This article was previously published by Law360 on September 13, 2016.
Recent U.S. court decisions, including Association for Molecular Pathology v. Myriad Genetics Inc., 133 S.Ct. 2107 (2013), have severely curtailed the biotechnology industry’s ability to obtain patent claims to newly discovered “products of nature,” on the grounds that such compounds — even when isolated “by the hand of man” from their natural environment — are not patent-eligible subject matter. However, one door remains ajar. A claim drawn to a process of manufacturing a product of nature can be asserted under 35 U.S.C. § 271(g) against anyone who sells an article in the U.S. that was made by the claimed process, even if the seller was not the entity who performed the claimed process. Because this strategy effectively confers patent protection on an unpatentable compound, it is a valuable and underexplored opportunity for a would-be patentee to secure her rights to her discovery — particularly important in the biopharmaceutical industry.
Parsing § 271(g)
Section 271(g) provides that “[w]hoever without authority imports into … or offers to sell, sells, or uses within the United States a product which is made by a process patented in the United States shall be liable” for infringement of the process patent. This provision differs importantly from the direct infringement provision, 35 U.S.C. § 271(a), in that a process patent can be asserted under § 271(a) only if the accused infringer was the one who carried out the steps of the patent, and only if he did so in the U.S. In contrast, a party infringes a process patent under § 271(g) merely by using or selling in the U.S., or importing into the U.S., a product that was made using the claimed process anywhere in the world, and by anyone. Section 271(g) therefore provides a powerful additional weapon for the patentee to prevent others from exploiting his invention, and is particularly useful in situations where § 271(a) is not available — e.g., if the process was carried out outside the U.S. And § 271(g) was enacted expressly to apply to a situation in which the product itself is not patentable. In explaining the legislative purpose for then-pending § 271(g), the Senate Committee on the Judiciary noted that:
[P]rocess patents promise to be increasingly important to … the fields of biotechnology and bioengineering research. Biotechnology companies are often built around a new process for artificial manufacture of a substance that occurs in nature and is therefore itself unpatentable.”
S. REP. NO. 100-83, at 30 (1987).
Although most commonly invoked against products made outside the U.S. and imported into the U.S., § 271(g) is available for domestically produced goods as well. Of course, if the claimed process was carried out in the U.S., the patentee may also assert the claims under § 271(a) against the U.S. manufacturer, in addition to asserting them under § 271(g) against the entity selling the product in the U.S.
Section 271(g) contains some exceptions that limit its scope. These include the following: “A product which is made by a patented process will … not be considered to be so made after — (1) it is materially changed by subsequent processes; or (2) it becomes a trivial and nonessential component of another product.” While the second exception should rarely be an issue in the pharmaceutical context, the first exception can easily be a stumbling block and requires careful attention to how the process claim is drafted.
The question of whether the product was “materially changed by subsequent processes” will arise if the compound that is the direct result of the final step recited in the claim undergoes some further alteration to produce the ultimate article (e.g., a pharmaceutical drug) that the accused infringer is selling. If a court finds that the accused article has significant changes in its structure or properties compared to the product of the claimed process, the article may be deemed “materially changed” and therefore noninfringing under § 271(g). Compare Eli Lilly & Co. v. American Cyanamid Co., 82 F.3d 1568, 1573 (Fed. Cir. 1996) (compound was “materially changed” from the product of the claimed process after additional synthetic steps altered the compound and conferred improved antibiotic activity, so did not infringe under § 271(g)) with Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, 1379 (Fed. Cir. 2009) (PEGylated erythropoietin (EPO) infringed under § 271(g) a claim to a process of making un-PEGylated EPO because PEGylation did not interfere with bioactivity and so did not “materially change” the EPO).
Of course, a “material change” — or even many nonmaterial changes such as the PEGylation in the Amgen case — will likely be deemed to turn the original product of nature into something that clearly is not a product of nature and so would qualify as patent-eligible subject matter. Obtaining a composition claim encompassing the changed product would moot the need to resort to the strategy we propose. But that requires being able to predict, when drafting the composition claim, exactly what form the commercial product will ultimately take. It thus may not be feasible. In such a situation, a carefully and broadly drafted process of manufacture claim may prove invaluable.
Drafting Effective Process Claims for Assertion under § 271(g)
A typical situation appropriate for this strategy involves a newly discovered protein. For example, suppose a scientist discovers a naturally occurring human anti-angiogenic polypeptide (Protein X) and clones its cDNA. Her patent attorney drafts this fairly routine recombinant process claim:
Claim 1: A method of manufacturing a polypeptide, the method comprising
a. culturing a cell containing a cDNA encoding Protein X (SEQ ID NO: 1), so that the cell expresses Protein X; and
b. collecting the Protein X expressed in (a).
