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Nick Landau
March 12
The Biotech Committee is Involved in Amending the TRIPS Agreement

The Committee continues to be deeply involved in the WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources (ICIPGR), Traditional Knowledge and Folklore.  The ICIPGR is undertaking negotiations with the objective of reaching agreement on a text of an international legal instrument, which will alter the TRIPS agreement with regard to intellectual property protection that involves “traditional knowledge” and “genetic resources.”  The Biotechnology’s Committee has sent representatives in the past to observe negotiations and issue recommendations.  The ICIPGR will in session on June 25-29.  Our committee’s efforts will continue throughout these negotiations.

What Are Genetic Resources and Traditional Knowledge?

"Traditional knowledge" has been defined by some as "knowledge, know how, skills, innovations or practices; that are passed between generations in a traditional context; and that form part of the traditional lifestyle of indigenous and local communities who act as their guardian or custodian."  "Genetic resources" have been defined as "genetic material of actual or potential value."

Why Amend the TRIPS Agreement?

Many national governments and groups of indigenous peoples have concerns about the inadequacy of extant IP systems to protect TK/GR.  These concerns are numerous and varied, but most seem to stem from the possibility that TK/GR might be shared by the custodial communities with others who could benefit from it, without acknowledgement or compensation paid to the custodial community.

What is the Biotech Committee Doing?

Representatives of the Committee attend WIPO meetings aimed at agreeing on amendments to the TRIPS agreement, submitting comments, and gathering opinions and observations of IP professionals throughout the world.  It goes without saying that the Committee will report all developments to the membership, through the Buzz and other means.

January 12
The Midwinter Institute is Around the Corner -- With Social and CLE!

As your new Vice Chair I urge and invite you to attend the first AIPLA meeting of the year at the Midwinter Institute. 

September 25
The Federal Circuit Rejects the E.D. Texas District Court’s Flexible Post-TC Heartland  Approach To Determining Venue, Ordering Transfer in In Re: Cray

​Please see my article in the September Buzz, on the Federal Circuit's first post-TC Heartland venue ruling in In Re: Cray Inc.  The Federal Circuit articulated three requirements which must be met to establish that a defendant has a "regular and established place of business" for purposes of establishing venue under the patent venue statute, 28 U.S.C. section 1400(b).

February 24
The Meaning of “Life” is “>1”:  A Single Component Cannot Constitute “A Substantial Portion of Components” of a 5-Component Invention for Purposes of Imposing Infringement Liability under 35 U.S.C. § 271(f)(1)

​             Last year, I blogged about the second Question Presented in Life Technologies Corporation v. Promega Corporation: “Whether the Federal Circuit erred in holding that supplying a single, commodity component of a multi-component invention from the United States is an infringing act under 35 U.S.C. § 271(f)(1), exposing the manufacturer to liability for all worldwide sales.”? [1]

At the time I had queried whether the Court would interpret the phrase “substantial portion” of the components as a numerical term (e.g., can a single component be a “substantial portion” of a 5 component combination); or whether the Court would take into account qualitative considerations, such as “how important or central” the component is to the invention,” as the Federal Circuit did in its decision. 
On February 22, 2017, the Supreme Court opted for the quantitative approach, holding that the text of the statute supported interpreting a “substantial portion” of the components of a patented invention as “a quantitative measurement.”[2]  The Court also noted that a qualitative standard would not help resolve close cases, and that it might prove too complicated for potential infringers or the jury to assess the qualitative importance of the components of an invention.  
Next, the Court considered the interaction between § 271(f)(1) and § 271(f)(2)[3] in reaching its ruling that a single component can never constitute a “substantial portion” of the components of a multicomponent, patented invention, for purposes of triggering liability under § 271(f)(1).  The Court reasoned that reading § 271(f)(1) to refer to more than one component, allowed that provisions to work in tandem with § 271(f)(2), which addresses infringement based on “any” singular component that is especially made or especially adapted for use in the patented invention.  Accordingly, the Court held that “one component does not constitute ‘all or a substantial portion’ of a multicomponent invention under § 271(f)(1).”
In other words, the meaning of Life v. Promega is “>1”. 
Although this ruling followed from the text of the statute, it did bring to mind Douglas Adam’s Scifi classic Hitchhiker’s Guide to the Galaxy , where a supercomputer,  Deep Thought, determine “the Answer to the Ultimate Question of Life, The Universe, and Everything,” comes up another quantitative Answer: 42. 
The Court specifically declined to reach the question of “how close to ‘all’ of the components ‘a substantial portion’ must be, leaving open the question of what fraction of components would qualify as a quantitatively “substantial” portion of the components of a patented invention.  E.g., are 3 of 5 components a “substantial” portion?  Can 1 of 2 components ever be a “substantial” portion of the components. 
Vicki Norton

