Bayer Schering v. Barr Labs, No. 2008-1282 (Fed. Cir. 2009)

Aventis Pharma v. Amphastar and Teva, S. Ct. Appeal No. 08-937 (2009)

The Supreme Court on Monday denied Aventis Pharma's (SNY) cert petition in a long-running dispute with generic biopharmaceutical manufacturer Amphastar. In its petition, Aventis had asked the Court to review a Federal Circuit decision affirming the unenforceability of its patent on Lovenox. In particular, Aventis asked the Court to overturn the Federal Circuit's "sliding scale" doctrine-–the doctrine that treats the two prongs of the inequitable conduct inquiry (materiality and intent) as inversely related to each other. The doctrine allows a court to infer that a patentee has acted with deceptive intent if the defendant can show that the alleged misconduct is highly material.

Eli Lilly & Co. (LLY) v. Teva Pharms. (TEVA) USA, Inc., No. 2009–1071 (Fed. Cir. 2009)

Under the Hatch-Waxman Act, final FDA approval of an ANDA is automatically stayed for thirty months when a patent owner files suit for patent infringement within 45 days of receiving a Paragraph IV notice letter. The purpose of the stay is to allow the parties to litigate the patent infringement claims while the ANDA filer pursues FDA approval of its generic drug. Pursuant to 21 U.S.C. § 355(j)(5)(B)(iii), a district court may shorten or lengthen the thirty–month stay if "either party to the action failed to reasonably cooperate in expediting the action."

Takeda v. Mylan and Alphapharm, Nos. 2007-1269, -1270 (Fed. Cir. 2008)

In an opinion released Monday, the Federal Circuit affirmed a district court decision granting $16.8 million for attorney fees, expenses and expert fees to Takeda (TKPHF.PK) for baseless paragraph IV certification letters and litigation misconduct by Mylan (MYL) and Alphapharm in ANDA litigation involving Actos (pioglitazone). We previously reported on the district court decision here; and on the Federal Circuit briefing here.

Merck & Co. v. Apotex, No. 2008-1133 (Fed. Cir. 2008)

In 2005, Hi-Tech Pharmacal (HITK) became the first company to file a paragraph IV certification relating to Merck's (MRK) glaucoma drugs Trusopt and Cosopt. Hi-Tech filed paragraph IV certifications with respect to all three of the Orange Book-listed patents for these drugs: U.S. Patent Nos. 4,797,413; 6,248,735; and 6,316,443.

Prasco v. Medicis Pharm. Corp., No. 2007-1524 (Fed. Cir. 2008)

Medicis markets a benzoyl peroxide cleansing product, Triaz.  Prasco sells a competing benzoyl peroxide cleansing product, Oscion.  Prasco filed a declaratory judgment complaint, requesting judgment that Oscion does not infringe four patents owned or licensed by Medicis (MRX).  Prasco alleged declaratory judgment jurisdiction based on three facts: 

Celgene and Novartis v. KV Pharm., No. 07-4819 (D.N.J. 2008)

KV Pharmaceutical (KVA) filed an ANDA for a generic version of Ritalin LA (methylphenidate HCl extended-release capsules) with paragraph IV certifications to Celgene's (CELG) U.S. Patent Nos. 5,837,284 and 6,635,284.  Apparently KV made an offer of confidential access to its ANDA, but Celgene and Novartis (NVS) (which markets Ritalin LA) declined it.  Last October, within 45 days of receiving notice of KV's paragraph IV certifications, Celgene and Novartis sued KV for infringing the two patents.

Eisai v. Dr. Reddy's and Teva, Nos. 2007-1397, -1398 (Fed. Cir. 2008)

Patents on chemical compounds are holding up well to obviousness arguments in the Federal Circuit, even after KSR. In an opinion released Monday, the Federal Circuit affirmed the nonobviousness of rabeprazole, the active ingredient in Aciphex.  This follows adecision last year affirming the nonobviousness of pioglitazone, the active ingredient in Actos.

AstraZeneca v. Teva Pharms. USA and Sandoz, No. 05-5333 (D.N.J. 2008)

On July 1, the U.S. District Court for the District of New Jersey granted AstraZeneca's (AZN) motion for summary judgment that its patent on quetiapine fumarate, the active ingredient in Seroquel, is not unenforceable for inequitable conduct.  The decision disposed of the last remaining issue in the case, as Teva (TEVA)  and Sandoz, which are challenging the patent, had already conceded infringement and validity.

Roche Palo Alto and Allergan v. Apotex, No. 2008-1021 (Fed. Cir. 2008)

In an opinion released Wednesday (pdf file), the Federal Circuit affirmed a district court decision granting summary judgment that Roche's (RHHBY.PK) U.S. Patent No. 5,110,493 is valid and infringed by Apotex's ANDA for a generic version of Acular LS (ketorolac tromethamine opthalmic solution).  Acular LS, marketed by Allergan (AGN), is indicated to reduce pain, burning and stinging following corneal refractive surgery.

