopidogrel Besylate (Sanofi's aproved form is Clopidogrel bisulfate in May. Sandoz (generic unit of Novartis) was set to market generic Plavix in Germany as per their agreement with Schweizerhall
Earlier, In a significant ruling favoring generic palyers in July, 2008 ,a German court has allowed generic launch of Clopidogrel besylate. the German Administrative Court in Cologne (Verwaltungsgericht Köln) had ordered the immediate execution of the product approval granted by the BfArM (Federal Institute for Drugs and Medical Devices, ). This ruling led Cimex AG, Schweizerhall and Novartis to launch this product in Germany and subsequently into the European market. Innovator Sanofi-Aventis and its U.S. partner Bristol-Myers Squibb announced that they would challenge a German court's decision to immediately authorize marketing of the generic versions of their blockbuster blood thinner Plavix (Clopidogrel). This was later challenged by innovator Sanofi-Aventis und Bristol-Myers Squibb. Afterwards, Sanofi-Aventis appealed to the German Higher Administrative Court Nordrhein-Westfalen against the ruling issued by the Administrative Courtin Cologne requesting a temporary suspension of the drug approval. However, the Higher Administrative Court Nordrhein-Westfalen dismissed this appeal on August 1, 2008. The latest decision of the Administrative Court Nordrhein-Westfalen regarding these preliminary legal proceedings can not be challenged by ordinary appeal.

Importantly, the above decision will increase chances of subsequent generic approval in other major European countries.

Clopidogrel was first disclosed in EP99802, which covers Clopidogrel racemic form generically. The said patent has expired in 2003 in most European countries. The innovator's patent EP281459, claims enatiomeric form of Clopidogrel sulfate as product and will expire on 15 Feb, 2013 (with SPC) in most European countries. The innovator has claimed various salts of Clopidogrel like hydrochloride, hrdrobromide, taurocholate and bisulfate form. generic companies designed around against the said patent by developing Besylate salt, not covered in the '459 patent.

Acino press release: Here
Earlier news of IPPharmadoc on this product Here

Wednesday, 1 October, 2008

Johnson & Johnson won $1.2 Billion as willful infringement damages

Innovator Johnson & Johnson announced that a U.S. court (U.S. District Court in Wilmington) has awarded the company $1.2 billion in an 11-year old patent battle with Medtronic Inc. and Boston Scientific Corp. over devices that prop open heart arteries after they're cleared of fat. Medtronic was ordered to pay infringement damages worth about $521 million and Boston Scientific to pay about $703 million in the dispute over the patent for the Palmaz balloon expandable stent.
The companies had been fighting over the basic technology for heart stents, tiny mesh tubes inserted in arteries. Johnson & Johnson's patents have expired and the specific stents involved in the case are no longer sold, yet the companies were still arguing over details about the patents and the question of whether a new trial on damages should be held.

Link for complete details Here

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Disclaimer: "IP Pharma Doc" blog is published for information purpose only. "IP Pharma Doc" blog contains no legal advice. I assume no legal responsibility for the views/information expressed here. “IP Pharma Doc” blog is my personal website and not edited by my employer, accordingly, no part of my blog should be attributed to my employer. All information on the present blog should be double checked for its accuracy and applicability. © Dr. Sarwal (2007)
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