This section will focus on three major hurdles created by the scenario posed in the introduction. The first is whether the anti-cancer herbal pill of the anthropologist can be patented. The other is whether the use or sale of the anti-cancer herbal pill by the anthropologist will infringe the pharmaceutical company’s patent on its anti-cancer drug. Finally, what alternative routes exist for the anti-cancer herbal pill and the patented anti-cancer drug to coexist together such that the patent of the pharmaceutical company is protected and at the same time consumers can have more choices and access to the herbal anti-cancer herbal pill.

Is the Anti-Cancer Herbal Pill Patentable?

At the outset, based on the holdings of Ex Parte Gray and Parke-Davis it seems that if the anthropologist is able to purify the active ingredient or ingredients of the herb, he may be able to secure a patent; the purified product of nature has “unexpected results” in that it will likely be more “efficient and constant in action” than the unpurified herb. However, to be patentable, an invention must also satisfy the utility, novelty, and non-obviousness of the 1952 Patent Act.

The utility requirement will likely be satisfied because an herbal pill that can cure skin cancer has substantial utility. In other words, a skin cancer curing herbal pill is very useful to persons who suffer from skin cancer. The novelty and non-obviousness requirements however, are not so straightforward and will be harder to satisfy. For the sake of simplification, it is assumed that the active ingredients found in the herb and claimed in the patent are identical.

The novelty requirement of 35 U.S.C § 102 requires that the invention, for which a patent is being sought, be something new. In the scenario presented here, it seems that the anti-cancer herbal pill of the anthropologist is not new even thought the herb from which it came from was not known. The anti-cancer active ingredient in the herb has been known, used, and patented by the pharmaceutical company. Because the compounds are identical and the compound in the herb is the same as the patented drug and directed to the same purpose, the anti-cancer herbal pill will likely be anticipated and unpatentable.[40] Under 35 U.S.C. § 102, because there was a patent already granted on a compound that is identical to the anti-cancer herbal pill, the anti-cancer compound of the herb was indirectly in the public domain; the anti-cancer herbal pill is not regarded as new and therefore not novel.

Although the patentability analysis will usually cease after it is found that the invention at issue is not novel, notwithstanding, it is worth mentioning the likely results of the non-obviousness analysis. In this case because the compound is known and patented and it is used for the purpose treating skin cancer, it is safe to say under 35 U.S.C. § 103 the anti-cancer herbal pill is obvious. It would be obvious for a reasonable person skilled in the art to know that an a compound found in an herb that is identical to an anti-cancer compound that is patented will also work as an anti-cancer herbal pill if purified from the herb.[41]

At first, it seemed that the anthropologist may be able to patent his anti-cancer herbal pill based on the holding of Pake-Davis, which stood for the proposition that a natural compound, if purified, may be patentable if it is more “efficient and constant in action.” However, because the anti-cancer herbal pill does not satisfy the requirements of the Patent Act, mainly the requirement for novelty, the anti-cancer herbal pill is unpatentable.[42] Therefore it is likely that the anthropologist would not be able to secure a patent for the anti-cancer herbal pill because the pharmaceutical company’s patent on its anti-cancer drug anticipates the anti-cancer herbal pill.

Will the Use or Sale of the Herbal Anti-Cancer Herbal Pill Infringe the Patent?

Infringement of a patent occurs when someone, without authority form the patentee, exercises the exclusive rights of the patent. 35 U.S.C. § 271 states in pertinent part: “whoever without authority makes, uses, offers to sell or sells any patented invention, within the United States or imports into the United states any patented invention during the term of the patent thereof, infringes the patent.” The question of whether a patent has been infringed depends largely on how the claims are drafted. “[T]he claims serve to circumscribe a property right by setting forth the metes and bounds of the patentee’s right to exclude.”[43] The scenario presented here assumes that the compound found in the herb and purified in the anti-cancer herbal pill is identical to the compound patented by the pharmaceutical company in the anti-cancer drug. Nonetheless a question naturally arises; whether a purified compound of an herb, which was not synthesized by the same process as the compound in the patent, will infringe the patent on the synthesized drug? To put it differently, will the reach of the patent claims to a drug cover the purified natural product of an herb. In a real world situation, the answer to this question will be very fact dependent, especially with regard to the wording of the claims in the patent. In a patent, the claims draw the boundary lines of the property interest of the patentee.[44] As stated above, in Parke-Davis, the court upheld the patentability of pure adrenaline derived from animal suprarenal glands. Claim six of the patent in that case was a broad claim covering the purified adrenaline from suprarenal glands. In interpreting the reach of that claim, the court seems to have in mind a similar scenario as presented in the introduction here. The court stated:

