Publications / McDermott Newsletters / IP Update, Vol. 6, No. 12, December 2003

IP Update, Vol. 6, No. 12, December 2003

December 2003

IN THIS ISSUE

Patents / Claim Construction

Specification Must Be Consulted to Aid Claim Construction
By Michael A. Messina

In a case turning on claim construction, the U.S. Court of Appeals for the Federal Circuit affirmed a lower court’s ruling of summary judgment of non-infringement, construing a claim directed to a method of making a low lethality projectile based on the syntax used in the claim, as informed by the context of the entire specification.  Combined Systems, Inc. v. Defense Technology Corporation of America and Federal Laboratories, Inc., Case No. 03-1251 (Fed. Cir. Nov. 20, 2003).

Combined Systems Inc. (CSI) sued Defense Technology Corporation of America (DTCA) for infringement of U.S. Patent 6,202,562, directed to a method of shaping a projectile so as to have a low lethality consequence upon impact against a person.  Claim 1 recites, in part, the steps of “forming folds” in the rear of a tubular sock-like projectile body after filling the projectile body with a select amount of lead shot and “inserting said formed folds” into the opening end of a projectile compartment (i.e., an empty shotgun shell).

The district court construed the “forming folds” limitation to require “the deliberate and systematic creation of folds.”  The court additionally held that the folds are formed prior to, and not during, insertion into the empty shotgun shell, based on the ordinary meaning of the term “inserting said formed folds.”  Because DTCA’s manufacturing process did not create folds prior to the insertion of the projectile into the shell, only during insertion, the district court granted DTCA a motion for summary judgment of non-infringement.  The district court further found that DTCA’s folds were not formed in “any systematic or deliberate matter” but were merely a consequence of inserting the projectile into the shell.  CSI appealed.

In affirming the district court’s decision, the Federal Circuit held that as a matter of grammar, in the absence of compelling intrinsic evidence to the contrary, the recitation of “inserting said formed folds [into the projectile compartment]” forecloses a construction permitting the folds to be formed during or after insertion.  Moreover, the Federal Circuit dismissed CSI’s argument that the “forming folds” limitation should be construed to include gathers in the material that incidentally occur when the sock-like body is closed using a tie or a pull-string.  The Court held that the affirmative recitation of “forming folds” as a step in the claimed process is consistent with the lower court’s determination that when the claim limitation is read in the context of the entire specification, the claim requires the “deliberate” forming of folds.

In response to CSI’s contention that the district court erred in its use of a dictionary definition of “fold” in its claim construction analysis, the Federal Circuit stated that if the lower court relied exclusively on a dictionary definition or allowed it to overcome clear language in the patent itself, its methodology would have been wrong.  The Court further noted that the specification should not be consulted “solely for the limited purpose of determining whether it contradicts the dictionary meaning of a claim term.”  Rather, “the written description must be examined in every case, because it is relevant not only to aid in the claim construction analysis, but also to determine if the presumption of ordinary and customary meaning
is rebutted.”

Patents / Claim Construction

Panel Insists Dictionary Is the Primary Source to Construe Claim Terms
By Shamita D. Etienne

In overturning a decision of non-infringement by a district court, the U.S. Court of Appeals for the Federal Circuit found that the district court’s reliance on the patent specification, rather than on dictionary definitions, yielded an erroneous claim construction because the lower court improperly read into the claim language limitations found in the specification but not included in the dictionary definition or required by the claim language.  Ferguson Beauregard/Logic Controls et al. v. Mega Systems, LLC et al., Case Nos. 02-1380,-1427 (Fed. Cir. Dec. 4, 2003).

The patents-in-suit claim various aspects of control systems and related methods used in the production of petroleum products from a well.  The parties dispute the construction of claim language directed to a plunger operation used to extract and deliver liquid petroleum products from the well.   Particularly, the parties disputed the scope of “normal” and “predetermined” in the claim elements, “normal plunger performance” and “predetermined plunger performance,” respectively.  Based on an example described in the patent specification, the lower court limited both claim terms to a performance that occurred within
an independent adjustable period of time of good window operation and, thus, implicitly interpreted both disputed claim terms identically.

In its analysis, the Federal Circuit panel looked first to a dictionary to ascertain the scope of the disputed claim terms and then reviewed the patent specification to determine if the specification contradicted the dictionary definitions.  The Court reasoned that “[i]n the absence of an express intent to impart a novel meaning to the claim terms, the words take on the full breadth of the ordinary and customary meanings attributed to them by those of ordinary skill in the art.  The ordinary and customary meaning of a claim term may be determined by reviewing a variety of sources.  Some of these sources include the claims themselves, dictionaries and treatises, the written description, the drawings, and the prosecution history.”

