On the final day of the term, the U.S. Supreme Court released its long-anticipated decision in Bilski v. Kappos. Experts discuss the implications of the decision, and give keen insight into the case.
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Prof. John F. Duffy, George Washington University Law School
Prof. David S. Olson, Boston College Law School
Moderator: Prof. Adam Mossoff, George Mason University School of Law
In this panel podcast — it was sort of a debate, but really more of a friendly discussion — Professors John Duffy and David Olson discuss the meaning and implications of the Bilski decision. As you probably know, these two professors are highly qualified to be discussing the Bilski decision, as both of them wrote or joined briefs in the case and wrote on it in the popular press, on blogs and in law journals. In fact, Professor Duffy even participated in oral argument before the en banc panel of the Federal Circuit. Confirming their important contributions to this area of patent law, Justice Stevens cited to law journal articles by both of these scholars in his in-depth concurring opinion.
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The European Court of Justice in Luxembourg ruled against Monsanto Co. stating that “Monsanto cannot prohibit the marketing in the EU of soy meal containing, in a residual state, a [patented] DNA sequence.” Therefore, the European patent for the trait that makes soybeans resistant to the company’s Roundup herbicide doesn’t extend to soy meal made from the patented seeds.
Monsanto is the holder of European patent EP 0 546 090 granted on 19 June 1996 relating to ‘Glyphosate tolerant 5-enolpyruvylshikimate-3-phosphate synthases’ (‘the European patent’). The European patent is valid, inter alia, in the Netherlands. Glyphosate is a non-selective herbicide. In a plant, it works by inhibiting the Class I enzyme 5-enol-pyruvylshikimate-3-phosphate synthase (also called ‘EPSPS’), which plays an important role in the growth of the plant. The effect of glyphosate is that the plant dies.
The European patent describes a class of EPSPS enzymes which are not sensitive to glyphosate. Plants containing such enzymes survive the use of glyphosate, whilst weeds are destroyed. The genes encoding these Class II enzymes have been isolated from three different bacteria. Monsanto has inserted those genes into the DNA of a soy plant it has called RR (Roundup Ready) soybean plant. As a result, the RR soybean plant produces a Class II EPSPS enzyme called CP4-EPSPS, which is glyphosate-resistant. It thus becomes resistant to the herbicide ‘Roundup’.
The RR soybean is cultivated on a large scale in Argentina, where there is no patent protection for the Monsanto invention. Argentine growers planted about 43 million acres of soybeans containing Monsanto’s Roundup Ready trait last year, making the country the company’s second-biggest soybean market after the U.S., according to a Monsanto report. About 95 percent of soybeans grown in Argentina contain Monsanto’s Roundup Ready trait.
Cefetra argued that if the DNA present in the soy meal can no longer perform its function in that substance, Monsanto cannot oppose the marketing of the soy meal solely on the ground that the DNA is present in it. There is a connection between the limited patentability referred to in recitals 23 and 24 in the preamble to the Directive and the scope of the protection conferred by a patent.
Monsanto argued that the purpose of the Directive is not to limit the protection for biotechnological inventions that exists in Member States. The Directive does not affect the protection conferred by Article 53 of the 1995 Law, which is absolute. A restriction on protection would be incompatible with Article 27 of the TRIPS Agreement.
The first question
By its first question, the national court asks, essentially, whether Article 9 of the Directive is to be interpreted as conferring patent right protection in circumstances such as those of the case in the main proceedings, in which the patented product is contained in the soy meal, where it does not perform the function for which it was patented, but did perform that function previously in the soy plant, of which the meal is a processed product, or would possibly again be able to perform its function after it has been extracted from the soy meal and inserted into the cell of a living organism.
In that regard, it must be noted that Article 9 of the Directive makes the protection for which it provides subject to the condition that the genetic information contained in the patented product or constituting that product ‘performs’ its function in the ‘material … in which’ that information is contained.
The second question
By its second question, the national court asks, essentially, whether Article 9 of the Directive effects an exhaustive harmonization of the protection it confers, with the result that it precludes national patent legislation from offering absolute protection to the patented product as such, regardless of whether it performs its function in the material containing it.
That question is based on the premise, referred to in the order for reference, that a national provision such as Article 53 of the 1995 Law does in fact accord absolute protection to the patented product.
The third question
By its third question, the national court asks, essentially, whether Article 9 of the Directive precludes the holder of a patent issued prior to the adoption of that directive from relying on the absolute protection for the patented product accorded to it under the national legislation then applicable.
