Life Sciences Legal Blog

Congress Decides to Withhold Funds from USPTO

Lindette Hassan — Tue, 10 May 2011 18:43:50 -0500

In a move that will effect the entire patent community, Congress has decided not to give the United States Patent and Trademark Office ("

USPTO") access to all of the funds it will collect this fiscal year. Specifically, Congress authorized Public Law 112-10, which calls for withholding approximately $85 million to $100 million from the agency. As a result, the USPTO will have to complete this fiscal year with less money than it anticipated.USPTO Director David J. Kappos broke the news to USPTO employees via email on April 21, 2011. According to the email, the USPTO will undergo major cutbacks, including freezing hiring, limiting training, and suspending overtime for USPTO employees. Additionally, the planned satellite office in Detroit and any consideration of additional satellite offices are postponed until further notice, which will set back the USPTO’s progress in reducing patent application backlog. Trademarks will be unaffected.

"I recognize that these measures will place additional burdens on your offices, your staff, and your ability to carry out the agency's mission," Kappos stated in his email, "[h]owever, I believe that they are absolutely necessary to ensuring that the agency can continue to operate through the remainder of this fiscal year and into FY 2012."

UpcomingTown Hall Discussion with CDRH - May 5, 2011

Christian Moffitt — Thu, 31 Mar 2011 22:32:32 -0500

By way of follow-up to our earlier post regarding changes to the 510k process, we wanted to make sure that those who are following us are aware of an upcoming town hall style discussion being held by the Director of CDRH. This public meeting will be held on May 5, 2011 from 8 AM to 12 PM at the Sheraton Orlando Downtown Hotel. The registration deadline is April 22, 2011.

FDA Releases Statement on Enforcement Discretion Regarding Makena

Christian Moffitt — Thu, 31 Mar 2011 22:05:56 -0500

In early February of this year, FDA approved a drug to help prevent premature birth in women who have had at least one preterm delivery. Manufactured by KV Pharmaceutical, which developed the drug with substantial assistance from the federal government, approval of the drug was long in coming and was much anticipated because of the rising rate of premature births within the United States. The license granted to KV provided KV with exclusive rights to the drug in the US for seven years. While FDA's approval of Makena was much anticipated, there was just one small wrinkle - the drug had already been compounded by pharmacists for years and had been sold for a price of $10-$20. KV's price? $1,500 per dose. As the drug is generally prescribed for 20 week periods, the total cost for a course of treatment would reach approximately $30,000. Quite a difference from the $200 to $400 price it had been offered for in the past.

Following FDA's approval, KV issued warnings to specialty pharmacies informing them that continued production of the compounded hydroxyprogesterone caproate would be unlawful and that FDA would no longer exercise enforcement discretion regarding the product. On March 30, FDA issued a release permitting pharmacists to continue compounding and selling the mixture to expectant mothers. FDA explicitly stated that, at this time, it does not intend to take enforcement action against pharmacists who make and sell the drug. FDA stressed that it may revisit its decision in the future, but that the instant situation presented unique circumstances.

Considering the current economic and political climate and, particularly, the reality that public money will soon be supporting these subscriptions at a higher level than they would have in the past, FDA made the right decision here. KV is certainly entitled to make a profit on their product and, it goes without saying, to cover the higher costs of performing the R&D and manufacturing a high quality sterile injectible. However, consumers should also have the right to choose whether the benefits of using that product are worth the 7,500% price differential , particularly when a safe, effective product has been on the market for years.

Follow-up on Senate Reform of Patent Laws

Lindette Hassan — Tue, 08 Mar 2011 13:33:46 -0500

The Senate is poised to have a final vote this Wednesday on the patent reform bill. As we discussed last week, this bill is designed to considerably revamp U.S. patent practice for the first time in almost 60 years.

Senators began considering this bill on February 28, 2011, and have spent the last week debating a series of major and minor amendments. Specifically, some of the amendments made to the bill in the past week include:

· correcting provisions related to the United States Patent and Trademark Office’s (“USPTO”) fee-setting authority;

· ending diversion of patent fees;

· creating a pilot program to examine business-method patents in the wake of the U.S. Supreme Court’s Bilski ruling;

· amending the definition of a “microentity” and striking litigation-related provisions pertaining to damage calculations and venue selection;

· authorizing the opening of three or more additional USPTO satellite offices around the country over the next year;

· establishing a small-business ombudsman at the USPTO;

· prioritizing the review of patent applications “important to the national economy's competitiveness”, such as applications for green energy inventions; and

· requiring the USPTO to disclose the length of time between when it begins its post-grant review and when it completes the review.

In addition to what we discussed earlier, key components of the bill also include the following:

giving third parties the opportunity to submit information relating to a pending patent application to the examiner;
improving the current system for making administrative challenges to the validity of a patent throughout its life;
setting new fees for applicants who do not use electronic filing methods;
precluding individuals from filing lawsuits challenging the validity of patents on marked products; and
allowing the USPTO to offset costs by raising fees, resulting in a net increase in USPTO fee collections of about $1.7 billion between 2011 and 2016.