Based on the appropriate dictionary definition and consistent with the specification, the Federal Circuit agreed with the lower court that a “normal plunger performance” is a performance during a good window of operation.  The Federal Circuit, however, found that the district court erred in further limiting the claim term by requiring that the window of operation fall within an independent adjustable period of time as described in the specification.  The Federal Circuit reasoned that the district court’s conclusion was in error because “it read into the claim language a limitation of independent adjustability of the upper and lower values not specified or required by the claim language, as properly construed.”

Similarly, the Federal Circuit disagreed with the district court’s implicit conclusion that “predetermined plunger performance” necessarily has the same construction as “normal plunger performance” because “[t]he coincidence of a particular predetermined window with a good window is irrelevant… .  There is no requirement, either in the claim itself or in the written description, that the values selected beforehand in the limitation ‘predetermined plunger performance’ must represent the good window, as with ‘normal plunger performance.’  There is also nothing in the claim language, written description or prosecution history to require that the upper and lower values that define the window of ‘predetermined plunger performance’ be set independently of each other.  The values must just be determined beforehand.”

Patents / Claim Construction

Uh Oh:  A Mistake the Court Cannot Correct
By Paul Devinsky

Unwilling to permit the word “a” to be construed to mean “and,” the U.S. Court of Appeals for the Federal Circuit has now held that unless a certification of correction has been issued by the U.S. Patent and Trademark Office (USPTO) under §§ 255 or 254, a district court may only correct an error in a patent if the correction is not subject to reasonable debate and if the prosecution history does not suggest a different interpretation.  Novo Industries Inc. v. Micro Molds Corp., Case Nos. 03-1230-1249 (Fed. Cir. Dec. 5, 2003).

Novo Industries sued Micro Molds for infringement of its patent on a carrier assembly for window blinds that permits realignment of misaligned slats.  The claim at issue reads, in part, “stop means formed on a rotatable with said support finger and extending outwardly there from into engaging relation with one or two spaced apart stop members formed on said frame,” (emphasis added).  The words “a rotatable with” did not appear in the original application.  Novo argued that the claim contained an obvious typographical error that could be corrected.

Micro Molds argued that the added words “rotatable with” indicated that the applicant had abandoned coverage of a stop means on the support finger itself and, therefore, the claim could not be construed to include a stop means on the support finger.  Rather, according to Micro Molds, the stop means had to be located on a separate “rotatable.”  Because the “rotatable” is not identified, Micro Molds argued the claim is invalid for indefiniteness.

The district court instructed the jury that “[t]he claim language includes an obvious typographical error, ‘a’ should be read as –and–.”  With that construction the district court did not reach the indefiniteness issue, and the jury found that Micro Molds had literally infringed the patent.  Micro Molds appealed.

The Federal Circuit observed that Novo never sought or obtained a certificate of correction from the USPTO pursuant to 35 U.S.C. § 255 and formulated the issue as whether a district court can correct an error in a patent by interpretation, where no certificate of correction has been sought or obtained.

Noting that nothing in the enactment of §§ 254 and 255 suggests that Congress intended to deny limited correction authority to the district courts, the Court reasoned that “for causes of action that arise before the correction becomes effective, the patent must be considered without the benefit of correction… .”

The Court stressed that the district courts do not have the authority to correct any and all errors that the USPTO is authorized to correct under §§ 254 and 255.  If the district courts were allowed to correct those errors that are correctable under §§ 254 and 255, “[T]he district court always would apply its own corrections retroactively in the action before it, unlike certificates of correction issued by the USPTO, which apply retroactively only in actions brought after the certificate of correction is issued.”  The Court concluded that the district court can only correct those errors where the correction is not subject to reasonable debate based on the consideration of the claim language and the specification, and the prosecution history does not suggest a different interpretation of the claims.

Applying that rule to the present case, the Court noted that not only did Novo itself suggest two different corrections (deletion of “a rotatable with” and deletion of “with said”), and the district court, by changing “a” to “and,” raised a third possibility.

“Since we cannot know what correction is necessarily appropriate or how the claim should be interpreted, we must hold [the] claim … of … [the] patent invalid for indefiniteness in its present form.”

