Can Old Products Be Patented Based On Newly Discovered Properties?

Entrenched in patent law is the principle that a challenge against a patent for anticipation or obviousness must be based on 'prior art,' and not on disclosure in the patent itself. Also entrenched in patent law is the principle that an otherwise known product cannot be patented merely because one discovers new and unobvious properties possessed by that product.  

The Federal Circuit wrestled with these two principles in
Elan Pharmaceuticals, Inc. v. Mayo Foundation for Medical Education and Research, 64 USPQ2d 1292 (Fed. Cir. 2002).   According to the majority, the district court invalidated Elan's patent by relying not on the prior art but on Elan's specification itself, in violation of the first principle recited above. However, according to the dissent, the majority sustained patentability of an otherwise known product based on Elan's discovery of new and unobvious properties of that product, in violation of the second principle recited above. In its upcoming en banc review, the Federal Circuit should reconcile this apparent doctrinal conflict.

Elan's Invention

Elan's patents are directed to transgenic animals altered to be susceptible to Alzheimer's disease. Specifically, Elan added to mouse DNA a mutated human gene, the 'Swedish mutation,' so-named because it was isolated from the cells of a Swedish family with an unusually high incidence of early-onset Alzheimer's.  
In the transgenic mice, the gene expresses human APP having the Swedish mutation (APPsw). This APPsw in turn produces human betaAPP, which is believed to cause plaques responsible for Alzheimer's. The production of betaAPP in the mouse brain is difficult to detect because the betaAPP molecule is relatively small. The Elan patents purported to solve this detection problem by detecting the larger cleavage fragment, ATF-betaAPP, which is a by-product of betaAPP production.
Claim 1 of Elan's '486 patent reads:

1. A transgenic rodent comprising a diploid genome comprising a transgene encoding a heterologous APP polypeptide having the Swedish mutation wherein the amino acid residues at positions corresponding to positions 595 and 596 in human APP695 are asparagine and leucine, respectively, wherein the transgene is expressed to produce a human APP polypeptide having the Swedish mutation, and wherein said polypeptide is processed to ATF-betaAPP in a sufficient amount to be detectable in a brain homogenate of said transgenic rodent (Emphasis Added).

The examiner granted the Elan patents only after Elan added the final clause to the claims.

District Court Decision

On summary judgment, the district court found that the Elan claims were anticipated by a patent issued to a third party, Dr. Mullan. Dr. Mullan had likewise identified and characterized the gene encoding the Swedish mutation as well as its corresponding protein. Mullan stated that transgenic animals containing the mutated gene can be used to research and treat Alzheimer's. Mullan did not, however, produce a transgenic animal with the Swedish mutation, or determine which of the known procedures would be effective for this purpose, or suggest conditions or details of any method for successful production of the desired animal.

  
Although the district court agreed with Elan that Mullan did not mention the formation of ATF-betaAPP, the district court concluded that its formation was inherent in Mullan's general teachings of transgenic mice with the Swedish mutation. The district court deemed it irrelevant that the ATF-betaAPP was not described in the prior art.

Federal Circuit Decision

The Federal Circuit reversed the district court on two grounds.
First, the Federal Circuitit accepted Elan's argument that Mullan's disclosure of known procedures for making a transgenic animal was simply an invitation to experiment, with no assurance of success. The Federal Circuit also agreed that general instructions to conduct such failure-prone activities as gene transfer between humans and animals, and the ensuing uncertainties with respect to gene expression and enzymatic cleavage of the mutated human protein with animal enzymes, do not meet the legal criteria of anticipation of the successful product of transgenic activity.

Second, the Federal Circuit agreed with Elan that detection of the ATF-betaAPP by-product was key to the invention because it permits determination of when the Swedish DNA has been successfully transferred.

Thus, the Federal Circuit agreed with Elan that the Mayo Foundation failed to prove inherency in view of Mullan. The court cited Continental Can Co. USA, Inc. v. Monsanto Co., 948 F.2d 1264, 20 USPQ2d 1746 (Fed. Cir. 1991), holding that facts asserted to be inherent in the prior art must be shown by evidence from the prior art. Accordingly, because it was Elan's application, and not the prior art, that disclosed formation and detection of ATF-betaAPP in the transgenic mouse, the court concluded that Mullan did not inherently anticipate the Elan patents.

