- Posts by Michael P. Visconti, IIIPartner
Michael P. Visconti, III is a partner and the Deputy Chair of Nutter's Intellectual Property Department. He is a member of the Life Sciences and Medical Devices practice group and also serves on the firm’s Hiring Committee.
In late June, the United States Supreme Court issued a long-awaited decision in Alice Corporation Pty. Ltd. v. CLS Bank International that may have broad-reaching implications on patenting software. At issue in the case was whether claims to a computer-implemented system and method for mitigating “settlement risk” in financial transactions are eligible for patenting under 35 U.S.C. § 101. In a unanimous decision, the Court held that the claims were directed to an abstract idea and, although implemented on a computer, were not patentable.
Following closely on the heels of the United States Supreme Court decision in Alice Corporation Pty. Ltd. v. CLS Bank International, 573 U.S. ___ (2014) (CLS Bank), the United States Patent and Trademark Office (USPTO) has issued guidelines for the examination of patent applications claiming abstract ideas, particularly, as those implemented on computers. The guidelines went into effect yesterday, but are preliminary: the USPTO indicates that it will issue additional guidance after further consideration of the Court's decision and public feedback. 1
Today’s long-awaited decision by the United States Supreme Court in Alice Corporation Pty. Ltd. v. CLS Bank International, 573 U.S. ___ (2014) may have broad-reaching implications on patenting software. At issue in the case was whether claims to a computer-implemented system and method for mitigating “settlement risk” in financial transactions are eligible for patenting under 35 U.S.C. § 101. In a unanimous decision, the Court held that the claims were directed to an abstract idea and, although implemented on a computer, were not patentable.
The Federal Circuit’s recent decision in Medtronic v. Edwards Lifesciences highlights the importance of maintaining accurate priority claims in patent applications, particularly those with multiple generations of priority.
The Patent Trial and Appeal Board (PTAB) at the USPTO recently issued a rare precedential opinion in Ex Parte Mewherter that addresses subject matter eligibility of computer program product claims under 35 U.S.C. § 101. The PTAB affirmed the examiner’s rejection of a claim that recited a “machine readable storage medium” as being directed to non-statutory subject matter under 35 U.S.C. § 101. In particular, the PTAB held that the term “storage” in “machine readable storage medium” did not save the claim from encompassing non-statutory signals, carrier waves, and the like. In light of this decision, patent applicants should continue to include the modifier “non-transitory” in software medium claims to avoid § 101 issues. Explicit support for the term “non-transitory” can be provided in the specification at the application drafting stage. Claims to a “non-transitory” medium can also be properly supported even when the specification does not expressly include the term, per a USPTO Official Gazette Notice that offers guidance on this issue. Patent applicants should also continue to provide written description support for propagating signals per se, as other jurisdictions such as Europe consider such embodiments to be patent eligible.
Now more than ever, care should be taken when drafting patent applications to avoid unintentionally narrowing the claims under the doctrine of claim scope disavowal.
On May 16, 2012, the United States Patent and Trademark Office (PTO) launched a new “Quick Path Information Disclosure Statement (QPIDS)” pilot program. The program is intended to reduce application pendency and applicant costs when it becomes necessary to submit an information disclosure statement (IDS) after the issue fee is paid for a patent application.
In recent weeks, the Court of Appeals for the Federal Circuit (Federal Circuit) decided a number of noteworthy patent cases. The cases that follow touch on a variety of issues, including claim construction, patentable subject matter, prior inventorship, standing, and industry standard compliance as evidence of infringement.
Implicit Redefinition of Claim Terms and Patentability of Printed Matter
– AstraZeneca LP v. Apotex, Inc. (November 1, 2010)
In AstraZeneca LP v. Apotex, Inc. the Federal Circuit reaffirmed that claim terms can be implicitly redefined in the specification, for example where the term is used throughout the specification in a manner consistent with only a single meaning.