Now that the Senate is poised to pass its patent reform legislation, attention is shifting to the U.S. House of Representatives, which is in the process of developing its own version of the legislation.

Senate Considering Patent Reform

Lindette Hassan — Wed, 02 Mar 2011 15:33:54 -0500

The Senate is taking up the Patent Reform Act, a bill sponsored by Judiciary Committee Chairman Senator Patrick Leahy, Senator Orrin Hatch, and Senator Chuck Grassley. This legislation is designed to overhaul the U.S. patent system and bring the patent system in line with 21st century technology, such as biogenetics.

Among other things, the bill proposes to make the following controversial changes:

1. Transition from a first-to-invent system to the first-to-file system used by the rest of the world;

2. Create a nine-month, post-grant procedure that allows challenges to recently issued patents;

3. Give the United States Patent Office the authority to set its fees at a level that will provide enough funds to reduce the backlog of its applications; and

4. Create a “micro-entity” class which allows for a 75% reduction in fees for independent inventors who have not been named on five or more previously filed applications and have gross incomes less that 2.5 times the national average.

Senator Leahy’s office lists a growing number of supporters for the bill, including Pfizer and other major drug companies, IBM, and the Association of American Universities. Opponents of the bill include the Coalition for Patent Fairness, a group of high-tech companies that would like to see more in the bill to “lessen the growing burden of abusive and unjustified patent infringement claims.” Other opponents of the bill, including the American Innovators for Patent Reform and the U.S. Business and Industry Council, assert that the bill favors multinational and foreign firms over start-up companies entering the U.S. market for the first time.

Congress has been trying for over a decade to rewrite patent law, so only time will tell if this attempt will be successful.

FDA and Xavier University Team Up for MedCon 2011

Christian Moffitt — Mon, 28 Feb 2011 10:49:15 -0500

On May 3, 2011, FDA and Xavier University in Cincinnati, Ohio will once again team up to hold MedCon. The goal is to bring together as many members of the global medical device community together to openly dicuss pressing issues facing the industry. Leading FDA officials and field investigators as well as a number of global industry experts will be in attendance. MedCon is geared towards medical device companies of all sizes, with a particular eye towards regulatory affairs, quality assurance, research adn development and risk management.

Key speakers include:

Bill Maisel, Deputy Director for Science, CDRH
Kim Trautman, Medical Device GMP, CDRH
Michael Marcarelli (invited), Director of Bioresearch Monitoring, CDRH
Christy Foreman, Director oof the Office of Device Evaluation, CDRH
Thinh Nguyen, Director of the Office of Combination Products, FDA

Registration is available here.

Lorillard and Reynolds Sue to Halt Regulation Based on Upcoming Report on Menthol Cigarettes

Christian Moffitt — Mon, 28 Feb 2011 10:36:15 -0500

Unsurprisingly, Lorillard, Inc. and Reynolds American, Inc.'s R.J. Reynolds Tobacco Company unit filed suit against FDA regarding an upcoming advisory panel board that will likely recommend a ban on menthol cigarettes. Lorillard's top seller is the Newport brand and Reynolds sells, among other things, several mentholated versions of its Camel brand cigarettes. FDA, of course, gained the power to regulate the tobacco industry in 2009 with the passage of the Family Smoking Prevention and Control Act. Shortly thereafter, on September 22, 2009, FDA banned flavored cigarettes, with a particular eye towards vanilla, chocolate and clove cigarettes. The ban of the latter raised some interesting WTO issues, but more importantly for our purposes, set the stage for the current controversy.

Although few know exactly what the upcoming Tobacco Products Scientific Advisory Committee (TPSAC) report on menthol cigarettes contains, many expect that the committee will call for an outright ban. The report is due to be released on March 23, 2011, and in advance of its release, TPSAC will meet twice more in early to mid-March. Following the report's release, FDA will consider the report and take whatever action it deems appropriate. With a ban both legally allowable and likely imminent, manufacturers of menthol cigarettes have no choice but to take action to protect their business interests.

In their Complaint, filed in the United States District Court for the District of Columbia, Lorillard and Reynolds have requested the Court to enter declaratory and injunctive relief requiring the defendants to bring TPSAC and the membership of the constituents subcommittee of TPSAC into compliance with the law and to prevent FDA from taking any action based on or influenced by or from making any use of any report provided by TPSAC or the constituents subcommittee as currently constituted. Specifically, the plaintiffs allege that three of the eight voting members of TPSAC have financial and appearance conflicts of interest and biases that are incompatible with TPSAC's roles as an impartial advisor to FDA. Substantively, the plaintiffs allege that those three members of TPSAC cannot act objectively because they have all either appeared as paid expert witnesses in litigation against tobacco-product manufacturers or are or have been employed by members of the pharmaceutical industry engaged in the production of nicotine replacement therapy or other smoking cessation products.

