Re: [PIUG List] Formulation patent

Dear Syed,

There are different factors involved to give correct answer to your
question. Based on the information provided,, it looks like your have
uses the same adjuvants and stabilizers with a combination of different
strains of the already patented bacteria.

If you review the Funk Bros.,333 U.S. at 127. case, here the inventor
had patented a product of nature because he merely aggregated several
species and their particular qualities into one product. The court
called the improvement "hardly more than an advance in the packaging of
the inoculants." (Id. at 131) The strains of bacteria accomplished
nothing as a mixture that they would not accomplish alone in nature.
They infected the same plants for the same use without any improvement
of their utility. (Id. at 131) Consequently, the mixture was not
patentable subject matter.
(http://www.law.duke.edu/journals/dltr/articles/2002dltr0027.html)

But if significant artificial changes are made (Amgen, 1991) then they
are patentable. Thus genetically engineered microorganisms, is
patentable as “manufacture” or “composition of matter” if it has =
been
altered by man (Chakrabarty).

Based on the above, in your case it seems like it is patentable as a
"manufacture" or "composition of matter" (but you have to confirm with
going through the actual elements claimed by the said patents and the
claim breath).

However, the doctrine of equivalents permits patentees to enforce their
patents against insubstantially different sequences. See, e.g.,
Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corporation and
Schering Corporation, Civ. No. 02-1026, -1027 (Fed. Cir. 2003), in which
the Court found that a claim to growing and isolating a specified
porcine virus strain was infringed by the propagation of a different
strain of the same virus. The Court was not dissuaded by evidence that
the accused strain was attenuated rather than virulent like the claimed
strain, did not react with a monoclonal antibody that recognizes the
claimed strain, grows poorly in pig lung macrophages unlike the claimed
strain, and has 73 nucleotides that are different than in the claimed
strain, because these differences are not substantial in the context of
claimed method of growing and isolating the virus.

(http://law.wustl.edu/Faculty/Documents/Kieff/HGPIP/Final/GEN_50_CH23.pdf=
)

 From an infringement point of view, it seems that your invention may
infringe upon the other patent. However, if you were to license the
rights owned by the original patent holder you may be safe. Alternately,
if you can claim a substantially different method of "manufacture" then
your idea may be patentable without potential cause for infringement.

Thanks,
Lakshmikant Goenka
& Vinod Singh
Dolcera
201 A South Delaware St. #306
San Mateo, CA 94401 USA

syed ali wrote:
> Dear Friends,
>
> My question relates to a vaccine formulation.
>
> A particular vaccine formulation is patented which comprises of four
> strains of a bacterium and different adjuvants and stabilizers. The
> question is, if one uses the same adjuvants and stabilizers but for
> different strains of the same bacterium will he be infringing the paten=
t?
>
> I asked this question to one of the IP expert and he considers it as
> infringement on the premise that the organism is same. But my argument
> is different strains behave differently even if they belong to the
> same organism. We cannot for sure say that the same composition will
> be a stable composition for these strains.
>
> Is my argument valid? What is your opinion?
> I would very much appreciate if someone can point towards any case laws=
.
>
> Thanks in anticipation
>
> Regards,
> Syed
>
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Received on Sat Mar 01 2008 - 07:05:25