Should some one hereafter discover that in the bones or scales of certain fish or in the root of some shrub there was a principle possessing all the physiological characteristics of the suprarenal glands, and should this discoverer, by some process wholly unlike [patentee’s] isolate that principle in the form of a substance which met the requirements of this claim, it might be held to infringe. So too if some one, without making use of any suprarenal glands, should chemically combine, CH, C, OH, CH2, NH, and CH3, so as to obtain a synthetic duplicate of the substance called for by this sixth claim, such substance might be held to infringe this claim.[45]

Simply put, the court stated that a claim to a chemical compound would be infringed if an accused compound met the requirement of the claims in the patent. This is true regardless of the origin of the accused compound or the process by which it was made. If a natural compound is purified and patented, a different compound from a wholly unrelated origin will infringe the patent if the accused compound meets the requirements of the written claims of the patent. The converse, which is analogous with the anti-cancer herbal pill scenario here must also be true; if someone synthesizes a compound and secures a patent for the compound, a natural compound that was purified from nature that meets the requirements of the written claims of the patent, will infringe the patent.

There is, however, one possible argument available to the anthropologist. The anthropologist can attack the validity of the pharmaceutical company’s patent by arguing that because the herb was in existence prior to synthesis of the anti-cancer drug, the synthesized drug is not novel, or that it would have been obvious in view of its use by the indigenous tribe as an anti-cancer herbal remedy. But, in view of the quote from the Parke-Davis above, this argument may not be successful. The gist of that quoted passage seems to indicate that once a patent is granted on a chemical compound, any other chemical that is purified or synthesized, which meets the requirements of the patent, regardless of its source, infringes the patent, as opposed to invalidates the patent. Nevertheless, the outcome of such an attack on the pharmaceutical’s patent by the anthropologist is not certain, especially when considering the fact that Parke-Davis was handed down by the Second Circuit Court of Appeals in 1912. Today the Second Circuit may reach a different result if the controversy between the pharmaceutical company and the anthropologist were to go to be litigated.

In conclusion, it is likely that the pharmaceutical company’s patent is valid and the active ingredient found in the anti-cancer herbal pill is unpatentable for lack of novelty in view of the patent. Because the patented anti-cancer drug is identical to the active ingredient of the herbal pill, the patent anticipates the herbal product rendering it unpatentable. Further, if the anthropologist imports into the United States, uses or sells in the United States the herbal anti-cancer herbal pill, his activity will constitute an infringement of the patent.[46] The analysis of claim six in Pake-Davis, as quoted above, also leads to the conclusion that although the anti-cancer herbal pill is derived from an herb, if the herbal compound meets the requirements of the patent claim, the herbal pill will infringe the patent. Because in this case the compounds are identical, the herbal pill will likely infringe the pharmaceutical company’s patent on the anti-cancer drug.

An alternative Conclusion

The patentability and infringement analysis and conclusion above, depend in large part on the presumed facts of the hypothetical scenario. For example it was concluded that the purified anti-cancer herbal compound would infringe the patent if it meets the requirements of the claims of the patent. But what if the anti-cancer herbal compound is no completely purified, such that the herbal anti-cancer herbal pill would not satisfy the requirements of the claims of the patent. Then, the likely conclusion is that there is no infringement, and it seems the herbal pill can be imported and sold in the United States. Such a conclusion is deceptively simple and to appreciate the full scope of such a conclusion further analysis is required.

