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Author Topic: Infringement of product claim when chemical substance present in small quantity  (Read 1515 times)

tati

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Suppose there is a claim to chemical compound X, granted. And then you have a chemical substance which is pure at 99.5% and let's say that 0.3% of it is compound X (as an impurity). My intuition tells me that there should be no infringement, but is there any relevant case law (either US or Europe)?
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lazyexaminer

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I don't know the answer to your question and chemical things are sometimes unusual.

But generally, that which anticipates if prior infringes if later.

So turn this around. Do you think you should be able to get a patent to X if the prior art has X, even in small quantities?
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still_learnin

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I don't know the answer and I don't even practice in the chemical arts.  But I know enough to say it: depends on what you mean by "substance" and "compound," and on EXACTLY what the claim says.

Hope a chemical guy will jump in here.
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tati

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Thank you both for your replies.

Claims to chemical substances are very simple, claiming "a compound of formula X (formula X drawn in the claim)" and where necessary, explaining the variables of the formula, if any.

The thing is, you can rarely produce a chemical compound with 100% purity, mostly you get around 99.0-99.9, so the rest of it is some impurities leftover from the manufacturing process at percentages like 0.1 or 0.2. So if a chemical compound Z I am selling contains compound X (protected by patent) at an amount like 0.1% does this constitute infringement?

My intuition tells me no, because it is not reasonable to claim economic damage from a product (chemical compound Z) which is sold as such and happens to contain a small (yet detectable) amount of compound X. Moreover, compound Z with as little as 0.1% of X is a totally different product than compound X itself.

It is an issue which should have appeared in all major jurisdictions, but so far I have only found relevant case law in Japan (the short answer is, no, there is no infringement).

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Rabid Levity

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I also do not know of any case law to support your position, but it seems it must have come up before.  But I also agree with your main point - that a patent to compound X should be unlikely to be considered infringed by a substance containing a de minimis fractional amount of X.

Does the specification of the patent claiming X say nothing that implies a certain purity level as to the compound X itself? 

Finally, to the point mentioned by lazyexaminer - was the 99.5% pure compound Z (having 0.3 wt% X as an impurity) available in anticipatory fashion before the filling of the patent to compound X? 

Or were other compounds available having low wt% X impurities?  If so, these should either force the current patent claim to be interpreted as requiring pure X, or certainly more pure than presence at the fractional impurity levels you mention, or outright invalidate the claim.
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MYK

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I also do not know of any case law to support your position, but it seems it must have come up before.  But I also agree with your main point - that a patent to compound X should be unlikely to be considered infringed by a substance containing a de minimis fractional amount of X.
I think intent might come into play.  If Bill decides to sell five pound bags of sodium chloride with 5% Laetril as an impurity, are cancer patients really buying it for the salt or for the (fake) chemotherapy drug?
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"The life of a patent solicitor has always been a hard one."  Judge Giles Rich, Application of Ruschig, 379 F.2d 990.

Disclaimer: not only am I not a lawyer, I'm not your lawyer.  Therefore, this does not constitute legal advice.

tati

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Yes, compound Z was available before compound X. Regarding the impurities level, this is not clear from the patent specifications. But in my view, it shouldn't matter, if you prepare compound Z from a series of reactions, which start from X, you might end up with something like 0.01% at the end, depending on how many reactions are interposed between X and Z. So the presence of impurities is anticipated by the sequence of reactions.

MYK you make an important comment about intention. But your example is an extraordinary case, as I suppose you intented it to be. My example is from real life, where you manufacture a chemical compound and traces of the materials which participated in the synthesis can be found at the end product. It is always an objective to prepare products with high chemical purity, so individual impurities rarely go above 0.3-0.5%.

I found relevant case law in Japan (with help...) which boils down to this "a product cannot be construed as being within the scope of a patent if the product does not have a working effect described in the specification of the patent even if the product includes all elements recited in a claim of the patent" (Aerosol Drug Case).

