Patent Law Weblog

recent posts

about

  • Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc. (Fed. Cir. 2012)

    By Kevin E. Noonan —

    It is a truism that each case that comes before an appellate court is decided on its own facts and on the court's application of the law to those facts.  The Federal Circuit has the additional burden of establishing consistency to how the law (patent law) is applied to the facts.  But that consistency has been difficult at times to appreciate in recent years, and this case is a good illustration of that difficulty.

    Momento PharmaceuticalsThe case involved a District Court grant of a preliminary injunction to Momenta in litigation between two ANDA filers.  Momenta entered the marketplace after ANDA litigation with the patent holder, Aventis, over Lovenox (enoxaparin), a specific formulation of heparin.  As explained in the opinion, heparin (unlike most drugs) is not "a single defined molecule" but rather a heterogeneous mixture of molecules that differ in "the length of the polysaccharide chain" and the "component disaccharide units and the corresponding distribution of disaccharide unit sequences in the polysaccharide chains."  This affects its molecular weight distribution as well as the distribution of uronic acid moieties.  Enoxaparin is the result of fragmentation of native heparin into a "diverse set" of oligosaccharides.  Accordingly, FDA approval for ANDA filers required five "criteria" or "standards of identity" to be met, including "[e]quivalence in disaccharide building blocks, fragment mapping, and sequence of oligosaccharide species" identified by specific enzymatic treatment and physical/chemical analyses of the drug product, including separation and spectroscopy.

    Although Amphastar filed its ANDA first, Momenta was first to market.  Perhaps tellingly, the Federal Circuit described the genesis of this lawsuit as follows:

    Being the only generic version of enoxaparin has it benefits:  its sales generated revenues of $260 million per quarter.  . . .  The approval of Amphastar's version of enoxaparin, and the resultant ruinous competition of another generic version of the drug, threatened this unique market position.  Understandably unwilling to give up a billion dollars in yearly revenue, Momenta initiated the present litigation two days after Amphastar received final FDA approval to market its generic enoxaparin.

    The legal basis for the suit was infringement of U.S. Patent No. 7,575,866 assigned to Momenta, which claimed methods for analyzing heparin and specifically low molecular weight heparins such as enoxaparin.  The opinion cited claims 6 and 15 as being "representative" of the '886 patent claims that Momenta asserted against Amphastar:

    6.  A method for analyzing an enoxaparin sample for the presence or amount of a non naturally occurring sugar associated with peak 9 of FIG. 1 that results from a method of making enoxaparin that included β-eliminative cleavage with a benzyl ester and depolymerization, comprising: providing an enoxaparin sample that has been exhaustively digested with two or more heparin degrading enzymes; using a separation method to determine, in the enoxaparin sample that has been contacted with two or more heparin degrading enzymes, the presence of a structural signature associated with the non naturally occurring sugar associated with peak 9 of FIG. 1 that results from a method of making enoxaparin that includes .beta.-eliminative cleavage with a benzyl ester and depolymerization; and making a determination about the enoxaparin sample based upon a comparison of the determination of the presence of a structural signature associated with the non naturally occurring sugar associated with peak 9 to a reference standard for enoxaparin, wherein the determination based upon the comparison to the reference standard regards the quality of the sample, to thereby analyze the enoxaparin sample.

    15.  A method for analyzing an enoxaparin sample for the presence or amount of a non naturally occurring sugar associated with peak 9 of FIG. 1 that results from a method of making enoxaparin that included β-eliminative cleavage with a benzyl ester and depolymerization, comprising: providing an enoxaparin sample that has been exhaustively digested with two or more heparin degrading enzymes; using a separation method to determine, in the enoxaparin sample that has been contacted with two or more heparin degrading enzymes, the presence of a structural signature associated with the non naturally occurring sugar associated with peak 9 of FIG. 1 that results from a method of making enoxaparin that includes .beta.-eliminative cleavage with a benzyl ester and depolymerization; and making a determination about the enoxaparin sample based upon a comparison of the determination of the presence of a structural signature associated with the non naturally occurring sugar associated with peak 9 to a reference standard for enoxaparin, wherein the level of one or more structural signatures associated with the non naturally occurring sugar associated with peak 9 of FIG. 1 is determined, to thereby analyze the enoxaparin sample.

    The Federal Circuit characterized Momenta's complaint as alleging that Amphastar infringed the '886 patent by complying with FDA requirements for testing its enoxaparin product as part of the quality control necessary for making this drug.

    Federal Circuit SealJudge Moore joined by Judge Dyk vacated the preliminary injunction and remanded, in an opinion that made it very unlikely that the District Court will be able to grant the injunction.  Chief Judge Rader wrote an extensive and vigorous dissent, once again directing his analysis not only to the specific matter before the Court but also opining more broadly on some of the underlying currents in this Court's, as well as the Supreme Court's, prejudices and presumptions in applying U.S. patent law.  The majority, while noting that review is on an "abuse of discretion" standard curiously then stated that Momenta, as the party seeking the injunction, bore the burden of establishing that it was entitled to the "extraordinary relief" of the injunction.  While true, Momenta presumptively bore that burden before the District Court, and the Federal Circuit (if not engaging in plenary review) should be limited to deciding whether the District Court abused that discretion.

    The question here is whether Momenta established a likelihood of (ultimate) success on the merits.  Amphastar's defense in opposing the injunction was that its activities fell within the "safe harbor" of 35 U.S.C. § 271(e)(1):

    It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention (other than a new animal drug or veterinary biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Act of March 4, 1913) which is primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site specific genetic manipulation techniques) 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 or veterinary biological products.

    The District Court rejected this contention because the infringing activity occurred after Amphastar received regulatory approval, and interpreted the statute to be limited to otherwise infringing acts that were performed in order to obtain approval (while acknowledging that the information was, ultimately, submitted to the FDA).  According to Judge Moore's opinion, the District Court interpreted the meaning of the statute with reference to its legislative history.

    And here, according to the majority, was the source of the District Court's error.  Importantly, Momenta relied in its appellate arguments on the Federal Circuit's recent decision in Classen Immunotherapies, Inc. v. Biogen IDEC, which under analogous circumstances held that post-approval activity does not fall within the § 271(e)(1) safe harbor.  In addition, Momenta argued that the FDA did not specifically require tests falling within the scope of the '886 patent to be performed, and non-infringing alternatives existed.

