Mary Till, Legal Advisor-Office of Patent Legal Administration at the U.S. Patent and Trademark, was speaking at the 11th Advanced Forum on Biotech Patents and mentioned that the USPTO has only received 9 comments to date. Therefore, the USPTO is extending the comment period to ensure that members of the public have sufficient opportunity to submit comments on the Interim Patent Subject Matter Eligibility Examination Instructions.
A notice extending the comment period will be published in the Federal Register, and it will provide a new comment deadline of 30 days from the publication date of the notice in the Federal Register. The USPTO will revise the instructions as appropriate based on comments received. Comments that have already been received are under consideration.
35 U.S.C. § 101 establishes the threshold for patentability by setting requirements for subject matter that is eligible for patenting. There are two criteria for determining subject matter eligibility and both must be satisfied. The claimed invention (1) must be directed to one of the four statutory categories (process, machine, manufacture, or composition of matter), and (2) must not be wholly directed to subject matter encompassing a judicially recognized exception, as defined below.
Note that the guidelines provide for the following:
A claim that covers both statutory and non-statutory embodiments (under the broadest reasonable interpretation of the claim when read in light of the specification and in view of one skilled in the art) embraces subject matter that is not eligible for patent protection and therefore is directed to non-statutory subject matter. Such claims fail the first step and should be rejected under § 101, for at least this reason. For example, a claim to a computer readable medium that can be a compact disc or a carrier wave covers a non-statutory embodiment and therefore should be rejected under § 101 as being directed to non-statutory subject matter.
The U.S. Court of Appeals for the Federal Circuit upheld a decision that Janssen Pharmaceutica NV’s patent covering a method for treating Alzheimer’s disease was invalid after it was attacked by a whole gaggle of generic-drug companies.
In a 2-1 decision, the Federal Circuit agreed with the district court’s decision that Janssen’s patent was invalid because of lack of enablement, finding that the patent application did not establish utility. In Re ‘318 Patent Infringement Litigation (a/k/a Janssen Pharma and Synaptech v. Teva, Mylan, Dr. Reddy’s, Barr and Purepac), 08-1594, 2009-1070.
Janssen’s U.S. Pat. No. 4,663,318 claims a method for treating Alzheimer’s disease with galanthamine (also spelled “galantamine”). Claim 1 is for:
“[a] method of treating Alzheimer’s disease and related dementias which comprises administering to a patient suffering from such a disease a therapeutically effective amount of galanthamine or a pharmaceutically-acceptable acid addition salt thereof.”
At the time of the ’318 patent’s application in early 1986, researchers had observed a correlation between Alzheimer’s disease symptoms and a reduced level of the neurotransmitter acetylcholine in the brain. At that time, galanthamine was known to inhibit acetylcholinesterase, an enzyme that breaks down acetylcholine. Acetylcholinesterase inhibitors like galantamine increase the amount of acetylcholine available for binding to muscarinic or nicotinic receptors.
The court noted that the specification for the ’318 patent was only just over one page in length, and it provided almost no basis for its stated conclusion that it was possible to administer “an effective Alzheimer’s disease cognitively-enhancing amount of galanthamine.”
The specification provided short summaries of six scientific papers in which galantamine had been administered to humans or animals. The specification then provided brief summaries of four scientific papers reporting brain effects and positive effects on memory from administering galantamine to animals. The specification did not provide analysis or insight connecting the results of any of these six studies to galantamine’s potential to treat Alzheimer’s disease in humans.
The specification noted that another prior art scientific paper described an animal testing model for replicating in animals the acetylcholine deficit and other effects of Alzheimer’s disease. However, the specification did not refer to any then-existing animal test results involving the administration of galantamine in connection with this animal model of Alzheimer’s disease.
The district court found that the ’318 patent was neither anticipated nor obvious. However, the district court concluded that the ’318 patent was invalid for lack of enablement on two distinct grounds. The district court found that the specification did not demonstrate utility because relevant animal testing experiments were “not finished . . . by the time the ’318 patent was allowed” and the specification provided only “minimal disclosure” of utility. ’
The district court alternatively found that the specification and claims did not “teach one of skill in the art how to use the claimed method” because the application “only surmise[d] how the claimed method could be used” without providing sufficient galantamine dosage information.
The enablement requirement of 35 U.S.C. § 112, ¶ 1 requires that the specification adequately discloses to one skilled in the relevant art how to make, or in the case of a process, how to carry out, the claimed invention without undue experimentation. The utility requirement of 35 U.S.C. § 101 mandates that any patentable invention be useful and, accordingly, the subject matter of the claim must be operable. If a patent claim fails to meet the utility requirement because it is not useful or operative, then it also fails to meet the how-to-use aspect of the enablement requirement.
