Typical patent claims are to products or processes but not both. But product-by-process claims exist and have existed for decades. Plainly, the typical product-by-process claim is designed to claim a product when made by a particular process. It is a hybrid type of claim. But questions arise of how product-by-process claims are interpreted when considering three stages in the patent life: patent prosecution; patent litigation for infringement; and patent litigation for invalidity. Are product-by-process claims really just to the final end-product, no matter how that product is made, or do the actual process steps matter? The following are examples of claims that are or were construed as product-by-process claims:
A pharmaceutical composition comprising a therapeutically effective amount of human erythropoietin and a pharmaceutically acceptable diluent, adjuvant or carrier, wherein said erythropoietin is purified from mammalian cells grown in culture. [US Patent No.: 5,955,422, claim 1]
An oral dosage form comprising … oxycodone hydrochloride active pharmaceutical ingredient having less than 25 ppm 14–hydroxy[ ], wherein at least a portion of the 14–hydroxy [ ] is derived from 8 a[ ] during conversion of oxycodone free base to oxycodone hydrochloride[.] [US Patent No.: 7,674,799, claim 1]
A method for immunomodulation or treating a viral conditions, a viral disease, cancers or tumors comprising the step of administering to a patient in need of such treatment a therapeutically effective amount of a composition comprising: (i) a recombinant polypeptide produced by a non-human host transformed by a recombinant DNA molecule comprising a DNA sequence selected from the group consisting of: (a) DNA sequences which are capable of hybridizing to any of the DNA inserts of […], and (b) DNA sequences which are degenerate as a result of the genetic code to the DNA sequences defined in (a); (ii) said DNA sequence being operatively linked to an expression control sequence in the recombinant DNA molecule.[ US Patent No.: 7,588,755, claim 1]
The above claims demonstrate the product-by-process feature because of the “is purified from” or the “is derived from” language. The ‘755 patent claim shows the product-by-process portion embedded within a method of treatment claim and is in the “produced by a non-human host” portion.
A. Product-by-process Claims During Patent Application Phase
During the patent application process, the proposed claim is compared against the prior art. The Patent Office’s Manual of Patent Examining Procedure (MPEP) section 2113 discusses the PTO’s viewpoint. Per the MPEP, product-by-process claims are limited to the final end-product claimed, and that the process steps don’t matter. That is, the patentability of the product does not depend on the process claimed. This means so long as the claimed product is the same as (e.g., anticipated) or only an obvious variant of a prior art product, then the claimed product is not patentable. The MPEP view is also supported by case law. See, e.g., In re Thorpe, 777 F.2d 695, 697-98 (Fed. Cir. 1985)(“For this reason, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself.”).
Now because the applicant probably believes that the process is important, the applicant may attempt to characterize the end-product by showing the end-product is, in fact, patentably distinct from the prior art product. And indeed there may be differences that can be elucidated through sophisticated testing and examination. Those differences could become the basis of patentability by being expressly claimed as a claim limitation. For example, suppose the new process results in a denser end-product that is not readily apparent. The Patent Examiner would reject the end-product based on the prior art. But the new testing could show that the density is greater via the new process than the prior art. Therefore, the new patent claim could be amended to now include a density limitation. It would not be enough to argue that the products have different densities because there is no claim limitation to that effect.
B. Product-by-process Claims During Invalidity Phase
Invalidity is the inverse of the patent application phase. To this end, product-by-process claims are interpreted in the same way as the patent application phase. During the invalidity analysis, the focus is still on the end-product, not the process steps in the claim. See, Amgen Inc. v. F. Hoffman-La Roche Ltd, 580 F.3d 1340, 1369-70 (Fed. Cir. 2009)(“In determining validity of a product-by-process claim, the focus is on the product and not on the process of making it.”).
C. Product-by-process Claims During Infringement Phase
This article would be boring if the interpretation of product-by-process claims during infringement followed the patent prosecution and invalidity theories. To this end, during the infringement analysis, the process steps matter. The process steps claimed, therefore, limits infringement. There was some controversy about whether process steps mattered during infringement, with various parties and courts pointing to different case law. The Federal Circuit clarified by holding en banc that the process steps matter. See, Abbott Laboratories v. Sandoz, Inc., 566 F.3d 1282, 1293 (Fed. Cir. 2009)(en banc in relevant part)(“Thus, based on Supreme Court precedent and the treatment of product-by-process claims throughout the years by the PTO and other binding court decisions, this court now restates that “process terms in product-by-process claims serve as limitations in determining infringement.””).