    The majority did not immediately address these arguments, but turned instead to its own independent interpretation of the statute.  In the majority's view, resort to the legislative history was unnecessary if the "plain meaning" of the statutory language was clear.  (Tellingly, the majority cites Supreme Court cases almost exclusively in its analysis.)  Indeed, the panel majority deems any such recourse to the legislative history to be improper, quoting United States v. Ron Pair Enters., Inc., 489 U.S. 235, 240 (1989), for the proposition that the "inquiry must cease if the statutory language is unambiguous and 'the statutory scheme is coherent and consistent.'"  Selectively quoting from portions of the legislative history, the opinion notes that the statute was enacted to "balance the need to stimulate innovation against the goal of furthering the public interest."  H.R. Rep. 98-857, pt. 2, at 2714 (Aug. 1, 1984).  (Note for later reference that the legislative history in the House, rather than the Senate, formed the basis for the majority's understanding of Congressional purpose.)  In citing the statute, the majority highlighted the clause reading that the safe harbor was "solely for uses reasonably related to the development and submission of information under a Federal law."  And this is the end of it, for the majority:  "Congress could not have been clearer in its choice of words," and thus "any activity" included acts taken after approval (provided that there was information submitted under a Federal law).  Moreover, for the majority it is significant that Congress did not limit (expressly) the scope of the safe harbor to the Food, Drug and Cosmetic Act but "broadly" included within the scope of the safe harbor "any federal law" that "regulates the manufacture, use, or sale of drugs."  This interpretation is consistent with the majority's parsing of the rest of the statute, citing portions of the provision that do specifically reference the FDCA (referring to animal drug or veterinary biological product[s]" and by reciting in § 271(e)(2) the specific provisions of the FDCA relating to submission of an ANDA (albeit, to be fair that citation was to provide a definition so that patent law and FDA law would be read consistently).

    For the majority, the fact that Congress included express reference to provisions of the FDCA relating to obtaining approval under § 271(e)(2) for infringement made it improper to "import" that limitation into the safe harbor provisions of § 271(e)(1).  Calling theirs the "only coherent and consistent interpretation of" provisions of  § 271(e) (1) relating to "a Federal law which regulates the manufacture, use, or sale of drugs," the majority declares its analysis of the scope of the safe harbor to be "complete":

    When the intent of Congress is expressed so clearly and consistently throughout the statute, there is neither the need nor the occasion to refer to the legislative history.  Id.  The scope of the Hatch-Waxman safe harbor does not stop at activities reasonably related to development of information submitted in an ANDA. Instead, the safe harbor applies "to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products."  As long as the allegedly infringing use is "for uses reasonably related" to the development and submission of that information it is not an act of infringement, regardless of where that requirement resides in the law.

    The panel majority cites two specific instances where the Supreme Court ruled on the meaning of § 271(e)(1) in a manner consistent with its interpretation:  Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 666 (1990), and Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193, 202 (2005).  In the Lilly case, the Court interpreted the safe harbor to include testing of medical devices because (despite the "clear and unambiguous language of the statute" that the safe harbor was limited to drugs) in the Court's view regulation of medical devices fell within the ambit of the FDCA.  And in Merck, the Supreme Court "reaffirmed this expansive view" of the safe harbor, holding that infringement of patent claims directed towards activities that were not directly related to obtaining data for submission to the FDA, i.e., clinical trials, but extended to basis compound discovery activities, on the grounds that Congress had used the word "any" in reciting the activities within the scope of the safe harbor.  And the panel also provided a reminder that Merck held that the phrase "reasonably related to the development and submission of information" relating to regulatory approval did not require that the activities actually resulted in information that was submitted for regulatory approval.  Accordingly, but with less than pellucid explication of their reasoning, the panel majority concluded that the Court's Merck decision "explicitly rejected the notion that §271(e)(1) was limited 'to the activities necessary to seek approval of a generic drug'" so long as "the accused infringer 'has a reasonable basis for believing' that the use of the patented invention might yield information that 'would be appropriate to include in a submission to the FDA.'"

    AmphastarTurning to the case before it, the panel majority rejected Momenta's contention that the process and quality control information obtained by Amphastar's infringement was not submitted to the FDA but was retained by defendants; these "batch records" must be maintained "for at least one year after expiration of the batch" of generic enoxaparin and must be "readily available for authorized inspection" by the FDA.  "The fact that the FDA does not in most cases actually inspect the records" does nothing to change the majority's view that the records are produced using the infringing method for producing information that the agency could demand to see.  The panel then based its decision that Amphastar's activities fall within the safe harbor expressly on the Merck decision, and in the process distinguished the Federal Circuit's earlier Classen decision (as it must to come to a contrary conclusion, as it did here).  Classen, the panel majority states, involved voluntary studies "not mandated by the FDA" and that produces "'information that may be routinely reported to the FDA, long after marketing approval has been obtained'" (i.e., adverse event information that is reported as it is obtained).  That is not the case here according to the opinion, because here the information obtained from infringing Momenta's patents is necessary for Amphastar to continue to sell enozaparin (and failure to do so could cause FDA to "suspen[d] or revo[ke] Amphastar's approval."  Accordingly, the opinion states that "[w]e therefore hold that post-approval studies that are "reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs" fall within the scope of the § 271(e)(1) safe harbor."  And under this interpretation of the law, the majority further holds that Momenta is not likely to prevail on the merits below.

    The panel majority also rejected Momenta's argument that the existence of non-infringing alternatives should motivate a decision to the contrary.  There is no such requirement in the statutory language, denying the safe harbor in instances where non-infringing alternatives exist.  According to the majority, "the safe harbor expressly allows the submitter the freedom to use an otherwise patented means to develop the necessary information demanded by the 'Federal law,'" which "makes good sense because it eliminates liability for infringement when that act of infringement is, in effect, required by the federal government as part of the continuing safety and efficacy monitoring of an approved drug."  It "also avoids the situation here, where a drug has received approval, but is nevertheless kept from the market based on an FDA mandated testing requirement."  Here, the majority noted that the U.S. Pharmacopoeia requires a determination of the chemical composition of Amphastar's enoxaparin in order to avoid it being rejected as an "adulterated drug," providing yet another rationale for finding Amphastar's activities to fall within the scope of the § 271(e)(1) safe harbor.

