Patent Docs

Amgen v. Sandoz Update — En Banc Rehearing Petitions Filed

September 10, 2015

By Andrew Williams —

On July 21, 2015, the Federal Circuit decided the Amgen v. Sandoz appeal in a case of first impression regarding the interpretation of the disclosure and notice provisions of the Biologics Price Competition and Innovation Act ("BPCIA"). As we reported at the time, the decision from the three judge panel was seriously fractured, with an outcome that would make neither party happy. Not surprisingly, therefore, on August 20, 2015, both Amgen and Sandoz filed petitions for an en banc rehearing. Amgen, of course, argued that the disclosure provisions of the BPCIA required that Sandoz supply a copy of its biosimilar application within 20 days after its application was accepted for review by the FDA. Sandoz, in turn, argued that the BPCIA does not require waiting until the FDA approves the biosimilar application before 180-day notice has to be provided. In essence, Sandoz argued, the Court's decision resulted in an improper extension of exclusivity by six months. And, in turn, on September 8, 2015, both parties filed responses, explained how the three-judge panel got its part of the case correct.

In addition to that briefing, three amicus curiae briefs were either filed, or requested to be filed — all of which supported the Sandoz petition. These briefs were submitted by (1) the Biosimilars Council, a division of the Generic Pharmaceutical Association ("GPhA"), (2) Mylan Inc, and (3) Hospira, Inc. and Celltrion.

The one issue that all of the parties agreed upon was that it is appropriate for en banc rehearing to occur at this time. This was due in part to the fractured nature of the decision, and because this case was a matter of first impression. In addition, as Amgen put it, this case was one "of critical importance to the biopharmaceutical industry." Therefore, "to help guide this developing industry," Amgen asserted that the full Court should rehear the decision now. Sandoz highlighted the fact that if the fragmented panel decision were to be left unreviewed, "the ruling would delay access by patients to all biosimilars . . . ." Because "[e]ach panel member had a different interpretation of this important statute," Sandoz continued, the full Court should weigh in to prevent "the fragmented interpretation [from binding] industry, district courts, and subsequent panels of this Court." And, Hospira pointed out that en banc review was required now because "resolving this case will establish the competitive framework that governs the biosimilars industry."

Amgen, naturally, focused on the rehearing the outcome of the disclosure and exchange provisions of the BPCIA. Amgen explained the balance that Congress attempted to create by allowing biosimilar applicants to rely on the approval data obtained by the innovator company, on the one hand, and protecting the public's interest in innovation by requiring the disclosure of information necessary to determine whether patent infringement has or will occur on the other hand. In fact, Amgen identified five ways in which Congress made clear that the disclosure provisions were mandatory. First, Congress tied the applicant's choice of the biosimilar "(k)" pathway to providing the requisite information (like the aBLA application) to the reference product sponsor by its use of the word "shall": "When a subsection (k) applicant submits an application under subsection (k), such applicant shall provide . . . the information required to be produced pursuant to" the BPCIA. Second, Congress used the mandatory word "shall." Third, Congress demonstrated its ability to use non-mandatory language elsewhere. Fourth, in several other places in the statute, Congress referred to the aBLA and manufacturing information as the "required" information. And fifth, Congress included manufacturing-process patents in the dispute-resolution regime (in other words, the type of information that is supposed to be discussed). This is, of course, in contradistinction to the Hatch Waxman scheme, which does not provide for the assertion of such patents prior to launch.

Most of the substance of Amgen briefing, however, focused on the remedy. This is likely because the panel appeared to agree in principle in the opinion that the "shall" provision was mandatory. However, because the statute appeared to already include a remedy (the ability to bring a patent infringement suit), the majority held that this was the sole remedy. Therefore, the Court found that it was not possible to compel compliance with this section, recover damages, or otherwise seek relief. Amgen also addressed the wording of newly added 35 U.S.C. § 271(e)(2)(C)(ii), which appears to define the act of infringement in such cases. Amgen argued to the contrary, asserting that this section of the Patent Act determines the "scope" of infringement — that under this section, the reference product sponsor is free to bring an infringement suit with regard to any patent that could have been identified during the "patent dance." This was not meant to be the only remedy, however, according to Amgen.

Sandoz, in turn, explained why the Court's holding with regard to the 180-day notice provision was incorrect. The problem, according to Sandoz, was that by requiring approval of the application before notice can be provided necessarily increases the exclusivity period from 12 years to 12 ½ years. The excuse that the Congress established the 180 days to allow the reference product sponsor time to seek a preliminary injunction was unconvincing to Sandoz. This goal does not require that notice be "post-approval," but instead is accomplished simply by giving notice prior to marketing. And allowing notice to be pre-approval does not subvert the larger role that this provision is supposed to play, according Sandoz, in lifting the "stay" on artificial-infringement declaratory judgement suits. Of course, Sandoz ignores the fact that this advantage is illusory for reference product sponsors in cases such as this one, where the biosimilar application was not provided. In these cases, the reference product sponsor can already bring a declaratory judgment infringement suit as the statutory remedy (although only for patents claiming the biological product or a use thereof). Therefore, very little is gained by the reference product sponsor if notice can be provided pre-approval. Because of this, if a biosimilar applicant chooses to withhold its application, it has little disincentive to giving notice of commercial marketing on the day the application is accepted by the FDA.