Judge Dyk's Dissent

In his dissent, Judge Dyk sounded an alarm arguing that the majority's decision will enable inventors to patent old products based on the discovery of new properties:
'This decision, if followed, will have serious and unfortunate consequences in the future by permitting the securing of patent rights to existing inventions so long as the patent applicant identifies an inherent characteristic of that product that was not identified in the prior art. That has never been our law.'
The dissent argued that the majority disregarded earlier Federal Circuit precedent by holding that 'an inventor's own disclosure may not be used under 35 U.S.C. '102 as proof of anticipation by inherent disclosure in a prior art reference.' The dissent characterized the touchstone of inherency as the inevitability of obtaining the claimed product by following the prior art teaching, and not whether proof of that inevitability came from 'prior art' or from some other source, including the inventor's own disclosure:

'There is simply no basis in our law to support the proposition that the source of proof for inherency must be found in the prior art and cannot be found in a patentee's own disclosure or other source. ' Thus evidence extrinsic to the cited prior art reference may be used, i.e., the party raising the issue of inherency may fill in the gap in the disclosure using any source. The majority's contrary conclusion is incorrect as a matter of law, and directly contradicts our law, which has repeatedly recognized that the discovery of an inherent characteristic of an old product cannot be patented.'

In this case, the dissent continued, Elan acknowledged in its own specification that the inventor's process was essentially the same as that followed by Mullan. Accordingly, the Mullan process 'would inevitably have detectable levels of ATF-betaAPP.' Indeed, '(w)ere plaintiffs to contend otherwise, their own patents would not be enabled.'

Thus, the dissent concluded, the disclosures of the Elan patents may be used to prove that the Mullan transgenic rodent inherently possessed the claimed characteristic, and further that the Elan patents in fact prove such inherency.

Issues for en banc Review

1. Federal Circuit should reverse majority's holding requiring 'prior art' to establish inherent properties.

On one hand, the majority acknowledges that an otherwise known product is not rendered patentable merely because a later inventor discovers new and unobvious properties possessed by that product. By definition, however, 'new and unobvious' properties are only new and unobvious because the prior art does not disclose them. Although the majority paid lip-service to this longstanding doctrine, the majority's decision effectively made it impossible to challenge a patent claiming an otherwise old product having new and unobvious properties. By definition, a challenger of such a patent will never be able to find 'prior art' disclosing properties that are new and unobvious to the inventor.

2. Majority did not have to overturn longstanding doctrine to reverse
district court.

One uncontestable fact that Elan, the Mayo Foundation, and the courts all recognized is that Dr. Mullan never actually prepared the transgenic animal including the gene with the Swedish mutation. Rather, Mullan merely proposed a number of known alternative methods for carrying
out such transformation. Because the transformed mouse was never actually made, the issue of anticipation, whether explicit or inherent, should never have even been raised because any transgenic mouse, much less a transgenic mouse having the properties claimed by Elan, was not the inevitable result of following the Mullan teaching. Thus, having never actually transformed a mouse and not knowing whether any of the proposed transformation techniques would even work, the certainty required for inherent anticipation was simply lacking. This lack of certainty related to the production of the transgenic rodent itself, and not to inherency of the properties possessed by the transgenic rodent.

3. Dissent violated entrenched principles of inherency, although it was correct that evidence of inherency need not be found in prior art.

The dissent arguably had its own foray into doctrinal heresy when it sustained the district court's invalidation based on inherency, rather than obviousness. The fact remains that Mullan never actually transformed an animal to express the Swedish mutation gene. It is therefore difficult to comprehend how the properties actually discovered by Elan for the transformants actually prepared by Elan could be 'inherent' in view of a prior art teaching that never showed preparation of the transformant, much less its properties. For the unpredictable art of biological molecules, the doctrine of inherency and its requirement of inevitability can generally be satisfied only if those molecules were made in the prior art.

