recent developments in chemical, pharma and bio patents ......2017/04/28 · multilayer stretch v....

RECENT DEVELOPMENTS IN

CHEMICAL, PHARMA AND BIO PATENTS

Craig A. McRobbie (BSKB)

MJ Edwards (Gilead Sciences, Inc.)

PRACTISING LAW INSTITUTE Patent Law Institute – San Francisco, April 28, 2017

Hour 1

OVERVIEW – Recent Developments in Bio, Pharma & Chemical Practice

• First Hour –District Court Decisions and Related

Appeals

• Second Hour – PTO Guidelines and PTAB Decisions

and Related Appeals

2 ©2017 Birch, Stewart, Kolasch and Birch, LLP

First Hour –

Legislation, District Court Litigation and

Related Appeals


Multilayer Stretch v. Berry Plastics (Fed. Cir. 2016)

1. A multi-layer, thermoplastic stretch wrap film

containing seven separately identifiable polymeric

layers, comprising:

(a) two identifiable outer layers . . . ; and

(b) five identifiable inner layers, with each layer

being selected from the group consisting of linear

low density polyethylene [LLDPE], very low density

polyethylene [VLDPE], ultra low density polyethylene

[ULDPE], and metallocene-catalyzed linear low

density polyethylene resins [mLLDPE] . . . .

©2017 Birch, Stewart, Kolasch and Birch, LLP 4

Multilayer Stretch v. Berry Plastics

Claim 10 - “at least one said inner layer comprises low

density polyethylene homopolymers.” (LDPE)

“There are two separate issues of claim construction

here: first, whether the Markush group of element (b) is

closed to resins other than the listed four, and, second,

whether the Markush group is closed to blends of the

four listed resins.”


First Issue – Decision

“the Markush group of element (b) must be construed as

closed to resins other than LLDPE, VLDPE, ULDPE, and

mLLDPE. To construe the inner layers of element (b) as

open…would be to construe the claims to cover any plastic

film with five compositionally different inner layers, each of

which contains any amount of one of the four recited resins.

Construing element (b) in this manner would render the ‘055

patent's Markush language—"each layer being selected

from the group consisting of"—equivalent to the phrase

“each layer comprising one or more of.”



“What is critical here is that the transitional phrase that

appears in element (b), “consisting of,” is a term of art in

patent law with a distinct and well-established meaning. Use

of the transitional phrase “consisting of” to set off a patent

claim element creates a very strong presumption that that

claim element is ‘closed’ and therefore ‘exclude[s] any

elements, steps, or ingredients not specified in the claim.’”



“Thus, if a patent claim recites ‘a member selected from the

group consisting of A, B, and C,’ the “member” is presumed

to be closed to alternative ingredients D, E, and F. By

contrast, the alternative transitional term “‘comprising’

creates a presumption that the recited elements are only a

part of the device, that the claim does not exclude additional,

unrecited elements.”



• Claim 10 was additionally found invalid under 35 U.S.C.

112, because the polymer of claim 10 was not one of the

polymers recited in the Markush group of claim 1.

• The District Court construed the term LDPE as having a

branched polymer backbone (unlike the LLDPE) and

held that claim 10 was invalid because it impermissibly

enlarged the scope of claim 1 since LDPE was not one

of the elements of claim 1.


Second Issue – Decision

• “Presumed” closed to mixtures/blends

• It was overcome

• Some members of Markush group overlap

• Specification also discusses blends


Take home message/practice tips:

• The phrase “consisting of” preceding a Markush group

creates a strong presumption that the group is closed to

unlisted elements. This presumption may be overcome

only by an unmistakable manifestation of the alternative

meaning in the specification or prosecution history. The

language “consisting of” also creates a presumption

against inclusion of mixtures and blends of Markush group

elements, but this presumption is weaker.



• When you use “consisting of” in a Markush language format, only do so if you are choosing to close the group to additional ingredients. If you do not want to “close” the group, then question why you are attempting to use Markush language in the first place.

• Also, if you intend for “blends” to be encompassed by your Markush language, then specifically recite blends (e.g., one or more resin selected from the group consisting of…). Of course, ensure that you have suitable written description for such scope.


Genetic Technologies Ltd.

v. Merial LLC, BMS

(Fed. Cir. April 8, 2016)


§ 101 and Patent Eligible Subject Matter

• At issue in Genetic Technologies Limited v. Merial

L.L.C., Bristol-Myers Squibb Co. was whether a claim

related to a method for detecting an allele by

amplifying and analyzing non-coding regions known to

be linked to the coding region was patent eligible

subject matter under 35 U.S.C. § 101.


Genetic Technologies owns U.S. 5,612,179

Claim 1. A method for detection of at least one coding region allele of a multi-allelic genetic locus comprising: a) amplifying genomic DNA with a primer pair that

spans a non-coding region sequence, said primer pair defining a DNA sequence which is in genetic linkage with said genetic locus and contains a sufficient number of non-coding region sequence nucleotides to produce an amplified DNA sequence characteristic of said allele; and

b) analyzing the amplified DNA sequence to detect the allele.