We will continue to monitor this case and report on any decision by the Court.
Media Rights Technologies, Inc. v. Capital One Financial Corp. (Fed. Cir. 2015)

September 9, 2015

Broad Claim Terms and Inadequate Support in Specification Render Patent Invalid

By Joseph Herndon —

In Media Rights Technologies, Inc. v. Capital One Financial Corp. (September 4, 2015), the Federal Circuit first transformed a broadly described element in a claim into a means-plus-function claim term, and then found the disclosure to be inadequate for the term rendering the claims indefinite under § 112.

When claim drafting, a patentee must be mindful that 35 U.S.C. § 112, ¶ 6 can be invoked in many ways. Even when unintended, if inadequate structure is recited in the claim, or broad/vague claim terms are used, 35 U.S.C. § 112, ¶ 6 can rear its head.

In this case, Media Rights sued Capital One alleging infringement of U.S. Patent No. 7,316,033 (the "'033 Patent"). The '033 Patent is generally directed to preventing illegal copying or sharing of copyrighted media.

Claim 1 is illustrative of the invention, and it recites:

A method of preventing unauthorized recording of electronic media comprising:
    activating a compliance mechanismin response to receiving media content by a client system, said compliance mechanismcoupled to said client system, said client system having a media content presentation application operable thereon and coupled to said compliance mechanism;
    controlling a data output pathway of said client system with said compliance mechanismby diverting a commonly used data pathway of said media player application to a controlled data pathway monitored by said compliance mechanism; and
    directing said media content to a custom media devicecoupled to said compliance mechanismvia said data output path, for selectively restricting output of said media content.

The District Court concluded that (1) the term "compliance mechanism" is indefinite and, (2) because every claim of the '033 Patent contained the term, all of the claims of the '033 Patent are invalid.

Claim Term – "compliance mechanism"

With respect to the "compliance mechanism" claim term, the District Court found that the claim language itself stated that the "compliance mechanism" was activated in response to the client system receiving media content, that it controlled a data output path, and that it monitored a controlled data pathway. Because this language only describes how the components of the invention are combined and the functions performed by the "compliance mechanism," without suggesting anything about the structure of the mechanism itself, the District Court determined that the claim language did not recite sufficient structure for the "compliance mechanism" term itself, and so the term must be a means-plus-function term. Next, following basic means-plus-function claim construction, the District Court considered what functions it performs, and then determined what structure identified in the specification performs these functions. Four functions were identified in the claims as being performed by the "compliance mechanism":

(1) "controlling a data output of [the] client system . . . by diverting a commonly used data pathway of [the] media player application to a controlled data pathway" (Claim 1);
(2) monitoring the controlled data pathway (Claims 1, 10 and 19);
(3) "managing an output path of [the] client system . . . by diverting a commonly used data pathway of [the] media player application to a controlled data pathway" (Claim 10); and
(4) "stop[ping] or disrupt[ing] the playing of [the] media content at [the] controlled data pathway when said playing of said media file content is outside of [the] usage restriction applicable to said media file" (Claims 10 and 19).

Because the structure for computer-implemented functional claims must be supported by a specific algorithm, and the specification here failed to describe "an algorithm whose terms are defined and understandable," the District Court determined that the "compliance mechanism" term is indefinite for lack of written description support.

Is "compliance mechanism" a means-plus-function claim term?

On its face, the claim term "compliance mechanism" does not seem like it would invoke § 112, ¶ 6, since the claim lacks the traditional "means for . . ." claim language.

For claim terms that use "means for . . ." language, it is presumed that § 112, ¶ 6 applies, and the opposite is true as well — for claim terms lacking the word "means for . . .", it is presumed that § 112, ¶ 6 does not apply. However, the presumption that § 112, ¶ 6 does not apply can be overcome if a party can "demonstrate[] that the claim term fails to 'recite sufficiently definite structure' or else recites 'function without reciting sufficient structure for performing that function.'"

MPEP § 2181 describes a general three prong analysis to determine if § 112, ¶ 6 is invoked:

1. Does the claim use magic phrase "means for" or "steps for"?
2. Is the "means for" modified by functional language? and
3. Does the phrase "means for" lack any modification by structure, material or acts for achieving the specified function?