    And to add insult to injury, the panel majority awarded costs to Appellants (i.e., imposing Amphastar's costs of its appeal on Momenta).

    A portion of Judge Rader's dissent has been discussed elsewhere (see "Chief Judge Rader (Not Surprisingly) Gets it Right about Chimerical 'Tragedy of the Anti-Commons'"), and the remainder will be the subject of a subsequent post.  And as preview, and in homage to the late Paul Harvey, that post will consider the rest of the story.

    Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc. (Fed. Cir. 2012)
    Panel: Chief Judge Rader and Circuit Judges Dyk and Moore
    Opinion by Circuit Judge Moore; dissenting opinion by Chief Judge Rader

  • USPTO Issues Final Rule to Implement Miscellaneous Post Patent Provisions of AIA

    By Donald Zuhn —

    USPTO SealOn Monday, the U.S. Patent and Trademark Office published its final rule to implement the miscellaneous post patent provisions of the Leahy-Smith America Invents Act (77 Fed. Reg. 46615).  The final rule, which takes effect on September 16, 2012, is the third final rule package for implementing AIA provisions to be published by the Office.

    In the Office's notice of proposed rulemaking regarding the miscellaneous post patent provisions, published in January (see "USPTO Proposes Rules Changes for Implementing AIA Provisions — Miscellaneous Post Patent Provisions"), the Office noted that AIA provisions would result in the following changes to Title 35:

    • AIA § 6(g) amends 35 U.S.C. § 301 to expand the information that can be submitted in the file of an issued patent to include written statements made by a patent owner before a Federal court or the Office regarding the scope of any claim of the patent;

    • AIA § 6(a) and (d) contain provisions in new 35 U.S.C. §§ 315(e)(1) and 325(e)(1) that estop a third party requester from filing a request for ex parte reexamination where the third party requester filed a petition for inter partes review or post grant review and a final written decision under 35 U.S.C. §§ 318(a) or 328(a) has been issued;

    • AIA § 6(h)(1) amends 35 U.S.C. § 303 to expressly identify the authority of the Director to initiate reexamination based on patents and publications cited in a prior reexamination request under 35 U.S.C. § 302;

    • AIA § 3(i) replaces interference proceedings with derivation proceedings;

    • AIA § 3(j) replaces the "Board of Patent Appeals and Interferences" with the "Patent Trial and Appeal Board" in 35 U.S.C. §§ 134, 145, 146, 154, and 305;

    • AIA § 6(a) replaces inter partes reexamination with inter partes review of a patent;

    • AIA § 6(d) provides for post-grant review of patents; and

    • AIA § 7 amends 35 U.S.C. § 6(b) to define the duties of the Patent Trial and Appeal Board.

    To implement these changes, the Office proposed a number of rules changes in January, including the following:

    • Rule 1.501 — rewritten to allow for the submission of "statements of the patent owner filed in a proceeding before a Federal court or the Office in which the patent owner took a position on the scope of any claim of a particular patent" (the final rule requires that such submissions must (1) identify the forum and proceeding in which the patent owner filed each statement, and the specific papers and portions of the papers submitted that contain the statements; (2) explain how each statement is a statement in which patent owner took a position on the scope of any claim in the patent; (3) explain the pertinency and manner of applying the statement to at least one patent claim; and (4) reflect that a copy of the submission has been served on the patent owner, if submitted by a party other than the patent owner);

    • Rule 1.501(f) — limits the use of statements of the patent owner and accompanying information for determining the proper meaning of a patent claim in an ex parte reexamination proceeding that has been ordered pursuant to 35 U.S.C. § 304, an inter partes review proceeding that has been instituted pursuant to 35 U.S.C. § 314, or a post grant review proceeding that has been instituted pursuant to 35 U.S.C. § 324;

    • Rule 1.510(b)(6) — requires a certification that the estoppel provisions of inter partes review and post grant review do not bar the third party from requesting ex parte reexamination, as well as a statement identifying the real parties in interest to allow for a determine as to whether an inter partes review or post grant review filed subsequent to an ex parte reexamination bars the third party from maintaining a pending ex parte reexamination (the requester can remain anonymous by providing the identification and requesting that the Office seal it); and

    • A number of rules would be rewritten to replace "Board of Patent Appeals and Interferences" with "Patent Trial and Appeal Board," add specific references to trial proceedings before the Patent Trial and Appeal Board, and add specific references to derivation proceedings.

    As with the other final rules, the Office made some changes to the proposed rules in response to comments received following publication of the Office's notice of proposed rulemaking.  In particular, the Office notes that in view of the comments it received:

    • The scope of what may be submitted pursuant to Rule 1.501(a) has been expanded relative to the proposed rule because "the final rule does not prohibit the submission of written statements 'made outside of a Federal court or Office proceeding and later filed for inclusion in a Federal court or Office proceeding'";

    • The scope of the estoppel provisions of Rule 1.501(a) is interpreted to only prohibit the filing of a subsequent request for ex parte reexamination; and

    • The final rule does not require an ex parte reexamination requester to identify themselves upon the filing of the request.

    Additional discussion of the amendments to the rules, a listing of the comments received by the Office in response to its notice of proposed rulemaking and the Office's responses to these comments, as well as revised versions of the affected rules, can be found in the Office's Federal Register notice (77 Fed. Reg. 46615).

  • News from Abroad: Recent Amendments to the Israel Patent Statute

    Pulling the Pace of Prosecution from the Purview of the Applicant

    By Daniel Feigelson —

    Israel FlagMost readers of this blog are familiar with the situation in which you or your client files a patent application before the invention is ready for commercialization, e.g., the chemical process described therein is still being optimized, or FDA approval will only occur in the (distant) future, or there's not enough investment capital yet to develop the product to a stage ready for launch.  If you're only filing in the USA, you can request that the application not be published, and thus preserve some of your competitive advantage; but let's suppose that that’s not an option here.  So at 18 months from priority, your application publishes.