Like the second question, the third is based on the premise that a national provision such as Article 53 of the 1995 Law did in fact accord absolute protection to the patented product when the patent was issued prior to the Directive.
The fourth question
By its fourth question, the national court asks, essentially, whether Articles 27 and 30 of the TRIPS Agreement affect the interpretation given of Article 9 of the Directive.
On those grounds, the Court (Grand Chamber) ruled:
Article 9 of Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions is to be interpreted as not conferring patent right protection in circumstances such as those of the case in the main proceedings, in which the patented product is contained in the soy meal, where it does not perform the function for which it is patented, but did perform that function previously in the soy plant, of which the meal is a processed product, or would possibly again be able to perform that function after it had been extracted from the soy meal and inserted into the cell of a living organism.
Article 9 of the Directive effects an exhaustive harmonization of the protection it confers, with the result that it precludes the national patent legislation from offering absolute protection to the patented product as such, regardless of whether it performs its function in the material containing it.
Article 9 of the Directive precludes the holder of a patent issued prior to the adoption of that directive from relying on the absolute protection for the patented product accorded to it under the national legislation then applicable.
Articles 27 and 30 of the Agreement on Trade-Related Aspects of Intellectual Property Rights, constituting Annex 1C to the Agreement establishing the World Trade Organization (WTO), signed at Marrakesh on 15 April 1994 and approved by Council Decision 94/800/EC of 22 December 1994 concerning the conclusion on behalf of the European Community, as regards matters within its competence, of the agreements reached in the Uruguay Round multilateral negotiations (1986-1994) do not affect the interpretation given of Article 9 of the Directive.
Apparrently, if a product has the DNA ground up, it never existed. I guess it’s all in the timing.
In situations in which two or more independent and distinct inventions are claimed in a single patent application, the United States Patent and Trademark Office (Office) is authorized by the patent laws and regulations to require the applicant to restrict the application to one invention. The practice for requiring an applicant to restrict an application to one invention in such situations is known as restriction practice. The Office is considering changes to restriction practice.
Details
The Office is seeking suggestions from the public regarding possible changes to restriction practice because this is a significant area of concern for the Office, applicants, and the public. Thus, the Office is soliciting comments from the public concerning several aspects of restriction practice.
First, the Office is asking for comments on what should be included in an Office action that sets forth a restriction requirement.
Second, because unwarranted restriction requirements can result in delays in prosecution, expenditure of excess claim fees, and/or the need to file multiple divisional applications, the Office is inviting suggestions from the public as to how to improve the process for traversing or requesting reconsideration of a restriction requirement to achieve more consistent, accurate, timely, and cost-effective review.
Third, the Office is aware that restriction requirements between related product inventions or related process inventions have been problematic, and thus is inviting public comments on the changes under consideration to clarify what is necessary in order to restrict between such inventions.
Fourth, the Office is also considering some changes with regard to restrictions involving claims with Markush groupings, and invites public comment on these changes as well as any other suggestions regarding the treatment of Markush claims.
Fifth, the Office is considering changes to rejoinder practice in an effort to simplify what claimed inventions would be eligible for rejoinder upon the determination that all elected claims are allowable, and invites public comments on these changes.
Finally, the Office invites comments specifically pointing out other areas in which restriction practice could be improved.
As discussed previously, the Office is considering changes to Office practice and policy with regard to restriction requirements. The Office is requesting public input on restriction practice. The Office is not presently proposing any changes to the rules pertaining to restriction practice, and this notice is not a notice of proposed rule making.
1. What should be included in an Office action that sets forth a restriction requirement?
The MPEP currently explains that two criteria must be met to require restriction between patentably distinct inventions, i.e., the inventions must be independent or distinct as claimed, and there must be a serious burden on the examiner if restriction is not required. See MPEP § 803. The Office is considering clarifying the MPEP to indicate that a restriction requirement (including an election of species requirement) must always set forth the reasons why the inventions are independent or distinct and why there would be a serious burden in the absence of a restriction requirement.
The Office is considering changes to the burden requirement, an area fundamental to restriction practice. The rationales set forth in the current MPEP to support the burden prong are based on the prior art search (i.e., the inventions have acquired a separate status in the art in view of their different classification; the inventions have acquired a separate status in the art due to their recognized divergent subject matter; and the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries)). See MPEP § 808.02. The Office is considering whether to revise the MPEP to indicate that there would be a serious burden if restriction is not required when the prior art applicable to one invention would not likely be applicable to another invention (e.g., because of a different field of art or different effective filing date).