December 15
Lost In Transition:  What does indefiniteness under Nautilus mean for claims reciting “consisting essentially of”?

A claim construction ruling by the District Court for the District of New Jersey in Horizon Pharma Ireland Ltd. v. Actavis Labs., UT, Inc., held, as an issue of first impression, that a claim reciting the transitional phrase “consisting essentially of” was indefinite under Nautilus,  where the patent specification did not describe the “basic and novel properties” of the formulation with reasonable certainty.  2016 U.S. Dist. LEXIS 109068 (D.N.J. Aug. 17, 2016).
In practice, claims that recite “consisting essentially of” are often introduced during prosecution as a fallback position for originally filed claims that recite the broader transitional phrase “comprising.”   This decision underscores the potential need for practitioners to consider whether to include a description of basic and novel properties of the invention in an application as a fallback position, and to consider whether the specification includes such a description before amending claims to recite “consisting essentially of.” 
In Nautilus, the Supreme Court held that for a claim term to be definite under 35 U.S.C. § 112, ¶ 2, "a patent's claims, viewed in the light of the specification and prosecution history, [must] inform those skilled in the art about the scope of the invention with reasonable certainty." Nautilus, Inc. v. Biosig Instruments, Inc., 134 S.Ct. 2120, 2129 (2014).
The Horizon Pharma ruling
As discussed by the Horizon Pharma court, "consisting essentially of" is a transitional phrase with a well-established legal meaning in Federal Circuit case law, which stakes out “a middle ground between the open-ended ‘comprising’ that does not exclude any unrecited claim elements and the closed ‘consisting of’ that excludes any elements not explicitly recited in the claim.”  "By using the term `consisting essentially of,' the drafter signals that the invention necessarily includes the listed ingredients and is open to unlisted ingredients that do not materially affect the basic and novel properties of the invention." PPG Indus. v. Guardian Indus. Corp., 156 F.3d 1351, 1354 (Fed. Cir. 1998).  
In an issue of first impression, the Horizon Pharma court considered whether the specification’s description of the “basic and novel properties” of the invention must meet the Supreme Court’s standard in Nautilus.  The district court determined that “[b]ecause the basic and novel properties of an invention are part of the construction of a claim containing the phrase ‘consisting essentially of,’ the Nautilus standard applies to the assessment of an invention's basic and novel properties.
To arrive at its ruling the court looked first at whether the specification of the patent identified the basic and novel properties of the invention.  Ultimately, the court accepted Horizon’s argument that the specification does not need to explicitly label properties of the invention as basic and novel.  The court held that the specification’s reference to five properties as “Characteristics of the Gel Formulation" and identification of those characteristics as features demonstrating improvement over the prior art was sufficient to identify these as the “basic and novel properties of the claimed invention.” 
However the court then determined that one of the five basic and novel properties of the claimed formulation –“better drying time” -- was not described with reasonable certainty.  The court noted that although the patent identified a method for determining relative drying time, none of the working examples used that method.  Moreover, the drying time data presented in the patent was obtained using two other methods for measuring drying time that gave inconsistent results for whether the gel formulation had a better drying time than a liquid formulation, and did not measure the drying for the same length of time.  Therefore, the court concluded that a POSA would not know under what standard to evaluate the drying rate of the claimed invention.  Accordingly, the court ruled that the "better drying rate" basic and novel property was indefinite and consequently, the term "consisting essentially of" must be construed as indefinite.
What does indefiniteness under Nautilus mean for claims reciting “consisting essentially of”?—Takeways
·         Although some schools of patent drafting avoid specifically identifying features of the invention as key or distinct over art known at the time of drafting, practitioners may want to consider identifying one or more features of the invention as basic or novel, in order to support claims reciting a “consisting essentially of” transitional phrase.  This is true even if the originally drafted claims do not recite the phrase, since the term may be introduced during prosecution as a fallback position.
·         If a basic feature of the invention is a measured parameter, practitioners may want to make sure that the patent specification describes the protocol and equipment used to take the measurement, especially where different methods may yield different results. 
August 17
Secrets to Maximizing Trade Secret Protection after passage of the Defend Trade Secrets Act of 2016 (“DTSA”)