The defendant, Apotex, filed an Abbreviated New Drug Application (ANDA) seeking FDA approval to manufacture and sell a generic version of Pulmicort®, a budesonide inhalation suspension developed and patented by AstraZeneca for treating asthma. AstraZeneca then filed a declaratory judgment action and moved to enjoin Apotex from distributing the generic.
Apotex challenged the validity of the asserted claims, which included both method of use claims and kit claims. The method claims recited administering a “budesonide composition” once daily. Apotex argued that the claimed “budesonide composition” should be construed to include budesonide encased in a liposome shell, once-daily administration of which was taught by a prior art patent. The court disagreed, finding that the patentee had implicitly defined “budesonide composition” in the specification to mean only compositions in which budesonide was dispersed in a solvent. The court noted that “the specification may reveal a special definition given to a claim term by the patentee that differs from the meaning it would otherwise possess” and that “the specification need not reveal such a definition explicitly.” Rather, “a claim term may be clearly redefined without an explicit statement of redefinition,” for example “when a patentee uses a claim term throughout the entire patent specification in a manner consistent with only a single meaning.” As a result, the recited “budesonide composition” differed from the prior art liposome-encased budesonide, and the validity of the method claims was affirmed.
Although the finding of implicit redefinition was helpful to the patentee in AstraZeneca, the case is an important reminder that care should be taken when drafting patent applications to avoid unintentionally redefining a claim term to have a narrower scope than intended.
The AstraZeneca court also addressed the issue of whether a kit claim directed to a known pharmaceutical in combination with a printed label indicating a new use of the pharmaceutical could give rise to a patentable invention.
The asserted kit claims recited the budesonide composition and a label indicating once-daily administration by nebulization. Apotex argued that the kit claims were invalid because the composition was known in the prior art, and because a printed label is of no patentable consequence. The court agreed, holding that printed matter is generally outside the scope of 35 U.S.C. §101, unless there is a functional relationship between the printed matter and its substrate. Here, the court found that “the instructions in no way function with the drug to create a new, unobvious product” and therefore the kit claims were invalid. The court also found the parties’ disagreement as to whether the “substrate” was the drug or the label to be immaterial, because under either interpretation the printed matter did no more than “explain how to use the known drug.”
Accordingly, patent applicants should not rely solely on printed matter in distinguishing their invention, and should instead recite other patentable features in the claims. Additionally, patentees who are considering asserting claims that recite printed matter should review the other features of the claim carefully to ensure that those features alone would withstand a validity attack.
Definition of “Prior Inventor” Under 35 U.S.C. §102(g) – Solvay S.A.
v. Honeywell International, Inc. (October 13, 2010)
The Federal Circuit in Solvay S.A. v. Honeywell International, Inc. held that a “prior inventor” under §102(g) must conceive of the invention and reduce it to practice in the United States. This clarification of the statute should be useful to those assessing whether a particular activity constitutes invalidating prior art.
The plaintiff, Solvay, sued Honeywell for infringement of its patent directed to methods for making HFC-245fa, an insulation agent commonly used in refrigeration and heat storage systems. Solvay appealed after the district court ruled that some of its asserted claims were invalid under 35 U.S.C. §102(g)(2).
The claimed invention was conceived and first reduced to practice in Russia by the Russian Scientific Center for Applied Chemistry (RSCAC). Pursuant to a research agreement, RSCAC reported its invention to Honeywell and provided detailed instructions for carrying out the inventive method. Honeywell subsequently began practicing the invention in the United States before the priority date of the asserted patent. Based on these undisputed facts, the district court found that Honeywell was a “prior inventor” under §102(g)(2) and therefore held the asserted claims to be invalid.
On appeal, the Federal Circuit reversed. The court held that §102(g)(2) requires the prior invention to be made in the United States, and that “invention” requires both conception and reduction to practice. Here, conception occurred in Russia by RSCAC, an entity entirely separate and distinct from Honeywell. Honeywell’s United States activity, which merely involved following the detailed instructions of RSCAC, did not amount to conception in the United States. Accordingly, Honeywell was not a “prior inventor” under the statute, and the district court’s invalidity ruling was in error.