A week ago, following a bench trial held in March, the U.S. District Court for the District of Delaware held that Boehringer Ingelheim's patent on Mirapex (pramipexole dihydrochloride) is invalid for obviousness-type double patenting.  Mirapex, indicated for the treatment of Parkinson's disease and Restless Leg Syndrome, has annual U.S. sales of approximately $380 million.

Barr Labs (BRL) filed its ANDA for a generic version of Mirapex in 2005 with paragraph IV certifications to Boehringer's U.S. Patent Nos. 4,843,086 and 4,886,812.  Mylan (MYL) filed its ANDA, with paragraph IV certifications to the same patents, shortly thereafter.  Barr's approval letter confirms that Barr was the first to file, and therefore is entitled to 180-day exclusivity.

Last month, we reported that King Pharmaceuticals (KG) had filed a citizen petition that could delay final approval of numerous ANDAs for generic versions of Altace (ramipril), which were set to earn final approval on June 7.  King's citizen petition asked FDA to require ANDA applicants for ramipril to file patent certifications with respect to newly-issued U.S. Patent No. 7,368,469, a method-of-use patent.

Yesterday, the Court of Appeals for the Federal Circuit affirmed a June 2007 district court decision finding that Mylan's (MYL) generic version of Prilosec (omeprazole) does not infringe two AstraZeneca patents (AZN), U.S. Patent Nos. 4,786,505 and 4,853,230.

Omeprazole is difficult to formulate because it is acid-labile.  Astra scientists developed a formulation that protects omeprazole from degradation in the acidic environment of the stomach.  Astra's formulation, which is claimed in the '505 and '230 patents, includes a core containing omeprazole and an alkaline reacting compound ["ARC"], a water soluble subcoat, and an outer enteric coating.

In November 2001, Apotex became the first company to file an ANDA for a generic version of Plavix (clopidogrel bisulfate) with a paragraph IV certification. In March 2002, Sanofi-Synthelabo and Bristol-Myers Squibb (BMY) sued Apotex for infringing the Orange Book-listed patent, U.S. Patent No. 4,847,265, thereby initiating an automatic 30-month stay of FDA approval of Apotex's ANDA.

With the patent litigation still pending, the stay expired in May 2005. In January 2006, FDA granted final approval to Apotex's ANDA. The litigation was proceeding toward trial when, on August 8, 2006, Apotex launched its generic clopidogrel bisulfate product at risk, starting its 180-day exclusivity period. 23 days later, the U.S. District Court for the Southern District of New York preliminarily enjoined (pdf file) Apotex from continuing to sell its generic version of Plavix. Thus, Apotex was enjoined, but its exclusivity continued to run.

On April 16, the U.S. District Court for the Northern District of California dismissed a declaratory judgment complaint filed by Impax against Medicis, ruling that the court lacks jurisdiction because there is no case or controversy between the parties. The decision (pdf file) is interesting because it follows two recent decisions in ANDA cases where the Federal Circuit expanded declaratory judgment jurisdiction: Teva (TEVA) v. Novartis (NVS) and Caraco (CPD) v. Forest (FRX). The district court, however, distinguished this case by finding that Impax had not alleged a cognizable injury-in-fact.

Medicis manufactures and sells Solodyn, a minocycline extended-release tablet used as an oral acne medication. Medicis owns U.S. Patent No. 5,908,838, which claims methods of treating acne by administering minocycline. However, because minocycline is an "old antibiotic," Medicis was not required (or allowed) to submit any patents on Solodyn to the FDA for listing in the Orange Book.

Following a week-long bench trial held last year, the U.S. District Court for the District of Delaware released an opinion (pdf file) on March 31 stating that Takeda's (TKPHF.PK) patents on Prevacid (lansoprazole) are valid and that Teva's (TEVA) ANDA for a generic version of Prevacid capsules infringes one of the patents. Prevacid, a treatment for acid reflux, heartburn and stomach ulcers, had $3.4 billion in U.S. sales last year.

Takeda asserted U.S. Patent Nos. 4,628,098, covering the lansoprazole compound, and 5,045,321, covering a pharmaceutical composition of lansoprazole, against Teva. Teva conceded that its generic drug product infringes the '098 patent, though it contested infringement of the '321 patent. Moreover, Teva argued that the '098 and '321 patents are invalid for obviousness and unenforceable due to inequitable conduct.

U.S. Patent No. 4,513,006 is listed in the Orange Book as protecting Topamax (topiramate), Ortho-McNeil's (JNJ) blockbuster anticonvulsant for the treatment of migraines and epilepsy. Mylan (MYL) and Cobalt seek to market generic versions of Topamax before the '006 patent expires in September. Last year, a district court construed the claims of the '006 patent and, on summary judgment, rejected Mylan's inequitable conduct, obviousness, and non-enablement arguments. On Monday, the Federal Circuit affirmed (pdf file) those decisions.

Claim 1 of the '066 patent is drafted in a form typical of chemical compound claims. Specifically, it is directed to a

sulfamate of formula (I) . . . wherein . . . R2, R3, R4 and R5 are independently hydrogen or lower alkyl and R2 and R3 and/or R4 and R5 together may be a group of formula (II)...

and appears in conjunction with the adverbs independently and together . . . [signaling] that and links alternatives that occur under the different conditions of independence or togetherness.