​By Vicki Norton and Guest Commentator Jennifer Kearns

In view of the recent enactment of the federal trade secret law, and recent court decisions impacting patent eligibility and the scope of discovery under the BPCIA, biotech companies are re-weighing the benefits of trade secret protection against the risk of a competitor filing first for patent protection.  In the attached article, we provide some practice tips for companies seeking to maximize trade secret protection for key technological developments maintained as trade secrets.  More


July 14
The Meaning of “Life” 2:  The Court’s Grant of Life’s Petition for Certiorari on What Constitutes “A Substantial Portion of Components” of a Patented Combination in 35 U.S.C. § 271(f)(1)?

The Supreme Court has granted certiorari in Life Technologies Corporation[1] v. Promega Corporation (Life v. Promega), to answer the question of what constitutes “a substantial portion of components” of a patented combination under 35 U.S.C. § 271(f)(1)—a case that will impact the potential risk of patent infringement liability for US exporters supplying a single staple component into global commerce.

My January Buzz article on Life v. Promega discussed Life’s petition to the Supreme Court to grant certiorari on two issues relating to infringement liability under 35 U.S.C. § 271(f), and the Supreme Court’s request for briefing from the Solicitor General on the two proposed issues presented:

Whether the Federal Circuit erred in holding that a single entity can “actively induce” itself to infringe a patent under 35 U.S.C. § 271(f)(1).[1]

Whether the Federal Circuit erred in holding that supplying a single, commodity component of a multi-component invention from the United States is an infringing act under 35 U.S.C. § 271(f)(1), exposing the manufacturer to liability for all worldwide sales.

Following the recommendation of the Solicitor, the Court granted Life’s petition for certiorari on the second question posed in Life’s petition, which asks whether the statutory requirement for supplying “a substantial portion of the components of a patented invention” can be met by supplying only a single component of a patented combination. 

Section 271(f)(1) imposes infringement liability for supplying in or from the United States “all or a substantial portion of the components of a patented invention,” in such manner as to “actively induce the combination of such components outside of the United States.”  After a jury found Life liable for willful infringement of five patents, including a kit claim in U.S. Patent No. RE 37,984, the district court granted JMOL of non-infringement.  The Federal Circuit reversed, holding that the ‘984 patent was infringed under § 271(f)(1), even though Life shipped only one of five components of the patented kit to its own manufacturing facility in the UK, where all five components were combined, and Promega appeared to concede that the product shipped was a commodity.[2] 

By way of further background, Claim 42 of the ‘984 patent recites a kit “for analyzing polymorphism in at least one” DNA locus, the kit comprising 5 components, including primers, a PCR polymerizing enzyme, dNTPs, a buffer and template DNA comprising a simple or cyptically simple nucleotide sequence:

a) at least one vessel containing a mixture of primers constituting between 1 and 50 of said primer pairs;

b) a vessel containing a polymerizing enzyme suitable for performing a primer-directed polymerase chain reaction;

c) a vessel containing the deoxynucleotide triphosphates adenosine, guanine, cytosine and thymidine;

d) a vessel containing a buffer solution for performing a polymerase chain reaction;

e) a vessel containing a template DNA comprising

i) a simple or cryptically simple nucleotide sequence having a repeat motif length of 3 to 10 nucleotides and ii) nucleotide sequences flanking said simple or cryptically simple nucleotide sequence that are effective for annealing at least one pair of said primers, for assaying positive performance of the method. 