While it remains to be seen whether this suit has any merit, at the least, it's sure to impede any further regulation of flavored cigarettes by FDA. We'll keep our eye on this and do our best to keep you up to date.

Upcoming Meeting and Live Webcast on the Medical Device Innovation Initiative

Christian Moffitt — Mon, 28 Feb 2011 10:32:43 -0500

FDA will hold a meeting on March 15, 2011 in Silver Spring, Maryland about its Medical Device Innovation Initiative. The purpose of the Medical Device Innovation Initiative is to assure that American patients have timely access to new technologies and next-gen products, while insuring the patient's safety. This Initiative proposes actions that the Center for Devices and Radiological Health ("CDRH") could take to accelerate and reduce the cost of regulatory evaluation of innovative medical devices. You may attend, but must register by no later than 5 PM on March 4, 2011. Alternatively, a live webcast will be available here.

FDA Greenlights Mobile Radiology App

Lindette Hassan — Fri, 11 Feb 2011 09:09:33 -0500

The United States Food and Drug Administration (“FDA”) has recently approved a mobile radiology application for the iPhone, iPad, and iPod touch, all manufactured by Apple, Inc. This application is the first of its kind and is designed to allow physicians to view medical images and make diagnosis based upon the images viewed on the mobile device.

This new application allows iPhone, iPad, and iPod touch users to receive radiology images taken at a physician’s office or hospital that are compressed and sent using software called Mobile MIM, manufactured by MIM Software, Inc. The iPhone, iPad, or iPod touch user is then able to view the radiology images on his or her mobile device and measure distance on the image. The device user is also able to measure image intensity values, and display measurement lines, annotations, and regions of interest.

The FDA evaluated this application by reviewing performance test results, and reviewing results from demonstration studies with qualified radiologists under different lighting conditions. It concluded that although the display performance of mobile devices can vary significantly, a mobile device using this application is sufficient for diagnostic image interpretation under the recommended lighting conditions.

Mobile MIM should be available soon in the United States Apple Store. This application is already available in many countries, including Austria, Belgium, Bulgaria, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Luxembourg, Netherlands, Norway, Poland, Romania, Spain, Sweden, Switzerland, United Kingdom, Australia, Hong Kong, Japan, Malaysia, New Zealand, Philippines, Singapore, India, Saudi Arabia, U.A.E, Costa Rica, Dominican Republic, El Salvador, Guatemala, and Paraguay.

USPTO to Open New Satellite Office

Lindette Hassan — Tue, 21 Dec 2010 08:50:13 -0500

The United States Patent and Trademark Office (“USPTO”) is opening its first ever satellite office in Detroit, Michigan, in 2011. The new office is expected to create more than 100 new jobs in its first year and to provide a boost to the region’s economy.

The satellite office represents the first phase of the USPTO’s Nationwide Workforce Program, an effort to hire more patent examiners and seek out additional resources and technical expertise in locations across the country. By opening satellite offices, the USPTO is working to reduce the patent backlog and create new jobs in geographically and economically diverse areas of the country.

The Detroit office enables the USPTO to draw upon Michigan’s workforce to help reduce the backlog of more than 700,000 patent applications. A year ago, the patent backlog stood at nearly 750,000 applications, but an agency push to get it below 700,000 has led to the first significant reduction in the patent backlog in a decade.

Following an evaluation of the Detroit satellite office, the USPTO will consider opening additional offices, which would provide the patent community greater access to the USPTO and the services it offers.

A specific location and anticipated opening date for the new Detroit office will be announced in the coming months. The office will work closely with the Commerce Department’s CommerceConnect facility in Pontiac, Michigan.

DOJ Opines that Genes Should Not Be Eligible for Patent Protection

Lindette Hassan — Fri, 10 Dec 2010 08:40:06 -0500

In a surprising opinion, the United States Department of Justice (“DOJ”) recently said that genes should not be eligible for patent protection because they are found in nature. This opinion could have a huge impact on the medical and biotechnology fields.

This opinion was declared in friend-of-the-court brief by the DOJ in a case involving two human genes linked to breast and ovarian cancer. The DOJ’s opinion is surprising because it is contrary to the long standing practices of the United States Patent and Trademark Office (“USPTO”), the National Institutes of Health (“NIH”), and other various government agencies.

Under U.S. patent law, anyone who invents any new and useful process, machine, manufacture, or composition of matter, may obtain a patent on that subject matter. In 1980, the Supreme Court found that this includes man-made products of genetic engineering. Using this rationale, the USPTO has issued numerous patents on a wide range of engineered DNA molecules. In 2010, the Supreme Court determined that the boundary between eligible and non-eligible subject matter is defined by the principle that patent laws do not embrace laws of nature, physical phenomena, or abstract ideas.

