Archive for the ‘patent’ Category
May
08
Posted under
Blog,
Companies,
Diagnostics,
Events,
Funding,
Mayo v. Prometheus,
Medical Devices,
Medical Supply,
patent,
patent eligibility,
Patently BIOtech,
personalized medicine,
Pharmaceuticals,
Startups,
Universities,
Videos by biotechnow@bio.org (Biotechnology Industry Organization)
Patent-Eligible Subject Matter after Mayo v. Prometheus: Exploring the Path Forward is a public round-table event hosted by the Biotechnology Industry Organization and the George Washington University Law School. Guest speakers at the round-table will discuss implementation of the Prometheus decision in patent prosecution practice, in examination guidance in the United States Patent Office, and in patent litigation. Speakers will also discuss the implications of the decision on personalized medicine and possible ways forward. Speakers include:
Join us on May 16th from 2-5 PM at the Faculty Conference Center, Burns 5th Floor, George Washington University Law School, 716 20th Street NW, Washington, DC 20052. A reception will follow the program. For more information and to RSVP please email iplaw@law.gwu.edu with “BIO” in the subject line.
May
04
Posted under
AIA,
American Invents Act,
Blog,
Companies,
Diagnostics,
Funding,
IPCC,
Medical Devices,
Medical Supply,
patent,
Patently BIOtech,
Pharmaceuticals,
Public Policy,
Startups,
Universities,
Videos by biotechnow@bio.org (Biotechnology Industry Organization)
By David Saravitz, Alston + Bird
Day 2 of the 2012 BIO Intellectual Property Counsels’ Committee (IPCC) Spring Conference kicked off with a panel on the America Invents Act (AIA). The panel focused on how practitioners and the U.S. Patent & Trademark Office (USPTO) are dealing with various provisions of this new patent act.
Mr. Ira Finkelstein, Senior Patent Counsel with Baxter Healthcare, led off the session initially discussing the first-inventor-to-file provision of the AIA (§ 3) which becomes effective on March 16, 2013, and the interplay of its one-year grace period for public disclosures by an inventor. Mr. Finkelstein reminded the audience that in most foreign countries a pre-filing, public disclosure by the first inventor would be disqualifying prior art. Thus, Mr. Finkelstein concluded that his strategy is: “Don’t rely on the grace period. File early, and file often!”
Mr. Finkelstein also discussed the best mode requirement of 35 U.S.C. § 112, first paragraph. Mr. Finkelstein pointed out that § 112 still requires an applicant for a patent to disclose the best mode contemplated by the inventors and that he will continue to require his inventors to disclose the best mode in patent applications. According to Mr. Finkelstein, it is likely that this information will need to be in the disclosure anyway, to support claims to narrow, dependent claims.
Dr. Murray Spruill, Leader of the Alston & Bird’s Biotechnology, Chemical and Pharmaceutical Patents Group, took the podium next to discuss “Post-Grant Proceedings.” Dr. Spruill pointed out that a defendant in an infringement lawsuit older than 1 year after the patent owner files a complaint alleging infringement of a patent needs to decide whether to bring an inter-partes challenge against the patent in USPTO before September 16, 2011 because the defendant would be barred from requesting the new inter partes review proceeding in such a circumstance. Finally Dr. Spruill reviewed similarities and differences between the new post-grant review and inter partes review proceedings
The third and final speaker was Dr. Remy Yucel, Director, Central Reexamination Unit (CRU), U.S. Patent & Trademark Office. Dr. Yucel indicated that since the inception of reexamination proceedings at the USPTO the number of reexamination filings per year has generally trended upward. She indicated that, although there has been a sharp increase in number of reexamination filings per year since 2002, the CRU had reduced the time from filing to the issuance of a reexamination certificate from about 40 months in 2006 to about 22 months in 2011.
Regarding reexamination and the AIA, Dr. Yucel pointed to three key changes that would impact the CRU: the change in the standard for granting an inter partes reexamination (IPR) effective September 16, 2011; the transition from inter partes reexamination to inter partes review at PTAB effective September 16, 2012; and the commencement of supplemental examination on September 16, 2012. Dr. Yucel indicated that the new, AIA-mandated “reasonable likelihood” standard for instituting an IPR does not require that the requester establish a prima facie case. And, unlike the prior standard of the “substantial new question,” the AIA-mandated standard does not require that a legal question be “new.”
Next, Dr. Yucel turned the focus to Supplement Examination. Some of the proposed rules that she discussed provide that the request must be filed by owner of the entire right, title, and interest in the patent, that third party participation is prohibited, that the number of items of information is limited to 10 per request, and that an unlimited number of requests may be filed at any time. Dr. Yucel also discussed proposed rule 610 which indicates that the request must include: a list of each item of information and its publication date; identification of each issue raised by each item of information; explanation for each identified issue; identification of how each item of information is relevant to each aspect of the patent to be examination and how each item of information raises each identified issue; a copy of each item of information; and a summary of each document over 50 pages in length.
Dr. Yucel discussed the equitable conduct immunization of supplemental examination but later indicated that if Director learns of “material fraud” committed in connection with the patent subject to supplemental exam, the Director has authority to confidentially refer the matter to the Attorney General and may take other action pursuant to § 257(e). She indicated that the Office regards “material fraud” to be narrower in scope than inequitable conduct as defined in Therasense. 77 Fed. Reg. at 3667. Before concluding her presentation, Dr. Yucel discussed some additional non-AIA-related changes to streamline the reexamination practice before yielding the podium to permit the audience to ask her and her fellow panelists some questions.