Patents / Festo Estoppel

Federal Circuit Reaffirms Re-Writing Dependent Claims in Independent Form Constitute a  Narrowing Amendment
By Matthew Weil, Firasat M. Ali and Arturo E. Sandoval

Quick on the heels of its recent opinion in Deering, the U.S. Court of Appeals for the Federal Circuit has reaffirmed that re-writing a dependent claim in independent form is a narrowing amendment giving rise to the Festo presumption that the narrowed limitation will be given no range of equivalents.  Ranbaxy Pharma v. Apotex, Case No. 02 - 1329 (Fed. Cir. Nov. 26, 2003).

The Ranbaxy case, as seems typical of litigation between generic and brand name pharmaceuticals manufactures, is a high-stakes battle.  Indeed, the Federal Circuit noted that, in less than two months from its launch date, the accused infringer had shipped $12 million worth of accused product and booked an additional $27 million worth of orders.  For this reason, the district court’s decision to deny the patent holder a preliminary injunction must have been a bitter pill to swallow.  Unfortunately for Apotex, in the post-Festo presumption of estoppel era, the Federal Circuit has offered no relief.

Last month, the Federal Circuit, in Deering Precision Instruments v. Vector Distribution Systems (reported in IP Update, Vol. 6, No. 11) held that in deciding whether a narrowing amendment has occurred, “[T]he correct focus is on whether [the] amendment surrendered subject matter that was originally claimed for reasons related to patentability.”  Here, as in Deering, the issue was whether re-writing dependent claims in independent form could fairly be termed a narrowing amendment.  Also, as in Deering, the Federal Circuit held that “the surrender is particularly clear” from the point of view of the (now canceled) original independent claim.  The dependent claims that were redrafted into independent form added additional limitations, further defining and circumscribing an existing limitation for the purpose of putting the claims in condition for allowance.

Having concluded that the district court properly determined that there had been a narrowing amendment, the Federal Circuit went on to apply its recent holding in Festo Corp. and affirmed the district court’s holding that Apotex would be unlikely to overcome the presumption that it had surrendered all range of equivalents between the scope of the original independent claim and the dependent claim.

Finally, the Court noted that even if Apotex could overcome the presumption, the accused acetone product was foreseeable at the time of the amendment and, in fact, was described in the subject patent specification as part of the prior art.  Under the circumstances, the Court concluded that coverage of the accused formation as a claimed equivalent had been surrendered.

Practice Note: It appears that the only safe bet in claim drafting is to make sure the claims you want to issue are, to the extent possible, included in the originally filed application.  If an inventor has some question whether a broader claim will pass muster, narrow claims should be included in independent, rather than dependent form.

Patents / Double Patenting

“Self-Help” Restriction Does Not Shield Claims Against Nonstatutory Double Patenting
By Astrid R. Spain and Deborah L. Cadena

Finding no record in the prosecution history of a restriction that would allow 35 U.S.C. § 121 to shield against double patenting, the U.S. Court of Appeals for the Federal Circuit affirmed a district court’s summary judgment invalidating the claims of several patents for nonstatutory (obviousness-type) double patenting.  Geneva Pharmaceuticals, Inc. v. GlaxoSmithKline PLC, Case No. 02-1439 (Fed. Cir. Nov. 21, 2003).

The invalidated patents originated from a parent application, which, as explained below, was “restricted” and resulted in a first set of patents, now expired, and a second set of recently granted patents.  The claims of the first-issued patents were directed to the antibiotic clavulanic acid and its salts.  A clavulanate salt is an active component of a commercially successful antibiotic marketed by GlaxoSmithKline (GSK) as Augmentin.  The appellees are generic drug makers (collectively Geneva) seeking to market generic versions of Augmentin.

Geneva argued that the newly issued patents were invalid for nonstatutory double patenting over other patents issuing from the same parent application.  GSK countered that the patents should be shielded from nonstatutory double patenting since they issued from divisional applications.  Geneva also argued that the patents are invalid for nonstatutory double patenting over unrelated patents that were acquired by GSK in corporate mergers.

The Federal Circuit considered whether § 121 shields the recent patents from double patenting because they resulted from a divisional application and found they were not.  First, the Court found that the original application did not contain the method claims alleged to have been restricted, noting that entry of claims in an application is required before they can be restricted.  Secondly, the prosecution history did not reflect the issuance of a formal restriction requirement.  GSK relied on an agreement in an examiner’s interview that the method claims would be prosecuted in a separate application as evidence of a restriction.  However, the Court concluded that a formal restriction requirement must be documented and that “consonance” must exist “between the divided groups of claims and an earlier restriction requirement.”  Since the prosecution history did not clearly reflect that the claims were considered to be separate and distinct, the patents were held to be invalid for nonstatutory double patenting.  Noting the unexplained “quarter century” hiatus between the prosecution of the earlier group of patents and the later group of patents, and the unavailability of the examiner whom GSK alleges made the “agreement,” the Court reasoned that the “thin and insufficient record simply does not operate to shield these patents under § 121 against double patenting rejections.”