The Office is also considering whether to revise the MPEP to specify that ‘‘a serious burden on the examiner’’ encompasses search burden and/or examination burden. Typically, the burden prong has been viewed as referring to the burden imposed by searching for patentably distinct inventions. However, the determination of whether a claimed invention is allowable requires both a search of the prior art and an examination of the application to determine whether the claimed invention meets the statutory requirements for patentability. The burden imposed by the examination of patentably distinct inventions is, in many cases, as serious as the burden imposed by searching for such inventions. Therefore, the Office is considering explaining that in addition to the rationales currently set forth in the MPEP, a serious burden in support of a restriction requirement may be based on the rationale that the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph. (emphasis added) In this situation, a serious search burden and/or examination burden may exist where issues relevant to one invention are not relevant to the other invention.
The MPEP currently provides for election of species practice when an application includes a generic claim along with separate claims to different species that fall within the scope of that generic claim and that may be patentably distinct. See MPEP § 806.04. The Office is considering revising the MPEP to indicate that in setting forth the species from which an applicant is required to elect, the examiner should group together species that are not patentably distinct from each other, the examiner should require election of either a single species or a single grouping of patentably indistinct species, and the applicant should not be required to elect a specific species within a grouping of patentably indistinct species.
2. What practice changes would result in more effective ways to seek higher level review of restriction requirements?
In various forums, members of the public have expressed overall dissatisfaction with the effectiveness of traversing or requesting reconsideration of requirements for restriction. Unwarranted restriction requirements can result in delays in prosecution, expenditure of excess claim fees, and/or the need to file multiple divisional applications to avoid dedication of unclaimed subject matter to the public. The Office invites suggestions from the public as to how to improve the traversal or request for reconsideration process within the framework of the current rules (see 37 CFR 1.143 and 1.144) to achieve more consistent, accurate, timely, and cost-effective review.
3. How could the Office clarify requirements for restriction between related product inventions or related process inventions where the relationship is not specifically provided for in MPEP Chapter 800?
The Office is considering providing for a new section in the MPEP to address restriction between related product inventions or related process inventions not otherwise provided for in MPEP §§ 806 through 806.05(j). See, e.g., MPEP § 806.04 et seq. for restricting between inventions in a genus/species relationship; MPEP § 806.05(c) for an explanation of the requirements to restrict between inventions in a combination/ subcombination relationship; MPEP § 806.05(d) for restricting between subcombinations disclosed as usable together; and MPEP § 806.05(j) for restricting between an intermediate and a final product. Specifically, the Office is considering explaining that to support a requirement for restriction between two or more related product inventions, or between two or more related process inventions, that are not otherwise provided for in MPEP §§ 806 through 806.05(j), there must be two-way distinctness (see MPEP § 802.01) and a serious burden if restriction were not required. The Office is considering explaining that for such related product inventions or such related process inventions, the inventions are distinct if:
The inventions as claimed have mutually exclusive characteristics (see MPEP §§ 806 through 806.05(f));
the inventions as claimed are not obvious variants over each other; and
each invention as claimed can be made by, or used in, a materially different process or product. In an effort to reduce the number of improper requirements for restriction between related product inventions or related process inventions, the Office is considering explaining that where claims of an application define the same essential characteristics of a single invention, e.g., the claims vary from each other only in breadth or scope (ranging from broad to detailed), the examiner should not require restriction between such claims.
4. How could the Office modify Markush practice?
The Office is considering whether to revise Markush practice in three particular ways. First, if the examiner determines that the elected species is allowable, the Office is considering specifying that the examination of the Markush-type claim will be extended to the extent necessary to determine the patentability of the claim, i.e., to determine whether any nonelected species is unpatentable for any reason (35 U.S.C. 101, 102, 103, or 112, or nonstatutory double patenting). If a nonelected species is determined to be unpatentable, the Markush-type claim would be rejected, and the search and examination would not be extended to cover all nonelected species.
Next, the Office is consideringrevising the treatment of amended Markush-type claims to clarify that whether an Office action may be made final is determined by whether the conditions in MPEP § 706.07 for making a second or subsequent Office action final are met and is not dependent upon whether the examiner previously required a provisional election of species.