That should be a general understanding in other jurisdictions as well.
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bartmans

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I know there was a case in The Netherlands where it was decided that the production of the infringing product as a byproduct was deemed to be infringement (and this was also a small amount, but I don't recall the percentage). The rationale was that it would be possible to remove it from the final product and although this would have made the endproduct more expensive, the infringer is expected have the duty to try everything in order not to infringe.

I tried to find th caese, but I was not successful, I will see if I can find it in the next days.
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tati

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Bartmans, thanks for the input. Netherlands and Germany have chemical plants, there should be something in those jurisdictions. I think I will try a search with german words...

Thank you all for your replies, if I find something relevant I will post it here, for the joy of sharing knowledge!
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lazyexaminer

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SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331 (Fed. Cir. 2005) appears to be relevant.

https://scholar.google.com/scholar_case?case=13789757509405064219&q

I'll make clear that I'm not a chemical person and may not understand the science here, but this case says to me that if the claim is not limited to any particular amount, then even trace amounts can anticipate/infringe.
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Tobmapsatonmi

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SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331 (Fed. Cir. 2005) appears to be relevant.

https://scholar.google.com/scholar_case?case=13789757509405064219&q

I'll make clear that I'm not a chemical person and may not understand the science here, but this case says to me that if the claim is not limited to any particular amount, then even trace amounts can anticipate/infringe.


That's a good find.  But I do also think it'd be pretty narrowly construed on its facts.

There, you have a certain drug (paroxetine - Paxil) that is off patent and an improved version of the same Paxil (more stable).  So because the accused product had majority old Paxil but also minority improved Paxil, it infringed.  As somewhat of an aside, the defendant was also making use of the newly patented Paxil crystals in manufacturing process for the old Paxil.  The plaintiff also walked themselves into invalidity (inherently disclosed in prior processes, and 101/breadth) with their "even a single crystal" of new Paxil infringes.

I wonder if in OP's case, the patentee trying to argue "a single smidgen" of X in OP's Z would similarly walk himself into the same inherent anticipation, as others here have suggested, as well as RR's 101/breadth invalidity problem.

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tati

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Thanks lazyexaminer. The case you are citing is a famous one among chemists, as a perfect example of "evergreening patents". Many pharmaceutical companies try to prolong the life of a drug, by patenting several physical forms (crystalline forms) of a drug. Those patents come after the patent which claims the drug as a compound, so in some cases the patent proprietor achieves some more months or even years of protection. But all in all, it is the same chemical formula, the only thing that changes is the positions of the atoms within the crystal lattice.

The "even a single crystal" phrase, which Tobmapsatonmi correctly underlines as a decisive point, is an obsolete characteristic nowadays, because there are concrete guidelines about those issues and analytical methods for precise measuring. This kind of wording was trying to frame any potential infringer, because the case is about two different crystalline forms of the same chemical compound, so it may well be that both of them appear within a single manufacturing step (and you can't purify crustals).

The situation I am describing is different, because compound X (even a single smidgen of it) might be present in Z only because it is a leftover from previous manufacturing steps. And since X is a different compound, it will have different properties than compound Z. In the paroxetine case, the two crystals may differn in solubility or storage stability, but once in the human body, they will exhibit the same function.

Apologies if all that is too technical, I am delighted, though, to hear your opinions, as they are more objective than a chemist's  ;)

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tati

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If anyone now, or in the future, is interested in the above question, there is a great article at AIPLA 2004, vol.32, No.3, p.425, by Todd R. Miller "Patented compounds inherently coproduced as trace impurities: Issues of inherent anticipation and literal infringement"

This article discusses many cases relevant to the initial question and analyzes key aspects, de minimis infringement, inherent anticipation, invariability and recognition requirements, reverse infringement test.

Looks like there is no statutory framework in the US, but the courts are somewhat limiting the scope of the claim interpretation to avoid finding the accused infringer liable. That of course, on a case by case basis and depending on the facts of each case.
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