The Court also examined nonstatutory double patenting rejections based on unrelated but co-owned patents.  GSK relied on the term “synergistically effective amount” as a distinguishing limitation to what Geneva argued was “substantially overlapping subject matter.”  This claim term was interpreted by the Court to mean any amount that is synergistic against any bacteria.  The Court distinguished the term at issue here from the term “effective amount” that is a common and generally acceptable term for pharmaceutical claims, finding that the limitation at issue here was purely functional.  The Court also rejected GSK’s argument that a formulation falls outside the scope of the claims if a given antibiotic, bacteria and disease combination provides no synergy, finding such an interpretation to be indefinite as a given embodiment would simultaneously infringe and not infringe the claims, depending on the particular bacteria chosen for analysis.

Patents / Inequitable Conduct

Time to Pay Up, At the Higher Rate
By Jeffrey A. Woller

In a case involving multiple payments of maintenance fees at the small entity rate, even after the patent had been licensed to non-qualified licensees, the U.S. Court of Appeals for the Federal Circuit applied its traditional “inequitable conduct” analysis in vacating and remanded a summary judgment ruling that a patent owner engaged in inequitable conduct by falsely claiming small entity status.  Ulead Systems, Inc. v. Lex Computer & Management Corp., Case Nos. 01-1320, -1402, -1448 (Fed. Cir. Dec. 9, 2003).

When the patent in suit was assigned to Lex Computer, it qualified as a small entity.  Lex later signed a non-exclusive license with Adobe Systems, a company having more than 500 employees.  Lex subsequently submitted a petition to the U.S. Patent and Trademark Office (USPTO) to accept late payment of the second maintenance fee at the reduced (small entity) amount and a verified statement, signed by its president, claiming small entity status.  The petition was granted and the patent was reinstated.  Lex paid the third maintenance fee (this time the petition was signed by its patent lawyer in a similar manner.  During litigation, when the maintenance issue fee issue was raised, Lex Computer paid the fee difference, submitting its payments under 37 C.F.R. § 1.28(c).

Ulead sought declaratory judgment that the subject patent is invalid, unenforceable and not infringed and filed a motion for summary judgment urging that Lex’s false claim of small entity status renders the patent unenforceable or invalid, and Lex’s failure to pay the correct maintenance fee and payment of the incorrect small entity fee without “good faith” caused the patent to expire.

Lex’s president testified that when he signed his declaration, he was unaware that a non-exclusive license could result in the forfeiture of small entity status.  Lex’s patent lawyer explained that when he paid the third maintenance fee, he was unaware that Lex had finalized license agreements with any companies having more than 500 employees. 

The Federal Circuit, applying its traditional inequitable conduct analysis from the en banc (1987) Kingsdown decision, an analysis based on materially and intent factors, concluded that Lex’s misrepresentation to the USPTO regarding its small entity status was material because it affected the “survival of the patent,” but ruled that there are genuine issues of material fact regarding Lex’s intent.  The Federal Circuit stated that the facts might show gross negligence, but “gross negligence is not, in and of itself, sufficient to satisfy the intent element of inequitable conduct.”

The Federal Circuit noted that 37 C.F.R. § 1.28(c) is the only provision “governing expiration for failure to pay the full maintenance fee because of an erroneous claim to small entity status,” and that the regulation does not require or authorize in inquiry into “good faith” by the USPTO or by the district court when determining whether a patent has expired for failure to pay maintenance fees.  However, this does not mean inequitable conduct cannot be found in connection with such a payment.  The Federal Circuit reasoned that if a patent owner knew that it did not qualify as a small entity when it paid a maintenance fee at the reduced, small entity rate, but attempts to submit the correct payment using the vehicle of § 1.28(c) to pay the difference, “the patentee may be found to have engaged in inequitable conduct.”

In a vigorous dissent, Judge Newman asserts that the majority has made it easier to revoke a granted property right.  She argues that the majority’s rational changes the standard applied to revoking a patent due to incorrectly paying maintenance fees from the higher fraud standard to the lower inequitable conduct standard.