With this in mind, the DOJ asserted in its brief that certain compositions of matter whose value is derived from the information-encoding capacity of DNA qualify as human-made inventions eligible for patent protection, such as cDNAs, vectors, recombinant plasmids, chimeric proteins, vaccines, and genetically modified crops. However, genomic DNA that is isolated from the human body, without further alteration or manipulation, is not considered patent-eligible. The unique chemical base pairs that induce a human cell to express a certain protein is not a human-made invention. According to the DOJ, the chemical structure of native genes is a product of nature, and is no less a product of nature when that structure is “isolated” from its natural environment than “cotton fibers that have been separated from cotton seeds or coal that has been extracted from the earth”.

It is not clear whether the USPTO will change its policies in the face of this brief. However, the potential impact on the medical and biotechnology fields is daunting. Isolated DNA can be used to induce a human cell to create certain proteins linked to certain diseases, such as the protein BRCA1, which is linked to certain cancers. Researchers can study the structure and function of these proteins to determine how these proteins contribute to the disease at issue, and to determine if there are any drug treatment therapies that can inhibit the function of the protein, thereby treating the disease.

If isolated DNA is not considered patentable, investors may be hesitate to fund expensive and time consuming research that does not provide a chance for the commercial reward of exclusive patent rights in the product of the research. Without funding for research that isolates DNA, there is a danger that one of the more successful ways to treat certain diseases, creating drug treatment therapies that target specific proteins within the body, will be severely hindered, if not eliminated.

FDA Update on Caffinated Alcoholic Beverages

Christian Moffitt — Sun, 28 Nov 2010 15:50:44 -0500

In response to pressure from law makers and published peer-reviewed literature, on November 17, 2010, FDA issued Warning Letters to four companies known to produce caffienated malt alcoholic beverages. FDA stated that it found no support for the claim that the addition of caffeinie to alcoholic beverages is 'generally recognized as safe' and that the combinations of caffeine and alcohol in the cited products may actually pose a public health concern. The Warning Letters required the four named manufacturers to respond to FDA within 15 days to inform it of the specific steps that the companies intended to take to remedy the violation or to provide evidence and supporting information to support its contention that the products are not unsafe. Although that may seem like a short amount of time to respond, the companies were on notice of FDA's concern as early as this time last year.

FDA reports that within the last week, significant progress has been made. All four manufacturers have reported that they have either ceased manufacturing, marketing and/or shipping the offending beverages or are having all product pulled from store shelves by December 13.

While the available fact sheets certainly indicate that bans and limitations on caffeinated alcoholic beverages may make sense and while FDA is certainly acting within the power granted to it by regulating these drinks, one has to wonder how far FDA plans on taking this issue. More than a few alcohol manufacturers promote the mixture of their alcoholic beverages with caffeinated drinks; there's nothing new or exciting about the combination of those two ingredients. FDA certainly has the ability to regulate advertisement of food and other beverages - the quetion is whether it will use that power to adversely impact major players in the alcohol game, or whether it will limit itself to wrist slapping a few minor producers to quiet public discontent.

Graphic Images On Cigarette Packages? Help FDA Select Them

Anton Ness — Wed, 17 Nov 2010 12:44:54 -0500

You, the public, are being asked to help select the images, and/or you may post comments on the FDA’s proposal, from now until January 11, 2011. On November 10, 2010, the FDA posted on the Internet a set of 36 graphic color images showing the dangers of smoking grouped in nine categories, which are to be placed on the packages with appropriate text warnings. The public is being asked to help select from the 36 images a set of nine of them, one from each of nine categories.

Congress enacted the Family Smoking Prevention and Tobacco Control Act in 2009, requiring pointed health warnings with color graphics on all cigarette packages and advertisement after September 12, 2012. Representing each of the nine categories, the text warnings, each to be coupled with a related image or photo, are:

v WARNING: Cigarettes are addictive

v WARNING: Tobacco smoke can harm your children

v WARNING: Cigarettes cause fatal lung disease

v WARNING: Cigarettes cause cancer

v WARNING: Cigarettes cause strokes and heart disease

v WARNING: Smoking during pregnancy can harm your baby

v WARNING: Smoking can kill you

v WARNING: Tobacco smoke causes fatal lung disease in nonsmokers

v WARNING: Quitting smoking now greatly reduces serious risks to your health

Each of these congressionally mandated warnings will accompany a related color image, together to cover 50% of the both the front and back panels of each package, and to cover at least 20% of each advertisement. The various warnings will rotate on each package and advertisement periodically.

Some of the scenes depicted are:

o smoke being exhaled from a tracheotomy opening of the smoker;

o a baby and mother, with second-hand smoke from the mother engulfing the baby’s face;

o side-by-side photographs of a healthy lung and a diseased lung;

o an illustration of a cigarette package with an arrow pointing to a gravestone; and

o second-hand smoke wafting from a smoker toward a non-smoker’s face during conversation.