The claim is drawn to a process, not a product, so does not claim a “product of nature.” Nor does the claim involve either of the other categories of patent-ineligible subject matter defined by the U.S. courts (“laws of nature” and “abstract ideas”). One might argue that the reasoning in Ariosa Diagnostics Inc. v. Sequenom Inc., 788 F.3d 1371 (Fed. Cir. 2015), cert. denied, No. 15-1182, 2016 WL 1117246 (U.S. June 27, 2016), could be applied to invalidate the above hypothetical claim 1 as claiming patent-ineligible subject matter. Such an argument might assert that, as in Sequenom’s claims drawn to a method for detecting fetal DNA in maternal plasma, the above claim 1 is “directed to” the naturally occurring material recited in the claim, and the steps recited in the claim are “well-understood, conventional and routine,” so do not turn the claim into patent-eligible subject matter. See id. at 1376-77. However, a more recent case suggests that the hypothetical claim 1 would be fine. The claims at issue in Rapid Litigation Management Ltd. v. CellzDirect Inc. No. 2015-1570, 2016 WL 3606624, at *2 (Fed. Cir. July 5, 2016), claimed a method of producing a population of hepatocytes (liver cells) comprising subjecting thawed hepatocytes to fractionation and cryopreserving them again, based on the discovery that a subpopulation of cells could survive the second freezing. The court held that the claims were not “directed to” a law of nature such as the cells’ natural ability to survive repeated freezing steps, but rather were “directed to” “a new and improved way of preserving hepatocyte cells.” Id. at *4. The court distinguished Sequenom’s claims on the grounds that the latter “amounted to nothing more than observing or identifying the ineligible concept” such that “the end result” or “essence” was patent-ineligible. In contrast, the claims in Rapid Litigation Management were characterized by the court as drawn to a “constructive process,” by which the court apparently meant a process that “constructed” something. Id.
Comparable to the “constructive process” claimed in Rapid Litigation Management, the manufacturing process of our hypothetical claim 1 is essentially a process of “constructing” Protein X, and certainly is not merely “observing or identifying” Protein X. Furthermore, the claim contains novel elements besides Protein X: i.e., the cDNA and a cell containing the cDNA, each of which is also new and presumably would be patent-eligible if claimed (assuming that genomic DNA encoding Protein X contains introns that are not present in the cDNA). Myriad, 133 S. Ct. at 2119. Another point in favor of eligibility is the fact that the claimed process inherently converts individual amino acids in the cell into Protein X, thus effecting a “transformation.” “Transformation and reduction of an article to a different state or thing is the clue to the patentability of a process claim that does not include particular machines.” Diamond v. Diehr, 450 U.S. 175, 184 (1981).
In sum, hypothetical claim 1 should survive a challenge on patent-eligibility grounds, whereas a claim drawn instead to Protein X per se, even if isolated or purified, likely will not. Assuming that Protein X and its cDNA are novel and non-obvious, a claim to a process of making Protein X by using its cDNA should be patentable. And since claim 1 claims a process of manufacture, it could be asserted under § 271(g) against someone who sells Protein X in the U.S., or imports Protein X into the U.S., if the Protein X was in fact produced by the claimed process anywhere in the world.
What if someone makes Protein X by the claimed process outside the U.S. — thereby avoiding liability for infringement under § 271(a) — and then modifies the protein before importing it into the U.S.? The product of the final step of the above claim 1 is simply Protein X, with nothing added or subtracted except what inherently results from expression in the cell (e.g., glycosylation). If the modifications made to Protein X before it is imported into the U.S. do not “materially change” the protein, its importer or seller in the U.S. will be liable for infringing claim 1 under § 271(g). However, the question of whether the modification constitutes a “material change” will need to be litigated, presenting a risk that the patentee might have been able to mitigate with some savvy claim drafting during prosecution. The key is to understand, to the extent possible, what modifications might be made to Protein X when turning it into a commercial product, and add a step or steps to the end of the claim to ensure those potential modifications are covered. The added step(s) can be quite broad, as they are not being relied upon for patentability. Possible alternative examples of steps (c) that could be added to claim 1, or put into claims depending on claim 1, include:
- formulating the Protein X for systemic administration to a human
- removing one or more amino acids from one or both termini of the Protein X
- removing or adding one or more phosphate or sugar groups to the Protein X
- conjugating a molecule to the Protein X
It may be that several claims with alternate wordings will be needed to cover all likely changes that may be made to Protein X before it is sold as a product. At least one claim should be broad enough to cover a process in which the final product is simply Protein X as produced in the cell, in case no changes are made to Protein X in the commercial product.
The above hypothetical example is merely illustrative, of course. The proposed strategy should also work where the product of nature is not a protein, and may work even if the claimed manufacturing process involves essentially nothing more than purification of a compound or extract from nature.
Some might argue that this approach constitutes an impermissible end-run around the policy behind the prohibition on patenting products of nature — that this strategy exalts form over substance, and that claims excluding the public from selling or importing products that are admittedly unpatentable products of nature should not be allowed, regardless of how the claims are articulated. Such critics should take note that the legislative history of § 271(g) shows that Congress explicitly intended this provision to apply to products of nature that are themselves unpatentable.