Patents / Attorney Fees

Federal Circuit to Patent Owner:  It’s Time to “Hang Up"
By Jeffrey A. Woller

In a case involving repeated, unsuccessful attempts by a patent owner to assert its patent against entities similarly situated to the defendant, the U.S. Court of Appeals for the Federal Circuit affirmed that attorney fees should be awarded, but remanded for a determination of the amount.  Phonometrics, Inc. v. Westin Hotel Co., Case No. 02-1501 (Fed. Cir. Nov. 26, 2003).

Prior to suing Westin, Phonometrics brought actions against various companies alleging infringement of its patent.  The claim limitation at issue in this case was the same limitation that had been an issue in previous actions and had been construed by the Federal Circuit prior to and during the course of the this action.

The Federal Circuit noted that in an earlier infringement claim against a similarly situated hotel defendant (Choice Hotels), the Federal Circuit affirmed summary judgment against Phonometrics based on a claim construction rendered in yet an earlier case filed by Phonometrics against Northern Telecom.  In the Choice Hotels decision, the Court rejected Phonometrics’ “contention that our earlier construction of the … limitation [in the Northern Telecom case] was ‘pure dictum’” as “baffling.”  The Federal Circuit also cautioned Phonometrics “against further litigation of that issue in this court.”

After the Federal Circuit’s Choice Hotels decision, the district court in the present action “asked Phonometrics whether it intended to continue to pursue its claims.”  When Phonometrics affirmed, the district court entertained motions for summary judgment and granted Westin summary judgment of non-infringement.

Westin then asked the district court for attorney fees and costs pursuant to 35 U.S.C. § 285 and 28 U.S.C. § 1927.  The district court found that maintenance of the suit after the Federal Circuit’s Northern Telecom decision was “vexatious,” supported a finding of bad faith and “resulted in unjustified multiplication of proceedings” and awarded attorney fees and costs incurred after the date of the Northern Telecom decision.

The Federal Circuit found no clear error in the district court’s determination that this case was exceptional and that pursuit of this action after the Northern Telecom decision was “unjustified, vexatious and [in] bad faith.”  The underlying reasoning by the majority was that the Northern Telecom decision established what was required to find infringement as a matter of law, and Phonometrics had never even accused Westin of infringing the patent in suit as it was construed in Northern Telecom.  The Federal Circuit noted that Phonometrics’ actions had been filed in the same district, were before the same judge and the appeals were prosecuted by the same counsel for Phonometrics.  The Court also noted that since Northern Telecom, each decision on the merits relied on the Northern Telecom claim construction, and “each presented Phonometrics and its counsel not merely the opportunity, but the obligation, to reconsider the viability of Phonometrics’ claims in light of the evidence, and to refrain from further prosecution.”

Legislation / Biotechnology

An Overview of the Changing Legal and Regulatory Landscape for Generic Drugs
By Robert B. Nicholas and Paul J. Larsen

Signed by President Bush on December 8, 2003, the Medicare Prescription Drug Modernization Act of 2003, Public Law No. 108-173 (the Act), institutes important changes to the ability of generic drug makers to bring their products to the marketplace.  The Act modifies several key provisions of the U.S. Drug Price Competition and Patent Term Restoration Act of 1984 (Waxman-Hatch Amendment), which amended the U.S. Federal Food, Drug and Cosmetic Act (FDCA), to allow the U.S. Food and Drug Administration (FDA) to approve, in certain instances, marketing of generic drugs.  In addition, it amends the patent infringement liability provisions applicable to generic drugs under 35 U.S.C. § 271(e), which provides (in part) that “[i]t shall be an act of infringement to submit…an application under section 505(j) of the [FDCA]…for a drug claimed in a patent or the use of which is claimed in a patent… .”  Finally, the Act necessitates the partial revision of a final rule enacted by the FDA earlier this year to streamline the process for making generic drugs available to consumers.

Prior Law

In 1984, the U.S. Congress passed the Waxman-Hatch Amendment to allow the FDA to approve, in certain instances, marketing of generic drugs.  To obtain approval of a generic drug, an applicant had to submit an abbreviated new drug application (ANDA) that included a certification which addressed each patent that claimed the listed drug.  Applicable patents are listed in a book published by the FDA, the Approved Drug Products With Therapeutic Equivalence Evaluations (Orange Book).