According to the Federal Circuit opinion, Life shipped Taq polymerase (component “b”) of a kit to its UK facility, while the remaining components were manufactured and combined with the Taq polymerase in the UK.  In addition, the opinion noted that Promega did not assert infringement under 271(f)(2) because “Taq polymerase is ‘a staple article or commodity of commerce suitable for substantial noninfringing use.’”

Life’s petition for certiorari reiterated two arguments previously rejected by the Federal Circuit; namely, (1) reference in § 271(f)(1) to “components” in plural form requires an infringer to supply more than a single component of a patented combination; and (2) a comparison of the provisions of § 271(f)(1) with § 271(f)(2) indicates that § 271(f)(1) governs when an accused infringer supplies multiple components of a patented combination, whereas, § 271(f)(2) governs liability for supplying a single component (it imposes liability for supplying “any component of a patented invention that is especially made or especially adapted for use in the invention.”)  The petition further argued that because § 271(f)(1) excludes liability if the single component is “a staple article or commodity,” Life’s offshore supply of Taq polymerase--a single, commodity product—could not be the basis for liability under § 271(f)(1).

            The Solicitor urged the Court to find that the Federal Circuit erred in holding that supplying a single component of a multi-component invention can give rise to liability under § 271(f)(1), asserting that the Federal Circuit incorrectly ruled that the term “substantial” in section 271(f)(1) means “’important’ or ‘essential’” and improperly concluded that “[n]othing in the ordinary meaning of ‘portion’ suggests that it necessarily requires a certain quantity.”  Solicitor’s Br. At 15-16. 

            More specifically, the Solicitor noted that § 271(f)(1) recites that liability can only be imposed for supplying “all or a substantial portion of the components of a patented invention, where such components are uncombined in whole or in part,” and that in this context, the term “substantial” should be interpreted to have a quantitative, rather than a qualititative meaning.  The Solicitor urged that the terms “all” and “portion” invoke  quantitative meanings, which support interpreting the term “substantial” to also have its quantitative meaning “of ample or considerable amount” rather than its qualititative meaning.  In addition, the Solicitor noted that the reference in § 271(f)(1) to “such components” to describe what is exported from the U.S. “implies that multiple components must be supplied from the United States in order to trigger the statutory ban”  Id. at 16-17.  Furthermore, the Solicitor observed that § 271(f)(2) specifies the circumstances in which export of a single component can give rise to liability, and that the Supreme Court stated in dicta in Microsoft, that Sections 271(f)(1) and section 271(f)(2) “differ, among other things, on the quantity of components that must be ‘supplie[d] . . . from the Untied States’ for liability to attach.”  Solicitor’s Br. at 17 (quoting Microsoft Corp. v. AT &T Corp., 550 U.S. 437, 454 n.16 (2007)).  The Solicitor concluded that because § 271(f)(2) only imposes liability for export of a single article where the article is “especially made or especially adapted for use in the invention and not a staple article or commodity of commere suitable for substantial non-infringing use,” § 271(f)(1) cannot impose liability for export of a single commodity article.  Id.

It will be interesting to monitor whether the Court arrives at the same result as the Solicitor (as it often does in patent cases).  The position suggested by the Solicitor raises the following question, however: 

·         First, can a patent claim covering a two-component product can ever be infringed underthe Solicitor’s test?  That is, can 50% of a two-component product qualify as a “high percentage” of “all . . . of the components”?

·         If a two component product claim cannot be infringed under the Solicitor’s test for § 271(f)(1) should the Court instead adopt a blended test in which both quantitative and qualitative factors are considered? 

·         Is the Solicitor’s proposed test the sort of “bright-line” test that the Supreme Court rejected for other tests in patent law, such as obviousness, patent eligibility, and enhanced damages and attorneys’ fees?

·         Alternatively, if the Solicitor’s “by-the-numbers” approach is too rigid, will the Court rule instead that it is appropriate to take into account considerations of “how important or central” the component is to the invention” as the Federal Circuit did in its decision? 

o   This approach appears to be consistent with the rationale of the dissenting Justices in the Deepsouth Packing Co., Inc. v. Laitram Corp.,[3] who indicated that manufacture abroad of even “only one vital part” of a patented combination might have altered their view that infringement liability should have been imposed under the facts of that case.