Lastly, the Office is considering situations where restriction may be proper between a subcombination and a combination when a subcombination sets forth a Markush grouping of alternatives. In particular, the Office is referring to a subcombination that (1) encompasses two or more subcombination embodiments within its scope, and (2) lists those embodiments using Markush-type claim language, i.e., lists the embodiments as a group of alternatives from which a subcombination embodiment is selected. For example, the Office is considering whether restriction would be proper between a subcombination claim to an individual DNA molecule selected from a list of alternative embodiments and a combination claim to an array comprising a plurality of DNA molecules wherein one or more of the DNA molecules are selected from the list of alternative embodiments set forth in the subcombination claim. In such a situation, the combination claim does not require all the elements of any particular claimed subcombination to be present in the claimed array.
Apart from these specific considerations, the Office invites suggestions from the public regarding changes to the practice of requiring election/restriction of Markush claims in a manner that balances the interests of the Office and those of the public in the context of the current statutory and regulatory framework.
5. How could the Office improve rejoinder practice?
The Office is considering changes to rejoinder practice as part of an effort to institute more uniform treatment of claims directed to nonelected subject matter upon the determination that all claims to the elected invention are allowable. The Office is considering whether to define “rejoinder” as the practice of withdrawing a restriction requirement as between some or all groupings of claims and reinstating certain claims previously withdrawn from consideration that occurs when the following conditions are met: (1) All claims to the elected invention are allowable; and (2) it is readily apparent that all claims to one or more nonelected inventions are allowable for the same reasons that the elected claims are allowable. Claims that meet the second condition for rejoinder may include, for example, those that (1) properly depend from an allowable elected claim; (2) include all of the limitations of an allowable elected claim; or (3) require no further search and/or examination. Claims that may not be eligible for rejoinder would include, for example, those that require additional consideration of the prior art or raise utility, enablement, or written description issues not considered during examination of the allowable elected claims.
Separately, the Office is also considering instructing examiners that when all claims directed to an elected invention are allowable, nonelected claims must be considered for rejoinder and withdrawal of the restriction requirement. In making this decision, examiners must reevaluate both aspects of the restriction requirement, i.e., whether the nonelected invention(s) as now claimed are independent or distinct from the claim(s) to the allowable elected invention and whether there would be a serious burden if the nonelected inventions were rejoined.
6. What other areas of restriction practice can the Office improve and how?
While the Office has set forth particular restriction practice issues for which comments are specifically being requested, the Office is in this request for comments inviting comments on any area in which restriction practice could be improved.
Comment Deadline Date
Written comments must be received on or before August 13, 2010. No public hearing will be held. Written comments should be sent by electronic mail message over the Internet addressed to Restriction_Comments@uspto.gov. Comments may also be submitted by mail addressed to: Mail Stop Comments—Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313–1450, marked to the attention of Linda S. Therkorn.
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The petition for a writ of certiorari is granted. The judgment is vacated, and the case is remanded to the United States Court of Appeals for the Federal Circuit for further consideration in light of Bilski v. Kappos, 561 U.S. ___ (2010). This case, a § 101 matter that parallels the issues in Prometheus v. Mayo, involves patents involving a mechanism for evaluating the safety of vaccine administration schedules by comparing or identifying the adverse events associated with various vaccine schedules.
The claims in Classen are directed to methods of selecting vaccine regimens by comparing two regimens and identifying the regimen less likely to cause chronic autoimmune disorders. The patent was killed as directed to patent ineligible processes under Section 101 under the belief that the immunization step was an “insignificant post-solution activity” and the claims were merely an indirect attempt to patent the idea that there is a relationship between vaccine schedules and chronic immune mediated disorders and “an attempt to patent an unpatentable natural phenomenon.”
The Federal Circuit affirmed the district court’s grant of summary judgment that these claims are invalid under 35 U.S.C. § 101 “in light of our decision in In re Bilski.” The held that the claims were neither “tied to a particular machine or apparatus” nor do they “transform[] a particular article into a different state or thing.”
The petition for a writ of certiorari is granted. The judgment is vacated, and the case is remanded to the United States Court of Appeals for the Federal Circuit for further consideration in light of Bilski v. Kappos, 561 U.S. ___ (2010). The Federal Circuit, reversing the district court, upheld Prometheus’s patent claims covering a means to measure the level of 6-thioguinine (6-TG) and 6-methylmercaptopurine (6-MMP), which indicates that an adjustment in drug dosage may be required at certain metabolite levels.