For each patent listed in the Orange Book, an applicant had to make one of four certifications.  If an applicant certified that the patent involved is “invalid or will not be infringed by the manufacture, use, or sale of the new drug,” the applicant had to give notice to the patent owner and the holder of the approved new drug application (NDA).  After the patent owner or NDA holder received such a certification, the patent owner and/or NDA holder had 45-days from the date notice provided to file a patent infringement suit.  If no such action was brought within the 45-days, the FDA had to approve the application.  If an action was brought for patent infringement, the statute provided that an automatic 30-month stay would be placed on the application.  At the end of that 30-month period, unless the court extended the stay, the FDA had to make the approval effective.

The Waxman-Hatch Amendment further provided that the first generic applicant to submit an ANDA that contained the above certification would be granted 180-days of marketing exclusivity based on either the date the applicant began “commercial marketing” of the drug or the date of a decision of a court “holding the patent … to be invalid or not infringed,” whichever came first.  Thus, any subsequent generic applicant whose application contained a similar certification could not be approved until the 180-day exclusivity had expired.

The New Law

The Act retains many of the central provisions of the Waxman-Hatch Amendment as described above, but it also institutes some important changes.  To begin, the Act closes a loophole relating to the 30-month stay in that a maximum of one 30-month stay is now permitted for each generic drug application.  Moreover, the 30-month stay is only available for patents listed before the filing of the ANDA.  When a patent is listed after the filing of an ANDA, but before approval of the ANDA, the 30-month stay provision will only be triggered if the ANDA applicant has amended the ANDA to include the certification before the date that the application is determined to be “substantially complete.”

The Act also requires ANDA applicants to notify the patent owner and NDA holder of an invalidity/non-infringement certification within 20 days of the filing of the ANDA, or at the time of the filing of an amendment or supplement containing the certification, regardless of whether such a notice has already been given in another certification.  An applicant may not amend or supplement an application to seek approval of a drug referring to a different listed drug identified in the application.  (The applicant may seek approval of a different strength of the drug, however.)  The FDA may approve the ANDA and, therefore, commence the 180-days of market exclusivity on the date of an appeals court decision, the date of a settlement order or consent decree or when a district court decision is not appealed.

If neither the patent owner nor the NDA holder files an infringement action within 45-days of notice of the certification, the ANDA applicant may bring an action against the patent owner or NDA holder “for a declaratory judgment that the patent is invalid or will not be infringed… .”  A new section 271(e)(5)
of title 35 states moreover that “the courts of the United States shall, to the extent consistent with the Constitution, have subject matter jurisdiction in any action brought by such person under section 2201 of title 28 for a declaratory judgment… .”  If the applicant’s notice to the owner of the patent or the NDA holder asserts non-infringement, the notice must further provide “an offer of confidential access to the [ANDA].”  Where, however, the owner of the patent or the NDA holder brings an action that alleges patent infringement, the applicant may instead assert a counterclaim against the owner of the patent or the NDA holder “seeking an order to correct or delete the patent information… .”  There is no basis for damages or an independent cause of action in this instance, however.

The Act also makes refinements to the provisions relating to the 180-day exclusivity period.  Specifically, multiple companies are now eligible to qualify for the 180-day “exclusivity” if they all file their application on the first day of eligibility.  Also, the right to exclusivity will be “forfeited” by the first generic in event of any of the following:  failure to market within specified time periods; withdrawal of the ANDA; amendment or withdrawal of “the certification for all of the patents with respect to which [the] applicant submitted a certification qualifying the applicant for the 180-day exclusivity period”; failure to obtain “tentative approval”; a decision by the U.S. Federal Trade Commission (FTC) or a court that an “agreement with another applicant, the listed drug application holder or a patent owner” has violated the antitrust laws; and expiration of all patents “as to which the applicant submitted a certification…”.

The Impact on the FDA’s Final Rule

Like the Waxman-Hatch Amendment, the Act does not completely overturn the provisions in the FDA’s Final Rule.  For example, the Final Rule’s provisions relating to the types of patents innovators must submit for listing in the Orange Book are unaffected.  Also, in contrast to the Act, the Final Rule does not focus on 180-day exclusivity.  However, as predicted in a statement delivered by the FDA chief counsel, to the Senate Committee on the Judiciary “the 30-month stay provision of the final rule [will be] impacted” by the Act.  As an illustration, the Act requires ANDA applicants to provide notice of an invalidity/non-infringement certification, regardless of whether such a notice has already been given regarding another similar certification.  However, the FDA’s Final Rule only requires that the notice be given once—for the first certification.  The FDA has not announced when it will issue a revised Final Rule.

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