Here, even though the magic "means for . . ." terms were not used, the Federal Circuit found that the claims do not use the term "compliance mechanism" as a substitute for an electrical circuit, or anything else that might connote a definite structure. Rather, the claims simply state that the "compliance mechanism" can perform various functions. Therefore, the phrase "compliance mechanism" lacks any modification by structure, and was instead, used for pure functional claiming.

Consequently, the claim term was interpreted as a means-plus-function claim term, and then held indefinite by the Federal Circuit because nowhere does the specification define "compliance mechanism" in specific structural terms. The Federal Circuit found that description alone of how the "compliance mechanism" is connected to and interacts with the other components of the system, what processes the "compliance mechanism" performs, and what structural subcomponents might comprise the "compliance mechanism" is insufficient to avoid the application of § 112, ¶ 6. Input and output "mechanisms" will not provide the necessary written description support for the component itself.

Here, because the specification does not disclose a specific algorithm for all of the four recited functions associated with the "compliance mechanism" means-plus-function claim limitation, it is treated as if the specification has no supporting algorithm disclosed at all. For the specific claim language, the specification fails to disclose an operative algorithm for both the "controlling data output" and "managing output path" functions. These two functions both require diverting a data pathway. The cited algorithm by Media Rights does not explain how to perform the diverting function, making the disclosure inadequate.

The Federal Circuit concluded that the claim term "compliance mechanism" is indefinite, and thus, the Federal Circuit did not need to address the additional arguments that the "custom media device" term is not indefinite, or Capital One's alternative argument that the District Court's invalidity decision also can be affirmed on 35 U.S.C. § 101 grounds.

In this case, the Federal Circuit followed well-established case law that provides a strict requirement for how to describe and claim a "means for [performing] . . ." a specific computer-implemented function. Disclosure of only a general purpose computer as structure for a function in a means-for claim term amounts to pure functional claiming, and will result in the claim being found to be indefinite. Thus, a specification must sufficiently disclose an algorithm to transform a general purpose microprocessor to the special purpose computer for adequate support for the means-for claim term. The algorithm must describe, in detail, how to perform each of the recited claim functions.

Notably, in the decision, the Federal Circuit stated that "[w]e have never found that the term 'mechanism' — without more — connotes an identifiable structure." Certain claim terms, such as "mechanism" or "module" often are found by courts to invoke § 112, ¶ 6. As a practice tip, if it is the intention of the claim drafter to avoid § 112, ¶ 6, it seems a good idea to avoid use of the magic "means for . . ." language, as well as the problematic vague terms "mechanism" and "module". Sometimes using these terms, while written with good intention hoping to provide broad claim scope, can cause undesirable claim interpretation. However, if such terms are used, dependent claims can further define the specific structure of what comprises the "module" or "mechanism" for backup support.

While the Federal Circuit found the claims invalid due to indefiniteness, it would have been interesting to see if such claims could have survived the § 101 challenge.

Media Rights Technologies, Inc. v. Capital One Financial Corp. (Fed. Cir. 2015)
Panel: Circuit Judges O'Malley, Plager, and Taranto
Opinion by Circuit Judge O'Malley
Amicus Briefs in Support of Sequenom’s Petition for Rehearing En Banc: IPO

September 8, 2015

By Donald Zuhn —

Earlier this summer, in Ariosa Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit affirmed a decision by the District Court for the Northern District of California granting summary judgment of invalidity of the asserted claims of U.S. Patent No. 6,258,540 (see "Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015)"). Last month, Sequenom filed a petition for rehearing en banc, arguing that the panel's decision in June was inconsistent with the Supreme Court's decisions in Diamond v. Diehr, 450 U.S. 175 (1981), Mayo v. Prometheus Laboratories, 132 S. Ct. 1289 (2012), and Association for Molecular Pathology v. Myriad Genetics, 133 S. Ct. 2107 (2013, and that the panel's decision poses a threat to patent protection in multiple fields of invention. On August 27, twelve amicus curiae briefs were filed in support of Sequenom's petition for rehearing en banc. Over the next few weeks, Patent Docs will examine these amicus briefs. Today, we review the brief submitted by the Intellectual Property Owners Association (IPO).

The IPO begins by expressing its support for the petition for rehearing en banc filed by Sequenom, Inc. and Sequenom Center For Molecular Medicine, LLC so that the en banc Court can "clarify the analysis for determining the patent-eligibility of a claimed invention in view of the evolving Supreme Court jurisprudence on patent-eligible subject matter." According to the IPO, the appeal presents the following question of exceptional importance:

[H]ow to determine, in view of the extensive recent Supreme Court jurisprudence on the subject, whether a claimed invention includes sufficiently more than patent-ineligible subject matter and thus is eligible for patenting under 35 U.S.C. § 101, including whether evidence that a claim at issue does not unduly preempt ineligible subject matter is relevant to such an analysis?