Quick discussion of technology at issue

• The inventor of the ‘179 patent was the first to discover that alleles of a particular gene may be detected by amplifying and analyzing non-coding regions (introns) in linkage disequilibrium with the coding region (exons).

• At the time of the invention, non-coding regions of DNA were referred to as “junk DNA” because, at that time, they appeared to serve no function.

• Applications of the method of the ‘179 patent include diagnosis and treatment of genetic disorders correlated with specific alleles (e.g., sickle-cell anemia, hemophilia, and cystic fibrosis).


Procedural posture and holding

• District Court dismissed for failure to state a claim.

• Federal Circuit affirmed finding claim 1 is not statutory

under 35 U.S.C.§101.

• Court went through the Mayo/Alice analysis

– (1) is claim directed to patent-ineligible concept? Yes.

Similar to Mayo.

– (2) do the elements of the claim transform the claimed

abstract idea [or law of nature] into eligible subject

matter? No. Ariosa is relevant.


Step 1 – Law of Nature?

• Beginning with step one of the Mayo/Alice two-step test for patent eligibility, the Federal Circuit ruled that claim 1 is directed to a relationship between non-coding and coding sequences and the tendency of non-coding sequences to be representative of the linked coding sequences, which is a law of nature.

• The Federal Circuit found that claim 1 broadly covers

essentially all applications of the law of linkage disequilibrium to the problem of detecting coding sequences of DNA.


Step 2 – Significantly More?

• Proceeding with step two of the Mayo/Alice analysis,

the Federal Circuit found that the steps of “amplifying

genomic DNA with a primer pair” and “analyzing the

amplified DNA sequence to detect the allele” were

“well known, routine and conventional” in the field of

molecular biology at the time of filing the application.

• Thus, the Court concluded that claim 1 did not include

additional elements sufficient to amount to

“significantly more” than the law of nature.



• When drafting or amending claims directed to a judicial exception, it is important to consider whether a non-obvious and unconventional element can be added to satisfy step two of the Mayo/Alice two-step test for patent eligibility.

• When a practitioner is concerned about a particular

application being patent ineligible, he/she must convey those concerns clearly to the inventor. This is best done during drafting, but certainly as soon as discovered.


Lifenet Health v. Lifecell Corp.,

837 F.3d 1316 (Fed. Cir. 2016)

Unusual facts surrounding a functional limitation stated

in the negative – literal infringement


Lifenet owns U.S. 6,569,200 (the ‘200 patent)

• Lifenet’s ‘200 patent concerns soft tissue grafts which

are plasticized and thereby avoid the problems of

freeze drying associated with prior art methods. Claim

1 of the ‘200 patent recites:

A plasticized soft tissue graft suitable for transplantation into a

human, comprising:

a cleaned soft tissue graft having an internal matrix; and

one or more plasticizers contained in said internal matrix;

said one or more plasticizers are not removed from said internal

matrix of said plasticized soft tissue graft prior to transplantation

into a human.


No removal of plasticizer from internal matrix of the soft tissue

• Lifecell’s accused products were soft tissue grafts

preserved in plasticizer, but Lifecell instructed users to

soak the tissue grafts in saline solution for a minimum

of two minutes prior to implementation. Lifecell’s saline

treatment removed a significant amount of plasticizer

from the soft tissue. However, the saline treatment did

not remove plasticizer from the internal matrix of the

soft tissue.


The “non-removal” limitation is a functional limitation described in the negative

• Lifecell argued that the non-removal limitation “said one or more plasticizers are not removed from said internal matrix…prior to transplantation” precludes direct infringement of the claim by Lifecell.

• Lifecell argued that the non-removal limitation could not be

met until a third party actually prepares and uses the accused product.

• The Federal Circuit disagreed and found that functional

limitations recited in the negative can describe capability and structural elements. Thus, the non-removal limitation did not relieve Lifecell of direct infringement.


The Medicines Company v. Hospira, Inc.

2014-1469, 2014-1504 (Fed. Cir. July 11, 2016)

Not a sale under 35 USC § 102(b)


2 ANDAs and Angiomax

• MedCo owns U.S. Patent Nos. 7,582,727 (“the ’727

patent”) and 7,598,343 (“the ’343 patent”) directed to a

form of bivalirudin.

• Both patents are listed in the FDA’s Orange Book as

covering Angiomax, the trade name of a bivalirudin

formulation that MedCo markets in the United States.

• Two ANDAs were filed by Hospira seeking FDA

approval to sell generic bivalirudin before the

expiration of the ’727 and the ’343 patents.