    Now suppose that a competitor sees your published application and submits prior art to the patent office, with comments explaining the relevance of the prior art.  This hasn't been possible in the USA until now, but in accordance with the AIA and the new rules just published by the USPTO, it will become a possibility as of September 16; and for many years it has been possible to make such submissions before the EPO, anonymously.  So although you're not thrilled with the idea of third party participation in the prosecution of your patent application, it's not the end of the world either.

    Let's further suppose that the examiner relies on some of the arguments submitted by your competitor and issues an OA in which he says the claimed invention is obvious.  Now let's throw a wrench or two into the works.  First, let's take away your ability to obtain extensions to respond.  If the applicant wants to present evidence of non-obviousness, for example comparative test results, the lack of extensions may put a crimp in those plans, necessitating the premature filing of less-than-ideal responses and ultimately the filing of continuations.  But let's complicate things more:  let's say that instead of the application having waited around the USPTO until its turn for examination arrived — normally a period of a year or more, time that you could have put to use commercializing the invention — the examiner picked it up for examination almost immediately after publication.

    Moreover, when, several years and several continuation filings later, you finally get a Notice of Allowance and pay the issue fee, a new type of pre-grant inter partes proceeding has been enacted:  the pre-grant opposition.  So the same competitor who (anonymously) submitted prior art now opposes the grant of the patent, during which time you don't have a patent with which to obtain injunctions.  Years later, after the PTO sides with you and all appeals have been exhausted, the patent finally issues — but there's no provision in the statute to adjust the term of the patent for the delay during the pre-grant opposition period.

    The enactment of the AIA notwithstanding, the situation in the USA isn't as bad for patent applicants as the one described above.  But the foregoing scenario encapsulates the current situation in Israel following the adoption on July 9 of a set of amendments to the Israel patent statute.  Pre-grant oppositions, and lack of patent term adjustment to compensate for reduction in the 20-years-from-filing patent term due to patent office delays or delays in grant due to oppositions, have been a part of the patent scene in Israel since the current statute was enacted in 1967.  The principal changes wrought by the current batch of amendments are (a) 18-month publication, (b) submission of prior art by third parties, and (c) third party requests for expedited examination of patent applications.  Taken together with the existing pre-grant opposition procedure, these changes, especially the last one, will make Israel an excellent forum in which to experiment with competitors' patent applications, particularly in the pharmaceutical field.

    The provisions for 18-month publication are uncontroversial; as Israel has been a member of the PCT since 1996, early publication of locally filed applications has been long overdue.  18-month publication is accompanied by a provision similar to that in US law, namely that to the extent a granted claim is substantially the same as a claim published at 18 months, after grant of the patent the patentee may sue for infringement retroactively to the date of the publication and recover a reasonable royalty for infringement that occurred between publication and grant.  This represents a change from the law in Israel until now, in which the patent statute provided no recourse for infringing activities that occurred prior to grant of the patent.  PCT applications that enter the national phase are to be published within 45 days of national phase entry, and although strictly speaking this should apply to applications that enter the national phase before the 18-month period has passed, in a recent announcement the ILPTO indicated that it would only publish national phase applications after the PCT application itself is published, i.e., after 18 months from the earliest priority date.

    The provisions for submission of prior art by third parties were added to the bill primarily as a result of lobbying by the Israeli generic drug industry, which includes both companies that sell only locally as well as companies with a global reach.  However, due to opposition by the Israel PTO, which did not want to be inundated with third-party comments on prior art, the window for submitting such art is fairly narrow:  such requests may only be filed within two months from the date on which the applicant replies to the ILPTO’s initial request for publications cited in corresponding applications.

    The real mischief in the amendments comes with the third party requests for expedited examination of patent applications (TPREEs).  Israel already had a mechanism for applicants to expedite examination of their applications (for example due to the inventor/applicant's age or poor health, infringement of the invention or the applicant's imminent launch of a product).  The idea to extend the ability to make such requests to third parties was the brainchild of the generic pharmaceutical lobby, which asserted that with the adoption of 18-month publication, its members would be left in legal limbo, knowing what the application claimed and possibly being on the hook for infringement of those claims, but not knowing what claims would eventually be granted (and thus what activities would be precluded).  By enabling TPREEs — so went the proponents' reasoning — third parties likely to be affected by the patent can ascertain earlier than they otherwise would the activities in which they may and may not engage.

    And so was born a new section of the statute (19A(c)) that in unofficial translation reads as follows:

    (c)    A person who is not the applicant, is not connected to the applicant does not act on his behalf, may submit to the Registrar a reasoned request, accompanied by a declaration to support the facts, for expedited examination of an application that has been published under section 16A [i.e. 18-month publication – DJF], if one of the following conditions is fulfilled:

    (1)    There is a basis for a suspicion that examination of the patent application in accordance with the order in which it was filed will cause the applicant for expedited examination in accordance with this sub-section, who deals in the field of the invention, to defer development or production of a product or process that is claimed in the patent application;

    (2)    the time that has passed since the submission of the patent application to the PTO under section 15 or its entry into the national phase under section 48D is unreasonably long, and included in this, is significantly longer in comparison to the time that has transpired until the commencement of examination of other applications of the same class;

    (3)    the public good;

    (4)    there are special circumstances that justify it.

    Even upon first reading, many readers will no doubt have questions regarding the exact meaning and scope of some of the wording of 19A(c), e.g., what does it mean that a party is "not connected to the applicant."  Nevertheless, since the whole point of a patent is to be able to exclude others from making or using the claimed invention, it's clear that almost anyone who competes with the applicant will have standing to file a TPREE, since that third party will be able to say with a straight face that it has to defer the development or production of a product or process while the application is being examined.  The upshot is that if you have a competitor in Israel — and why would you file a patent application in Israel if you didn't have a competitor here? — that competitor will probably be able to request that your application be examined immediately.

    Moreover, if the PTO has granted the TPREE, new section 19A(e) says that no extensions will be given to the applicant to respond to OAs and the like, "unless the Registrar found that the extension was necessary for reasons that neither the applicant nor his attorney had control over or the ability to prevent."  This is in contrast to the present situation, in which up to 15 months of extensions may be obtained during ex parte prosecution without a show of cause.