The utility requirement prevents mere ideas from being patented. The utility requirement also prevents the patenting of a mere research proposal or an invention that is simply an object of research. As the Supreme Court stated in Brenner, “a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.”
The Federal Circuit noted that:
Typically, patent applications claiming new methods of treatment are supported by test results. But it is clear that testing need not be conducted by the inventor. In addition, human trials are not required for a therapeutic invention to be patentable. Our predecessor court, the United States Court of Customs and Patent Appeals, held in In re Krimmel that patent applications need not “prove that compounds or other materials which [the applicant] is claiming, and which [the applicant] has stated are useful for ‘pharmaceutical applications’ are safe, effective, and reliable for use with humans.” 292 F.2d 948, 954 (CCPA 1961). As we observed in In re Brana, “[w]ere we to require Phase II testing [human trials] in order to prove utility, the associated costs would prevent many companies from obtaining patent protection on promising new inventions, thereby eliminating an incentive to pursue . . . potential cures.”
We have held that results from animal tests or in vitro experiments may be sufficient to satisfy the utility requirement. Our predecessor court held in Krimmel that animal tests showing that a new nonobvious compound “exhibits some useful pharmaceutical property” are sufficient to demonstrate utility. 292 F.2d at 953. We noted in Cross v. Iizuka that “[w]e perceive no insurmountable difficulty, under appropriate circumstances, in finding that the first link in the screening chain, in vitro testing, may establish a practical utility for the [pharmaceutical] compound in question” in order for a patent to issue. 753 F.2d 1040, 1051 (Fed. Cir. 1985). We concluded that in vitro test results for a claimed pharmaceutical compound, combined with animal test results for a structurally similar compound, showed “a reasonable correlation between the disclosed in vitro utility and an in vivo activity, and therefore a rigorous correlation is not necessary where the disclosure of pharmacological activity is reasonable based upon the probative evidence.”
In this case, however, neither in vitro test results nor animal test results involving the use of galantamine to treat Alzheimer’s-like conditions were provided. The results from the ’318 patent’s proposed animal tests of galantamine for treating symptoms of Alzheimer’s disease were not available at the time of the application, and the district court properly held that they could not be used to establish enablement.
The decision of the district court was affirmed.
Circuit Judge Gajarsa dissented, noting that:
The parties do not dispute that Dr. Davis’s insight regarding galantamine’s utility for treating Alzheimer’s Disease (AD) was correct; later animal studies and human clinical trials proved and confirmed galantamine’s effectiveness. The relevant question here is whether, at the time Dr. Davis filed her application, the patent’s written description would have credibly revealed to an ordinarily skilled artisan galantamine’s utility for AD treatment. See In re Cortright, 165 F.3d 1353, 1356 (Fed. Cir. 1999) (noting that the patent’s written description must “illuminate a credible utility” to meet the enablement requirement). The district court failed to answer that question.
Teva was unable to show inequitable conduct in its attempt to get AstraZeneca’s U.S. Pat. No. 4,879,288 declared invalid when the district court ruled that there wasn’t sufficient evidence that, in prosecution of the subject patent application in the Patent and Trademark Office, AstraZeneca made a misrepresentation of material fact or an omission of material fact to the patent office, with intent to deceive or mislead the patent examiner into granting the patent.
This is serious business since the determination that there is inequitable conduct in obtaining the patent, the district court may in its discretion declare the patent permanently unenforceable. Here, the court found that AstraZeneca didn’t have to disclose all related test data. Astrazeneca Pharma v. Teva Pharma and Sandoz (2008-1 480, -1481).
The ’288 patent claims the antipsychotic drug quetiapine, which AstraZeneca markets under the brand name “SEROQUEL®.” This product is an “atypical” antipsychotic drug, which means that, unlike “typical” antipsychotics, it does not produce involuntary body movements including torsion spasms, muscle spasms and dystonia of the face, neck, or back with protrusion of the tongue, and tonic spasms of the limbs (dyskinesias).
The issue here relates to the extent to which the patent applicant, having fully disclosed the relevant prior art and having provided comparative data to the satisfaction of the patent examiner, must also present any additional unpublished information in the applicant’s possession concerning other less structurally similar compounds, and must also synthesize additional compounds for comparative testing.
AstraZeneca filed an Information Disclosure Statement (“IDS”) listing several references including Compound 21076, Compound 24028, Perlapine and Fluperlapine. AstraZeneca had internal test data for these four compounds — as well as for many other compounds — not included in its IDS. AstraZeneca’s data showed that some prior art compounds potentially exhibited atypical antipsychotic activity, and Teva argued that this information should have been reported to the patent examiner.
