FDA practice and intellectual property rights

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FDA practice and intellectual property rights

• Jill B. Deal, Principal
• Fish Richardson P.C.

Gregory J. Glover, M.D., J.D Dorsey Whitney LLP
Food Drug Law Institute41st Annual Educational
ConferenceDecember 10, 1997
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Patent and Non-Patent Market Exclusivity
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Patent Market Exclusivity - Patent Rights

• 35 U.S.C. 102Conditions for Patentability
  novelty and loss of right to patent
• 35 U.S.C. 103Conditions for Patentability
  non-obvious subject matter
• Patent Protection prohibits others from making,
  using, or selling a patented invention for 20
  years from date of filing (formerly 17 years from
  grant)

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Non-Patent Market Exclusivity

• Non-patent market exclusivity is crucial to
  commercial success as an adjunct to patents or in
  circumstances where patent protection is not
  available. Different types of non-patent market
  exclusivity are available through the
  Hatch-Waxman Act, the Orphan Drug Act, and trade
  secrets

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Hatch-Waxman Exclusivity

• NCE (New Chemical Entity) no application which
  refers to the pioneer drug (e.g., ANDA,
  505(b)(2)) may be submitted
• Period 5 years (or 4 years with patent
  certification)
• Non-NCE approval of an application which refers
  to the pioneer drug may not be made effective
• Period 3 years

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Orphan Drug Status

• FDA cannot approve the same drug for the same
  indication
• Period 7 years from approval

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Trade Secret Protection

• Proprietary compositions or methods of
  manufacture may remain a trade secret indefinitely

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Patent Term Extensions
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Applicability of a Patent Term Extension

• 1. What are the chances of a patented invention
  making it to the market?
• Less than 1 of issued patents ever get into
  clinical trials
• Less than 0.4 of clinical tested patents ever
  makes it to market
• Fewer than 1 out of 25,000 drug patent ever
  make it to market
• 2. What is at stake?
• Average cost to develop
• 350 million
• Prozac and Prilosec examples
• 1996 - 4.75 million/day

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Applicability of a Patent Term Extension (cont.)

• 3. What does extension get?
• Typical life after FDA approval
• 10-12 years
• Average years recaptured
• 2 to 4 years
• Maximum of 5 years
• 4. What patents are eligible for term extension
  (35 U.S.C. 156)?
• Products
• Methods of use
• Methods of manufacturing

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Applicability of a Patent Term Extension (cont.)

• 5. Products covered
• Drug products - readily defined
• Medical devices - PMA only
• Food and color additives

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Criteria for Term Extension

• 1. Term must not have expired before PTO
  application
• Interim extension available (15 days, 6 months
  before expiration
• 2. Term not previously extended
• 3. FDA permission to market after review period
  is first commercial marketing or use under law
  requiring regulatory review
• 4. Extension limited to approved uses or methods
  of manufacturing claimed in patent
• Claim specific vs. field of use specific
• Example drug patent with broad claim for
  treating gastric conditions and narrow claim
  for treatment of peptic ulcers FDA approves
  narrow claim only narrow claim extended
• 5. Maximum extension - 5 years

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Criteria for Term Extension (cont.)

• 6. Remaining term plus extension cannot exceed 14
  years
• 7. Only one patent extended per regulatory review
  period
• Example formulation patent separate from method
  of manufacturing patent - applicant must choose
• 8. Patent owner must be involved at least
  indirectly in the regulatory review process
• What about the passive licensor?

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Computing Regulatory Review Period

• Start computing after patent has issued
• Time of clinical trials divided by 2
• Add FDA review period (specifically defined for
  drug, device, etc.)
• Subtract applicants lack of due diligence

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PTO Petition and Procedures

• Petition to extend must be filed within 60 days
  of FDA approval
• PTO must notify FDA within 60 days
• FDA has 30 days to review dates in petition and
  publish in Federal Register
• Special procedures for FDA finding of no due
  diligence
• Interim extension available for expiring patents

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GATT-related issues

• 1. Patent term not previously extended
• 2. Merck v. Kessler - term extension tacked onto
  GATT-extended term of patent

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Patent Law Accommodations for Generic Drugs
An ANDA permits generic drug companies to place
their FDA-approved bioequivalent drugs on the
market as soon as the patent on the brand name
drug expires.
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Patent Filing Requirements for Pioneer NDAs