When the public comment period ends on January 11, 2011, the FDA will use the comments and scientific research and results to pare the list of 36 images to nine. Secretary Kathleen Sebelius of U.S. Department of Health and Human Services says that she is hopeful that the tragic images will stop young people from picking up their first cigarette and also give smokers the incentive to quit. “Every day,” Secretary Sebelius says, “almost 4,000 youths try a cigarette for the first time, and 1,000 youths become regular, daily smokers.” Over 2,600 adults also try smoking for the first time every year.

The Centers for Disease Control and Prevention says tobacco use is the single biggest cause of preventable death in the United States, killing more than 443,000 users and victims of second-hand smoke every year, and causing serious illness in 8.6 million Americans. Most of smokers dying began smoking when they were under the age of eighteen.

The proposed rules were published in Federal Register, Vol. 75, No. 218, Friday, November 12, 2010.

To see the graphic color images with their text warnings, go to:

www.flickr.com/photos/fdaphotos/collections/72157625232230587/

To submit comments on the warning labels and the proposed rule, through Tuesday, January 11, 2011:

a) go to: www.regulations.gov and insert docket number FDA-2010-N-0568-0001 into the “Search” box. (The proposed regs should be at the top of the list of Titles, and follow the prompts, clicking on the docket number in the fourth column to view the regs; to comment on the proposed regs and the color images, click on “Submit a Comment” in the right-hand column.)

b) send a fax*, with your comments, to: 301-827-6870

c) for paper submissions*, or disk* or CD-ROM* submissions, send by mail, or courier or hand delivery to :

Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, MD 20852

*NOTE: All comments should be identified by Docket ID No. FDA-2010-N-0568, and only one copy is necessary.

For the FDA’s notice, click here or go to this link

More information below:

As provided in the “Background” section of the proposed regulations, in 1964 the U.S. Surgeon General of the Public Health Service issued the landmark report titled “Smoking and Health,” which concluded that cigarette smoking is a health hazard of sufficient importance in the U.S. to warrant appropriate remedial action. Shortly thereafter, Congress passed the Federal Cigarette Labeling and Advertising Act of 1965, which required a printed warning to appear on cigarette packaging. Although the current text warnings on packages have been in use for twenty-five years, there is considerable evidence that the current warnings are given little consideration by viewers, and the warnings are said to have become “invisible” and fail to convey relevant information in an effective way.

The FDA says that there is evidence of a strong worldwide consensus that effective tobacco health warnings should be large and should include a graphic image component. The World Health Organization’s (WHO) Framework Convention on Tobacco Control (FTCT) has called for such a program of graphic images, and over 30 nations or jurisdictions have implemented such a program, including Canada, India, Mexico and the United Kingdom, with efforts pending in several others. (As of August 2010, there are 168 signatories to the Convention, including the United States, although the U.S. has not ratified this Treaty.)

Results from the 2009 National Health Interview Survey (NHIS) indicate that approximately 46.6 million U.S. adults are cigarette smokers (20.6% of the adult population). During the period of 1998 to 2009, adult smokersdeclined from 24.1% to 20.6%, although from 2005 to 2009 rates showed virtually no change.

Social Media - Still No Guidance, but FDA Is Getting Interested

Christian Moffitt — Mon, 15 Nov 2010 17:35:27 -0500

The bad news? Despite claims made earlier this year that it was on track to issue guidance regarding the use of the internet and social media by the industry, the FDA has remained mum. At this point, release of guidelines before the end of the year is doubtful, but we remain hopeful for the beginning of next year. Even then, due to the scope of the issues being addressed by FDA, we do not expect the first round of guidance to be very instructive.

The good news? If you've been paying close attention, it looks like someone at FDA is starting to understand the importance of social media and other online marketing and communication tools. In the last year, FDA has moved into Facebook, Flickr, and even Twitter to communicate to the public regarding everything from salmonella outbreaks caused by peanuts to salmonella outbreaks caused by eggs. FDA's Twitter feed is particularly active, with over 1,200 notifications of drug, device, biologic and food recalls since the account has been opened.

Most, if not all, companies involved in the manufacturing and production of regulated devices and drugs should be paying close attention to social media issues and start preparing for the guidance that FDA will likely issue in the next three to six months. For those who want to get started early, there is at least one conference being held in Washington D.C. this January.

USPTO and EPO Partner to Create Joint Classification System

Lindette Hassan — Thu, 28 Oct 2010 12:38:16 -0500

The United States Patent and Trademark Office (USPTO) and the European Patent Office (EPO) have agreed to work together to form a joint patent classification system. One of the goals of the partnership is to align the U.S. and the EPO classification systems with the International Patent Classification (IPC) system used by the World Intellectual Property Organization (WIPO), a specialized agency of the United Nations. The jointly developed classification system will be more detailed and designed to improve patent searching. As a result, the two offices will move closer to eliminating the unnecessary duplication of work between the two offices, thus promoting more efficient examinations, while also enhancing patent examination quality.