    So now patent applicants in Israel may be at the mercy of their competitors when it comes to controlling the timing of patent prosecution.  That may force applicants to spend resources on patent prosecution in a manner different than they had planned to, and possibly to disclose information earlier than they would like to (or even to disclose information that they had planned to keep secret altogether).

    Where things have the potential to move from mischievous to insidious is when the TPREE is combined with a pre-grant opposition.  Unlike the poorly-named "inter partes reexamination" in the USA, in which the requestor's participation is limited, and in contrast to post-grant oppositions at the EPO in which there is almost never live testimony, pre-grant patent oppositions in Israel are full-blown inter partes proceedings, in which direct evidence is offered by way of affidavit or expert opinion, with the affiant or expert being subject to cross-examination in a hearing at the ILPTO.  The real utility of TPREEs is thus not to facilitate the speedy grant of a patent, but to enable the opposition to begin earlier.  For Israeli companies that operate globally, this will provide an opportunity for a sneak peak at the patentee's arguments and data, in a relatively low-cost manner (discovery in oppositions is far more circumscribed than in court proceedings in the USA) so that when the time comes to do battle in the jurisdictions that matter — the USA and the EU — the Israeli companies will be better prepared.

    Unlike the other amendments, the provisions for TPREEs will not take effect until January 12, 2013, and the statute does allow for a fee to be set for a TPREE.  However, even if the fee is set relatively high by local standards — say on the order of $10,000 — it is expected that many, if not most, applications filed by innovator pharma and biotech companies will be subject to such requests.

    However, it is also expected that the TPREE provisions will be subject to legal challenge.  To give one example, Israel's Supreme Court, acting in its capacity as High Court of Justice (a court of first instance set up by the British to deal with administrative law in Mandatory Palestine, now perpetuated in the form of the Israel Supreme Court which also sits as the HCJ) has determined that the right to property is a fundamental right.  A challenge to the TPREE may therefore be advanced on the grounds that the ability to control the rate of prosecution of one's patent application is such a property right, since patent prosecution involves the allocation of capital and resources.  Another example of a likely legal challenge arises from the fact that nothing in the amendments explicitly requires the third party requestor or the ILPTO to notify the applicant that a TPREE has been filed, let alone to give the applicant an opportunity to respond to the request.  There is another section of the statute, section 159, that could be read as giving the applicant the right to respond, but if the ILPTO decides that that section doesn't apply here, the TPREE amendment is likely to be challenged as denying due process.  (If the ILPTO decides that section 159 does apply, look for a third party requestor to challenge the ILPTO's interpretation.)

    Even if the TPREE provisions withstand Supreme Court scrutiny, there are steps that applicants may take to minimize the likelihood that their applications will be subjected to a TPREE.  To mention an obvious one, an applicant could file an application in Israel with a set of claims that are fully supported by the specification, but concomitantly file a preliminary amendment that reduces the number of claims to one very narrow claim.  This would limit the ability of third parties to file TPREEs on the grounds that examination of the application will "defer development or production of a product or process that is claimed in the patent application."  While it wouldn't eliminate the other three grounds for making a TPREE, those grounds will likely be more difficult to demonstrate.  The applicant would then be able to re-introduce the canceled claims later, once substantive examination has commenced.

    Experienced patent prosecution practitioners will no doubt appreciate other ways, short of abstaining from filing in Israel, to lessen the likelihood of a TPREE being filed or granted.  That's important, because the antipathy to patents that seems to be increasingly fashionable in the USA hasn't yet taken root in Israel.  Although the present amendments raise the risks to the applicant during the patent procurement process, they don't lessen the value of an issued Israel patent:  once parties have patents in hand, Israeli courts are still willing to enforce them.

    It is unfortunate that during adoption of the TPREE provisions, the discussion in the Knesset committee focused solely on the pharmaceutical industry, as if there are no other industries that could be adversely affected by the TPREE provisions, which appear to be a uniquely Israeli invention.  While Israel has produced only a handful of new drugs of its own but is home to a thriving generic drug industry that will not be harmed by the TPREE provisions (and only stands to benefit from these in combination with pre-grant oppositions), Israel is also home to many start-ups and many high-tech companies, a reflection of the creativity and smarts that abound in Israel.  Enabling competitors to speed up the rate of prosecution of those companies' patent applications may lead to sub-optimal or even no patent protection for those companies' innovations, ultimately resulting in less innovation, non-growth and non-creation of jobs, and lower tax revenues than the state would otherwise have had.

    Mr. Feigelson is a practitioner with 4th Dimension IP and the author of the America-Israel Patent Law blog.

  • Chief Judge Rader (Not Surprisingly) Gets it Right about Chimerical “Tragedy of the Anti-Commons”

    By Kevin E. Noonan —

    Chief Judge RaderIn his dissent from the majority opinion in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc. (a case have interesting features discussed elsewhere), Chief Judge Randall Rader (at right) opines eloquently regarding the so-called "tragedy of the anti-commons" and the widespread but unsupported idea that patents inhibit innovation (Justice Breyer to the contrary):

    The safe harbor provision at issue in this case, due to its origin and purpose in reversing Roche v. Bolar, receives attention as an exception that permits experimentation.  This link to experimentation and its role in advancing the progress of technology requires some commentary as well.  Too often patent law is misunderstood as impeding more than promoting innovation.  This academic proposition, called the tragedy of the Anti-commons in some scholarly presentations, suggests that exclusive rights impede the flow of information and limit experimentation that might lead to the next generation of technological advance.  Michael A. Heller & Rebecca S. Eisenberg, Can Patents Deter Innovation? The Anticommons in Biomedical Research, 280 SCIENCE 698 (1998).