Standing for Subsequent Paragraph IV ANDA Filers – Teva
Pharmaceuticals USA, Inc. v. Eisai Co., Ltd. (October 6, 2010)
In Teva Pharmaceuticals USA, Inc. v. Eisai Co., Ltd., the Federal Circuit held that a subsequent Paragraph IV Abbreviated New Drug Application (ANDA) filer had standing to initiate a suit that could trigger the exclusivity period of the first-filer. Generic drug manufacturers who find themselves second in line for ANDA approval should consider whether their situation mirrors that in Teva, and thus whether initiating a suit to trigger a first-filer’s exclusivity period would be worthwhile.
By way of background, a manufacturer seeking to market a generic version of a previously-approved drug must file and receive approval of an ANDA and must submit a certification with respect to any patents on the drug that are listed in the FDA’s Orange Book. The first manufacturer to file a “Paragraph IV Certification” is entitled to 180 days of generic marketing exclusivity. Until the first-filer’s exclusivity period has run, the FDA may not approve ANDA applications by other manufacturers who have filed Paragraph IV certifications for the same patent. The exclusivity period begins when the first-filer commences marketing activity of the drug, or upon entry of a court judgment finding the patent invalid or not infringed, whichever happens first.
In the instant case, the Federal Circuit was asked to decide whether a subsequent Paragraph IV filer has Article III standing to seek declaratory judgment of invalidity or non-infringement and thereby trigger the first-filer’s exclusivity period. Here, the subsequent filer (Teva) sued the patent holder (Eisai) in an effort to start the 180 day window afforded to the first-filer (Ranbaxy Laboratories). The district court dismissed the case for lack of standing.
On appeal, the Federal Circuit held that a generic drug company’s injury (i.e., exclusion from the market) is fairly traceable to the patent holder’s actions because “but-for” the patent holder’s decision to list a patent in the Orange Book, FDA approval of the generic drug company’s ANDA would not have been independently delayed by that patent. The court went on to state that “when an Orange Book listing creates an ‘independent barrier’ to entering the marketplace that cannot be overcome without a court judgment that the listed patent is invalid or not infringed—as for Paragraph IV filers—the company manufacturing the generic drug has been deprived of an economic opportunity to compete.” The court thus found that Teva had Article III standing for a declaratory judgment suit because such a suit redresses this alleged injury by eliminating the potential for the corresponding listed patent to exclude the generic drug from the market.
Industry Standard Compliance as Evidence of Infringement –
Fujitsu Limited v. Netgear Inc. (September 20, 2010)
The Federal Circuit in Fujitsu Limited v. Netgear Inc. held that an accused product’s compliance with an industry standard covered by an asserted claim can be evidence of infringement. The court’s holding should help dramatically reduce the time and cost required to litigate cases involving standards-compliant accused products.
The plaintiffs, Fujitsu, Phillips, and LG, sued Netgear for infringement of their respective patents directed to wireless communication technologies. Each of the patents related to at least one of two popular wireless standards: the “IEEE 802.11 Standard” and the “WMM Specification.” The plaintiffs are part of a licensing pool that purports to include patents that any manufacturer of 802.11 and WMM compliant products must license.
After claim construction, the plaintiffs moved for summary judgment of infringement, arguing that by simply complying with the standard, Netgear necessarily infringed the asserted claims. The district court denied the motion, holding that the plaintiffs must show evidence of infringement for each accused product.
On appeal, the Federal Circuit held that a district court may rely on an industry standard in analyzing infringement. If the district court construes the claims and finds that the reach of the claim includes any device that practices a standard, then this can be sufficient for a finding of infringement. The court reasoned that, while claims should be compared to an accused product, if the accused product operates in accordance with a standard, then comparing the claims to that standard is the same as comparing the claims to the accused product. In addition, the court found that public policy favored such an approach, as it would be a waste of judicial resources to separately analyze every accused product when it is undisputed that the accused products practice the standard. The court recognized that an accused infringer is of course free to either prove that the claims do not cover all implementations of the standard, or to prove that its product does not practice the standard.