Currently, the USPTO classification system is a system for organizing all U.S. patent documents and many other technical documents based on common subject matter. Each subject matter division includes a major component called a class and a minor component called a subclass. A class generally delineates one technology from another. Subclasses delineate processes, structural features, and functional features of the subject matter encompassed within the scope of a class. Unlike other major patent document classification systems, the U.S. patent classification system is not based on the IPC system because it predates the IPC.

The forming of this joint classification system is seen as a milestone achievement for the Five IP Offices (IP5). The IP5 is a forum of the five largest intellectual property offices in the world that is being set up to improve the efficiency of the examination process for patents worldwide. The members of the IP5 are:

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).

The IP5 Offices account for 90% of all patent applications filed worldwide and for 93% of all work carried out under the Patent Cooperation Treaty (PCT).

With the USPTO and EPO collaborating on this joint classification project, the IP5 offices can continue to move toward a Common Hybrid Classification. This Common Hybrid Classification is one of the ten Foundation Projects of the IP5, which were devised to harmonize the search and examination of patent applications in each office and to standardize the information-sharing process between patent offices.

FDA Announces Public Hearing on Abbreviated Approval Process for Biologic Products

Christian Moffitt — Wed, 20 Oct 2010 07:53:11 -0500

The Biologics Price Competition and Innovation Act of 2009 (“the Act”), which is included in the Patient Protection and Affordable Care Act signed into law on March 23, 2010, provides an abbreviated regulatory approval pathway for biologic products shown to be biosimilar to or interchangeable with an FDA-licensed reference biological product. The objectives of the Act are similar to those of the Drug Price Competition and Patent Term Restoration Act of 1984 (the Hatch-Waxman Act), which provides an abbreviated pathway for the regulatory approval of small molecule drugs. However, the implementation of the abbreviated approval process for biologics by the Food and Drug Administration (FDA) will necessarily differ due to the complexity of biologic products and their methods of production as compared to small molecule drugs.

The Act provides for abbreviated approval of biological products as biosimilar or interchangeable. As set forth in the Act, a product may be shown to be biosimilar to a reference product based upon studies demonstrating that it is “highly similar” to the reference product and that there are no “clinically meaningful differences” in terms of safety, purity and potency. A product may be determined to be interchangeable with the reference product if it is biosimilar to the reference product, can be expected to produce the same clinical result in a given patient, and if the risk, in terms of safety and efficacy, of switching between use of the biologic product and reference product is not greater than the risk of using the reference product without such switch. Products that meet the higher standard of interchangeability may be substituted for the reference product by a pharmacist without the intervention of the prescribing healthcare provider.

The Act does not provide any further clarification of the terms biosimilar and interchangeable, nor does it define “highly similar” or “clinically meaningful differences.” It provides little guidance on the specifics of the review process, and permits, but does not require, the FDA to issue general or specific guidance after the opportunity for public comment. The Act also requires the FDA to develop recommendations to present to Congress with respect to a user fee program.

After the law was signed, the FDA established a working group, the Biosimilar Implementation Committee (BIC), to plan an approach to implementation. The BIC reported that it was addressing issues including resource evaluation, policy development and budgetary planning, and that it intended to hold public hearings to solicit comments from members of the public.

On October 5, 2010, the FDA announced the much anticipated hearing in the Federal Register. 75 Fed. Reg. 61497 (Oct. 5, 2010). In the notice, the agency stated that the Act is consistent with its policy of permitting reliance on information that is already known about a drug, but acknowledged that implementation of the approval pathway “can pose scientific and technical challenges associated with the larger molecular structure and manufacturing of biological products” relative to small molecule drugs.

The FDA has requested comments from interested stakeholders on a number of specific questions, as well as any issues related to biosimilar and interchangeable biological products. The public hearing will be held at the FDA’s White Oak campus in Silver Spring, Maryland on November 2 and 3, 2010, and will also be webcast. The FDA will accept electronic and written comments until December 31, 2010.

This article was written by Janet MacLeod, Ph.D., Esq.

FDA Sets New Rules For Reporting Adverse Trial Events

Anton Ness — Thu, 14 Oct 2010 14:03:55 -0500

The U. S. Food and Drug Administration is announcing a final rule that will improve the quality of safety reports and better protect people participating in clinical trials for drugs. The final rule clarifies the safety information that drug sponsors (drug manufacturers) must report to FDA for Investigational New Drug applications (INDs).

NOTE: The FDA is still developing separate rules for postmarketing safety reporting.

The newly announced procedures are aimed at speeding up reporting and analysis of potential safety problems encountered in clinical trials while cutting down on adverse-event filings that the agency considers useless. The new rules cap more than seven years of work for the FDA, which first proposed a revision of safety reporting from drug studies in early 2003.

The rule applies only to adverse events in trials for drugs and biologics that are conducted under IND protocols, including (for the first time) bioavailability and bioequivalence (BA/BE) studies of generic drugs covered by INDs.