During the prosecution the applicant and the examiner discussed the prior art compounds, which had small structural differences among these various compounds. The examiner based a rejection on structural similarity alone, and the applicant in response pressed the unpredictability of the critical physiological property of atypicality, and that the prior art provided no reason to make the particular compound quetiapine for the purpose of obtaining atypical antipsychotic properties. AstraZeneca pointed to the long-felt need for such a drug, because the use of clozapine was severely limited and no suitable replacement was available in the United States.
The examiner stated that in order to overcome the structural obviousness rejection AstraZeneca must provide proof that the prior art compounds:
do not necessarily or inherently possess the characteristics of the claimed product. . . . In other words, once a condition of prima facie structural obviousness has been made out, it must be overcome by a side-to-side comparison with the closest art compound(s). In this case, one would test both the prior art species ([Horrom compound] and [Schmutz X]) and the claimed specie for their ability to avoid e.g. tardive dyskinesia (or whatever undesirable side effect applicant wishes to focus on).
AstraZeneca submitted the test data in a declaration of one of the inventors, Dr. Migler. Teva argued that AstraZeneca did not submit to the PTO its internal test data for perlapine, fluperlapine, compound 21076, and compound 24028. Teva tried to show that it was a material withholding to provide test data only for the compounds on which the examiner relied, stating that AstraZeneca’s internal test data showed that compounds other than quetiapine possessed potential atypical antipsychotic activity. Thus, they argued that the Migler Declaration was deliberately misleading.
The district court found that AstraZeneca properly addressed the closest prior art, in response to the examiner’s specific requests, and that the premises of the factual allegations of material withholding with deceptive intent had not been shown sufficiently to avoid the grant of summary judgment, citing that inequitable conduct in patent prosecution requires proof by clear and convincing evidence of both (1) an affirmative misrepresentation of material fact, a failure to disclose material information, or submission of false material information, and (2) an intent to deceive the examiner by such material falsity.
Here, the Court of Appeals for the Federal Circuit agreed:
Although there may be situations in which the failure to conduct specific tests of specific compounds can be criticized, in this case there was no evidence that the information gleaned, if such tests had been conducted, would have been material to patentability. It was not disputed that it was unpredictable whether a given compound would exhibit atypical antipsychotic properties. The record demonstrates that structural similarity is not a predictor of whether antipsychotic behavior would be typical or atypical. As AstraZeneca points out, the properties of these structurally similar compounds vary significantly with minor structural changes.
The Appellants also argue that AstraZeneca should have submitted to the examiner its existing test data for Compound 24028 because Compound 24028 and Schmutz B are “equally close” to quetiapine. The Appellants state that the data should have been submitted although not identified or requested by the examiner.
To ascertain what is “equally close,” in identifying the structurally closest prior art, the compounds are viewed as they would be perceived by persons experienced in the particular field of science. Precedent suggests that as a starting point it is useful to ascertain the common elements of the claimed invention and the prior art.
We conclude, as did the district court, that the evidence cannot support a finding that AstraZeneca misrepresented or omitted material information.
The U.S. Patent and Trademark Office published a notice in the Federal Register inviting public comment regarding the Requirements for Patent Applications Containing Nucleotide Sequence and/or Amino Acid Sequence Disclosures (74 Fed. Reg. 40163).
Patent applications that contain nucleotide and/or amino acid sequence disclosures must include a copy of the sequence listing in accordance with the requirements in 37 CFR 1.821–1.825. The rules of practice require applicants to submit these sequence listings in a standard international format that is consistent with World Intellectual Property Organization (WIPO) Standard ST.25 (1998). The USPTO uses the sequence listings during the examination process to determine the patentability of the associated patent application.
Sequence listings that are extremely long (files larger than 600K or approximately 300 printed pages) are published only in electronic form and are available to the public on the USPTO sequence data Web page. The sequence listing may be submitted on paper, compact disc (CD), or through EFS–Web, the USPTO’s online filing system. Sequence listings for international applications may be submitted on paper or through EFS– Web only, though sequence listings that are too large to be filed electronically through EFS–Web may be submitted on a separate CD. Applicants may use EFS– Web to file a sequence listing online with a patent application or subsequent to a previously filed application.
This Notice gives the general public and other Federal agencies the opportunity to comment on the revision of a continuing information collection, which must be submitted to the Office of Management and Budget as required by the Paperwork Reduction Act of 1995, Public Law 104–13 (44 U.S.C. 3506(c)(2)(A)). This information collection pertains to the sequence listings that are submitted with biotechnology patent applications.