The court further noted that, in some cases, the standard may not provide the level of specificity required to establish that practicing the standard would always result in infringement. Likewise, when the relevant section of the standard is optional, then standards compliance alone would not establish that that accused product implements the optional section. Because the instant case involved one of these exceptions, the district court’s denial of summary judgment was affirmed.
This advisory was prepared by Nutter's Intellectual Property practice. For more information, please contact your Nutter attorney at 617.439.2000.
This update is for information purposes only and should not be construed as legal advice on any specific facts or circumstances. Under the rules of the Supreme Judicial Court of Massachusetts, this material may be considered advertising.
On August 7, 2010, Elena Kagan officially assumed office as an Associate Justice of the Supreme Court of the United States. Justice Kagan was born in New York, New York and has earned degrees from Princeton, Oxford, and Harvard Law School, where she served as supervising editor of the Harvard Law Review.
Justice Kagan clerked for Abner Mikva of the U.S. Court of Appeals for the District of Columbia Circuit and for Justice Thurgood Marshall of the Supreme Court of the United States. She also worked as an associate at Williams & Connolly, LLP, as professor at the University of Chicago Law School and at Harvard Law School, and as associate counsel to President Clinton. Justice Kagan also served as deputy assistant to the President for Domestic Policy, as Deputy Director of the Domestic Policy Council, and as the 11th dean of Harvard Law School. President Obama nominated her to serve as the 45th Solicitor General of the United States and then to serve as an Associate Justice of the Supreme Court.
Leading up to Justice Kagan’s confirmation, much was written about the relative lack of a “paper trail” from which one might infer her position on certain issues. Indeed, as a non-judge, she had never authored a court decision or opinion prior to joining the Supreme Court. In addition, Justice Kagan has written comparatively few journal articles and other scholarly papers. As a result, Justice Kagan’s views on the law of intellectual property remain mostly a mystery.
Nonetheless, Justice Kagan certainly does have experience with IP issues. For example, as Solicitor General, she oversaw her office’s handling of the Bilski1 case. In that case, the Solicitor’s Office supported the Federal Circuit’s “machine or transformation” test for determining patent eligible subject matter under 35 U.S.C. §101 and argued that the petitioner’s claims were directed to an unpatentable method of organizing human activity.
During her time as Solicitor General, Justice Kagan was also involved in the Able Time2 trademark case, in which her office opposed the petitioner’s argument they were free under the Tariff Act to import items bearing a registered trademark, so long as the trademark owner did not yet make the same item.
Justice Kagan also has experience with copyright issues. While she was Solicitor General, her office opposed certiorari in Cable News Network, Inc. v. CSC Holdings, Inc., 129 S.Ct. 2890 (2009), a copyright case concerning remote-storage DVR technology.In the brief, Justice Kagan’s office supported the lower court’s holding that the technology wouldn’t violate copyright holders’ rights, and argued that the technology was a fair use. Her office also submitted an amicus brief in the Reed Elsevier3 case, arguing that a federal statute requiring registration of a copyrighted work before an action for infringement can be instituted did not limit the subject-matter jurisdiction of the federal courts.
During her time at Harvard Law School, Justice Kagan was a proponent of the school’s Berkman Center for Internet & Society, and was credited with recruiting Lawrence Lessig and other prominent IP scholars.
In sum, while Justice Kagan’s judicial philosophy on intellectual property issues is thus far unknown, there is no question that she has considerable experience in the field.
1Bilski v. Kappos, 130 S.Ct. 3218 (2010).
2Able Time, Inc. v. United States, 129 S.Ct. 2864 (2009).
3Reed Elsevier, Inc. v. Muchnick, 130 S.Ct. 1237 (2009).
This advisory was prepared by Nutter's Intellectual Property practice. For more information, please contact your Nutter attorney at 617-439-2000.This update is for information purposes only and should not be construed as legal advice on any specific facts or circumstances. Under the rules of the Supreme Judicial Court of Massachusetts, this material may be considered advertising.