·         If qualitative considerations are weighed should patent considerations factor into the analysis as well as technical considerations?  The Federal Circuit relied in part on technical considerations in determining that the Taq polymerase supplied by Life was a “substantial portion” of the kit, stating essentially that but for Taq polymerase, “the genetic testing kit recited in the [‘984] patent would be inoperable because no PCR could occur.”  The Federal Circuit’s appeared to be influenced by the evidence in the case which included an admission by Life’s own witness that the Taq polymerase was one of the “main” and “major” components of the accused kits.  Going forward, it will be interesting to see if other factors should be considered in the “substantial portion” analysis under § 271(f)(1), such as whether a component was cited by the patentee during prosecution as a patentable distinction from cited art. 

Vicki Norton

[1] Life has been acquired by Thermo Fisher Scientific.​The Court appeared to take the Solicitor’s recommendation to not grant certiorari on the first Question Presented.  The Solicitor argued first that the Federal Circuit correctly decided that a single legal entity supplying components to its own foreign manufacturing facility can “induce the combination” of such components outside the U.S., because in the context of § 271(f)(1), the term “induce” means “to bring about, produce, or cause,” as opposed to “influence” or to “persuad[e]” another.  Solicitor’s Br. at 8.  The Solicitor’s further reasoned that “because multinational corporations typically act through locally incorporated subsidiaries or affiliates, components exported from the United States will seldom be combined abroad by the same legal entity,” or alternatively, if components are combined abroad by the same legal entity, Congress’ intention that § 271(f) close the loophole created by Deepsouth justifies imposing liability on that single actor.  The Solicitor also noted that the district court held that Promega had forfeited its rights to raise the (new) argument that Life had in fact induced its foreign divisions, subsidiaries or employees (not itself) to combine the products, and that Life did not appear to dispute that Life had induced the conduct of foreign affiliates. 

[2] The remaining four patents-in-suit were held invalid for lack of enablement. 

[3] Deepsouth is the Supreme Court case which spurred Congress to expand infringement liability by enacting § 271(f)(1), in order to close the loophole caused by the majority’s ruling that an accused infringer wasn’t liable for infringement, even though the accused infringer supplied all of the components of a patented combination to a third party, with instructions on how to combine the components).

May 31
Summary of Spring Meeting 2016 Biotech-FDA Committee Joint CLE Presentation

At the Spring 2016 Meeting I was fortunate to moderate a panel of experts for the Joint Biotech Committee/FDA Committee CLE presentation provided their insights on “Mars 101-International and Interplanetary Considerations for GMOs: Patents, Export control, Biodiversity and Regulation.”  Our panel of experts includes Marian T Flattery, Assistant Chief IP Counsel of DuPont Pioneer and DuPont Crop Protection, Professor Kan Wang, from the Department of Agronomy at Iowa State University, Biotech Committee Chair Debora Plehn-Dujowich, a partner at Prismatic IP Group and Kate Hibbard, a partner at Greene Espel. 

Professor Kan Wang, Professor and Director of the Center for Plant Transformation and Co-PI of the Crop Bioengineering Consortium at Iowa State, led off the discussion, providing an overview of current techniques for creating new traits in plants, ranging from Agrobacterium transformation, to breeding in zones of high radiation (which would include Mars!), to the latest gene-editing technologies, including TALENs (Transcription activator-like effector nuclease) and CRISPR/Cas9.  Professor Wang also discussed various government approaches to regulating engineered plants, including the process based approach of Europe and Japan (which focuses on the method used to generate the new traits), the product/phenotype approach of Canada which focuses on the features of the engineered plants), and the US case by case approach, which looks both at the product and the process used to create the product. 