David Boundy, the Vice President of Intellectual Property for Cantor Fitzgerald — and perennial watchdog of OMB burdens regarding new rules proposed by the USPTO — held a conference call with Dr. Richard Belzer (a former economist with OMB), and Donald Zuhn of the Patent Docs blog.
The sequence listing notice is not a new rule but a publication required as part of the various statutory and administrative processes that the USPTO is obligated to follow. Boundy and Belzer wanted to bring this Notice to light (a) because patent practitioners should know about the importance of providing comments and (b) because, at least historically, the USPTO has complied as minimally as possible with the Paperwork Act–in some cases, not at all–and it has relied on the fact that few members of the public understand the law and fewer still are willing to engage in the review process.
It is important to understand that if no one engages in the process, OMB tends to rubber stamp such procedures. The USPTO is obligated under the Paperwork Reduction Act of 1980 to prepare and accept public comment on an objectively supported estimate of burden and the practical utility of any information it requires, such as from patent applicants. This is called a 60-day notice. There’s also a 30-day notice which occurs later in the process, and in that notice agencies are obligated to respond to comments it has received.
For several recent rules, the USPTO neglected to publish 60-day notices. In the case of the notorious BPAI appeals rule, the USPTO issued the notice the day before promulgating the final rule. Boundy and Belzer were instrumental in getting the rules blocked — on the date it was scheduled to become effective (December 10, 2008) — and USPTO’s neglect of proper procedure was a significant issue in dealings with the Office of Management and Budget on the matter.
It is worth notice that the Notice provides that the USPTO estimates that it will take the public approximately ten minutes (0.17 hours) to one hour and 20 minutes (1.33 hours) to gather the necessary information, prepare the sequence listing, and submit it to the USPTO, depending on whether the listing is submitted on paper, on CD, or electronically. Furthermore, the USPTO expects that the information in this collection will be prepared by paraprofessionals [only] at an estimated rate of $90 per hour.
Although it does not disclose its methods for coming up with these estimates, the USPTO currently belieces that the end-to-end process of training staff, acquiring and setting up technology, gathering sequence information, validating it, formatting it into required form, burning it onto one CD for submission and another duplicate for your own records, preparing the CD for mailing, mailing it, record retention, and attorney supervision of paralegal staff, takes on average all of 15 minutes, which is billed at $90/hour paralegal rates. If you have an objective basis to provide your own estimate, then you may want to pass along your comments to the USPTO.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, e.g., the use of automated collection techniques or other forms of information technology.
Comments submitted in response to the notice will be summarized or included in the request for OMB approval of this information collection; they also will become a matter of public record.
Written comments must be submitted on or before October 13, 2009. You may submit comments by email to Susan.Fawcett@uspto.gov. Include A0651–0024 comment@ in the subject line of the message. Comments may also be submitted by fax to: 571–273–0112, marked to the attention of Susan K. Fawcett; or mail to: Susan K. Fawcett, Records Officer, Office of the Chief Information Officer, Administrative Management Group, United States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313–1450.
Mr. Boundy and Dr. Belzer stressed that the new USPTO administration appears willing to work with members of the patent community to improve all aspects of the examination process.
The Patent Office estimates (without disclosing any objective basis for the estimate, see 5 C.F.R. § 1320.8(a)(4)) that the end-to-end process of training staff, acquiring and setting up technology, gathering sequence information, validating it, formatting it into required form, burning it onto one CD for submission and another duplicate for your own records, preparing the CD for mailing, mailing it, record retention, and attorney supervision of paralegal staff, takes an average of 15 minutes, all of which is billed at $90/hour paralegal rates. If you have objective basis to provide an alternative estimate, …
The infamous Troll Tracker suit has come to an end. As we reported, Rick Frenkel, the anonymous blogger of the Troll Tracker blog who revealed his identity, along with his employer Cisco, were sued for defamation by two attorneys from Texas, Eric Albritton and T. John “Johnny” Ward, Jr. The lawsuit was over a posting over who filed what when in a lawsuit against Cisco for patent infringement.
East Texas patent litigators Albritton and Ward sued claiming that Frenkel and his former employer Cisco Systems libeled them when Frenkel wrote that the two litigators conspired with a courthouse clerk to change a date on a patent infringement suit filing.
The original post contained a mixture of fact and opinion but it seems that the facts that Frenkel noted were accurate. The filing did originally have the earlier date on it, and the court clerk was later convinced to change it. However, Albritton claims that the post made it look like a criminal conspiracy and said he’d been “hurt” and “humiliated.” Explaining why he didn’t just complain to Frenkel, Ward said, “You don’t wrestle with a snake, you cut its head off.”