4. Dissent could have supported district court without violating entrenched principles.

Even though Elan's transgenic rodent was not inherent in view of the Mullan reference, existing doctrine would have permitted the Federal Circuit to sustain the invalidation of the Elan patents based on obviousness. Although the Mullan reference did not actually prepare a transgenic rodent expressing the Swedish mutation, it did set forth a number of alternative transformation techniques. Assuming that one of ordinary skill in the art would have harbored a 'reasonable expectation of success' that one or more of these transformation techniques would have been successful, the transgenic rodent of Mullan would have been obvious. Absolute predictability is not required.

Likely Outcome

It is difficult to envision the full court affirming the majority's position that a patent challenger must rely on 'prior art' to demonstrate inherency of new and unobvious properties in an otherwise old product.   To affirm such a position would, as the dissent argues, result in the issuance of patents for old products based on newly discovered properties, for the simple reason that there will be no 'prior art' disclosing those properties.

However, the full court can avoid reversing the majority's overall decision by holding that the numerous alternative transformation methods set forth in the prior art neither necessarily produce the product (overcoming inherent anticipation) nor create a reasonable expectation of success (overcoming obviousness).
Hopefully, the full court will not focus so much on the issue of using evidence other than prior art to prove inherency that it fails to address the propriety in this case of relying on the doctrine of inherency at all.   Such a failure might lead to a whole new type of rejection ' obviousness by inherency. Despite the arguments of the dissent, obviousness by inherency is a non sequitur because it essentially states that a property can be inherent in something that never existed.

Ideally, the full court will hold:

1) that inherency may be established by evidence other than prior art, but that
2) the doctrine of inherency was inapplicable in this case because the Mullan reference disclosed no production of the actual transgenic rodent.

Then, to decide whether to reverse or sustain the earlier panel decision, the full court could use well-entrenched doctrines of claim interpretation (as to how much weight to give to the process limitations in the product claims) and obviousness (whether there would have been a reasonable expectation of success
that one of the Mullan transformation techniques would have been
successful).

Entrenched in patent law is the principle that a challenge against a patent for anticipation or obviousness must be based on 'prior art,' and not on disclosure in the patent itself. Also entrenched in patent law is the principle that an otherwise known product cannot be patented merely because one discovers new and unobvious properties possessed by that product.  

The Federal Circuit wrestled with these two principles in
Elan Pharmaceuticals, Inc. v. Mayo Foundation for Medical Education and Research , 64 USPQ2d 1292 (Fed. Cir. 2002).   According to the majority, the district court invalidated Elan's patent by relying not on the prior art but on Elan's specification itself, in violation of the first principle recited above. However, according to the dissent, the majority sustained patentability of an otherwise known product based on Elan's discovery of new and unobvious properties of that product, in violation of the second principle recited above. In its upcoming en banc review, the Federal Circuit should reconcile this apparent doctrinal conflict.

Elan's Invention

Elan's patents are directed to transgenic animals altered to be susceptible to Alzheimer's disease. Specifically, Elan added to mouse DNA a mutated human gene, the 'Swedish mutation,' so-named because it was isolated from the cells of a Swedish family with an unusually high incidence of early-onset Alzheimer's.  
In the transgenic mice, the gene expresses human APP having the Swedish mutation (APPsw). This APPsw in turn produces human betaAPP, which is believed to cause plaques responsible for Alzheimer's. The production of betaAPP in the mouse brain is difficult to detect because the betaAPP molecule is relatively small. The Elan patents purported to solve this detection problem by detecting the larger cleavage fragment, ATF-betaAPP, which is a by-product of betaAPP production.
Claim 1 of Elan's '486 patent reads:

1. A transgenic rodent comprising a diploid genome comprising a transgene encoding a heterologous APP polypeptide having the Swedish mutation wherein the amino acid residues at positions corresponding to positions 595 and 596 in human APP695 are asparagine and leucine, respectively, wherein the transgene is expressed to produce a human APP polypeptide having the Swedish mutation, and wherein said polypeptide is processed to ATF-betaAPP in a sufficient amount to be detectable in a brain homogenate of said transgenic rodent (Emphasis Added).