    In the first place, in an era of empirical research, one might ask the reason that this academic notion has never actually been verified.  Although studied, no research has substantiated this alleged attack on the patent system.  In fact, "the effects predicted by the anti-commons hypothesis are not borne out in the available data."  Timothy Caulfield, Human Gene Patents: Proof of Problems?, 84 Chi.-Kent L. Rev. 133, 137 (2009); see also American Association for the Advancement of Science, INTERNATIONAL INTELLECTUAL PROPERTY EXPERIENCES: A REPORT OF FOUR COUNTRIES 12 (2007) (finding the results of a 2006 survey of U.S. and Japanese researchers "offer very little evidence of an 'anticommons problem'" and that "IP-protected technologies remain relatively accessible to the broad scientific community").  Surveys of academic researchers have revealed that "only 1 percent . . . report having to delay a project, and none abandoned a project due to others' patents."  Wesley M. Cohen & John P. Walsh, Real Impediments to Academic Biomedical Re-search, in 8 INNOVATION POLICY AND THE ECONOMY 1, 10-11 (Adam B. Jaffe, Josh Lerner, & Scott Stern eds. 2008), available at http://www.nber.org/~marschke/mice/Papers/cohenwalsh.pdf (citing John P. Walsh et al., The View from the Bench: Patents, Material Transfers and Biomedical Research, 309 SCIENCE 2002 (2005)).  In other words, patents on research tools and biomedical innovations do not significantly slow the pace of research and do not deter researchers from pursuing promising projects.

    The reason that patents have not been proven to impede more than stimulate technological advance is simple:  it does not happen.  It does not happen for several reasons.  First, experiments advancing technology rarely, if ever, generate commercial value.  Thus patent owners have little, if any, incentive to license or inhibit research.  Stated otherwise, even if a patent owner wanted to sue or license potential researchers, experiments do not produce income or a source of damages.  See id. at 12.

    Second, in the modern age of technology, the character of technological advance has changed.  The era when the Bell Labs or some other tech center could hire the most promising engineers and essentially invent everything for the world has passed.  With the vast specialization of all fields of research, advances in technology require great cooperation.  A new product or a new direction in biotechnology or electronics will be produced by cooperation between a professor in Chengdu, China, a young programmer in Bangaluru, India, an engineer at a large corporation in Munich, Germany, a graduate student at Tokyo University, and a team at a small start-up company in Silicon Valley.  The patent system can help inform each of them of the other and bring together their incremental advances to achieve the next generation of progress in some tiny corner of human progress.

    Thus, patents properly remain a tool for research and experimentation because the system encourages publication and sharing of research results.  Disclosure of how to make and use the invention is the "quid pro quo" of the patent grant.  See JEM Ag Supply, Inc. v. Pioneer Hi-Bred Int'l, Inc., 534 U.S. 124, 142 (2001).  In exchange for disclosure, the inventor receives a limited term of exclusivity to benefit from commercialization of his invention.  Without this promise of exclusivity, researchers at corporations would be forced to turn to secrecy as the best protection for their inventions.  Even academic researchers may delay publication of results in order to maintain an edge over the competition, Cohen & Walsh, supra at 14, and the race to the patent office helps counteract this tendency toward secrecy by rewarding earlier disclosure.  "The information in patents is added to the store of knowledge with the publication/issuance of the patent.  . . .  [It] is not insulated from analysis, study, and experimentation for the twenty years until patent expiration."  Classen, 659 F.3d at 1072.  Rather, information shared through patent applications is immediately available for others to build upon.  It speeds the progress of scientific endeavor.  In other words, the patent system's modern benefits facilitate experimentation far more than any hypothetical inhibition.

    To reiterate:

    "[I]n an era of empirical research, one might ask the reason that this academic notion has never actually been verified.  Although studied, no research has substantiated this alleged attack on the patent system."

    "[P]atents on research tools and biomedical innovations do not significantly slow the pace of research and do not deter researchers from pursuing promising projects."

    "The reason that patents have not been proven to impede more than stimulate technological advance is simple:  it does not happen."

    "[I]nformation shared through patent applications is immediately available for others to build upon.  It speeds the progress of scientific endeavor."

    "In other words, the patent system's modern benefits facilitate experimentation far more than any hypothetical inhibition."

    (emphasis added).

    The facts cannot be more clearly recited.  But "there are none so blind as those that cannot see," or perhaps even more so those who would rather not be confused by the facts.

  • Court Report

    By Sherri Oslick —

    Gavel About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases.

    Sunovion Pharmaceuticals Inc. v. Watson Pharmaceuticals Inc. et al.
    1:12-cv-00993; filed July 27, 2012 in the District Court of Delaware

    • Plaintiff:  Sunovion Pharmaceuticals Inc.
    • Defendants:  Watson Pharmaceuticals Inc.; Watson Laboratories Inc.; Watson Pharma Inc.

    Infringement of U.S. Patent No. 7,256,310 ("Levalbuterol Salt," issued August 4, 2007) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of Sunovion's Xopenex® HFA (levalbuterol hydrochloride inhalation aerosol, used to treat bronchospasm caused by asthma and chronic obstructive pulmonary disease).  View the complaint here.


    Southern Research Institute et al. v. Abon Pharmaceuticals LLC
    2:12-cv-04709; filed July 27, 2012 in the District Court of New Jersey

    • Plaintiffs:  Southern Research Institute; Genzyme Corp.
    • Defendant:  Abon Pharmaceuticals LLC

    Infringement of U.S. Patent No. 5,661,136 ("2-Halo-2'-Fluoro ARA Adenosines as Antinoplastic Agents," issued August 26, 1997) following a Paragraph IV certification as part of Abon's filing of an ANDA to manufacture a generic version of Genzyme's Clolar® (clofarabine injection, used to treat acute lymphoblastic leukemia).  View the complaint here.


    Meda Pharmaceuticals Inc. v. Cadila Healthcare Ltd. et al.
    3:12-cv-04719; filed July 27, 2012 in the District Court of New Jersey

    • Plaintiff:  Meda Pharmaceuticals Inc.
    • Defendants:  Cadila Healthcare Ltd.; Zydus Cadila; Zydus Pharmaceuticals USA Inc.

    Infringement of U.S. Patent No. 8,071,073 ("Compositions Comprising Azelastine and Methods of Use Thereof," issued December 6, 2011) following a Paragraph IV certification as part of Cadila's filing of an ANDA to manufacture a generic version of Meda's Astepro® (azelastine hydrochloride nasal spray, used to treat hay fever and allergy symptoms).  View the complaint here.