After federal district court judge Richard Schell ruled that the jury would have to find “actual malice” on the part of Frenkel and Cisco in order for the plaintiffs to win punitive damages, the the parties involved quickly settled the defamation trial in an undisclosed agreement.
Even though Albritton was not a public figure, he ruled, the “actual malice” standard adopted by the Supreme Court in New York Times Co. v. Sullivan was appropriate because the issues raised in Frenkel’s blog posts were of public concern.
Cisco Systems said that the case had been “resolved to [the parties’] mutual satisfaction, and Rick Frenkel and Cisco apologize for the statements of Rick Frenkel on the Troll Tracker blog regarding Eric M. Albritton.”
Joe Mullin, of IP Law & Business, has been reporting the case blow-by-blow.
In the suit, there was a corresponding British patent which had been held invalid in view of certain prior art. The competitor of the patentee initiated a revocation action against the Australian patent. Subsequent to the commencement of revocation proceedings in Australia, the patentee sought the permission of the court to amend its claims in order to add narrower claims.
Note, prior to court proceedings commencing, amendments can be made by the patentee as of right, provided that the claims are not broadened, and provided that no new matter is claimed – however, once court proceedings are commenced, amendments can only be made with the consent of the court.
Here, Apotex tried to get Les Laboratoires Servier’s Australian Patent No 2001276418 (AC Patent) declared invalid while Servier tried to amend the AC Patent under s 105(1) of the Patents Act 1990 (Cth) to add an additional set of narrower claims.
Section 105 of the Act confers a discretion on the Court in relation to an application to amend a patent. That is, even if proposed amendments are otherwise allowable under s 102 of the Act, the Court may still refuse to direct the amendments on discretionary grounds. The Court should consider all relevant factors in deciding the exercise of that discretion.
Guidelines identified as relevant to the exercise of discretion:
Whether there has been a full disclosure of all relevant matters;
Whether the patentee has sought to obtain an unfair advantage from the unamended patent;
Whether there has been any unreasonable delay in seeking amendment; and
Whether any circumstances arise that would lead the Court to refuse the amendment.
Here, the onus is on the patentee to satisfy the court that the amendments should be allowed. The court is concerned with the conduct of the patentee and not with the merit of the invention:
Mere delay does not warrant refusal although the patentee must explain any delay, which should be reasonable;
If a patentee becomes aware of the undue breadth of its claims, it must act to amend them without undue delay.
In the case in question, the court refused to exercise the discretionary power to allow the amendment. The two main factors relied upon by the court in not allowing the amendment were (a) delay on the part of the patentee, and (b) the patentee was seeking an unfair advantage by also retaining the original broader claims.
In relation to the second factor, the court noted that the patentee was seeking to add narrower claims which better reflected what was said by the patentee to be the crux of the invention, whilst concurrently maintaining the broader claims which went beyond the scope of the invention as asserted by the patentee.
Servier was clearly aware of the contents of the specification of the AC Patent, its own prior patent (held to anticipate the equivalent patent in the UK and in the Netherlands), the Coquerel reports written by the inventor of the AC Patent and its own prior product. Servier submits that these matters formed no part of its reasons to amend or to pursue amendment. I find that difficult to accept.
…
Servier had ample opportunity to amend the AC Patent application if it was of the view that it contained additional claimable matter. It litigated the unamended patent in the UK and pursued the grant of the unamended patent in Australia, abandoning the s 104 amendments. Servier has not sufficiently explained why it took this course. At the time of abandoning the s 104 amendments, Servier was aware of the first instance decision in the UK. Servier’s conduct in relation to the amendments disentitles it from presently amending the AC Patent in circumstances where litigation over the validity of that patent with Apotex was in clear prospect and the contest over the patent had already commenced. The lack of forthrightness in providing Servier’s reasons to amend reinforces that conclusion.
Therefore, patentees should carefully review their issued Australian claims whenever new art comes to light, and should seek to diligently make any amendments prior to any court proceedings commencing, if at all possible.
University of Tennessee (UT) Professor John Reece Roth, 72, of Knoxville, Tennessee, was sentenced to 48 months in prison for violating the Arms Export Control Act by conspiring to illegally export, and actually exporting, technical information relating to a U.S. Air Force (USAF) research and development contract. (See indictment here)
Prof. Roth was convicted by a jury in the U.S. District Court for the Eastern District of Tennessee of conspiring with Atmospheric Glow Technologies, Inc. (AGT) to unlawfully exporting fifteen different defense articles to a citizen of the People’s Republic of China, in violation of the Arms Export Control Act (AECA), 22 U.S.C. § 2778.
