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17 Dec, 2008 10:19 pm
... a prima facie case of invalidity that it must be described as 'baseless.'" Ouch! The court also analyzed what it saw as Alphapharm's
litigation misconduct and found that this was "the exceptional case where an examination of the totality of the circumstances amply justifies, ... 's numerous allegations of litigation
misconduct committed by Mylan in its pursuit of an inequitable conduct claim. Alphapharm argued that its Paragraph IV letter was not baseless
under structural obviousness law. Alphapharm ...
11 Dec, 2008 8:03 am
... be known when the certification of invalidity is made, we do not believe that the district court faulted Alphapharm simply for changing its
obviousness argument at trial from the theory advanced in the Paragraph IV letter. Rather, the court ... lead compound; Takeda's expert emphatically disagreed with the assertion that
benzene and pyridine rings are bioisosteres; and Alphapharm's expert testified that the properties of compound 14 taught nothing with respect
to pyridines. We find it unsurprising ...
28 Jun, 2007 9:19 pm
... Actos, Takeda's blockbuster drug for the treatment of diabetes. The decision is particularly important because the generic challenger, Alphapharm, had argued on appeal that the Supreme Court's recent decision in KSR v. Teleflex, as well ... use as a lead compound. The Federal Circuit agreed
with this finding, stating that it alone was a sufficient basis for concluding that Alphapharm had failed to establish a prima facie case of
obviousness. The Federal Circuit squarely addressed whether KSR affects ...
4 Jul, 2007 6:18 pm
By Donald Zuhn -- Last Thursday, the Federal Circuit upheld a judgment from a District Court that Defendant-Appellant Alphapharm Pty., Inc. had
failed to prove invalidity and unenforceability of claims 1, 2, and 5 of U.S. Patent No. 4,687,777 (the '777 patent). Specifically, the Federal Circuit held that the District...
3 Jul, 2007 10:47 am
... ethyl compound because the ethyl substituent is attached to the 5-position on the pyridyl ring. That portion of the compound is depicted as: Alphapharm, a generic drug manufacturer, filed an Abbreviated New Drug Application (ANDA) pursuant to the Hatch- ... misapplied the law, particularly the law
governing obviousness in the context of structurally similar chemical compounds. According to Alphapharm, compound b was the most effective
antidiabetic compound in the prior art, and thus the court erred ...
10 Dec, 2008 5:18 am
... of arguments,' that supported the finding that the certification was baseless." The court concluded that "the district court correctly found that Alphapharm's filing would amount to litigation misconduct supporting an exceptional case finding if it were ' ... paragraph IV ANDA filings. The court stated,
"It is clear from the district court's opinion that it was not faulting Alphapharm or Mylan for the act of filing an ANDA that challenged the
pioglitazone patent, nor did it limit the filers to the ...
11 May, 2008 9:12 pm
... the Hatch-Waxman Act. Moreover, according to the court, they "each engaged in other litigation misconduct," including (by Alphapharm),
"constantly shifting its theory of obviousness," in bad faith; attempting at trial to insert "entirely frivolous" arguments of inequitable ... and (by Mylan), acting "without a
reasonable basis and in bad faith in pursuit of its inequitable conduct claim." Alphapharm and Mylan appealed both decisions to the Federal
Circuit. In June of last year, the Federal Circuit ...
1 Jul, 2007 11:53 pm
... that an invention may be deemed obvious if it was "obvious to try." The evidence showed that it was not obvious to try. Similarly, Alphapharm's reliance on Pfizer fares no better. In Pfizer, we held that certain claims covering the besylate salt of ... that the court failed to correctly
apply the law relating to prima facie obviousness of chemical compounds. Because Alphapharm's obviousness argument rested entirely on the court
making a preliminary finding that the prior art would have led to the ...
23 May, 2007 11:45 pm
... 7(3) and the use which can be made of 'admissions' in a specification. There are also some clarifications of aspects of the Alphapharm
decision and some important observations on the nature of invention. Now, those of us who have been following this gripping ... mounted or mortice mounted; claim 13, however, related
only to rim mounted locks. The problem for Doric (in shades of Alphapharm's downfall) was that it never occurred to any of the witnesses,
including one of Doric's own experts who was an ...
2 Jul, 2007 9:18 pm
... v. Alphapharm (Fed. Cir. 2007). Alphapharm filed an ANDA with the FDA - hoping to begin making
generic version of Takeda's patented diabetes treatment ACTOS. ($1.7 b annual sales). The district court found the invention nonobvious, but Alphapharm asked the CAFC to review the case under the new standards of KSR v. Teleflex. On appeal, the CAFC affirmed. Graham Primary Law: In the 1966 case of
Graham v. John Deere, the Supreme Court set forth the primary methodology for determining obviousness. ...
9 Dec, 2008 5:32 pm
... , which had sued two generic drug companies -- Mylan Laboratories and Alphapharm Pty. Ltd. -- for patent infringement. The generic drug
companies had sought approval to ... for their certification filings and had engaged in litigation misconduct. The court ordered Alphapharm to
pay $5.4 million and Mylan to pay $11.4 million. In ... of attorney fees and related expenses." Takeda Industries v. Mylan and Alphapharm, nos.