Debora Plehn-Dujowich, partner at Prismatic Law Group (who received her Ph.D. in the lab of Nobel Prize Winner Sidney Altman!)  then provided an excellent overview of conventions and treaties relating to genetic resources, including the Convention on Biological Diversity (CBD), which strives for conservation of biological diversity, the sustainable use of its components, and the fair and equitable sharing of benefits arising from genetic resources.  Debora also discussed The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization is a supplementary agreement to the CBD (“the Nagoya Protocol”).  The Nagoya Protocol was adopted on October 29, 2010 as a supplementary agreement to the CBD, and focuses on access and benefit sharing (ABS) for genetic resources.  Additionally, Debora also provided her insights on the Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC), which has been meeting for fifteen years at WIPO, and has been focused in meetings in 2016 on whether there should be a mandatory disclosure requirement to identify the source of genetic resources.  Debora updated us on the recent IGC meeting in Geneva, which Debora attended.

Marian Flattery, Assistant Chief IP Counsel of DuPont Pioneer and DuPont Crop Protection provided her insights on patent eligibility issues relating to natural sweeteners (possibly patent eligible, depending on the formulation), radiation bred mutant plants (likely not patent eligible, in our scenario) and plants engineered using genetic editing techniques such as CRISPR (likely patent eligible, in our scenario).  As part of her analysis, Marian provided a timely summary of the U.S. Patent and Trademark Office’s May 4, 2016 Guidance on Patent Eligibility and the new Life Sciences examples.  Marian also provided her thoughts on whether inventions made on Mars on a U.S. owned space station would be governed by 35 U.S.C. § 105, and the possible impact of the Outer Space Treaty of 1967 on patenting discoveries made on Mars.  (35 U.S.C. § 105 provides “Any invention made, used or sold in outer space on a space object or component thereof under the jurisdiction or control of the United States shall be considered to be made, used or sold within the United States for the purposes of this title, except with respect to any space object or component thereof that is specifically identified and otherwise provided for by an international agreement to which the United States is a party.”)

Kate Hibbard, Partner at Green Espel also provided her insights into asynchronous authorizations for export of genetically modified plants, including risks to keep in mind with respect to export markets, whether supply chain participants have a right not to handle genetically modified organisms, and what litigation risks exist with respect to commercialization of genetically modified plants without the necessary foreign approvals. 

Vicki Norton​

April 24
Will the judicial exception to patent eligibility now engulf method of treatment claims?

A recent challenge to classic method of treatment claims in Bristol-Myers Squibb Co. v. Merck & Co., Inc. (Civil Action No. 15-560-GMS) may have patentees wondering if one of the last bastion of patent eligibility in the life sciences is about to also be engulfed by the judicial exception to patent eligibility.

Following the Supreme Court’s ruling in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012), where the Court held certain methods of optimizing treatment patent ineligible, courts have expanded the scope of judicial exceptions to patent eligibility, finding patent ineligible claims to technologies such as isolated DNA having the same sequence as natural DNA; live-born cloned mammals; and Myriad Genetics’ claims to methods of detecting breast cancer gene mutations.  Additionally, the PTO also provided post Myriad guidance that claims to purified small molecule drugs not markedly different from the natural source are also not patent eligible.  

Recently, in November 17, 2015, the District Court for the District of Delaware granted a 12(b)(b) motion, holding patent ineligible method of treatment claims.  Although facially similar to the claims in Mayo, the Endo claims recited not only a first administering step and a measuring step to optimize treatment, but also recited a second administering step which adjusted the dose based on the measurement.  Although the ruling in Endo Pharmaceuticals Inc. v. Actavis Inc., C.A. No. 14-1381-RGA (D. Del. Nov. 17, 2015) seemed to expand the Court’s holding in Mayo to claims reciting a second administering step, the Claims from the Endo case and Mayo case otherwise appear similar when compared side by side, below:.