• 1. Patents to be listedThe applicant must file
  the patent number and the expiration date of any
  patent
• Which claims the drug for which the applicant
  submitted the applicationOR
• Which claims a method of using such drug and with
  respect to which a claim of patent infringement
  could reasonably be asserted if a person not
  licensed by the owner engaged in the manufacture,
  use, or sale of the drug

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Orange Book Practice - Requirement for Drug
Licensing

• 1.The official and proprietary name of each drug
  which has been approved for safety and
  effectiveness under 21 U.S.C. 355(c)
• 2. The date of approval if the drug is approved
  after 1981 and the number of the application
  which was approved and
• 3.Whether in vitro or in vitro bioequivalence
  studies, or both such studies, are required for
  applications filed under this 355(c) which
  will refer to the drug published.

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Patent Certifications for 505(b)(2) and ANDA
Filings

• 1. Patent Certification Requirements (ANDA,
  505(b)(2))
• Patent information on the drug has not been
  filed.
• The original patent has expired.
• The date on which the patent will expire or
• The patent is invalid or will not be infringed by
  the manufacture, use, or sale of the new drug for
  which the application is submitted (Paragraph IV
  certification).

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Patent Certifications for 505(b)(2) and ANDA
Filings (cont.)

• 2. Paragraph IV Certification
• The act of filing an ANDA with a paragraph IV
  certification is deemed to be an act of
  infringement in order to provide potential
  remedies to the patent holder.
• 3. Notice Requirement
• If the ANDA applicant certifies that a patent is
  either invalid or will not be infringed by the
  new drug (a paragraph IV certification), the
  applicant is also required to notify the holder
  of the approved New Drug Application on which the
  drug is based and each patent holder that the
  ANDA has been filed.

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Patent Certifications for 505(b)(2) and ANDA
Filings (cont.)

• 4. Procedures for Infringement Action
• ANDA for a competitive product - Patent
  Protection includes declaratory judgment action
  for infringement.
• If a paragraph IV certification is filed and the
  patent holder disagrees with the certification,
  the holder may file an action seeking a
  declaration that the patent is infringed and
  valid.
• A declaratory judgment action can delay the
  processing of any ANDA for up to 30 months.

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35 U.S.C. 271(e)(1)

• 1. Purposes
• It shall not be an act of infringement to make,
  use or sell a patented invention ... solely for
  uses reasonably related to the development and
  submission of information under a Federal law
  which regulates the manufacture, use or sale of
  drugs.
• The Essence of U.S.C. 271(e)
• Not a research exemption.
• Exemption to conduct commercial activities.
• Commercial activities limited to making, using or
  selling a patented invention for developing
  information to obtain FDA approval.

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35 U.S.C. 271(e)(1)

• 2. Apparent Scope
• Potential for Interpretation
• The purpose of section 271(e)(1) and (2) is to
  establish that experimentation with a patented
  drug product, when the purpose is to prepare for
  commercial activity which will begin after a
  valid patent expires, is not a patent
  infringement.

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Acts of Infringement, 271(e)(2)

• 1. Purpose of 271(e)(2)
• Provide patent protection to the holder of the
  original patent by making the filing of an ANDA
  under U.S.C. 505(j) an act of infringement.
• 2. Filings That Are Acts of Infringement271(e)(2)
  states
• It shall be an act of infringement to submit an
  application under Section 505(j) of the Federal
  Food, Drug and Cosmetic Act or described in
  section 505(b)(2) of such Act for a drug claimed
  in a patent or the use of which is claimed in a
  patent..

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Acts of Infringement, 271(e)(2)

• 2. Filings That Are Acts of Infringement271(e)(2)
  states continued
• if the purpose of such submission is to obtain
  approval under such Act to engage in the
  commercial manufacture, use or sale of a drug or
  veterinary biological product claimed in a patent
  or the use of which is claimed in a patent before
  the expiration of such patent.

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Judicial Interpretation
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Eli Lilly Co. v. Medtronics, Inc.(842 F.2d 402
(Fed. Cir. 1989))

• 35 U.S.C. 271(e) allows a party to make, use or
  sell any type of patented invention if solely
  for uses reasonably related to development and
  submission of information under federal law.
• Ruling extended the scope of the 271(e) exemption
  to include devices and biologics.