The IPO then urges the Court, sitting en banc, "to hold that a claimed method must be considered as a whole for purposes of determining patent eligibility, and may not be dissected into its individual steps when considering whether it claims more than routine, conventional, and well-understood activity," and further, "to clarify that evidence that a claim does not unduly preempt use of ineligible subject matter strongly supports a finding that it recites a patent-eligible invention."

With regard to the first issue, the brief notes that "[t]he Supreme Court has long held that claimed inventions must be analyzed as a whole in order to determine their patent eligibility," citing Diamond v. Diehr, 450 U.S. 175, 188 (1981), for the proposition that "a new combination of steps in a process may be patentable even though all the constituents of the combination were well known and in common use before the combination was made." The brief also points out that in Mayo Collaborative Servs. v. Prometheus Labs, Inc., the Supreme Court reiterated the importance of considering claims as a whole as part of the eligibility analysis, and declares that "the Mayo Court did not establish some new, heightened requirement that individual elements of an invention must themselves be 'inventive.'" The IPO, however, argues that "since Mayo, courts and the PTO faced with questions of patent-eligibility have not consistently considered claimed inventions in their totality, improperly denying patent protection to deserving inventions," and states that in the instant case "the panel acknowledged the requirement to consider claim elements both individually and as an ordered combination but then failed to do so."

According to the IPO, the claimed methods in Mayo and those in the instant appeal are distinguishable "because even as an ordered combination as a whole, [the claims at issue in Mayo] amounted to nothing more than enunciating a natural law in the context of a process that was already routine practice." The brief also argues that the instant claims and those in Ass'n for Molecular Pathology v. Myriad Genetics, Inc. are also distinguishable, stating that:

[I]n Myriad, the Court held that isolated genes were laws of nature, such that claims merely reciting them and nothing more were drawn to patent-ineligible subject matter. In contrast, the claims here recite a use of cffDNA in pregnant women's blood, not merely its existence [citation omitted; emphasis in brief].

The IPO contends that "the panel overlooked the real question here: whether the groundbreaking application of a natural phenomenon, as described in a claimed method as a whole, is patent eligible" (emphasis in brief). With respect to this first issue, the IPO concludes:

The panel's misapplication of the Supreme Court's jurisprudence on this issue is representative of the difficulties courts and the PTO are often having in properly evaluating patent eligibility since Mayo. As a result, many inventions are improperly being denied protection and there is significant uncertainty among patentees and patent applicants as to the breadth of the judicially created exclusions from patent eligibility. To assist courts and the PTO in the proper analysis of patent eligibility, IPO urges this Court to emphasize how claimed methods must be evaluated as a whole when determining patent eligibility. Preventing the continuing trend of judicial and PTO decisions holding claimed methods to be ineligible for patenting beyond what the Supreme Court envisioned, let alone required, is an issue of exceptional importance to the patent-owning community, and this case presents an ideal opportunity for this Court to curb that unfortunate trend.

On the second issue, the IPO notes that "[t]he Supreme Court has consistently couched its patent-eligibility jurisprudence as designed to prevent the undue preemption of laws of nature, natural phenomena, and abstract ideas." Although the Ariosa panel acknowledged that the principle of preemption is the basis for the judicial exceptions to patentability, the panel "[p]aradoxically . . . called preemption concerns in this case 'moot.'" The IPO argues that:

Taken to its logical conclusion, the panel decision in this case would mean that under the test for patent eligibility described by the Supreme Court in Mayo, an invention may be found patent ineligible no matter how much evidence there is that it does not unduly preempt a law of nature, natural phenomenon, or abstract idea. This is not a result compelled by Mayo or the other the recent § 101 decisions by the Supreme Court. Indeed, it undermines the entire stated purpose of the Supreme Court's patent-eligibility jurisprudence: to prevent undue preemption. The approach taken by the panel is not what the Supreme Court said and cannot be what it intended in view of its focus on preventing preemption.

Asserting that "Sequenom presented substantial evidence that its claims do not unduly preempt the use of cffDNA found in pregnant women's blood," the brief observes that "[y]et the panel improperly disregarded all of this evidence as 'moot.'" The IPO concludes the brief by urging the en banc Court to rehear the case in order "to clarify that evidence of a lack of preemption is never 'moot' under the Supreme Court's two-step test for patent eligibility."

For additional information regarding this topic, please see:

• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: Professors Lefstin and Menell," September 6, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: 23 Law Professors," September 3, 2015
• "Amici Support Sequenom's Petition for Rehearing En Banc," August 28, 2015
• "Sequenom Requests Rehearing En Banc," August 18, 2015
• "Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015), June 22, 2015
Sandoz’ NEUPOGEN® Biosimilar Now on the Market

September 7, 2015

By Kevin E. Noonan —

Sandoz is having a good year. The company succeeded in having their NEUPOGEN^® (filgrastrim) biosimilar product, Zarxio™, approved by the FDA in March, a mere ten months after filing its biosimilar application last July. The biosimilar applicant also avoided the disclosure provisions of the Biologics Price Competition and Innovation Act (BPCIA) (codified at (42 U.S.C § 262(l)(2)(A)), successfully arguing those provisions were optional before the District Court and the Federal Circuit. And they were also fortunate that the Court did not maintain the injunction that prevented marketing Zarxio™ during the pendency of Amgen's appeals.

