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Intellectual Property and FDA Regulatory Attorneys
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Thursday, December 29, 2011
In addition to the approval and oversight of drugs, the Food and Drug Administration
(FDA) also has jurisdiction over medical devices. The Agency was given authority over medical devices in 1976; the year
manufacturers were first required to register with the Agency. Currently, medical devices fall under the auspices of
the FDA’s Center for Devices and Radiological Health (CDRH).
The FDA classifies medical devices into one
of three categories (I, II, or III). Class I and II devices are generally considered to be lower risk and require FDA clearance
of a submission, referred to as a premarket notification (or 510(k)), in order for the device to be sold in the United States.
(However, many Class I devices are exempt from submission to the FDA). The sponsor of the 510(k) submission must prove substantial
equivalence of the proposed device to an already marketed device or devices. While the program is deemed a notification
process, it is, in reality an approval process since a device cannot be marketed until a letter of substantial equivalence
from the FDA is received. Class III devices, which tend to be higher risk and first-of-a-kind devices, require FDA approval
through a premarket approval (PMA) application
When the FDA took over responsibility for devices it regulated over
100 Class III device types through the 510(k) program. The initial intent was that FDA’s 510(k) regulation of these
devices would be temporary and that over time, FDA would reclassify those class III device into Class I or II or to maintain
the classification in Class III and require manufacturers to seek a PMA.
Over the years, the FDA has made progress
in the reclassification of the original Class III/510(k) medical devices. However, as of 2009, 26 medical devices remained
in this transitional state awaiting final classification. At the same time the FDA has come under fire for it’s
handling of medical devices and, in particular, 510(k) devices. As a result, there has been renewed effort to finalize
the classification of these remaining devices.
In reviewing the devices, the FDA essentially follows five steps
for each medical device type: Step 1- collect existing scientific information in the public domain and/or from scientific
experts in the medical community; Step 2- assess the risks versus benefits, as well as the clarity of knowledge of the medical
device type subject to the reclassification; Step 3- issue a proposed rule (proposed classification) of the device type into
Class I, II, or III; Step 4- receive and review comments submitted by the public; Step 5- issue a final rule (final classification)
on the device type to Class I, II, or III.
Step 1 -
Collect Existing Information The first step in the process consists
of FDA seeking and obtaining scientific information that exists in the public domain. The official method through which this
is done is with FDA’s publishing of a Federal Register (FR) notice. The public is then free to submit any known relevant
information on the medical device type under consideration. The FDA may also choose to solicit information through other
means, most commonly through the holding of a public FDA Advisory Committee (or Panel) Meeting. During this meeting, the FDA
solicits advice from experts in the field in question. The Public also has an opportunity to present information at
this meeting. Step 2 - Assess the Risks and Benefits In the second step, FDA conducts its expert scientific analysis of the information regarding
the safety and effectiveness of the medical device type. In this analysis, FDA will form an expert team (usually consisting
of an engineer, physician, life scientist and/or other specialists) that will evaluate the scientific merits of reclassification
of the device type to Class I or II, or to sustain the classification into Class III. The bases for each category are described
as follows: Class I: to be reclassified as a Class I device, the FDA must make a determination that the program category is
of very low risk. Because most Class I devices are also exempt from 510(k) submission, the FDA also needs to determine that
future devices classified Class I would not require 510(k) clearance before they could be marketed in the United States; Class
II: to be reclassified as a Class I device, the FDA must make a determination of several things, including: (1) that the program
category is of moderate risk; and (2) the development of “special controls” that characterize the testing and
documentation which would be required for all future 510(k) applications in the product category; Class III: the FDA can choose
to keep a device type classified in Class III. In this case, FDA would determine that the program area is of high risk and/or
that the knowledge of the program area is insufficient for special controls to be developed. In this case, sponsors who have
previously received 510(k) clearance for their medical devices will need to submit PMA applications in order to continue to
market their devices. Step 3 - Propose Classification The third step of the reclassification process requires that the FDA issue a Federal
Register Notice that proposes the regulation of the device type into Class I, II, or III. The Public then has an opportunity
to provide comment in response to FDA’s proposed rule.
Step 4 - Receive and Review Comments The fourth step consists
of FDA receiving and reviewing any comments made in response to the issuance of the proposed rule. FDA will consider all of
the comments and may choose to make any changes to the classification (and/or special controls as applicable for Class II
devices) based on its consideration of the comments. Step
5 - Render Final Decision The fifth and final step consists of FDA
issuing its decision of the final classification (or final rule) of the medical device type in the Federal Register.