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NeoRx v. Immunomedics Inc.31 USPQ2d (Decided
March 31, 1994)

• NeoRx asserted that Immunomedics had accelerated
  its manufacture of products in order to stockpile
  inventory for commercial sale of products.
  Immunomedics claimed that it had been producing
  additional commercial-scale lots in case the FDA
  requested further information.
• The Court ruled that given the uncertainty of
  FDA's needs in its approval process, production
  of additional commercial-scale lots was
  reasonably related to the submission of data to
  FDA. The Court stated that the reasonably
  related standard was designed to give parties
  some discretion in committing infringing acts
  that would generate data for FDA applications.

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NeoRx v. Immunomedics Inc.31 USPQ2d (Decided
March 31, 1994)

• Submission of data to foreign regulatory agencies
  was exempt from infringement pursuant to 35
  U.S.C. 271(e). However, shipment of samples of
  products to foreign regulatory agencies to obtain
  foreign regulatory approval was not permissible
  under the 271(e) exemption, and therefore not a
  de minimis infringement.
• A decision by the defendant not to submit data
  from a clinical trial does not dispose of a claim
  to the 271(e) exemption. A party cannot simply
  lose the 271(e) exemption because it failed to
  generate information in which the FDA was
  interested or generated more information than
  necessary to secure FDA approval.

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Baxter Diagnostics v. AVL Scientific Corp.(789
F. Supp. 612 (C.D. Cal. 1992))

• The United States District Court held that 35
  U.S.C. 271(e) applied only to Class III Medical
  devices, not to all medical devices.
  Accordingly, infringing use related to the
  development of regulatory data for a Class I or
  II medical device is not protected by 35 U.S.C.
  271(e)(1).

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Abtox Inc. v. Exitron Corp.(Fed. Cir. - Decided
- August 1, 1997)

• Although, the Defendant Class II medical device
  was entitled to the benefits of 271(e)(1), the
  Plaintiff was not entitled to the benefits of
  Section 156 which allows an extension of patent
  life because of the time necessary for FDA
  approval.

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Case Studies - Hypotheticals
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Case 1 Patent Term Extension

• Patentee discovers two (2) new methods of use for
  a compound that is coming off patent.

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Case 2 Patent Term Extension

• Patentee files a patent for a new formulation and
  method of manufacturing for a compound that is
  coming off patent. The PTO examiner indicates
  that a restriction requirement may be imposed,
  forcing a division of the patent.

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Case 3 Patent Term Extension

• Patentee owns a method of manufacturing patent
  that is discovered to have applicability in the
  field of drug delivery. Patentee obtains an NDA
  (route of administration) for a combination drug
  and device manufactured under the patent. After
  the NDA issues, patentee seeks term extension in
  the medical field.

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Case 4 Safe Harbor InfringementUnder 271(e)(1)

• A manufacturer is conducting clinical trials on a
  patented pioneer product. The manufacturer
  intends to include the results in an ANDA. The
  manufacturer has a choice of delivery systems to
  use in its clinicals and elects to use one which
  is patented. In compiling the clinical data, the
  manufacturer uses a new software product that
  will save weeks worth of number crunching, that
  is also patented. At the end of the trials the
  manufacturer rewards each of its sponsors with a
  personalized pill box that is the subject of a
  design patent. The manufacturer is not licensed
  to make use or sell any of the patents.

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Case 5 Orange Book Filing

• A new drug applicant holds a patent on a new
  formulation drug and method of delivery -- i.e.,
  a drug delivery system (DDS). The patent is
  listed in the FDAs Orange Book when the NDA is
  approved. Subsequently, a generic manufacturer
  files an ANDA and certifies that it does not
  infringe the DDS patent. The patentee alleges
  that one of the claims in its patent is, in fact,
  being infringed by the ANDA. The claim describes
  only device features.

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Proposed Solutions
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271(e)(1)

• It shall not be an act of infringement to make,
  use or sell a patented invention solely for uses
  reasonably related to the development and
  submission of information under a Federal law
  which regulates the manufacture, use or sale of
  drugs.

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Orange Book Listing

• The applicant must file the patent number and the
  expiration date of any patent.
• Which claims the drug for which the applicant
  submitted the application or
• Which claims a method of using such drug and with
  respect to which a claim of patent infringement
  could reasonably be asserted if a person not
  licensed by the owner engaged in the manufacture,
  use, or sale of the drug.