And now Sandoz has decided to begin to reap the benefits of those victories, bringing Zarxio™ to market in a September 4th announcement (two days after the injunction expired) (see the Sandoz press release). According to several media reports, Zarxio™ will be priced at a 15% discount on Amgen's NEUPOGEN^® product, on the low end of estimates that the discount would range from 15-30% (but consistent with estimates, most famously by the Federal Trade Commission that price reductions would be much lower than small molecule generic drugs brought to market under the Hatch-Waxman Act). NEUPOGEN^® is a $1.2-1.4 billion dollar per year product for Amgen, and it is unclear (in the short term) what the effect of Sandoz Zarxio™ marketing will be. This is due at least in part to an anticipated lag in physician acceptance: unlike conventional "generic," generally small molecule, drugs (which cause upwards of 90% reductions in drug prices from the innovator brand price very quickly after entering the marketplace), biosimilar drugs are both more complex than small molecule drugs and are administered by physicians (typically by injection) and thus continue to actively involve medical personnel during a course of treatment. Consequently, physician acceptance of biosimilar drugs is much more of an issue than for generic drugs and thus market penetrance is expected to be delayed for 1-5 years, even by Sandoz. These estimates are in line with industry expectations for biosimilar drugs in general; for example, Express Scripts has estimated that while U.S. healthcare costs may be reduced by about $250 million between 2015 and 2025, biosimilar sales worldwide will only increase from $1.3 billion to $35 billion by 2020, even taking into account the robust approval climate for biosimilar drugs on Europe (where the EMEA has approved 21 biosimilar drugs over the past 10 years; it should be noted that cost savings in Europe from biosimilars amount to about a 10% reduction).

Also significant is that Sandoz' approval is but the first of many NEUPOGEN^® biosimilar approvals waiting FDA action, and thus there is some pressure for Sandoz to gather its metaphorical biosimilar rosebuds now before facing additional biosimilar competition. There is also the continuing litigation with Amgen (the decision subject to Federal Circuit review was on Amgen's motion for summary judgment; litigation on the merits is ongoing). Amgen also has filed a petition for rehearing en banc that could reverse Sandoz' victories to date (or perhaps certiorari review by the Supreme Court, which ultimately could be more costly in view of the time to decision while Zarxio™ is on the market). This situation is reminiscent of an "at-risk" launch in the ANDA context, and Sandoz' willingness to take this apparent risk suggests that it may not believe that Zarxio™ infringes the patent Amgen has asserted. This illustrates the strategic disadvantage to the reference product sponsor that the courts' interpretation of the BPCIA has created, and provides another reason for Congress to clarify whether it meant what it said when it crafted the disclosure provisions to state that the biosimilar applicant "shall" make the disclosures Sandoz has thus far been able to avoid.

For additional information regarding this and other related topics, please see:

• "Federal Circuit Lifts Injunction Against Sandoz," September 2, 2015
• "'Don't Stop the Dance'[*] — The Dissents-in-Part from Amgen v. Sandoz," July 23, 2015
• "Amgen v. Sandoz (Fed. Cir. 2015)," July 22, 2015
• "Federal Circuit Decides Amgen v. Sandoz (in an opinion that will make neither party happy)," July 21, 2015
• "Amgen v. Sandoz — Federal Circuit Oral Argument," June 7, 2015
• "Amgen Wins Injunction against Neupogen® Biosimilar Pending Appeal," May 6, 2015
• "Amgen v. Sandoz Update — Amgen's Continuing Efforts to Obtain Preliminary Injunction," April 28, 2015
• "Amgen v. Sandoz Update — BIO Files an Amicus Brief at the Federal Circuit," April 21, 2015
• "Amgen Receives No Help from the FDA — A Biosimilar Update," April 15, 2015
• "The Tyranny of the Judiciary," March 23, 2015
• "Gotta Dance? Apparently Not — A Biosimilar Update," March 19, 2015
• "The First Biosimilar Application Has Been Approved — But What About the Patent Issues?" March 12, 2015
• "FDA Approves Sandoz Filgrastim Biosimilar," March 8, 2015
• "'No Clinically Meaningful Differences': The First Accepted Biosimilar Application Has Been Recommend for FDA Approval," January 14, 2015
• "Sandoz Inc. v. Amgen Inc. (Fed. Cir. 2014)," December 9, 2014
• "Finally, A Biosimilar Application Has Been Accepted By The FDA," July 28, 2014
Inquiries from Abroad

September 7, 2015

Julian Cockbain, a former partner at the UK patent firm Dehns, sent us the following request:

Could I ask a favour? That you ask on your blog that readers send me copies of papers or theses that they have written on the subject of patent-eligibility (what is the proper subject matter for patents rather than what is new, inventive, etc)? I've written a book on the subject in relation to European law with Sigrid Sterckx (CUP, 2012) and would like to spend the summer reading others' ideas [including yours].