To start, a fundamental question must be answered; what can the anthropologist do to avoid infringing the patent? Again, this question depends entirely on the wording and reach of the claims in the patent. As the court in Parke-Davis emphasized, infringement occurs only if the accused compound meets the requirements of the claim or claims in the patent. It can be safely assumed that the pharmaceutical company patented its anti-cancer drug without any reference to the herb in question here. The herb in question was not known to the modern world until its indirect discovery by the anthropologist. Because the requirements of the patented drug do not include the presence of the herbal impurities, the anthropologist can avoid infringement if his anti-cancer herbal pill is somewhat impure. If there are herbal impurities present in the anti-cancer herbal pill, which are not required by the pharmaceutical company’s patent for its anti-cancer drug, the patent that does not specifically and expressly calls for such impurities cannot be infringed.[47]

It now appears that the anthropologist may be able to avoid infringement of the pharmaceutical company’s patent on the anti-cancer drug. However, other hurdles lay in his way before he can safely import and sell the anti-cancer herbal pill in the United States. An example of such hurdles appeared in the recent case of Pharmanex v. Shalala.[48] In that case the court addressed the application 21 U.S.C. § 321(ff)[49] with regard to a natural product “cholestin” marketed by Pharmanex. “Cholestin is made from red yeast rice, and contains a natural substance, mevinolin, which is chemically identical to the active ingredient, lovastatin, in the prescription drug, Mevacor.”[50] The FDA had issued a final decision “holding that Cholestin does not meet the definition of “dietary supplement” provided by 21 U.S.C. § 321(ff)(B)(i)”[51], and therefore “subject to regulation as a drug”.[52] § 321 defines dietary supplements as follow: The term “dietary supplement” . . . does . . . not include . . . an article that is approved as a new drug [ ] which was not before such approval, certification, licensing, or authorization marketed as a dietary supplement or as a food . . . .”[53]

Pharmanex filed an action for declaratory and injunctive relief “to hold unlawful and to set aside the FDA decision.”[54] The district court set aside the FDA decision, “holding that Cholestin is a “dietary supplement” within the definition set forth by § 321(ff).”[55] The district court concluded that § 321(ff)(3)(B) was limited to “finished drug products”[56] and does not include active ingredients.[57] The Tenth Circuit reversed because it reached “the opposite conclusion.”[58]

During the course of litigation, the FDA argued that based on the text of the statute, “an article that is approved as a new drug” covers “active ingredients as well as finished drug products.”[59] The essence of FDA’s argument was that the active ingredients present in Cholestin, derived from red yeast rice, is an “article” within the meaning of the statute and covers “both component and finished drug product”, therefore Cholestin must be regulated as a drug and not as a dietary supplement.[60] Pharmanex, in turn, argued that “the plain meaning of 21 U.S.C. § 321(ff)(3)(B)(i) cannot exclude Cholestin or lovastatin from the definition of ‘dietary supplement.’”[61] Further Pharmanex argued that Cholestin was never approved as a new drug, therefore, it cannot possibly be “an article that is approved as a new drug” within the meaning of the statute.[62] Moreover, Pharmanex argued that the definition of “new drug” precludes components or ingredients from being “approved as a new drug.”[63] Under such interpretation, “a manufacturer could identify a naturally occurring substance that was identical to . . . the active ingredient in a prescription drug, and market it as a dietary supplement.”[64]

The Tenth Circuit began its interpretation by looking at the language of the statute. The Court stated “[i]nstead of using more precise terms . . . the drafters opted for the more general expression ”article.” This suggests ambiguity.”[65] The Court rejected Pharmanex’s argument and instead held that “active ingredients” in addition to “finished products” can be excluded from the definition of dietary supplement.[66] The court held that “the exclusionary clause would reach naturally occurring substances . . . indistinguishable from the active ingredients in new drugs, provided the substance is question was not previously marketed as a food or dietary substance.” The court’s conclusion was based the ambiguity in the text of the statute, and that such an interpretation would have the effect of “carving out breathing room for dietary supplements while ensuring that drug manufacturers will not exploit this flexibility to make an end-run around the stricture of the new drug approval process.”[67] In sum, the Tenth Circuit reversed the decision of the district court where the district court had held that Cholestin was a dietary supplement. The Tenth Circuit’s conclusion was that Cholestin is a drug and must be regulated as such.

