[e-drug] Generic omeprazole (7)

[Kirsten Myhr <kirsten.myhr@relis.ulleval.no>]

E-drug: Generic omeprazole (7)
------------------------------------------------------------


Below are two quotes from Scrip no 2693, 7 November and no 2696
respectively, related to AstraZeneca's patent on omeprazole, that I 
think may be of interest to E-druggers. [Copied as fair use]

The first gives the conclusion of a court case in Oslo:
'' The Oslo City Court in Norway has upheld AstraZeneca's 
formulation patent for Losec (omeprazole) in a further strengthening 
of its legal defence against generic competition.
The case was against Scand Pharm Generics, a subsidiary 
of Merck KGaA, which launched a generic version of omeprazole in 
Norway in December 1999. In May of last year, AstraZeneca was 
granted a preliminary injunction against Scand Pharm preventing it 
from selling its generic product in Norway. The latest desicion will 
keep the Scand Pharm product off the Norwegian market for the 
foreseeable future.
        Scand Pharm is considering whether to appeal against the 
decision, the company's managing director Lennart Soderman, told 
Scrip.
        While the ruling strengthens AstraZeneca's position in 
Norway it is only part of a wider legal contest involving the 
company's formulation patents and its supplementary protection 
certificates (SPCs) for Losec.
        The biggest battle is in Germany where the company has 
initiated lawsuits against a number of generic companies. It lost a 
legal challenge to its formulation patent on March 21st, 2000, and 
this has allowed the generic manufacturers to keep their products 
on the German market.
        In February last year, the focus of the legal battle shifted to 
the European Court of Justice after the German Supreme Court 
referred a number of questions to it relating to the effective date of 
AstraZeneca's SPC. The ECJ's eventual opinion will affect not only 
the suits in Germany, but also separate litigation in Norway 
involving Scand Pharm.
        Not only has Scand Pharm challenged the validity of 
AstraZeneca's formulation patent for Losec and lost, but it has also 
challenged the validity of AstraZeneca's SPC in Norway. It won the 
first action in the SPC challenge, but AstraZeneca appealed against 
the decision, and the appeals court has put a stay on the 
proceedings pending the opinion from the ECJ, Mr Soderman said.
        Meanwhile, the EC Commission is investigating whether 
AstraZeneca has violated competition rules by the manner in which 
it has sought to protect its patent rights for Losec. The probe was 
announced in May last year, but the results are not yet known.''

The second quote gives you an insight into the world of patents and 
the numerous ways of evergreening a patent:
'' The US FDA is asking generic companies to conduct 
bioequivalence studies of omeprazole administered with apple 
sauce following the approval by the FDA of AstraZeneca's new 
labelling for Prilosec (omeprazole) administered with apple sauce.
        AstraZeneca conducted new studies to support the use of the 
Product sprinkled on apple sauce in patients who have difficulty 
Swallowing capsules.

{The FDA asked for similar studies from generic companies in 1999 
when apple sauce sprinkle tests were required before obtaining 
approval for genericversions of Verelan (verapamil)}.

Typically, the submission of data from a sprinkle study would be 
classified as a major amendment, and the FDA would have up to six 
months to evaluate the data. A generic firm would most likely have 
to set aside about 12 weeks to conduct the studies.
        The requirement for sprinkle studies is another hurdle for 
generic firms with regard to generic omperazole. The companies 
are already facing formulation issues raised by AstraZeneca and the 
US chemical services company, aaiPharma. AstraZeneca has sent 
letters to the FDA outlining new information on the chemical 
complexity of omeprazole, and the aaiPharma's methods for 
controlling the ratio of the two isomers present in the product.
It claims that tight control of the ratio is necessary for stability of the
product (Scrip no 2685, p 12).
        In its letter AstraZeneca asked the FDA to ''review the 
ANDAs to satisfy itself that the manufacturing processes for 
omeprazole used in those products are appropriately controlled and 
those products consistently deliver the labelled quantity of 
omeprazole throughout their shelf lives''.  The FDA is believed to be 
reviewing stability data provided by the generics manufacturers as a 
result.
        In the meantime, generic manufacturers are preparing for the 
AstraZeneca patent litigation trial in New York City, expected to 
begin on December 5th.  The trial is consolidating cases against 
Andrx, Genpharm, Reddy-Cheminor and Schwarz Pharma.
        The US consumer advocacy group, Stop Patent Abuse Now 
(SPAN), continues to call for an investigation of the FDA's actions 
regarding Prilosec.

Concerns have also been raised that the FDA's investigation 
potentially gives AstraZeneca extra time to have some sort of late-
listed patent put in the Orange Book.''

[I am confident that lawyers will not be unemployed in the 
foreseeable future!!  I would not be surprised if the next step would be to
patent the apple sauce. What next? Mango juice? - KM]

Kirsten

Kirsten Myhr, MScPharm, MPH
Head, Eastern Region Drug Information Centre

RELIS Ost
Ulleval University Hospital
N-0407 OSLO
Tel: +47 23 01 64 11  Fax: +47 23 01 64 10
kirsten.myhr@relis.ulleval.no (w)
myhr@online.no (h)
www.relis.no

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