May
01
Posted under
Blog,
Companies,
Diagnostics,
Funding,
IPCC,
Medical Devices,
Medical Supply,
patent,
Patently BIOtech,
Pharmaceuticals,
Public Policy,
Startups,
Universities,
Videos by biotechnow@bio.org (Biotechnology Industry Organization)
By John W. Cox, Counsel at Alston+Bird LLP
The Spring 2012 BIO Intellectual Property Counsels’ Committee (IPCC) Conference, held in Austin, Texas, provided an excellent forum for intellectual property (IP) practitioners in the biotech industry to socialize, network, and participate in panel discussions focusing on the dynamic developments in the patent laws. The conference began for the general participants over margaritas and Tex-Mex fare, where attendees were already discussing recent Supreme Court and Federal Circuit decisions impacting the industry. By the final panel on Wednesday morning, the Supreme Court had handed down two more opinions impacting the biotech industry.
Patent practitioners have been monitoring the guidance provided by the Federal Circuit since its creation almost 30 years ago. The patent laws for biotech inventions have evolved over much the same time period, stemming from Diamond v. Chakrabarty in 1980. But in the past few years, more cases involving biological arts have not only reached the Federal Circuit but been taken up by the Supreme Court. Indeed, it appears that the Supreme Court has been more active in the patent field related to the biotech industry since the Fall 2011 BIO IPCC meeting than any similar time period. Moreover, two new acts of Congress impacting the industry have come into play, namely the America Invents Act and the Biologics Price Competition and Innovation Act.
The first of two panels discussing case law focused on Prometheus and the guidance – or lack thereof – provided therein. The panel, including Richard P. Bress of Latham & Watkins and Raymond Chen of the U.S. Patent & Trademark Office (PTO), provided insight into the Supreme Court’s opinion, describing the new frontier for biotech IP.
The final panel took up the mantel to update the conference on a wide range of case law that will impact the practice of IP in biotech. Four of the most talked about cases in patent law happen to impact the biotech industry, and they are either currently active or were recently decided. Deepro Mukerjee, of Alston & Bird, led a discussion of Novo Nordisk, the case decided by the Supreme Court just the previous day. Dr. Jitty Malik, also of Alston & Bird, presented the Therasense case, which, until Prometheus, was the main case IP practitioners had been talking about. Steve Reese, of Olswang in London, provided the European perspective on the standards to obtain or avoid injunctions in patent cases and compared that with the recent Kimberly-Clark decision. Any one of these cases could have spurred discussion on the Supreme Court’s recent interest in patent cases. Together, they signal both danger and opportunity to patent practitioners in this industry and have BIO member companies and IP practitioners alike looking to the Supreme Court and Federal Circuit together for guidance.
To close out the conference, Dr. Judy Jarecki-Black of Merial returned us to the Myriad Genetics case, which the Supreme Court vacated and remanded back to the Federal Circuit in view of Prometheus. Dr. Jarecki-Black raised a myriad of issues associated with the case—from ethical considerations to the scope of patentable subject matter in the biotech industry and what is necessary to save claims directed to genetic diagnostic testing—leading a dynamic discussion to formerly close out the conference.
All of the attendees, panelists included, are now figuring out what to do in view of Prometheus. The PTO recently provided guidelines to its examiners based on that opinion, though the impact of the 9-0 decision has yet to make itself heard in other cases. That, however, is not the situation for the industry itself. BIO member companies are considering how to pursue their research and protect their IP, aware that the Supreme Court has moved the boundaries of the frontier for patentable subject matter in this field.
Despite the clock signaling the end of the Spring 2012 BIO IPCC program, the attendees once again returned to the Prometheus and Myriad Genetics cases. The venerable Driskill Hotel heard musings about what will happen as Myriad Genetics moves up and down the appellate ladder. The conference provided a forum at which IP practitioners came together to see old friends and meet new ones, enjoy some Texas hospitality, and get briefed on the hot topics in IP currently impacting the industry. At its close, instead of scattering to the south Texas winds, we departed with renewed interest in considering, together, what dangers and opportunities this new frontier holds.
Apr
26
Posted under
Biotechnology,
Blog,
Companies,
Diagnostics,
Funding,
International IP,
Medical Devices,
Medical Supply,
patent,
Patently BIOtech,
Pharmaceuticals,
Public Policy,
Startups,
Universities,
Videos by biotechnow@bio.org (Biotechnology Industry Organization)
The House Judiciary Committee conducted a hearing on World IP Day on “International Patent Issues: Promoting a Level Playing Field for American Industry Abroad.” BIO submitted written comments for the record highlighting the unique patenting challenges that biotechnology companies face around the world.
“To fully understand what is needed to level the playing field for the biotechnology sector in international markets, one must understand the intellectual property (IP) needs of the biotechnology sector. Biotechnology innovation requires predictable and effective upstream (early stage) and downstream (product) IP protection. Biotechnology innovation generally starts with an early laboratory discovery, and thus upstream protection helps to generate investment and interest in the further, applied research and development of the invention. Upstream protection includes broad patent eligibility for biotech innovations, consistent patent term, flexible licensing practices, and effective patent enforcement.
Downstream protection is just as important. As mentioned above, the research and development of a biological product can take decades and cost more than a billion dollars to complete. A significant portion of this time and money goes towards developing the regulatory data package that is required by the U.S. FDA, USDA, or similar foreign regulatory offices to approve the biotech product. Therefore, downstream protection for biotech products must include sufficient protection against foreign and domestic competitors relying on the innovator’s data package to secure abbreviated approval of competitive products in such markets. “
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