Roth and Atmospheric Glow Technologies (a licensee of UT technology) were indicted in connection with violations of the Arms Export Control Act. AGT had two contracts with the U.S. Air Force to conduct research and hired Professor Roth in connection with the contracts. The technology under development was controlled by the Department of State.
The illegal exports by Dr. Roth of technical information, known as “technical data,” related to his illegal disclosure and transport of restricted military information associated with the USAF contract to develop specialized plasma technology for use on an advanced form of an unmanned air vehicle (UAV), also known as a drone.
The illegal exports by Dr. Roth of military technical information involved specific information about advanced plasma technology that had been designed and was being tested for use on the wings of drones operating as a weapons or surveillance systems. The Arms Export Control Act prohibits the export of defense-related materials, including the technical data, to a foreign national or a foreign nation.
The AECA prohibits the export of defense-related materials, including the technical data, to a foreign national or a foreign nation. These defense articles related to different specific military technical data that had been restricted and was associated with the USAF project to develop plasma technology for use on weapon system drones.
Exports include “deemed exports,” defined as an unauthorized release of technology or services to a foreign national (defined as an natural person who is not a U.S. citizen, a lawful permanent resident or a political refugee/asylum holder under 8 U.S.C. §1324(b)(a)(3)), either domestically or overseas. Deemed exports occur when access to defense technology or services is provided to a foreign national.
The government alleged that Roth did not obtain permission to take the sensitive documents to China and lied to the Defense Department about his employment of Chinese foreign national Xin Dai and Iranian foreign national Sirous Nourgostar. Both graduate research assistants were given unrestricted access to information about the technology developed for use in the Air Force drones. Roth was also accused of ordering Xin Dai to e-mail to another Chinese citizen a report that also contained military defense secrets
A jury found that Dr. Roth violated the deemed export rules when he assigned a Chinese national in his laboratory to work on the plasma research project without first obtaining the appropriate license from the State Department and when he used a Chinese colleague’s workstation to download export controlled data.
What seemed to have sunk Roth’s boat was that he was advised by a UT export control officer to not disclosure the information. Violation of the Act requires willful conduct and specific intent (“voluntary, intentional violation of a known legal duty”). But, according to the government’s trial brief, Roth knew what he was doing and forged ahead anyway:
On May 3, 2006, AGT, through Project Manager Briggs, advised Roth that, “for obvious security reasons, your Iranian student is not going to be acceptable” as a replacement for Dai. Roth responded that he did not feel it was AGT’s position to tell him who he could use on the project.
On May 5, 2006, Roth met with Robin Witherspoon, the Contract Administrator and Export Control Officer at UT, and attempted to add Nourgostar to the Phase II contract and requested UT to seek an export license to accomplish this. Witherspoon then learned from Roth that Chinese national Dai had been working on the Phase II project since May 2005 without a license from the State Department. Three days later, on May 8, 2006, Witherspoon e-mailed Roth advising him that the Phase II contract was export controlled and providing him with the text of the clause so stating. She warned Roth to be cautious about what he took with him on his forthcoming trip to China and not to disclose anything about the Phase II project. Witherspoon called Roth on May 11, 2006, and advised him that she spoke to the State Department and found out that both Iran and China are prohibited countries for export control purposes.
Apparently, Dr. Roth believed that his research qualified for a fundamental research exclusion. Roth traveled to China and presented a lecture at Fudan University titled “Subsonic Plasma Aerodynamics for Flight Control of Aircraft.” On return to the US, his USB drive storage device and laptop were found to contain reports and the entire AGT Proposal to the Defense Advanced Research Projects Agency (DARPA). The DARPA proposal and the
reports were certified as a defense articles, i.e., technical data as defined in the U.S. Munitions List.
Dr. Roth probably didn’t set out with the intent of organizing an international spy ring. I could imagine that, as a professor with his reputation at stake, he let his ego and his need to report cutting edge research cloud his judgment.
The case is a reminder that universities need to be careful in complying with the the Arms Export Control Act in doing sponsored research. Anyone working with export controlled technology should review their access protocols before booking that next trip abroad.
The goods and technical data subject to control under AECA are articulated at the U.S. Munitions List, which can be found at 22 C.F.R. § 121, the International Traffic in Arms Regulations (ITAR). Technical data includes information required for the design, development, production, testing, or modification of defense articles. Defense services are also regulated, examples of which are furnishing of assistance to foreign persons in the design, development, testing or use of defense articles, whether this takes place in the U.S. or elsewhere.