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). The Federal Circuit may now have a chance to take up some issues that were avoided due to the earlier Bilski decision.
—————————- *The Supreme Court of the United States may issue GVR orders (stands for grant, vacate, and remand). These orders are especially appropriate when there has been a change in the law subsequent to the lower court or agency’s decision such as with Bilski. GVR orders are not full explications.
FROM: Robert W. Bahr, Acting Associate Commissioner For Patent Examination Policy
SUBJECT: Supreme Court Decision in Bilski v. Kappos
Today, the Supreme Court affirmed the USPTO’s decision that the claims in the patent application at issue in Bilski v. Kappos are not patent-eligible under 35 U.S.C. § 101.
The purpose of this memorandum is to provide interim guidance to the Patent Examining Corps.
The Supreme Court confirmed that section 101 “specifies four independent categories of inventions or discoveries that are eligible for protection: processes, machines, manufactures, and compositions of matter.” The Supreme Court also confirmed that, although the text of section 101 is broad, it is not without limit in that its “precedents provide three specific exceptions to § 101’s broad patent-eligibility principles, ‘laws of nature, physical phenomena, and abstract ideas.'”
The Supreme Court decided that under its precedents (Benson, Flook, Diehr) the claims in Bilski are not patent-eligible processes under section 101 because they are an attempt to patent abstract ideas.
The Supreme Court indicated that the machine-or-transformation test is not the sole test for patent-eligibility of processes under 35 U.S.C. § 101. However, the Supreme Court indicated that its “precedents establish that the machine-or-transformation test is a useful and important clue, an investigative tool, for determining whether some claimed inventions are processes under § 101.”
Significantly, the Supreme Court also indicated that a business method is, at least in some circumstances, eligible for patenting under section 101.
The Supreme Court indicated that the patent-eligibility inquiry under section 101 is only a threshold inquiry, and that a claimed invention must also satisfy the Patent Act’s requirements that it be novel, nonobvious, and fully and particularly described.
Examiners should continue to examine patent applications for compliance with section 101 using the existing guidance concerning the machine-or-transformation test as a tool for determining whether the claimed invention is a process under section 101. If a claimed method meets the machine-or-transformation test, the method is likely patent-eligible under section 101 unless there is a clear indication that the method is directed to an abstract idea. If a claimed method does not meet the machine-or-transformation test, the examiner should reject the claim under section 101 unless there is a clear indication that the method is not directed to an abstract idea. If a claim is rejected under section 101 on the basis that it is drawn to an abstract idea, the applicant then has the opportunity to explain why the claimed method is not drawn to an abstract idea.
The USPTO is reviewing the decision in Bilski and will be developing further guidance on patent subject matter eligibility under 35 U.S.C. § 101.
This morning, the Supreme Court issued its long awaited opinion in Bilski v. Kappos, a case which dealt with whether new processes were patentable only if they were performed with a specific machine, or resulted in a physical transformation of some article. In the run up to the decision, many commentators had predicted that the Court would issue a restrictive ruling, and that it might go so far as to declare that inventions in the fields of software and business methods could not be patented.
The Supreme Court rejected both of those options. Instead, it stated that the language of the Patent Act precluded any rule that categorically excludes business method patents. The Court also explicitly rejected the argument that new technology areas, such as software and medical diagnostic methods, should be excluded from patentability, and stated that excluding such inventions would “frustrate the purposes of the patent law.”
However, the Supreme Court did not indicate that there were no limits on the types of inventions that are eligible for patent protection. In its ruling, the Court reiterated its longstanding rules that laws of nature, physical phenomena and abstract ideas are not patent eligible. It then applied those principles to declare that the invention at issue in the case, which was directed to a method for hedging risk of price changes, was directed to an abstract idea, and therefore was unpatentable. The Court also stated that trying to patent an abstract idea in the limited context of a particular field was not sufficient to avoid the general prohibition on patents for abstract ideas.
Going forward, the practical impact of this decision is that it opens the potential for patent protection for inventions that would not have qualified under the “machine or transformation” test. However, further decisions will be necessary to see exactly how lower courts will apply today’s ruling. For further information, please drop us an email.
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
On the final day of the term, the U.S. Supreme Court released its long-anticipated decision in Bilski v. Kappos. Experts discuss the implications of the decision, and give keen insight into the case.