Under a final rule that will go into effect in March, 2011, reportable events are redefined as “any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.” Such events must be reported to the FDA within 15 days of becoming aware of an occurrence (which was previously not required), although serious unexpected events should be reported immediately. The standard the agency wants sponsors and investigators to apply is whether there is “a reasonable possibility” that a study drug caused the event.

Reports of adverse events are to include:

findings from clinical studies, epidemiological studies or pooled analyses of multiple studies that suggest a significant risk to humans exposed to the drugs in the studies;

serious suspected adverse reactions that occur at an increased rate than expected, as listed in the protocol or investigator brochure;

serious adverse events from bioavailability studies which determine what percentage and at what rated the drug is absorbed by the bloodstream and bioequivalence studies which determine whether a generic drug has the same bioavailability as the brand name drug.

Sources: MedPage Today, published September 29, 2010, and the FDA’s press release of September 28, 2010.

http://

For the new rule:

Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans (PDF - 163KB)

To obtain the draft guidance information document for industry and investigators, click here.

The proposed rule will replace the defined phrase “associated with the use of the drug” with the term “suspected adverse drug reaction (SADR).” The rule also will permit the determination that an SADR is life-threatening to be based on the opinion of either the investigator or sponsor (as opposed to only the investigator). It will now be required that a “minimum data set” be submitted for each report of an SADR.

Examples of evidence are provided by the rule document that would suggest that an investigational product may be the cause of a safety problem. Under current regulations, drug sponsors often report all serious adverse events, even if there is little reason to believe the product caused the event. The examples also address when a single event should be reported or when there is a need to wait for more than one occurrence.

The document urged that individual investigators not try to assess whether a study drug actually caused a given event. However, the agency doesn’t want to receive reports on events that are probably or definitely unrelated to study drugs. Some events should not generally be reported in individual filings, such as those that are counted as endpoints in such a trial, and also those that would be expected to occur at some level in the study population anyway, such as strokes or heart attacks in elderly individuals. As the document explains, “[t]hese types of reports are generally uninformative when reported as single events, (i.e., without a comparison of the incidence of the event in treated and untreated subjects) and, therefore, do not meaningfully contribute to the developing safety profile of an investigational drug.” Such events should be aggregated by the investigators or sponsors and the totals compared with a control group, and be presented in a narrative format.

The FDA clarified that, in placebo-controlled trials, treatment assignments for patients suffering unexpected adverse events will typically have to be unblinded: “[i]n general, if the blind is broken and the subject was receiving placebo, the event should not be report in an IND safety report because there is not a reasonable possibility that the drug caused the adverse event.”

Furthermore, the agency explained that, since many clinical trials are conducted in countries outside the United States, the new rule revises definitions and reporting standards so that they are more consistent with two international organizations -- the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, and the World Health Organization’s Council for International Organizations of Medical Sciences. The changes are designed to help ensure harmonized reporting of globally conducted clinical trials.

Other issues highlighted in the guidance document:

Each event report submitted by sponsors must also include information on previous reports of similar events and how the new event fits into the overall context;
Sponsor-produced brochures explaining study protocols to investigators must be updated whenever new safety information comes up;
As before, sponsors must report relevant safety-related findings from other sources such as animal experiments or epidemiological data;
Safety events occurring in offshore trials must be reported if the trial is included in a U.S. IND; and
All serious adverse events occurring in bioavailability or bioequivalence studies conducted under INDs, whether or not they are potentially drug related, must be reported to the FDA.

Jury Awards Plaintiff $21 Million in Bartlett v. Mutual Pharmaceutical Co., Inc.

Christian Moffitt — Mon, 27 Sep 2010 08:45:37 -0500

Last month we posted an article regarding Bartlett v. Mutual Pharmaceutical Co., Inc., a suit brought in the United States District Court for the District of New Hampshire by a plaintiff who claimed that her use of Sulindac, a generic version of the non-steroidal anti-inflammatory drug ("NSAID") Clinoril, caused her to develop Stevens-Johnson Syndrome ("SJS"). Ruling on motions for summary judgment, the Court refused to grant summary judgment on the plaintiff's strict liability design defect and negligent design defect claims. At that time, the court concluded that the plaintiff had presented enough evidence to create a trial-worthy issue as to whether the NSAID was unreasonably dangerous and whether that defective condition caused her injuries.

On September 8, 2010, the jury in Bartlett awarded the plaintiff $21 million, finding that the manufacturer should have known that the NSAID was unreasonably dangerous and that the NSAID caused plaintiff's injuries, which included blindness. The plaintiff demonstrated at trial that Sulindac had been linked with other incidents of SJS and that the rate of SJS occurence among those prescribed Sulindac was higher than those prescribed other anti-inflammatory medications.

