USPTO and EPO Partner to Create Joint Classification System

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

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

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 immediatelyThe 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.

 

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