A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:

(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and

A method of treating pain in a renally impaired patient, comprising the steps of:
  a.  providing a solid oral controlled release dosage form, comprising:
       i.  about 5 mg to about 80 mg of oxymorphone or a pharmaceutically acceptable salt thereof as the sole active ingredient; and
      ii.  a controlled release matrix;

(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,     

b.  measuring a creatinine clearance rate of the patient and determining it to be (a) less than about 30 m[L]/min, (b) about 30 mL/min to about 50 mL/min, (c) about 51 mL/min to about 80 mL/min, or (d) above about 80 mL/min; and  

wherein the level of 6-thioguanine less than about 230 pmol per 8x108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject; and

wherein the level of 6-thioguanine greater than about 400 pmol per 8x108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject

  c.  orally administering to said patient, in dependence on which creatinine clearance rate is found, a lower dosage of the dosage form to provide pain relief;
    wherein after said administration to said patient, the average AUC of oxymorphone over a 12-hour period is less than about 21 ng•hr/mLd cells indicates a need to decrease the amount of said drug subsequently administered to said subject

Now, in a March 17, 2016 order, the District Court for the District of Delaware addressed Merck’s challenge to what looked like a standard method of treatment claim for treating lung cancer—exemplary claim 1 is shown below:

1. . A method of treating a lung cancer comprising administering a composition comprising a human or humanized anti-PD-1 monoclonal antibody to a human with the lung cancer, wherein the administration of the composition treats the lung cancer in the human.

Although the district court denied Merck’s 12(b)(6) motion to dismiss the case on the basis that the claims were patent ineligible, the Court accepted Merck’s argument that the claims were directed to the natural phenomenon of using T cells to activate the immune system, thereby satisfying the first prong of a 101 analysis under Alice and Mayo.:

The '999 patent claims treatment for lung cancer by using antibodies that inhibit signals of PD-1, PD-Ll or PD-L2 to activate immunity to the cancer virus.  The '999 patent relies on the scientific fact that blocking activation of the PD-1 pathway enables the patient's T cells to perform their normal biological activity of removing cancer cells.  .  . ..

First, the court concludes that, contrary to Bristol-Myers contention, the '999 patent touches upon a natural phenomenon by using T cells to activate the immune system.  The inventors relied on the fact that inhibiting "signals of PD-1, PD-L 1 or PD-L2 inhibit cancer proliferation through the mechanism of the recovery and activation of immune function."  This interaction is a natural phenomenon.

Bristol-Myers Squibb Co. v. Merck & Co., Inc., (Civil Action No. 15-560-GMS) (D. Del. March 17, 2016) at n.1 (citations omitted; emphasis added).  Turning to the second inquiry under Alice,  "whether the claims do significantly more than simply describe these natural relations,” the court determined that read in a light most favorable to the Bristol-Myer (the non-moving party) there were “at the very least,” material factual disputes over “[w]hether the claims amount to an implementation step,” that could not be resolved on a motion to dismiss:

Merck contends that the process method consists of administering a synthetic agent through a single step to induce a natural reaction.  Bristol-Myers insists that administering anti-PD-1 antibodies is not a diagnostic step as in Mayo, but provides the treatment itself.  Whether the claims amount to an implementation step is a complicated factual determination that the court could better resolve after discovery.

Id.  (citations omitted). . Regardless of the ultimate outcome in Bristol-Myers, it appears that litigants in cases involving method of treatment claims may want to prepare to raise and defend against patent eligibility challenges.

Vicki Norton

March 21
Interstellar Intellectual Property Rights

Our panel of experts at AIPLA’s Spring 2016 meeting will explore the final frontier of patent eligibility for GMOs on Mars, including the “thorny” issue of whether exceptions for patent eligibility include both Terran and Martian natural principles, and the impact of the UN-sponsored Outer Space Treaty of 1967 on intellectual property rights in space.  (The treaty, signed by 104 nations, appears to echo the sentiment expressed in patent eligibility cases that that the discovery and use of natural resources, in this case the moon and other celestial bodies, shall be carried out for the “benefit and in the interests of all countries” and “shall be the province of all mankind.”).  

I have to confess that I find this topic fascinating because my father was at the controls of one of the successful Surveyor unmanned craft landings on the moon, and my brother-in-law is a rocket scientist for one of the leading players working on commercializing space travel.

Our expert panelists tackling this issue include Marian T Flattery, Assistant Chief IP Counsel of DuPont Pioneer and DuPont Crop Protection, Professor Kan Wang, from the Department of Agronomy at Iowa State University, and Biotech Committee Chair Debora Plehn-Dujowich.  

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