PTO Denies PTE for SYMBICORT Patent; Decision Puts to Rest the Notion of PTE Availability for Synergistic Combination having Previously Approved drugs

In June, the U.S. Patent and Trademark Office (“PTO”) determined that AstraZeneca’s U.S. Patent No. 5,674,860 (“the ‘860 patent”), which covers the drug product SYMBICORT (budesonide; formoterol fumarate dihydrate) Inhalation Aerosol, is ineligible for a Patent Term Extension (“PTE”). The PTO’s decision is important in that it clarifies the Office’s position that a PTE is not available for a drug product containing two previously approved active ingredients that purportedly act synergistically to create a new product.

Under the PTE statute at 35 U.S.C. § 156, the term of a patent claiming a drug shall be extended from the original expiration date of the patent if: (1) the term of the patent has not expired; (2) the patent has not been previously extended; (3) the PTE application is submitted to the PTO by the owner of record within 60 days of New Drug Application (“NDA”) approval; (4) the product, use, or method of manufacturing claimed has been subject to a “regulatory review period” before it is commercially marketed; and (5) the NDA is the first permitted commercial use of the drug product. In this case, the PTO denied AstraZeneca’s PTE request because the SYMBICORT NDA was not the first permitted commercial use of budesonide or formoterol fumarate dihydrate, and also because the PTE application was not submitted within the 60-day statutory period. (Spoiler Alert: While this post deals solely with the first basis for the PTO’s denial, the second basis – i.e., not meeting the 60-day period criterion – is another issue simmering at the PTO that we will post on in the near future.)

The details can be read here.

The whole decision can be read here.

BIO Submits Amicus Brief in Amgen v. Hoffman-LaRoche

The Biotechnology Industry Organization (BIO) submitted an amicus brief today to the Court of Appeals for the Federal Circuit in the Amgen v. Hoffman-LaRoche case (see "Brief of Biotechnology Industry Organization as Amicus Curiae in Support of Appellee and Affirmance "). This case involves Roche's Mircera® drug product, a form of recombinant EPO that has been covalently linked to polyethylene glycol. Last October, a jury found that Mircera® infringed several Amgen patents. That verdict found that Roche's Mircera® infringed claims 3, 7, and 8 of Amgen's U.S. Patent No. 5,547,933 (claim 12 was found not to be literally infringed but infringed under the Doctrine of Equivalents); claims 1 and 2 of U.S. Patent No. 5,441,868; and claims 6 through 9 of U.S. Patent No. 5,618,698. (Amgen's infringed claims were directed to recombinant methods and recombinant EPO protein.) In addition, the jury found that Roche had not sustained its burden of establishing that any of Amgen's asserted claims were invalid.

The details can be read here.

Novartis acquires 25% stake in Alcon from Nestlé

Novartis has acquired a 25 per cent stake in Alcon Inc. as part of a definitive agreement with Nestlé S.A. reached in April 2008 that provides the right to acquire majority ownership of the world leader in eye care in two steps.

The first step was completed on July 7 when Novartis purchased the Alcon stake from Nestlé for approximately USD 10.4 billion in cash. This purchase price was approximately USD 200 million less than previously announced to account for the Alcon dividend paid in May 2008 for these shares to Nestlé rather than Novartis.

The whole story can be read here.

Fresenius Kabi to acquire APP Pharmaceuticals for US$ 3.7 billion

Fresenius Kabi, a business segment of the health care group Fresenius, has signed definitive agreements to acquire APP Pharmaceuticals, Inc., a leading manufacturer of intravenously administered generic drugs (IV generics) in North America.

According to a Fresenius Kabi press release, APP shareholders will receive a cash purchase price of US$ 23.00 per share and a registered and tradeable Contingent Value Right (CVR) that could deliver up to US$ 6.00 per share, payable in 2011, if APP exceeds a cumulative adjusted EBITDA target for 2008 to 2010.

The whole story can be read here.

Epeius Biotechnologies' Tumor-Targeted Rexin-G Receives FDA Orphan Drug Designation for The Treatment of Osteosarcoma

Epeius Biotechnologies Corporation today announced that Rexin-G has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of osteosarcoma. Based on several criteria, including the rarity, seriousness, and current lack of effective therapies for metastatic osteosarcoma, as well as the scientific and medicinal merit of Rexin-G, the granting of Orphan Drug Status by the FDA validates the unique clinical development strategy of Epeius Biotechnologies: that is, to demonstrate the profound single-agent efficacy of Rexin-G where traditional treatments have historically failed.

The details can be read here.

FDA Grants Invitrogen Premarket Approval of Breast Cancer Test

Jul 8, 2008 - Invitrogen Corporation, a provider of essential life science technologies for research, production and diagnostics, today announced it has received U.S. Food and Drug Administration (FDA) premarket approval (PMA) for its SPOT-Light(R) HER2 CISH Kit, indicated as an aid in the assessment of breast cancer patients for whom trastuzumab (Herceptin(R)) treatment is being considered. The approval marks the first PMA that Invitrogen has received from the FDA. The whole story cna be read here.

FDA Approves Eovist to Detect and Characterize Focal Liver Lesions

Bayer HealthCare Pharmaceuticals Inc., a leader in diagnostic imaging, announced today that the U.S. Food and Drug Administration (FDA) has approved Eovist(R) (Gadoxetate Disodium) Injection, a gadolinium-based contrast agent, for intravenous use in T1-weighted magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in adults with known or suspected focal liver disease. The approval makes EOVIST the first organ-specific MRI contrast agent approved in the United States in more than a decade.

The whole story can be read here.