This makes sense. The scope of product-by-process claims in infringement is narrower than typical product claim infringement because the process steps must necessarily result in the end-product. If the process steps are different from the claimed invention and the accused product/processes, then necessarily the end-products are different. And if the end-products are different there is no infringement. The courts also apply a simple logic:
Assume a hypothetical chemical compound defined by process terms. The inventor declines to state any structures or characteristics of this compound. The inventor of this compound obtains a product-by-process claim: “Compound X, obtained by process Y.” Enforcing this claim without reference to its defining terms would mean that an alleged infringer who produces compound X by process Z is still liable for infringement. But how would the courts ascertain that the alleged infringer’s compound is really the same as the patented compound? After all, the patent holder has just informed the public and claimed the new product solely in terms of a single process. Furthermore, what analytical tools can confirm that the alleged infringer’s compound is in fact infringing, other than a comparison of the claimed and accused infringing processes? If the basis of infringement is not the similarity of process, it can only be similarity of structure or characteristics, which the inventor has not disclosed. Why also would the courts deny others the right to freely practice process Z that may produce a better product in a better way?
In sum, it is both unnecessary and logically unsound to create a rule that the process limitations of a product-by-process claim should not be enforced in some exceptional instance when the structure of the claimed product is unknown and the product can be defined only by reference to a process by which it can be made. See, Abbott Laboratories v. Sandoz, Inc., 566 F.3d 1282, 1294 (Fed. Cir. 2009)(en banc in relevant part).
D. Product-by-process Claims Within a Method Claim
In Biogen v. EMD Serono (976 F.3d 1326, 1334 (2020)), the Court explained how to handle an embedded product-by-process limitation within on overall method of treatment claim. The claim was:
A method for immunomodulation or treating a viral conditions, a viral disease, cancers or tumors comprising the step of administering to a patient in need of such treatment a therapeutically effective amount of a composition comprising: (i) a recombinant polypeptide produced by a non-human host transformed by a recombinant DNA molecule comprising a DNA sequence selected from the group consisting of: (a) DNA sequences which are capable of hybridizing to any of the DNA inserts of […], and (b) DNA sequences which are degenerate as a result of the genetic code to the DNA sequences defined in (a); (ii) said DNA sequence being operatively linked to an expression control sequence in the recombinant DNA molecule.[ US Patent No.: 7,588,755, claim 1]
The italicized portion is the product-by-process claim element because the polypeptide is produced by a non-human host. Biogen argued that the “produced by” limitation didn’t matter because the claim as a whole is to an overall method of treatment through individualized method steps. The Court, however, stated that the product-by-process steps mattered because that portion of the claim limitation was part of the claim limitation step. The Court fully explained that:
We are also unpersuaded by the district court’s and Biogen’s reasoning that a product-by-process-type analysis is inappropriate here because the composition was otherwise capable of definition other than by the process. That argument is precluded by Amgen, where the product was also well-defined in the claims: “human erythropoietin … wherein said erythropoietin is purified from mammalian cells grown in culture.” 580 F.3d at 1364. Furthermore, as noted supra, the rule in Amgen is a necessary outgrowth of the black-letter legal principle that an old product made by a new process is not novel and cannot be patented. Logic compels extending that rule to the present case; an old method of administration of an old product made by a new process is not novel and cannot be patented.
Biogen is certainly correct that the scope of composition and method of treatment claims is generally subject to distinctly different analyses. But where, as here, the novelty of the method of administration rests wholly on the novelty of the composition administered, which in turn rests on the novelty of the source limitation, the Amgen analysis will necessarily result in the same conclusion on anticipation for both forms of claims.
Logic compels extending that rule to the present case; an old method of administration of an old product made by a new process is not novel and cannot be patented. Biogen MA Inc., 976 F.3d at 1334.
Practical Considerations
For patent drafters, it is important to know the distinctions between patentability, infringement, and invalidity. When process claims are truly novel, then such process claims should be presented separately. If it’s suspected that the process results in a different product, whose features may be unknown, the applicant may be advised to conduct some testing on the product to determine certain features that are now present but were not in the prior art product. And if the end-product has newly discovered features, the drafter can file for product claims also. For example, if the process is truly novel and the end-product has truly novel features, then the applicant could apply for the 3 different types of claims: pure product; pure process; and product-by-process claims. For patent drafters, it is also important to know when patent claim language may be construed as a process limitation to maximize enforceability.
During any infringement and invalidity analysis, knowing the different interpretations are mandatory. In conducting prior art searches, the searcher needs to know what to search for, process steps or products in the prior art. Claim construction may also be impacted in a litigation. Suppose a challenger files a motion to dismiss or summary judgment on the basis of non-infringement because the processes used are different or on the basis of same-product prior art, then the patentee may argue that the motions are premature, that a formal claim construction is needed, and giving the judge to defer the motions until later in the proceeding.
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