(Professor Sterchx's publications can be found here).

Julian can be reached at julian.cockbane@btopenworld.com or Julian Cockbain, Hoogpoort 28A101, B-9000 Gent, Belgium. He also has suggested that his views may not be entirely consistent with those expressed on this blog, and accordingly this is an opportunity for our readers to enlighten him.
Conference & CLE Calendar

September 7, 2015

September 8, 2015 – Patent Quality Chat webinar on Global Patent Prosecution (U.S. Patent and Trademark Office) – 12:00 to 1:00 pm (EDT)

September 9, 2015 – "A Kinder, Gentler PTAB? Proposed New Trial Rules & Important Recent Decisions" (Intellectual Property Owners Association) – 2:00 to 3:00 pm (ET)

September 9, 2015 – "Where to Challenge Patents? International Post Grant Practice — Strategic Considerations Before the USPTO, EPO, SIPO and JPO" (Practising Law Institute) – 1:00 to 2:00 pm (Eastern)

September 10, 2015 – Biotech Patent Law Road Show (American Intellectual Property Law Association) – Boston, MA

September 10, 2015 – "Patent Infringement: Structuring Opinions of Counsel — Leveraging Opinion Letters to Reduce the Risks of Liability and Enhanced Damages" (Strafford) – 1:00 to 2:30 pm (EDT)

September 10-11, 2015 - "Advanced Patent Prosecution Seminar 2015: Claim Drafting & Amendment Writing" (Practising Law Institute) – Chicago, IL

September 14, 2015 – Biotechnology/chemical/pharmaceutical (BCP) customer partnership meeting (U.S. Patent and Trademark Office)

September 15-17, 2015 – World IP Forum (Intellectual Professionals LLP) – Bangkok, Thailand

September 17, 2015 – "Professional Negligence: Real-Life Case Studies in IP Malpractice & How to Avoid Them" (American Intellectual Property Law Association) – 12:30 – 2:00 pm (Eastern)

September 18, 2015 – IP & Diagnostics Symposium (Biotechnology Industry Organization) – Alexandria, VA

September 18, 2015 – Developments in Pharmaceutical and Biotech Patent Law 2015 (Practising Law Institute) – San Francisco, CA

September 22, 2015 – "The Evolving World of Biosimilars Litigation" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

September 23, 2015 – "Pharma Leaders IP Conference" (J A Kemp) – London

September 24, 2015 – "Trade Secrets and Cybersecurity: Protecting Intellectual Property, Mitigating Loss and Navigating Legal Responses" (Strafford) – 1:00 to 2:30 pm (EDT)

September 24, 2015 – "Patent Term Adjustments and Extensions: Leveraging Recent Decisions and USPTO Rule Changes" (Strafford) – 1:00 to 2:30 pm (EDT)

September 24-25, 2015 - Advanced Patent Law Seminar (Chisum Patent Academy) – Washington, DC

September 24-25, 2015 – Seminar on European Patent Law (Grünecker) – Munich, Germany

September 27-29, 2015 – 43rd Annual Meeting (Intellectual Property Owners Association) – Chicago, IL

September 30 to October 1, 2015 – Paragraph IV Disputes master symposium (American Conference Institute) – Chicago, IL

September 30 to October 1, 2015 – FDA Boot Camp (American Conference Institute) – Boston, MA

October 2, 2015 – Developments in Pharmaceutical and Biotech Patent Law 2015 (Practising Law Institute) – New York, NY

***Patent Docs is a media partner of this conference or CLE
Amicus Briefs in Support of Sequenom’s Petition for Rehearing En Banc: Professors Lefstin and Menell

September 6, 2015

By Donald Zuhn —

Earlier this summer, in Ariosa Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit affirmed a decision by the District Court for the Northern District of California granting summary judgment of invalidity of the asserted claims of U.S. Patent No. 6,258,540 (see "Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015)"). Last month, Sequenom filed a petition for rehearing en banc, arguing that the panel's decision in June was inconsistent with the Supreme Court's decisions in Diamond v. Diehr, 450 U.S. 175 (1981), Mayo v. Prometheus Laboratories, 132 S. Ct. 1289 (2012), and Association for Molecular Pathology v. Myriad Genetics, 133 S. Ct. 2107 (2013), and that the panel's decision poses a threat to patent protection in multiple fields of invention. On August 27, twelve amicus curiae briefs were filed in support of Sequenom's petition for rehearing en banc. Over the next few weeks, Patent Docs will examine these amicus briefs. Today, we review the brief submitted by Professors Jeffrey A. Lefstin and Peter S. Menell.