The examiner granted the Elan patents only after Elan added the final clause to the claims.

District Court Decision

On summary judgment, the district court found that the Elan claims were anticipated by a patent issued to a third party, Dr. Mullan. Dr. Mullan had likewise identified and characterized the gene encoding the Swedish mutation as well as its corresponding protein. Mullan stated that transgenic animals containing the mutated gene can be used to research and treat Alzheimer's. Mullan did not, however, produce a transgenic animal with the Swedish mutation, or determine which of the known procedures would be effective for this purpose, or suggest conditions or details of any method for successful production of the desired animal.

  
Although the district court agreed with Elan that Mullan did not mention the formation of ATF-betaAPP, the district court concluded that its formation was inherent in Mullan's general teachings of transgenic mice with the Swedish mutation. The district court deemed it irrelevant that the ATF-betaAPP was not described in the prior art.

Federal Circuit Decision

The Federal Circuit reversed the district court on two grounds.
First, the Federal Circuitit accepted Elan's argument that Mullan's disclosure of known procedures for making a transgenic animal was simply an invitation to experiment, with no assurance of success. The Federal Circuit also agreed that general instructions to conduct such failure-prone activities as gene transfer between humans and animals, and the ensuing uncertainties with respect to gene expression and enzymatic cleavage of the mutated human protein with animal enzymes, do not meet the legal criteria of anticipation of the successful product of transgenic activity.

Second, the Federal Circuit agreed with Elan that detection of the ATF-betaAPP by-product was key to the invention because it permits determination of when the Swedish DNA has been successfully transferred.

Thus, the Federal Circuit agreed with Elan that the Mayo Foundation failed to prove inherency in view of Mullan. The court cited Continental Can Co. USA, Inc. v. Monsanto Co., 948 F.2d 1264, 20 USPQ2d 1746 (Fed. Cir. 1991), holding that facts asserted to be inherent in the prior art must be shown by evidence from the prior art. Accordingly, because it was Elan's application, and not the prior art, that disclosed formation and detection of ATF-betaAPP in the transgenic mouse, the court concluded that Mullan did not inherently anticipate the Elan patents.

Judge Dyk's Dissent

In his dissent, Judge Dyk sounded an alarm arguing that the majority's decision will enable inventors to patent old products based on the discovery of new properties:
'This decision, if followed, will have serious and unfortunate consequences in the future by permitting the securing of patent rights to existing inventions so long as the patent applicant identifies an inherent characteristic of that product that was not identified in the prior art. That has never been our law.'
The dissent argued that the majority disregarded earlier Federal Circuit precedent by holding that 'an inventor's own disclosure may not be used under 35 U.S.C. '102 as proof of anticipation by inherent disclosure in a prior art reference.' The dissent characterized the touchstone of inherency as the inevitability of obtaining the claimed product by following the prior art teaching, and not whether proof of that inevitability came from 'prior art' or from some other source, including the inventor's own disclosure:

'There is simply no basis in our law to support the proposition that the source of proof for inherency must be found in the prior art and cannot be found in a patentee's own disclosure or other source. ' Thus evidence extrinsic to the cited prior art reference may be used, i.e., the party raising the issue of inherency may fill in the gap in the disclosure using any source. The majority's contrary conclusion is incorrect as a matter of law, and directly contradicts our law, which has repeatedly recognized that the discovery of an inherent characteristic of an old product cannot be patented.'

In this case, the dissent continued, Elan acknowledged in its own specification that the inventor's process was essentially the same as that followed by Mullan. Accordingly, the Mullan process 'would inevitably have detectable levels of ATF-betaAPP.' Indeed, '(w)ere plaintiffs to contend otherwise, their own patents would not be enabled.'

Thus, the dissent concluded, the disclosures of the Elan patents may be used to prove that the Mullan transgenic rodent inherently possessed the claimed characteristic, and further that the Elan patents in fact prove such inherency.