Santarus Announces Issuance Date of Additional U.S. Patent Covering Zegerid Products

Jul 8, 2008 - Santarus, Inc. (NASDAQ:SNTS), a specialty pharmaceutical company, today announced that its licensor, the University of Missouri, has received an Issue Notification from the U.S. Patent and Trademark Office (USPTO) indicating that U.S. patent application number 10/641,732 will issue on July 15, 2008 as U.S. patent number 7,399,772. The new patent has claims covering methods for treating acid-caused gastrointestinal disorders by administering a solid pharmaceutical composition comprising non-enteric coated omeprazole and certain antacids. A Notice of Allowance was sent by the USPTO in April 2008. The new patent will have a July 2016 expiration date.

The details can be read here.

Albemarle Enters Ibuprofen Agreement with Dr. Reddy's

Specialty chemicals maker Albemarle Corporation , a leading global manufacturer of the anti-inflammatory agent ibuprofen and other active pharmaceutical ingredients (APIs), has signed a global agreement with pharmaceutical company Dr. Reddy's Laboratories Ltd. As per the agreement, effective immediately, Albemarle has appointed Dr. Reddy's as a non-exclusive distributor of Albemarle's bulk ibuprofen API. As part of the agreement, Dr. Reddy's will market, sell and distribute Albemarle's ibuprofen API to Dr. Reddy's global client base. In addition, Albemarle will also supply Dr. Reddy's a substantial quantity of its ibuprofen API requirements for use in the company's generic ibuprofen tablets.

The details can be read here.

SkyePharma's asthma drug Flutiform meets endpoint in phase III trial

SkyePharma PLC announced that its third phase III efficacy study evaluating Flutiform for the treatment of mild to moderate asthma in adolescent and adult patients has met its primary endpoints. This is the third of several clinical efficacy studies being carried out in preparation for regulatory filing and completes the original core clinical trial programme.

The details can be read here.

Archemix' ARC1779 Granted Orphan Designation in EU for the Treatment of TTP, a Life-Threatening Blood Disorder

Jul 7, 2008 - Archemix Corp., a biotechnology company focused on discovering, developing and commercializing aptamer therapeutics for rare hematological diseases, today announced that ARC1779 has received orphan drug designation from the European Commission (EC). ARC1779 also received orphan drug designation from the U.S. Food and Drug Administration (FDA) in April 2008.
An orphan designation in the European Union confers a range of benefits to sponsor companies including market exclusivity for a period of 10 years, EMEA scientific advice on protocol development, direct access to the centralized procedure for review of marketing authorizations, EMEA fee reductions and eligibility for grant support from European agencies.

The whole story can be read here.

Digestive Care, Inc. Announces the Filing of the First Module of NDA Submission for PANCRECARB (pancrelipase)

Digestive Care, Inc. (DCI) announced today that it has submitted the first module of its New Drug Application ("NDA") for PANCRECARB(R) (pancrelipase), used in the treatment of Exocrine Pancreatic Insufficiency ("EPI"), with the U.S. Food and Drug Administration ("FDA"). The FDA has granted the product Fast Track designation.

The details can be read here.

Labopharm Reacquires UK Sales And Marketing Rights to Its Once-Daily Tramadol Product

Labopharm Inc. today announced that it has reacquired the sales and marketing rights to its once-daily tramadol product (Tradorec XL(R)) for the United Kingdom from Recordati Ireland Ltd. (Recordati). To promote its product in the UK, the Company will engage a contract sales organization and pursue a new licensing and distribution agreement with an appropriate marketing partner.
The details can be read here.

Court Report

Source:http://patentdocs.typepad.com/

As reported by Sherri Oslick in their site i.e. patent docs, following are the details of new cases filed. More details can be obtained from http://patentdocs.typepad.com/

Shire LLC v. Nostrum Pharmaceuticals, Inc. et al.
3:08-cv-03309; filed July 2, 2008 in the District Court of New Jersey
View the complaint here.

E8 Pharmaceuticals LLC et al. v. Affymetrix, Inc.
1:08-cv-11132; filed July 1, 2008 in the District Court of Massachusetts
View the complaint here.

Bavarian Nordic A/S v. Oxford Biomedica PLC et al.
3:08-cv-01156; filed June 30, 2008 in the Southern District of California
View the complaint here.

AstraZeneca UK Ltd. et al. v. Dr. Reddy's Laboratories, Ltd. et al.
3:08-cv-03237; filed June 27, 2008 in the District Court of New Jersey
View the complaint here.

Novartis Corp. et al. v. Cobalt Laboratories, Inc. et al.
3:08-cv-03237; filed June 27, 2008 in the District Court of New Jersey
View the complaint here.

Wyeth v. Biovail Corp. et al.
1:08-cv-00390; filed June 26, 2008 in the District Court of Delaware
View the complaint here.

AstraZeneca bolstered by Seroquel patent victory

A court in New Jersey granted AstraZeneca's motion for summary judgment on the basis of no inequitable conduct, making unnecessary a trial that had been slated to begin on August 11.

AstraZeneca had sued both Teva Pharmaceutical Industries and Sandoz, the generics arm of Novartis , alleging their plans to launch generic versions of Seroquel infringed its patents.
Teva and Sandoz had already conceded infringement and the validity of AstraZeneca's patent, so only the issue of inequitable conduct remained to be resolved.

"We are pleased with the court's decision to uphold our valid intellectual property. Seroquel remains an important part of our company's portfolio," AstraZeneca Chief Executive David Brennan said in a statement.

The details can be read here.

The whole Judgement can be read here.