The authors of the brief are professors of law at the University of California who teach intellectual property law. In addition to their law degrees, Prof. Lefstin holds a doctorate degree in biochemistry and Prof. Menell holds a doctorate degree in economics.

The amici offer four arguments justifying the grant of Sequenom's petition for rehearing en banc. First, the amici argue that the case presents vitally important issues at a critical juncture in the development of patent-eligibility law. Noting that "[t]he past 40 years have witnessed the most rapid period of technological change in our nation's history," the brief states that "Congress has been reluctant to weigh in on the scope of patentable subject matter, and the Supreme Court stood on sidelines for much of this critical period." However, the brief points out that since 2010, the Supreme Court has decided four patent-eligibility cases: Bilski v. Kappos, 561 U.S. 593 (2010); Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012); Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013); and Alice Corp. v. CLS Bank Int'l, 134 S. Ct. 2347 (2014).

In discussing these cases, the amici note that "Mayo explained that the distinction between an unpatentable law of nature and a patentable invention lay in the patentee's application: whether it evinced an 'inventive concept' beyond the underlying law of nature.'" However, the brief suggests that Mayo "glossed over several key issues, including how to reconcile prior discordant decisions (Flook and Diehr), and whether the requirement of 'inventive concept' demands an unconventional application, or merely more than the generic instruction to 'apply the law.'" The brief also notes that "Justice Breyer, the architect of Mayo, later commented [during oral argument in Alice Corp.] that Mayo did no more than 'sketch an outer shell of the content' of the patent-eligibility test, leaving the content to be developed by the patent bar in conjunction with the Federal Circuit." The brief further notes that the Myriad Court "upheld the eligibility of claims to cDNAs — DNA molecules derived from naturally occurring RNA by known, conventional, and routine laboratory procedures," and in Alice, the Court "confirmed that Mayo's framework governs all patent-eligibility determinations under § 101."

While stating that "[t]he primary responsibility for developing patent-eligibility doctrine now rests with this Circuit," the amici contend that "[t]he panel's decision uncritically accepts an expansive reading of Mayo that conflicts with insights from Myriad and Alice," and argue that, as a result, "[t]here is serious risk that failure to engage this issue at this juncture could set the patent system on a dire course." The brief declares that "given Congress's reluctance to take on these critical questions [about the patentability of diagnostic testing] and the Supreme Court's less than lucid articulation of standards, the Federal Circuit has an especially important role in ensuring that this controversy receives thorough evaluation."

The amici next argue that Mayo does not require that a new discovery be applied by unconventional means in order to be patent-eligible, and contend that "the [Ariosa] panel was incorrect to conclude that Mayo dictates a test of unconventional application." The brief notes instead that "Mayo suggests two other possibilities for an 'inventive concept': non-preemptive application; and non-generic application." Looking to Myriad, the brief explains that:

There was no pretense in the case that the act of reverse-transcribing natural mRNA into cDNA was inventive, and indeed the production of cDNA was known, routine, and conventional when the Myriad patents were filed in 1994. Had the Court required unconventional application over the natural phenomenon of mRNA, the Court could not have sustained the eligibility of the cDNA claims.

As for Alice, the brief states that this case "clarified that the § 101 inquiry asks not whether a claim represents an unconventional application of a fundamental principle, but whether a claim does more than state a fundamental principle, plus a generic instruction to 'apply it.'"

According to the amici, while the Supreme Court's interest in unconventional activity "is best understood as a sufficient condition for patent-eligibility: claims are patent-eligible if they implement a fundamental principle by unconventional means," the Ariosa panel "goes well beyond that test by elevating unconventional activity to a sufficient and necessary condition for patent-eligibility: claims are patent-eligible if and only if they implement a fundamental principle by unconventional means."

The third argument presented by amici for granting Sequenom's petition for rehearing en banc is the prohibition in Mayo and Alice against dissecting the claims into old and new components. The brief suggests that Diamond v. Diehr, 450 U.S. 175, 188 (1981), "made clear that even processes consisting of previously known steps could be patent-eligible." The brief also contends that "it is surely clear that Diehr's prohibition against dissecting claims has not been set aside by the Court's more recent decisions," including both Mayo and Alice. The amici argue, however, that "under the panel opinion's statement of the law, any process claim based on a natural phenomenon is ineligible for a patent unless the individual steps of the process are novel."