Issues for en banc Review

1. Federal Circuit should reverse majority's holding requiring 'prior art' to establish inherent properties.

On one hand, the majority acknowledges that an otherwise known product is not rendered patentable merely because a later inventor discovers new and unobvious properties possessed by that product. By definition, however, 'new and unobvious' properties are only new and unobvious because the prior art does not disclose them. Although the majority paid lip-service to this longstanding doctrine, the majority's decision effectively made it impossible to challenge a patent claiming an otherwise old product having new and unobvious properties. By definition, a challenger of such a patent will never be able to find 'prior art' disclosing properties that are new and unobvious to the inventor.

2. Majority did not have to overturn longstanding doctrine to reverse
district court.

One uncontestable fact that Elan, the Mayo Foundation, and the courts all recognized is that Dr. Mullan never actually prepared the transgenic animal including the gene with the Swedish mutation. Rather, Mullan merely proposed a number of known alternative methods for carrying
out such transformation. Because the transformed mouse was never actually made, the issue of anticipation, whether explicit or inherent, should never have even been raised because any transgenic mouse, much less a transgenic mouse having the properties claimed by Elan, was not the inevitable result of following the Mullan teaching. Thus, having never actually transformed a mouse and not knowing whether any of the proposed transformation techniques would even work, the certainty required for inherent anticipation was simply lacking. This lack of certainty related to the production of the transgenic rodent itself, and not to inherency of the properties possessed by the transgenic rodent.

3. Dissent violated entrenched principles of inherency, although it was correct that evidence of inherency need not be found in prior art.

The dissent arguably had its own foray into doctrinal heresy when it sustained the district court's invalidation based on inherency, rather than obviousness. The fact remains that Mullan never actually transformed an animal to express the Swedish mutation gene. It is therefore difficult to comprehend how the properties actually discovered by Elan for the transformants actually prepared by Elan could be 'inherent' in view of a prior art teaching that never showed preparation of the transformant, much less its properties. For the unpredictable art of biological molecules, the doctrine of inherency and its requirement of inevitability can generally be satisfied only if those molecules were made in the prior art.

4. Dissent could have supported district court without violating entrenched principles.

Even though Elan's transgenic rodent was not inherent in view of the Mullan reference, existing doctrine would have permitted the Federal Circuit to sustain the invalidation of the Elan patents based on obviousness. Although the Mullan reference did not actually prepare a transgenic rodent expressing the Swedish mutation, it did set forth a number of alternative transformation techniques. Assuming that one of ordinary skill in the art would have harbored a 'reasonable expectation of success' that one or more of these transformation techniques would have been successful, the transgenic rodent of Mullan would have been obvious. Absolute predictability is not required.

Likely Outcome

It is difficult to envision the full court affirming the majority's position that a patent challenger must rely on 'prior art' to demonstrate inherency of new and unobvious properties in an otherwise old product.   To affirm such a position would, as the dissent argues, result in the issuance of patents for old products based on newly discovered properties, for the simple reason that there will be no 'prior art' disclosing those properties.

However, the full court can avoid reversing the majority's overall decision by holding that the numerous alternative transformation methods set forth in the prior art neither necessarily produce the product (overcoming inherent anticipation) nor create a reasonable expectation of success (overcoming obviousness).
Hopefully, the full court will not focus so much on the issue of using evidence other than prior art to prove inherency that it fails to address the propriety in this case of relying on the doctrine of inherency at all.   Such a failure might lead to a whole new type of rejection ' obviousness by inherency. Despite the arguments of the dissent, obviousness by inherency is a non sequitur because it essentially states that a property can be inherent in something that never existed.

Ideally, the full court will hold:

1) that inherency may be established by evidence other than prior art, but that
2) the doctrine of inherency was inapplicable in this case because the Mullan reference disclosed no production of the actual transgenic rodent.

Then, to decide whether to reverse or sustain the earlier panel decision, the full court could use well-entrenched doctrines of claim interpretation (as to how much weight to give to the process limitations in the product claims) and obviousness (whether there would have been a reasonable expectation of success
that one of the Mullan transformation techniques would have been
successful).