As of December 26, 2012, the FDA has made the following progress in its reclassification efforts of the final 26 initial
Class II/510(k) devices:
DEVICE
PROJECT STAUS (STEP)
automated external defibrillator
Step 2
cardiovascular permanent pacemaker electrode
Step 3
cranial electrotherapy stimulator
Step 3
electroconvulsive therapy device
Step 2
endosseous dental implant (blade-form dental implants) Step 2
external cardiac compressor
Step 2
external counter-pulsating device
Step 2
external pacemaker pulse generator
Step 3
female condom
Step 5
hip joint metal/metal semi-constrained, with an
uncemented acetabular component, prosthesis
Step 2
hip joint metal/metal semi-constrained, with
cemented acetabular component, prosthesis
Step 2
implantable pacemaker pulse generator
Step 3
implanted blood access device Step
2
intra-aortic balloon and control system Step
2
iontophoresis device
Step 2
mandibular condyle prosthesis
Step 2
membrane lung for long-term
pulmonary support (i.e., ECMO) Step
2
nonroller-type cardiopulmonary bypass blood pump
Step 2
pacemaker programmers
Step 3
pacemaker repair or replacement material
Step 5
pedicle screw spinal system
Step 2
shortwave diathermy
Step 2
sorbent hemoperfusion system
Step 2
topical oxygen
Step 5
transilluminator for breast evaluation Step
4
ventricular bypass device Step
5
While fulfilling it mandate under the law is of vital importance, as importance is the effect of the FDA’s
reclassification efforts on industry. Manufacturers have been waiting for decades to have some conclusion on the classification
and, therefore, approval or re-approval, efforts they will have to take to market or continue marketing their devices.
This can have a profound impact on a company’s plans to move forward with a new product or improvements on existing
products as the time, money, and effort required to have a Class III device approved is considerable compared to a 510(k)
submission (tens of millions of dollars for a PMA versus tens of thousands of dollars for a 510(k). While medical devices
are of vital importance to the healthcare industry and consumers of those products (e.g., physicians and patients), not all
products are economically worth a multiple million-dollar investment.
Please contact Wiemelt Knechtel at 602-901-4250
or 312-372-7664 or by email at rknechtel@wiemeltlaw.com or mark@wiemeltlaw.com to discuss how we can help you navigate the FDA regulatory approval process.
2:23 pm cst
Tuesday, December 13, 2011
Last week the United States Supreme Court heard arguments
in the case of Mayo Collaborative Services v. Prometheus Laboratories, a case that addresses whether there is a right
to gain patent monopoly over a medical diagnostic technique, or more generally, whether a patentee can monopolize basic, natural
biological relationships. The case involves, strictly speaking, Section 101 of the Patent Act, the section of the Act
that determines when an invention qualifies for a patent (patent eligibility). The case seems to have been expanded,
however, to include Sections of the Act that are more settled, namely Sections 102 and 103, sections of the Act that determine
patentability (novelty and obviousness).
As background, Prometheus holds the license to
two patents for measuring the blood concentration of the metabolites of a certain type of drug. Originally, Prometheus
filed an infringement suit involving the two patents. A federal court judge threw out the patents concluding that the
testing method simply involved the laws of nature (natural phenomena cannot be patented) and a doctor’s use of medical
learning to gauge how a patient’s natural chemistry reacted to drug dosage. The patents, the judge found, simply
gave Prometheus a monopoly on making the kind of correlations that doctors conventionally make.
Prometheus
appealed. The United States Court for the Federal Circuit found that the two patents were patent eligible under Section 101
of the patent law. (The case was before the Federal Circuit twice. Each time the court found the patents to be patent
eligible.) The rulings were consistent with the finding in Bilski v. Kappos which devised the exclusive “machine
or transformation” test (an invention must either be tied to a machine or apparatus, or transform an article into a
different state or thing) to determine when an inventor is entitled to a patent.
Now, at
the Supreme Court, Mayo argues that the Prometheus patents are invalid because they merely claim medical judgments that have
been “familiar to physicians for decades”: providing a drug to a patient at a certain dose, monitor the patient’s
reaction, and adjust the drug level accordingly to meet the therapeutic goals. Prometheus, on the other hand, argues
that the patents in question are sophisticated methods of gauging how particular and specific but well-known drugs are transformed
in the body at various dosage levels. Prometheus further argues that because the drugs in question are effective but
known to be highly toxic, many physicians are reluctant to prescribe them because dosing is difficult. The method of
the patents reduces the dosing risk, thereby creating patentable subject matter.
The original issue here was one of patent eligibility (Section
101). However, the issue has been expanded by Mayo to include whether questions of patentability (Sections 102 and 102) should play a part in patent eligibility. Accordingly,
Mayo has framed the issue as to whether Section 101 is satisfied by a patent claim that covers observed correlations between
blood test results and patient health, so that the patents effectively preempts use of the naturally occurring correlations
simply because well-known methods used to administer prescription drugs and test blood may involve “transformations”
of body chemistry.
Prometheus,
of course, is asking the Court to keep the question strictly limited to Section 101 and answer the question of whether the
Federal Circuit correctly found that concrete methods for improving the treatment of patients suffering from specific diseases
by using individualized metabolite measurements to inform the calibration of the patient’s dosages of drug are patentable
under Section 101.
The case as it stands before the Supreme Court does not appear to be
dispositive for either side. If Prometheus prevails it will undoubtedly find itself with patent eligible patents that
will be attacked, perhaps successfully, on questions of patent ability- namely validity and obviousness. If Mayo prevails,
it likely walks away with an advisory opinion on Section 101, then having to re-enter the battle on the validity of the Prometheus
patents using the opinion as guidance.