The amici conclude by arguing that the Ariosa panel's rule would invalidate claims that the Mayo Court deemed to be patent-eligible. The brief sets forth two examples: Nielsen's hot-blast smelting process, which disclosed the heating of air prior to its introduction into the blast furnace, and the new use of an existing drug, both of which the amici note the Mayo Court deemed to be patent-eligible. As for the first, because both the heating of air and the introduction of air into the blast furnace were well-known, "[u]nder the panel opinion's analysis, because Neilson implemented his discovery by old and known means, his patent would be invalid." As for the second example, the amici contend that "under the panel opinion's statement of the law, a claim to administering a known drug to treat a new condition would be ineligible, because the steps of administering the drug to a patient would be known and conventional at the time of filing."
IPO Webinar on New PTAB Rules and Recent Decisions

September 5, 2015

The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "A Kinder, Gentler PTAB? Proposed New Trial Rules & Important Recent Decisions" on September 9, 2015 from 2:00 to 3:00 pm (ET). Hon. Michael Tierney, Lead Administrative Patent Judge, Patent Trial and Appeal Board, U.S. Patent & Trademark Office; Steven Baughman of Ropes & Gray LLP; and Lissi Mojica of Dentons US LLP will discuss what the proposed PTAB rules changes are likely to mean in practice, focusing on: 1) the patent owner’s new ability to offer evidence in its preliminary response, and 2) the lowering of the hurdle to amend claims through clarification of the relevant prior art, as explained in the recent inter partes review opinion ImageMaster 3D. The panel will also discuss the pros & cons of a proposed pilot program under which a single APJ would decide whether to institute an IPR trial, with two additional APJs being assigned to conduct the IPR trial, if instituted.

The registration fee for the webinar is $130 (government and academic rates are available upon request). Those interested in registering for the webinar can do so here.
Webcast on International Post Grant Practice

September 5, 2015

Practising Law Institute (PLI) will be offering a one-hour webcast entitled "Where to Challenge Patents? International Post Grant Practice — Strategic Considerations Before the USPTO, EPO, SIPO and JPO" on September 9, 2015 from 1:00 to 2:00 pm (Eastern). Dr. Jeffery P. Langer, Christophe Besnard, Shigeki Takeuchi, and Cliff Yang of Osha Liang LLP will:

• Provide an overview of post grant proceedings before the USPTO, EPO, SIPO, and JPO;
• Highlight strategic considerations and relevant emerging issues when seeking review before these offices; and
• Discuss the strengths and weaknesses of the procedures before the offices and how to use these to your client’s advantage.

The registration fee for this webcast is $299. Those interested in registering for the webcast, can do so here.
ACI FDA Boot Camp

September 5, 2015

American Conference Institute (ACI) will be holding the next session of its FDA Boot Camp conference on September 30 to October 1, 2015 in Boston, MA. ACI faculty will help attendees:

• Master the basics of the application and approval processes for drugs, biologics, and devices;
• Comprehend the structure of the FDA and the roles of the three major agency centers: CDER, CBER, and CDHR;
• Develop a practical working knowledge of clinical trials for drugs and biologics and the clearance process for devices;
• Learn how devices are classified, monitored, and regulated;
• Appreciate the complexities of pharmaceutical IP and the regulatory balance between brand name and generic products;
• Recognize the pivotal role of labeling in the drug and biologics approval process;
• See the importance of cGMPs to the post-approval regulatory process; and
• Navigate the protocols of adverse events monitoring, signal detection, product withdrawals, and recalls.

In particular, ACI's faculty will offer presentations on the following topics:

• Brief Overview of FDA Practice
• The Nature of the Approval Process
• Understanding the Clinical Trial Process for Drugs and Biologics
• Drugs and Biologics: Labeling
• Patent and IP Overview for Drugs and Biologics: Understanding The Connection Between FDA Regulation and IP and Related Mechanisms Under Hatch-Waxman and BPCIA
• Part 1 — Patents, Trademarks and Other IP Protections and Mechanisms
• Part 2 — Hatch-Waxman and BPCIA Overview
• Using FDA's Citizen Petition Process and Litigation to Achieve Market Success
• cGMPs: Drugs and Biologics (Current Good Manufacturing Practices)
• The Drug Supply Chain Security Act — Summarizing the Act and Its Effect on FDA Practice
• Medical Devices: Classifications, the Essentials of the Premarket Review Process, and Post-Market Requirements and Concerns
• Adverse Events Monitoring, Pharmacovigilance and Risk Management, and Recalls

A pre-conference workshop on the "Fundamentals of FDA Regulatory Law" and "Resolving Ethical Challenges Encountered During the Drug Approval Process" will be offered on September 29, 2015 from 1:00 to 5:00 pm. Two post-conference master classes will be offered on October 1, 2015. The first master class is entitled "Hatch-Waxman and BPCIA: Overview of Biosimilars and Life Cycle Planning for Drugs and Biologics," and the second master class is entitled "Post-Approval Marketing Guidance and Preemption Protocols."

An agenda for the conference can be found here, and additional information regarding the workshop and master classes can be found here. A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.

The registration fee is $2,195 (conference alone), $2,795 (conference and workshop or conference or one master class), or $3,095 (conference, workshop, and one master class). Those interested in registering for the conference can do so here, by e-mailing CustomerService@AmericanConference.com, by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.

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