Under the interpretations of the Tenth Circuit, the anthropologist’s herbal anti-cancer pills, which have the same active ingredient as the pharmaceutical company’s patented anti-cancer drug, would be regulated as a drug and not as a dietary supplement. However, the Tenth Circuits decision in this case is not the final word on this issue. Perhaps other circuits would reach the opposite result as the Tenth Circuit, the United States Supreme Court may reach the opposite result, or Congress can amend the statute to remove the ambiguity of the statute. Of all these possibilities, an amendment by Congress that would make clear that 21 U.S.C. § 321(ff)(3)(B) applies only to “finished products” would be the easiest and best way to enable the anthropologist to bring his herbal pills to the United States market. Action by Congress would be best, because as of now, the Tenth Circuit’s decision is the only one on this issue, and would likely serve as precedent in other Circuits should they hear similar cases. Congress may well have intended to only exclude finished products as Pharmanex argued before the Tenth Circuit. The Tenth Circuit itself conceded that such an interpretations was possible when in the conclusion of its opinion it stated “Pharmanex’s argument is linguistically possible.” Notwithstanding, the Tenth Circuit held that active ingredients may be deemed as drugs rather than dietary supplements.

To allow the anthropologist to import and sell his herbal anti-cancer pills in the United States would be beneficial to the public by giving an extra choice to consumers, especially those that would not be able to afford the anti-cancer drug of the pharmaceutical company. Because dietary food supplements are not regulated as heavy as drugs are regulated, and because the expense of bringing the anti-cancer herbal pill to market would be much less than a prescription drug, it follows that the anti-cancer herbal pill would cost much less and be more affordable. Furthermore the herbal pills would not infringe pharmaceutical company’s patent because the herbal pills include herbal impurities that are not specifically called for by the claims of the patent. The pharmaceutical company would have a new competitor, but the competitor in this case did not gain any unlawful advantage. As a general rule competition favors consumers, therefore allowing the anthropologist to bring his herbal pills in the market would benefit the public at large. This result comports with the policies behind the statutes at issue in the Phrmanex case. Such statutes were “enacted to alleviate the regulatory burdens on the dietary supplement industry, allowing consumers greater access to safe dietary supplements in order to promote greater wellness in among the American population.”[68]

In conclusion, the anthropologist can avoid infringement of the pharmaceutical company’s patent by leaving some impurities in the anti-cancer herbal pill. Because the patent of the anti-cancer drug was granted without any requirement of impurities of the herb, it follows that the herbal pill would not infringe the pharmaceutical company’s patent. The patent at issue would only protect what has been claimed in the patent and nothing more. The pharmaceutical company would enjoy the protection of its patent and at the same time the anthropologist will enjoy the benefits of his work and research. By not infringing the patent, the anthropologist would not be committing an unlawful or tortuous act, in fact he would benefit the public by introducing more affordable alternative to expensive drugs for those suffering from skin cancer. The anthropologist’s anti-cancer herbal pill is subject to regulation by the FDA. The rules in place for such regulations are meant to lessen the burdens on the health industry and allow greater access to consumers to promote greater wellness. If Congress removes the ambiguity that exists is the applicable statute and exclude only finished drug products from being regulated as a dietary supplement, the decision in Pharmanex would be virtually reversed. In Pharmanex, the court held that natural products, which are not approved as drugs may be regulated as drugs, while at the same time conceding that the opposite conclusion is possible as the lower court in that case had held. Such an Act by Congress would not be a substantial change of position, it would be a mere clarification of existing law, and at the same time would have much beneficial effect for the consumers at large. There would be more incentive for companies to tap natural products for beneficial compounds, and as a result more beneficial compounds would be discovered. Such naturally occurring compounds would be regulated as dietary supplements, which would be much cheaper than synthesizing and manufacturing finished drug products. Consumers would be greatly benefited by more choices in the market place and competition would lower prices for consumers. In sum, a clarification by Congress that only finished drug products are excluded as dietary supplement would have immense beneficial consequences.