Biocom Urges Congress to Oppose Patent Litigation Legislation
On December 2,2013, Biocom sent a letter to the House leaders urging them to postpone a vote on H.R.3309, the Innovation Act, until Congress has had adequate time to fullyconsider more input from innovation stakeholders. Joining Biocom as co-signersinclude: BayBio, the California Healthcare Institute (CHI), CONNECT, OCTANe,Tech Coast Angels, and CleanTECH. Biocom is also actively urging Members of theCalifornia Congressional delegation to oppose the bill should it come to thefloor for a vote. Clickhere to view the letter.
Unlike the America Invents Act (AIA) which weaved its way to a consensus agreement after several years of study and debate, H.R. 3309 was fast-tracked through the House withoutmuch consultation with the industry. As a result, the bill is likely toinadvertently harm the world’s greatest innovation system by trying to curbabusive patent litigation. Indeed, the bill establishes more rigorousrequirements and greater penalties on all patent holders, not just the patenttrolls to which it is targeted.
Examples ofsuch limitations include more costly pleading and reporting requirements,restrictions on additional discovery requests, burdensome fee shiftingprovisions, and narrowing of the post-grant review estoppel. H.R.3309 willlimit our companies’ ability to assert their patent rights and increaselitigation risks, which will in turn lower the value of patent assets andreduce investment in early innovation.
Biocom Applauds Enactment of National Drug Traceability Bill
H.R.3204,the Drug Quality and Security Act, was signed into law on November 27, 2013.The bill had previously passed the House on September 28 and the Senate onNovember 18. It will supersede efforts by the California Board of Pharmacy toenact a California-specific e-pedigree system. Biocom had long advocated for anational drug tracing system that pre-empts patchworks of state laws, ensuringharmonization and predictability for the industry.
The new lawwill establish the first national drug tracing system in the US, by requiringthat all members of the pharmaceutical supply chain - including manufacturers, wholesaledistributors, pharmacies, repackagers, and third-party logistics providers -keep records of drug transactions. The new law’s implementation date is January1, 2015, but the FDA will have ten years to put in place an electronic systemfor unit-level tracking of drugs.
The bill alsoaddresses the need to reform compounding pharmacies regulations, following theoutbreak of fungal meningitis that originated from the New England CompoundingCenter last year and killed 64 people. Under the law, pharmacies conductinglarge-scale compounding of sterile drugs will be able to register as“outsourcing facilities” and be subject to oversight by the FDA. Traditionalpharmacies will continue to be regulated by state boards of pharmacy.
City of San Diego: Linkage Fee Update
Last week the Linkage Fee (Housing Impact Fee) Ordinance, renamed by the San Diego Housing Commission as the” Workforce Housing Offset Program Fees (WHO)”, was passed by the San Diego City Council by a 5-4 vote to support raising the linkage fee. The fee shall be applied to “(a) non-residential development projects that are proposing construction, addition or interior remodeling of any non-residential development projects (pg. 3).” The current Research & Development fee is $0.80/square foot. The increase will be effective January 1, 2014 at the 1996 level (R&D raised to $1.60/sq. ft.) with a two-year phase-in (July 1, 2014 R&D raised to $2.87/sq. ft. and July 1, 2015 R&D raised to $4.14/sq. ft.).
There was discussion of a pipeline provision, meaning projects deemed “complete” by July 2014 would be exempt from the new ordinance fee level. There was some confusion over what the City would define as complete and will be specified at the November 21st Council meeting. Starting July 1, 2016, the San Diego Housing Commission will adjust the revenue levels each year on a ministerial basis, according to the ENR (Engineering-News Record) Construction Cost Index already used by the City’s municipal code. There is a variance, waiver, adjustment and reduction section in the ordinance (pgs. 5-6) that outlines the application process. To receive a variance, adjustment or reduction one must apply through the Housing Commission. To request a waiver, the applicant must file an application with the City Council, through Development Services. “ (b) The City Council may approve or conditionally approve an application for a complete waiver of the fees required….if Council finds that there is an absence of any reasonable relationship between the impact of the development and the intended use or amount of the fee or fee requirement (pg. 6).” There are not any specific details on what defines “absence of reasonable relationship” for the waiver application. The Jobs Coalition (that Biocom has been long-time member of) has discussed beginning a referendum and concurrent litigation process, which will also require fundraising from interested stakeholders. More details will be provided to Biocom membership as soon as possible.
SDG&E Biotech & Pharmaceutical Workshop, December 11th
SDG&E is having a Biotech and Pharmaceutical workshop being held on Wednesday, December 11th from 8:30am-12:30pm at the Energy Innovation Center. Learn about new ways to reduce your energy consumption and save money while not impacting research/manufacturing. Please see below for registration and more information.
In the biotech and pharmaceutical industries, it's important to recognize the fine balance between conducting good science and reducing energy costs. SDG&E® invites you to this special event where we will discuss how incorporating energy efficiency strategies can help lower operating budgets as your company remains focused on making a difference in the world.
We will examine cost efficient tactics and technologies available for research facilities, such as:
× fume hood and airflow controls
× water reduction strategies and chilled water plant optimization
× energy dashboard and web services retro commissioning and automation for older buildings
Who Should Attend: Office and building managers, facility engineers and energy management professionals for biotech, pharmaceutical, bioscience and life science companies.
Speakers: Franks Shadpour, P.E., LEED AP, is the president of SC Engineers, Inc., a certified commissioning authority, and an ASHRAE Fellow. Read more...
Richard Yardley graduated with a bachelor's degree in mechanical engineering from Stanford University in 1980. Read more...
The Patent Prosecution Highway – New Construction
Patentees seeking international coverage are often aghast at the cost and complexity of obtaining that coverage even in a moderate number of jurisdictions for what is seemingly the same invention. They often dream of a single “world” patent. While we are far from that “dream” – and it seems quite doubtful that a single world patent granting body would exist in our lifetime – the world’s intellectual property offices are attempting to at least coordinate examination to reduce costs and increase efficiencies.
The world’s five largest intellectual property offices (“IP5 offices”): the European Patent Office (EPO), the Japan Patent Office (JPO), the Korean Intellectual Property Office (KIPO), the State Intellectual Property Office of the People’s Republic of China (SIPO) and the United States Patent and Trademark Office (USPTO), have agreed to launch a comprehensive new Patent Prosecution Highway (PPH) as of January 2014. Building on the existing work-sharing vision, the new program hopes to advance efficient examination among the offices by reducing duplication of work.
Meeting in Geneva, the heads of the IP5 offices endorsed a pilot program which leverages fast track patent examination procedures already in place at the IP5 in order to enable obtaining patents faster and more efficiently. Under the program, applicants whose patent claims have been found to be patentable by one office may ask for accelerated processing of their corresponding applications pending before the other IP5 offices. Those offices will leverage existing examination results for their own examinations.
We are hopeful that this baby step toward the dream will be successful. How it works in practice still remains a question.
- The BIOCOM IP Committee.
The views expressed here are those of Leslie B. Overman, Ph.D., J.D., who is solely responsible for the content.