The patent includes only two active steps, “administering” the drug and then “determining” metabolite levels. The claim really just explains the correlation between metabolite levels and therapeutic efficacy and “what the inventors claim to have discovered is that particular concentrations of 6-TG and 6-MMP correlate with therapeutic efficacy and toxicity in patients taking AZA drugs.” The district court decided as a matter of law that the asserted claims were drawn to non-statutory subject matter and as such, unpatentable.
Thankfully, cooler heads appear to have prevailed and the US Court of Appeals for the Federal Circuit has held that methods of treatment claims fall squarely within the realm of patentable subject matter. Prometheus Laboratories, Inc. v. Mayo Collaborative Services (08-1403).
Prometheus is the sole and exclusive licensee of U.S. Patents 6,355,623 and 6,680,302, which claim methods for calibrating the proper dosage of thiopurine drugs and are used for treating both gastrointestinal and non-gastrointestinal autoimmune diseases.
These drugs include 6-mercaptopurine (6-MP) and azathiopurine (AZA), a pro-drug that upon administration to a patient converts to 6- MP, which are used to treat inflammatory bowel diseases such as Crohn’s disease and ulcerative colitis. 6-MP is broken down by the body into various 6-MP metabolites, including 6-methyl-mercaptopurine (6-MM P) and 6-thioguanine (6-TG) and their nucleotides. The patents involve measurements of these two metabolites. Drugs that deliver 6-TG are widely used for their cytotoxic and immunosuppressive properties.
Although drugs such as 6-MP and AZA have been used for years to treat autoimmune diseases, non-responsiveness and drug toxicity may complicate treatment in some patients. So, these patents claim methods to optimize therapeutic efficacy while minimizing toxic side effects.
As written, the methods typically include two separately lettered steps: (a) administering a drug that provides 6-TG to a subject and (b) determining the levels of the drug’s metabolites, 6-TG and/or 6-MMP, in the subject. The measured metabolite levels are then compared to pre-determined metabolite levels, wherein the measured metabolite levels indicate a need to increase or decrease the level of drug to be administered so as to minimize toxicity and maximize efficacy of treatment.
Prometheus marketed a PROMETHEUS Thiopurine Metabolites test (formerly known as the PRO-PredictRx® Metabolites test) that used the technology covered by the patents in suit. Mayo Collaborative Services and Mayo Clinic Rochester formerly purchased and used Prometheus’s test, but in 2004, Mayo announced that it intended to begin using internally at its clinics and selling to other hospitals its own test. Mayo’s test measured the same metabolites as Prometheus’s test, but Mayo’s test used different levels to determine toxicity of 6-TG and 6-MMP.
The district court held that Mayo’s test literally infringed claim 7 of the ’623 patent, construing “indicates a need” to mean “a warning that an adjustment in dosage may be required.” This construction did not require doctors to adjust drug dosage if the metabolite level reached the specified levels; rather, the court found the wherein phrases to mean “that when the identified metabolites reach the specified level, the doctor is warned or notified that a dosage adjustment may be required, if the doctor believes that is the proper procedure.”
Mayo argued that the patents claim natural phenomena — the correlations between, on the one hand, thiopurine drug metabolite levels and, on the other hand, efficacy and toxicity — and that the claims wholly preempt use of the natural phenomena.
The district court noted that the warning step does not require any actual change in dosage and that “it is the metabolite levels themselves that ‘warn’ the doctor that an adjustment in dosage may be required.” With this understanding of the claims, the court concluded that the claims recited the correlations between particular concentrations of 6-TG and 6-MMP and therapeutic efficacy or toxicity in patients taking AZA drugs.
So, the district court found that those correlations were natural phenomena and not patentable inventions because the correlations resulted from a natural body process. The court stated that the inventors did not “invent” the claimed correlation; rather, “6-TG and 6-MMP are products of the natural metabolizing of thiopurine drugs, and the inventors merely observed the relationship between these naturally produced metabolites and therapeutic efficacy and toxicity.”
Section 101 provides that:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent thereof, subject to the conditions and requirements of this title. 35 U.S.C. § 101.
The Supreme Court has construed § 101 broadly, noting that Congress intended statutory subject matter to “include anything under the sun that is made by man.” Diamond v. Chakrabarty. But, the Court has held that a claim to a process is not patent-eligible if it claims “laws of nature, natural phenomena, and abstract ideas.” Diamond v. Diehr.
At the same time, it has also been established that “while a claim drawn to a fundamental principle”—i.e., a law of nature, natural phenomenon, or abstract idea—“is unpatentable, ‘an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection.’” Bilski quoting Diehr.