In an effort to improve patent quality and accelerate patent examination, the European Patent Office (EPO) adopted a number of rule changes that are set to take effect on April 1, 2010. This article summarizes some of the more-significant changes.
Divisional Applications (Rule 36)
At present, European divisional applications can generally be filed at any time during the pendency of the application to which they claim priority.
Under the new rules, divisional applications must also be filed within 24 months of the first communication from the Examining Division issued in the family or within 24 months of the first lack of unity objection raised in the immediate parent application, whichever is later. It is still required that the immediate parent application be pending for a claim of priority to be made.
Although this new divisional rule applies retroactively to pending applications, a grace period has been established that gives applicants in such cases at least until October 1, 2010, to file divisional applications. Accordingly, applicants should review all of their pending European applications to determine the need for divisional filings. This is especially true for applications that received a first official communication more than two years ago.
Mandatory Response to Search Reports (Rule 161 & Rule 70a)
The new rules also make responses to search reports compulsory in many cases. For example, in PCT applications where the EPO acts as the International Searching Authority (ISA), the EPO will now invite applicants to submit a response to the Written Opinion of the International Search Report (ISR) shortly after entering the European regional phase of prosecution. A response to this invitation is mandatory and must be filed within one month of the EPO communication. This relatively short period for response should be considered when applicants select the ISA for their PCT application, and applicants should begin preparing a response strategy very soon after the ISR is published.
For direct European filings or for PCT applications in which the EPO was not selected as the ISA, the new rules require applicants to respond to objections raised in the European Search Report, a practice that had typically been optional in the past.
Identification of Claims to be Searched (Rule 62a)
Currently, the EPO typically searches all independent claims in an application, even if there are multiple independent claims in the same category (e.g., product, process, etc.). In such cases, the EPO will often require the applicant to restrict the claims during examination to just one claim per category.
Under new Rule 62a, only one independent claim will be searched for each category. When an application contains more than one such claim, the EPO will invite applicants to indicate the claim that should be searched. Unless the applicant responds within two months, the EPO will simply search the first claim in each category.
In view of this rule change and the new time limits on filing divisional applications, applicants should carefully review any applications that contain multiple independent claims to determine the need for divisional filings.
Identification of Subject Matter to be Searched (Rule 63)
In contrast to present practice, the EPO will be permitted under the new rules to require applicants to identify the subject matter to be searched, for example when the EPO deems that the claims are too broad or unclear to conduct a meaningful search, or that the claims are directed to non-patentable subject matter. In such cases, a two month deadline for responding will be set by the EPO.
Amendments to European Applications (Rule 137)Although most applicants already adhere to this practice, it will now be mandatory for applicants to identify the support in the original application for any amendments to the application.
In addition, changes to Rule 137 reduce the number of opportunities for applicants to make voluntary amendments. For example, while applicants currently have the right to amend an application twice as a matter of right – once after the European Search Report issues and once during examination – the new rules eliminate this latter opportunity. Instead, applicants can only make voluntary amendments in response to the European Search Report. Further amendments can only be made with permission of the Examining Division.
The upcoming European rule changes require applicants to elect subject matter and address claim objections at a much earlier stage of prosecution. They also make it more difficult to protect a number of distinct inventions in a single application filing and greatly reduce the time period in which divisional applications can be filed. These changes can therefore have a dramatic impact on prosecution strategy and budgeting. Applicants should now review applications more closely before filing in Europe, be prepared to file substantive responses much sooner than usual, and work closely with their attorneys to ensure that no loss of rights occur due to missed divisional filing deadlines.
This advisory was prepared by Nutter's Intellectual Property practice. For more information, please contact your Nutter attorney at 617-439-2000.This update is for information purposes only and should not be construed as legal advice on any specific facts or circumstances. Under the rules of the Supreme Judicial Court of Massachusetts, this material may be considered as advertising.
Maximizing the protection and value of intellectual property assets is often the cornerstone of a business's success and even survival. In this blog, Nutter's Intellectual Property attorneys provide news updates and practical tips in patent portfolio development, IP litigation, trademarks, copyrights, trade secrets and licensing.