We will, hopefully, however, end up with an opinion
from the Court that more settles Section 101 and what considerations can be taken into account when determining patent eligibility.
The case may also have significant impact on scientific research and legal strategies going forward. It is also significant
in that the Court has taken a keen interest recently in the patent law having agreed to hear an unusual number of patent cases.
This underscores, we believe, the importance of intellectual property to business and United States competitiveness.
Please contact Wiemelt Knechtel at 602-901-4250 or 312-372-7664 or by email at rknechtel@wiemeltlaw.com
or mark@wiemeltlaw.com to discuss how we can help you protect your intellectual property.
1:27 pm cst
Tuesday, December 6, 2011
In a case that involves issues spanning the fields of patent law
and FDA regulatory law, the United States Supreme Court on Monday heard oral argument in the case of Caraco Pharmaceutical
Laboratories, Ltd. V. Novo Nordisk A/S.
As a brief background,
the Hatch-Waxman Act, the law that governs the generic drug field, has provisions that enable generic drug makers to avoid
patent litigation by marketing generic versions of an approved drug solely for non-patented uses. The FDA, however,
lacks the authority and expertise required to determine whether the patent information submitted by brand name drug companies
is fair and accurate. Accordingly, it relies on the patent descriptions submitted by brand name drug companies regarding
the scope of their patents. As a result, brand name drug companies can block the approval of generic drugs by submitting
overly broad patent descriptions to the FDA, effectively extending their patents to non-infringing uses. To address
this problem, the Hatch-Waxman Act allows generic drug companies the ability to file a “counterclaim seeking an order
requiring the [patent] holder to correct or delete patent information submitted by the holder on the ground that the patent
does not claim an approved method of using the drug.”
In this case, Caraco Pharmaceutical Laboratories, a
generic drug manufacturer, sought FDA approval to market a certain drug. Relying on the Hatch-Waxman Act’s expedited
FDA application process for generic drugs, Caraco certified that its drug label would not conflict with Novo Nordisk’s
patented use of the drug. The FDA, in turn relying on Novo Nordisk’s description of its patent, denied the certification.
Caraco then filed a counterclaim under the Hatch-Waxman Act seeking an order requiring Novo Nordisk to narrow its patent description.
The United States District Court granted summary judgment for Caraco and ordered Novo Nordisk to correct its description
of the relevant patent. On appeal, the United States Court of Appeals for the Federal Circuit reversed, finding that
the counterclaim provision is unambiguous and only available where the patent does not cover the drug in question or any
of the approved methods of use. Additionally, the Federal Circuit found that the term “patent information’
in the counterclaim provision refers only to the patent number and expiration date, thus precluding Caraco’s counterclaim
to correct the patent’s use-code. Caraco appealed the Federal Circuit’s decision claiming that the ruling
expressly invalidates longstanding FDA regulations defining “patent information.” The Unites States Supreme
Court agreed to hear the case to resolve the scope of the counterclaim provision.
The questions before the Court
are whether the counterclaim provision applies when (1) there is “an approved method of using the drug” the “the
patent does not claim” and (2) the brand name drug company submits “patent information” to the FDA that
misstates the patent’s scope, requiring correct[ion].
Caraco argues that the counterclaim provision is available
when the patent does not cover a proposed method-of-use, and that the Federal Circuit’s interpretation of the counterclaim
provision is inconsistent with the use of similar language in the rest of the Hatch-Waxman Act. Novo Nordisk, on the
other hand, argues that the plain language of the statute clearly indicates the counterclaim is not available because its
patent does cover an approved method-of-use.
Several outside groups have expressed interest
in the outcome of the case. Those in favor of generic drug companies’ efforts to hold down health care costs argue
that a finding for Novo Nordisk will stifle competition. The United States government has even weighed in contending that a decision in favor
of Novo Nordisk will allow brand name manufacturers to exploit a weakness that the Hatch-Waxman sought to address. The
government maintains that brand name companies will use overly broad patent descriptions and the FDA approval process to delay
generic products into the market, thereby extending the effectiveness of their patent monopoly beyond what Congress intended.
On the other side of the fence, brand name companies argue that a decision in favor of Novo
Nordisk is in the public’s best interest as it would protect patent rights and encourage research and innovation in
accordance with the Hatch-Waxman Act. These companies assert that allowing generic companies to market the same drug,
simply by “craving out” any mention of a patented method-of-use, provides too little protection to the patent
holder, since the market could substitute the generic for any use, whether patented or not.
The Supreme Court’s
decision in this case may have far reaching impact on the pharmaceutical market, and following, the cost of health care.
The Supreme Court is about to decide under what conditions a generic drug manufacturer can invoke the counterclaim provision
of the Hatch-Waxman Act. This decision could potentially impact the speed at which cheaper generic drugs reach the market,
and the incentive for brand name manufacturers to find new uses for existing drugs.
If you have questions, contact
Wiemelt Knechtel at 602-910-4250 or 312-372-7664 or by email at rknechtel@wiemeltlaw.com or mark@wiemeltlaw.com.
9:42 am cst
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