    Galderma Laboratories LP et al. v. Watson Pharmaceuticals Inc. et al.
    3:12-cv-02563; filed July 27, 2012 in the Northern District of Texas

    • Plaintiffs:  Galderma Laboratories LP; Galderma SA; Galderma Research & Development SNC
    • Defendants:  Watson Pharmaceuticals Inc.; Watson Laboratories Inc.

    Infringement of U.S. Patent Nos. 8,071,644 ("Combinations of Adapalene and Benzoyl Peroxide for Treating Acne Lesions," issued December 6, 2011), 8,080,537 (same title, issued December 26, 2011), 8,105,618 ("Dermatological/Cosmetic Gels Comprising At Least One Retinoid and/or Retinoid Salt and Benzoyl Peroxide," issued January 31, 2012), and 8,129,362 ("Combination/Association of Adapalene and Benzoyl Peroxide for Treating Acne Lesions," issued March 6, 2012) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of Galderma's Epiduo® Gel (adapalene and benzoyl peroxide, used to treat acne vulgaris).  View the complaint here.


    Purdue Pharma L.P. et al. v. Actavis Elizabeth LLC
    1:12-cv-05615; filed July 20, 2012 in the Southern District of New York

    • Plaintiffs:  Purdue Pharma L.P.; Grunenthal GmbH
    • Defendant:  Actavis Elizabeth LLC

    Infringement of U.S. Patent No. 8,114,383 ("Abuse-Proofed Dosage Form," issued February 14, 2012 following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Purdue Pharma's OxyContin® (controlled release oxycodone hydrochloride, used to treat pain).  View the complaint here.

  • Conference & CLE Calendar

    Calendar

    August 21, 2012 – Mayo v. Prometheus: The Supreme Court's New Methodology for Analyzing Patent Eligibility (American Bar Association) – 1:00 – 2:30 pm (EDT)

    August 24, 2012 – The America Invents Act: The Boundaries of Prior Art (American Bar Association) – 1:00 – 2:30 pm (EDT)

    September 6, 2012 – A Review of the Impact of Recent Supreme Court and Federal Circuit Decisions on Patent Strategy (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 – 11:15 am (CT)

    September 9-11, 2012 – IPO Annual Meeting (Intellectual Property Owners Association) – San Antonio, TX

    September 10-12, 2012 – Business of Biosimilars & Generic Drugs (Institute for International Research) – Boston, MA

    September 20-21, 2012 – FDA Boot Camp*** (American Conference Institute) – Boston, MA

    September 24-25, 2012 – Biosimilars and Biobetters*** (SMi) – London, UK

    September 25-26, 2012 – EU Pharma Regulatory Law*** (C5) – Brussels, Belgium

    October 10-11, 2012 – Maximizing Pharmaceutical Patent Lifecycles*** (ACI) – New York, NY

    October 10-11, 2012 – Biotech & Pharmaceutical Patenting*** (C5) – London, UK

    ***Patent Docs is a media partner of this conference or CLE

  • ABA Webinar/Teleconference on Mayo v. Prometheus

    ABAThe American Bar Association (ABA) Section of Intellectual Property Law, Health Law Section, and Center for Professional Development will be offering a live webinar and teleconference entitled "Mayo v. Prometheus: The Supreme Court's New Methodology for Analyzing Patent Eligibility" on August 21, 2012 from 1:00 – 2:30 pm (EDT).  Denise W. DeFranco of Finnegan, Henderson, Farabow, Garrett & Dunner, LLP will moderate a panel including Robert A. Armitage, Senior Vice President and General Counsel for Eli Lilly and Company, and Thomas W. Krauss, Special Counsel for Intellectual Property Litigation for the U.S. Patent & Trademark Office.  The panel will cover the U.S. Supreme Court's recent decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. regarding the eligibility of inventions directed to personalized medicine and more generally to diagnostic methods for treating disease, and explain the Supreme Court's newly articulated methodology for analyzing patent eligibility of inventions implicating laws of nature and how that methodology might be applied to a broad swath of inventions.

    The registration fee for the webcast is $95 for members of any of the sections sponsoring the webinar, $99 for government attorneys, $150 for ABA members, and $195 for the general public.  Those interested in registering for the webinar, can do so here or by calling 800-285-2221.

  • ABA Webinar/Teleconference on the AIA

    ABAThe American Bar Association (ABA) Section of Intellectual Property Law, ABA-IPL Young Lawyers Action Group, Young Lawyers Division, and Center for Professional Development will be offering a live webinar and teleconference entitled "The America Invents Act: The Boundaries of Prior Art" on August 24, 2012 from 1:00 – 2:30 pm (EDT).  Janet S. Hendrickson of Senniger Powers LLP will moderate a panel including Steve S. Chang of Banner & Witcoff, Ltd., and Susanne T. Jones of O’Brien Jones PLLC.  The panel will provide practical guidance regarding changes in practice in view of the differences in prior art definitions, discuss traps arising from the one year grace period to an inventor's own disclosures that was retained in the Act while providing ways for applicants to avoid these traps, address the areas of uncertainty in the implementation or interpretation of the AIA prior art provisions, and provide guidance for analyzing various courses of action.

    The registration fee for the webcast is $95 for members of any of the sections sponsoring the webinar, $99 for government attorneys, $150 for ABA members, and $195 for the general public.  Those interested in registering for the webinar, can do so here or by calling 800-285-2221.

  • Webinar on Impact of Recent Supreme Court and Federal Circuit Decisions

    MBHB Logo 2McDonnell Boehnen Hulbert & Berghoff LLP will be offering a live webinar on the "A Review of the Impact of Recent Supreme Court and Federal Circuit Decisions on Patent Strategy" on September 6, 2012 from 10:00 am to 11:15 am (CT).  MBHB attorney Grantland Drutchas will provide an overview of recent Supreme Court and Federal Circuit decisions and their impact on patent prosecution and litigation in each of the following areas:

    • 35 U.S.C. §101
    • 35 U.S.C. §145
    • Orange Book and Use Codes
    • Injunctions after eBay
    • Inequitable Conduct after Therasense
    • Doctrine of Equivalents
    • Joint Infringement
    • Exceptional Case and Patent Enforcement

    While there is no fee to participate, attendees must register in advance.  Those wishing to register can do so here.  CLE credit is pending for the states of California, Georgia, Illinois, North Carolina, New Jersey, New York and Virginia.

  • Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd. (Fed. Cir. 2012)

    By Andrew Williams —

    Novo NordiskOn Monday, the Federal Circuit issued an Order in the Novo Nordisk A/S v. Caraco Pharm. Labs. Ltd. case, modifying an injunction against Novo issued by the lower court from one dictating express language to amend its Orange Book use code to one that required Novo to amend the use code.  The Order, however, provides flexibility for the exact language, provided that the language accurately describes the scope of the Orange Book-listed patent claim.  Judge Dyk dissented in part because he believed that the lower court's injunction should not have been modified because district courts are supposed to have broad authority to shape remedial injunctive orders.

    Caraco Pharmaceutical LaboratoriesThe Novo case had an extensive history, with the most recent stop at the Supreme Court, resulting in a reversal of the Federal Circuit's previous opinion and a remand for further proceedings consistent with the Supreme Court's decision.  The history and outcome of the Supreme Court's opinion has been discussed here, and therefore this summary will only provide a brief introduction to provide the proper context for the Federal Circuit's recent order.  Novo markets the drug PRANDIN® for the treatment of Type 2 (adult-onset) diabetes.  Repaglinide, the active ingredient in PRANDIN®, is covered by Reissue Patent No. RE37,035, and the use of repaglinide in combination with metformin is covered by U.S. Patent No. 6,677,358 ("the '358 patent").  However, PRANDIN® was also approved for use as a monotherapy and in combination with thiazolidinediones, and the use code listed in the Orange Book was broad enough to cover these other non-patented uses.  Caraco filed an ANDA to market a generic version of PRANDIN®, and included a Section viii statement to "carve-out" the claimed method of use in an attempt to circumvent the '358 patent.  Nevertheless, because the use code was overly broad, the FDA rejected Caraco's carve out label.  As a result, Caraco sought a court order requiring the FDA to narrow the Orange Book listed use code.  After the District Court granted such an order, and the Federal Circuit vacated the injunction, the Supreme Court held that 21 U.S.C. § 355(j)(5)(c)(ii)(I) provided an ANDA applicant an opportunity to challenge inaccurate use codes and designations.  The current order is a result of Caraco's motion for a summary affirmance of the injunction based on the Supreme Court's remand of the case.

    The first issue raised by Novo's challenge to the motion was whether the current use code was actually incorrect.  All three members of the panel believed that, based on the admitted facts of this case, the Supreme Court's decision foreclosed any argument to the contrary.  Therefore, the only remaining issue advanced by Novo was whether the mandatory injunction of the District Court was in error.

    The majority answered this question in affirmative.  It began with the language of the counterclaim statue, which provides that the court can issue "an order requiring the holder to correct or delete the patent information submitted by the holder" to the FDA.  The Court also noted that the FDA regulations make the branded company responsible for drafting the use code in the first place, and in fact must certify that the information was accurate and complete.  When viewed in combination, these two provisions provide that the only appropriate order would allow the branded company to draft its own corrected use code.  The District Court's injunction, however, dictated the exact language of the modification (even if the exact language was a previously appearing use code for PRANDIN®):

    Novo Nordisk is hereby directed by mandatory injunction under 21 U.S.C. § 355(j)(5)(C)(ii)(1)(bb) to correct within twenty (20) days from the date of this Order and Injunction its inaccurate description of the '358 patent by submitting to FDA an amended form FDA 3542 that reinstates its former U-546 listing for Prandin and describes claim 4 of the '358 patent in section 4.2b as covering the "use of repaglinide in combination with metformin to lower blood glucose."

    As a result, the Court found that the District Court had abused its discretion.  Of course, the Court noted that the use code must accurately describe the patented use, and that it is appropriate for a district court to construe the scope of the patent claims (which will influence the scope of the use code).  Also, in response to the dissent's concerns, the majority pointed out that the district court always has the power to correct any attempt to submit an overly broad revised use code.  Therefore, the majority revised the injunction to read:

    Novo Nordisk is hereby directed by mandatory injunction under 21 U.S.C. § 355(j)(5)(C)(ii)(1)(bb) to correct within twenty (20) days from the date of this Order and Injunction its inaccurate description of the '358 patent by submitting to FDA an amended form FDA 3542 for Prandin that accurately describes the scope of claim 4 of the '358 patent in section 4.2b.  The description shall be clearly limited to use of repaglinide in combination with metformin to treat non-insulin dependent diabetes mellitus.

    In dissent, Judge Dyk also began with the language of the statue, as provided above.  However, he could find no prohibition from allowing the district court to dictate the particular use code as a corrective measure.  The dissent also pointed out that district courts have traditionally had broad authority to shape injunctive orders.  Finally, Judge Dyk pointed out that there is no statute or regulation that says that a district court cannot correct a use code under the counterclaim statute, which would be required to prevent a court from doing so (citing Weinberger v. Romero-Barcelo, 456 U.S. 305, 313 (1982) ("[T]he comprehensiveness of this equitable jurisdiction is not to be denied or limited in the absence of a clear and valid legislative command.")).  By way of illustration, it analogized this current situation to an order from a lower court amending the inventorship of a patent, noting that the Federal Circuit has never limited a lower court to ordering a general correction of an incorrect list of inventors rather than directing exactly how the inventorship should be changed.  This might not be a completely appropriate analogy, but the dissent had a valid point when it noted that a patent holder should not be allowed to continue to "throw a wrench" into the ability of the FDA to approve generic drugs, and such a ruling by the majority would have this effect.  Whether Novo in this case, or some future NDA holder in a separate case, could craft a revised use code that still accurately reflects the patented use but also thwarts the attempts of an ANDA applicant to obtain a "carve out" remains to be seen.

    Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd. (Fed. Cir. 2012)
    Panel: Chief Judge Rader and Circuit Judges Clevenger and Dyk
    Order for the court by Chief Judge Rader; opinion concurring in part and dissenting in part by Circuit Judge Dyk