2007-1269, 1270. The panel also found "unpersuasive" an argument by both companies ...
16 Jun 9:31 am
... the foregone appeal, Daiichi cannot now recover more than its total entitlement by obtaining those same costs again from Mylan. Thus, Daiichi cannot have its cake and eat it, too.
Related posts: What's the Cost of Misconduct in a Patent Lawsuit? $16.8M for Alphapharm and Mylan. In Takeda Congressional Budget Office:
Patent Reform Act Will Cost $3 million According What's Two Extra Weeks Of Exclusivity for Evista® Worth? A Lot. The U.S. C Related posts brought to you by Yet Another Related Posts ...
9 Jul, 2007 3:49 am
... prima facie basis for a rejection due to lack of written description Takeda Chemical Industries, LTD., et al. v. Alphapharm PTY., LTD., et
al. (06/28/2007): appeal of decision that patent-in-suit was not invalid for obviousness ... creates a prima facie case of obviousness"; detailed application of KSR; conclusion that the
district court did not err in holding that Alphapharm failed to establish a prima facie case of obviousness; "one who claims a compound, per
se, which is structurally similar to a ...
28 Sep, 2007 8:51 am
... the FDA Amendments Act of 2007 into law Thursday (AP story). FDA put out this press release. PhRMA released this statement. Also Thursday, the Federal Circuit denied Alphapharm's petition for rehearing en banc of Takeda v. Alphapharm, in which the court previously upheld Takeda's
patent on Actos. No opinion was issued with Thursday's decision. The Federal Trade Commission announced in a press release Thursday that it is challenging Mylan's proposed ...
1 Oct, 2007 8:51 am
... Act of 2007 into law last Thursday (AP story). FDA put out this press release. PhRMA released this statement. Also Thursday, the Federal Circuit denied Alphapharm's petition for rehearing en banc of Takeda v. Alphapharm, in which the court previously upheld Takeda's
patent on Actos. No opinion was issued. The Federal Trade Commission announced in a press release Thursday that it is challenging Mylan's proposed acquisition of E. Merck oHG, which is
...
2 May, 2008 7:00 am
... Biotech - Products Kytril (Granisetron) - Exclusivity 'parking' still possible under Teva ruling: (IP Law360), Lantus (Insulin glargine) - Aventis launches insulin drug Lantus in
India: (Spicy IP), Lexapro (Escitalopram) - Australia: The patentability of enantiomers: Alphapharm Pty Ltd v H Lundbeck A/S: (IPRoo), (IP Down
Under), Lipitor (Atorvastatin) - USPTO to confirm patentability of Lipitor basic patent: (SmartBrief), (IP Law360), (GenericsWeb), (TherapeuticsDaily), Lipitor (Atorvastatin) - ...
17 Dec, 2008 5:54 am
... to U.S. Patent No. 4,687,777. The challenges to the '777 patent had been initiated by Defendants-Appellants Mylan Laboratories, Inc., Mylan Pharmaceuticals, Inc., and UDL
Laboratories, Inc. (Mylan) on the one hand, and Defendants-Appellants Alphapharm Pty., Inc. and Genpharm, Inc. (Alphapharm) on the other. Seeking approval to market a generic version of the antidiabetic agent,
5-{4-[2-(5-ethyl-2-pyridyl)ethoxy]benzyl}-2,4-thiazolidinedione, commonly referred to as pioglitazone, both...
19 Dec, 2008 1:00 pm
... medicine: A Patent Office perspective (Patent Docs) US: Science article 'Trends in Human Gene Patent Litigation' should help allay gene patenting fears (Patent Docs) Products Actos
(Pioglitazone) - US: What's the cost of misconduct in a patent lawsuit? $16.8 million for Alphapharm and Mylan: Takeda v Mylan (Patent
Baristas) (Patent Docs) Boniva (Ibandronic acid) - US: Apotex challenges validity of Hoffmann-La Roche's Boniva patent (Law360) Boniva (Ibandronic acid) - US: Orchid Chemicals & ...
5 Jan 8:09 am
... ) is special because it combines two types of migraine treatments into one pill: naproxen sodium (Aleve) and sumatriptan (Imitrex). Alphapharm (Mylan) filed an abbreviated new drug application (ANDA) to begin marketing a generic version of the drug - arguing that the patent is invalid. On
January 2, Pozen sued Alphapharm for infringement in the Eastern District of Texas. Claim 1 of the asserted patent reads as follows: 1. In a
method for treating a migraine ...
17 Jun 3:02 am
... - Australia: Full Federal Court confirms enantiomers patentable for 20 year term: H Lundbeck A/S & Anor v Alphapharm Pty Ltd (Mallesons
Stephen Jaques) Levaquin (Levoflaxacin) - US: CAFC: $1,000,000 in translation costs awarded to prevailing ... - Australia: Full Federal Court confirms enantiomers patentable for 20 year
term: H Lundbeck A/S & Anor v Alphapharm Pty Ltd (Mallesons Stephen Jaques) Mucinex (Guaifenesin) - US: Reckitt Benckiser files patent
infringement suit against Watson Lab's ...
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