The key issue for patentability, then, at least on the present facts, is whether a claim is drawn to a fundamental principle or an application of a fundamental principle. Although this inquiry is hardly straightforward, following the Supreme Court, we articulated in Bilski a “definitive test” for determining whether a process is patent-eligible under § 101: “A claimed process is surely patent- eligible under § 101 if: (1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing.” Id. The machine-or-transformation test is a “two-branched inquiry,” i.e., the patentee “may show that a process claim satisfies § 101 either by showing that his claim is tied to a particular machine, or by showing that his claim transforms an article.” Id. at 961.
The machine-or-transformation test has two further aspects: “the use of a specific machine or transformation of an article must impose meaningful limits on the claim’s scope to impart patent-eligibility,” and “the involvement of the machine or transformation in the claimed process must not merely be insignificant extra-solution activity.” Bilski, 545 F.3d at 961-62 (citations omitted).
Prometheus argued that the claimed processes satisfy § 101 because they meet both prongs of the machine-or-transformation test articulated in Bilski. That is, that the patents inextricably rely on numerous machines to process the bodily sample, determine the metabolite levels, and thereby calibrate the proper dose.
Prometheus contended that the district court was wrong to not look at the dependent claims, some of which specify measurement through high pressure liquid chromatography, which clearly requires the use of machines. In addition, Prometheus argued that the synthetic drugs used in its treatment methods are compositions of matter, and the claims’ central reliance on those drugs is enough to meet the machine-or-transformation test.
Prometheus points to three “transformations” within its claimed process: (1) the first step of administering a synthetic drug transforms the biochemical makeup of the patient’s body for the purpose of treating disease; (2) the second step requires the transformation of a bodily sample to determine the created metabolites’ concentration levels; and (3) the metabolite levels are transformed into a warning for a doctor to alter the dosage. Prometheus felt that physical transformations, such as the human body’s metabolic reaction to drugs, initiated by human actions and artificial chemical compounds, such as the administration of a thiopurine drug into the body, cannot be unpatentable under Bilski simply because they proceed according to natural laws or occur within the human body because everything proceeds according to natural laws.
Prometheus also argued that all of the methods available to determine the metabolite levels in a bodily sample require a physical transformation of blood or human tissue in order to extract the metabolite and determine its concentration. And, the processes transform the patient’s treatment regime while avoiding deadly side effects by transforming the metabolite levels into a warning regarding dosage.
The Federal Circuit decided that more was involved here than just mere natural phenomenon:
We conclude that the methods of treatment claimed in the patents in suit squarely fall within the realm of patentable subject matter because they “transform an article into a different state or thing,” and this transformation is “central to the purpose of the claimed process.” See Bilski, 545 F.3d at 962. The transformation is of the human body following administration of a drug and the various chemical and physical changes of the drug’s metabolites that enable their concentrations to be determined. Because the claimed methods meet the transformation prong under Bilski, we do not consider whether they also meet the machine prong.
Contrary to the district court, we do not view the disputed claims as merely claiming natural correlations and data-gathering steps. The asserted claims are in effect claims to methods of treatment, which are always transformative when a defined group of drugs is administered to the body to ameliorate the effects of an undesired condition.
A further requirement for patent-eligibility is ensuring that the involvement of the transformation in Prometheus’s claimed process is not merely insignificant extra- solution activity.
The crucial error the district court made in reaching the opposite conclusion was failing to recognize that the first two steps of the asserted claims are not merely data- gathering steps…. While it is true that the administering and determining steps gather useful data, it is also clear that the presence of those two steps in the claimed processes is not “merely” for the purpose of gathering data. Instead, the administering and determining steps are part of a treatment protocol, and they are transformative.
The presence of a mental step does not detract from patentability:
A subsequent mental step does not, by itself, negate the transformative nature of prior steps. Thus, when viewed in the proper context, the final step of providing a warning based on the results of the prior steps does not detract from the patentability of Prometheus’s claimed methods as a whole. The data that the administering and determining steps provide for use in the mental steps is obtained by steps well within the realm of patentable subject matter. The addition of the mental steps to the claimed methods thus does not remove the prior two steps from that realm.
Thus, the claimed methods satisfy all of the requirements under Bilski’s transformation prong for patent-eligible subject matter under § 101.
Editor-in-Chief Barista Stephen Jenei is a patent attorney and Owner of Jenei LLC. When not serving up patent chat over a steaming cup of java, he's handling a diverse intellectual property practice in the biotechnology, pharmaceutical and chemical fields. More info @ Jenei LLC