REMINDER: Feedback and Comments on 510(k) Preliminary Reports Due By October 4

Christian Moffitt — Fri, 24 Sep 2010 08:52:49 -0500

Several weeks ago, we issued a blog post and an industry alert advising members of the medical device industry of the opportunity to participate in an informational podcast being held by CDRH. In that post, we also advised you that the preliminary reports on changes to the 510(k) process had been opened for comment by FDA. FDA relies heavily on industry discussion and comment before finalizing its procedures and reports, but it can't do that if you as an industry participant do not stand up and make your voice heard.

FDA will be accepting comments on "Center for Devices and Radiological Health Preliminary Internal Evaluations" until October 4, 2010, which is only a few short weeks away. You can submit your comments by writing to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, or online through http://www.regulations.gov.

Federal Court Halts Expansion of Embryonic Stem Cell Research

Lindette Hassan — Fri, 17 Sep 2010 08:17:28 -0500

The New York Times reported that United States District Court Chief Judge Royce C. Lamberth issued a preliminary injunction blocking the federal funding of human embryonic stem cell research. This ruling severely impairs the progress of human embryonic stem cell research in the United States.

STEM CELL RESEARCH - GENERALLY

Presently, there are three types of stem cells used for research purposes: (1) human embryonic stem cells (“ESCs”); (2) adult stem cells (“ASCs”); and (3) induced pluripotent stem cells (“IPSCs”). Each type has unique research capabilities.

ESCs are pluripotent, meaning can to give rise to any of the approximately 200 types of cells in the human body, and can be used to treat diseases in two different ways - researchers can transplant ESCs into patients, or researchers may use ESCs to study disease mechanisms that cannot be studied within the human body, and to develop of the non-stem cell based therapies for these conditions. Recent studies using both methods of treatment suggest that ESCs will contribute to the development of medical knowledge in the future.

ASCs are found in tissues that are normally discarded after birth, such as the umbilical cord, and in the body. However, ASCs are limited because they are not pluripotent like ESCs. As such, ASCs cannot differentiate into the 200 types of cells within the human body.

IPSC research, the newest form of stem cell research, includes adult stem cells that have been genetically reprogrammed such that they are virtually identical to embryonic stem cells.

REGULATORY HISTORY REGARDING STEM CELL RESEARCH

The availability of federal funding for ESC research has been an issue for some time. In 1996, Congress enacted the Balanced Budget Downpayment Act, which contained a rider known as the Dickey-Wicker Amendment (“Amendment”). The Amendment prohibited the use of federal funds for (1) the creation of a human embryo or embryos for research purposes, or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under acceptable federal regulations. This amendment is passed annually by Congress in every appropriations bill for Health and Human Services since 1996.

Some stem cell researchers reasoned that the Amendment did not apply to ESC research because ESCs are not embryos, and research on ESCs does not result in the destruction of an embryo. Specifically, a distinction was drawn between work that leads to the destruction of embryos — which could not be financed by the federal government— and work using stem cells created through embryonic destruction, which could be funded.

In 2001, President Bush issued an Executive Order prohibiting federal funding for research on ESCs that were created after August 9, 2001. On March 9, 2009, President Obama issued an Executive Order removing President Bush’s limitations on ESC research. As a result, President Obama directed the National Institutes of Health (“NIH”) to review its existing stem cell research guidelines and issue new NIH guidance on research that is consistent with his Executive Order.

Accordingly, the Guidelines for Human Stem Cell Research (“Guidelines”) were drafted by the NIH to allow funding for research using human embryonic stem cells that were derived from human embryos created using in vitro fertilization for reproductive purposes and were no longer needed for that purpose.

SHERLEY V. SEBELIUS

In the present case, Chief Judge Lamberth granted the preliminary injunction effectively blocking the federal funding of ESC research. In his opinion, Chief Judge Lamberth reasoned that the NIH Guidelines violate the language of the Amendment, because the Amendment prohibits research in which a human embryo is destroyed. In order to perform ESC research, ESCs must be derived from an embryo, and the process of deriving ESCs from an embryo results in the destruction of the embryo. Specifically, he reasoned that “if one step or ‘piece of research’ of an ESC research project results in the destruction of an embryo, the entire project is precluded from receiving federal funding.”

Next, Chief Judge Lamberth reasoned that Plaintiffs would be irreparably injured if ESC researchers were allowed to seek federal funding for ESC research. Specifically, Plaintiffs, researchers that specialize in ASC research, asserted that obtaining NIH funding is necessary for their continued research, and the Guidelines, by allowing federal funding of ESC research, increases the competition for NIH funding. According to this opinion, competition for federal funding is enough of an injury to make a preliminary injunction a potential remedy.

Furthermore, Chief Judge Lamberth reasoned that it is in the public’s best interest to carry out the “will of Congress” and adhere to the Amendment. As such, federal funding of human embryonic stem cell research is presently enjoined.

This case is particularly interesting because although stem cell research can be a polarizing topic in our society due to the moral implications, it is the fight for funding between researchers that successfully brought this issue before a judge, and may ultimately decide whether human embryonic stem cell research may receive federal funding. It leads one to believe that no matter how moral the implications, money makes the world go around!