No invalidating on-sale bar

• Among other issues, in MedCo, the Federal Circuit,

sitting en banc, overturned an earlier Federal Circuit

panel decision and affirmed the District Court’s holding

that there was no invalidating on-sale bar under 35

U.S.C. § 102(b).

• The Federal Circuit held that as a general proposition,

it looks to the Uniform Commercial Code (UCC) to

determine whether the facts at issue are sufficient to

rise to the level of a commercial offer for sale.


Bivalirudin

• Bivalirudin is a synthetic peptide comprised of twenty

amino acid residues that is used as an anticoagulant:


Relevant facts

• The patents claim pH-adjusted pharmaceutical

batches of bivalirudin and a pharmaceutically

acceptable carrier.

• The bivalirudin active pharmaceutical ingredient,

without further processing, is too acidic for human

injection, therefore, MedCo prepares Angiomax using

a compounding process in which it creates a

bivalirudin solution, adjusts the solution’s pH with a

base, and then freeze-dries the solution.


Relevant facts

• A potential adverse consequence of this compounding

process is degradation of bivalirudin, which may form

impurities such as Asp9-bivalirudin (“Asp9”). The

bivalirudin may become unusable if high levels of Asp9

form.

• In 1997, MedCo contracted with Ben Venue

Laboratories (“Ben Venue”), a third-party provider, for

manufacture of commercial quantities of an original

formula of Angiomax not covered under the patents-in-

suit.


Relevant facts

• In June 2005, Ben Venue manufactured a batch of bivalirudin drug product with an Asp9 level of 3.6% (which exceeded the FDA’s approved maximum level of 1.5%).

• MedCo discarded that batch and shut down production of Angiomax for six months to investigate the problem and revise its process.

• In 2006, another batch had an unacceptable Asp9 level, so MedCo again shut down production of Angiomax and hired a specialist to investigate and resolve the issue.


Relevant facts

• The investigation led to the development of the new

compounding process claimed in the patents-in-suit.

• Ben Venue has made all batches since October 2006

using the new process.

• According to MedCo, the process produces an improved

Angiomax product with a maximum Asp9 level of 0.6%.

• The ’727 and ’343 patents contain product and product-by-

process claims, respectively, for pharmaceutical batches of

the improved drug product with a maximum impurity level

of Asp9 of 0.6%.


Fed. Cir. Looks to the UCC

• Held that a contract manufacturer’s sale of

manufacturing services to the inventor where neither

title to the embodiments nor the right to market the

same passes to the supplier does not constitute an

invalidating sale under § 102(b).


Claim from both patents

• Claim 1 of the ‘727 patent:

• Claim 1 of the ‘343 patent:


The applications for the ’727 and ’343 patents were filed on July 27, 2008.

• The critical date from which the on-sale bar of § 102(b) must be measured is, therefore, July 27, 2007.

• In late 2006, MedCo paid Ben Venue to manufacture three batches of bivalirudin according to the patents-at-issue. Ben Venue completed the first such batch on October 31, 2006, the second batch on November 21, and the third batch on December 14, 2006.

• Once manufactured by Ben Venue, the three batches were placed in quarantine with MedCo’s distributor, Integrated Commercialization Solutions (“ICS”), pending FDA approval.


MedCo and ICS entered into a Distribution Agreement effective February 27, 2007.

• The Distribution Agreement made ICS the exclusive authorized distributor of Angiomax in the U.S. and stated that title and risk of loss would pass to ICS following release from quarantine.

• Under the Distribution Agreement, ICS would place individual purchase orders with MedCo on a weekly basis, which MedCo could accept or reject.

• It was not until August 2007 (after the July 27, 2007 critical date) that MedCo released the three batches from quarantine and made them available for sale.


The transactions between MedCo and Ben Venue did not constitute commercial sales of the patented product. • The Federal Circuit rationalized that when assessing the

on-sale aspect of § 102(b), the court must focus on those

activities that would be understood to be commercial sales

and offers for sale “in the commercial community.”

• The Court also stressed that “[a]s a general proposition,

we will look to the Uniform Commercial Code (‘UCC’) to

define whether . . . a communication or series of

communications rises to the level of a commercial offer for

sale.”


The Court explained that 1) the mere sale of manufacturing services by a contract

manufacturer to an inventor to create embodiments of a patented product for the inventor does not constitute a “commercial sale” of the invention;

2) with regard to the issue of “stockpiling” by an inventor, it clarified that “stockpiling” by the purchaser of manufacturing services is not improper commercialization under § 102(b); and

3) commercial benefit - even to both parties in a transaction - is not enough to trigger the on-sale bar of § 102(b). Rather, the transaction must be one in which the product is “on sale” in the sense that it is “commercially marketed.”


In reaching these decisions, the Federal Circuit explained that three main reasons were key:

1) only manufacturing services were sold to the

inventor - the invention was not;

2) the inventor maintained control of the invention, as

shown by the retention of title to the embodiments

and the absence of any authorization to Ben Venue

to sell the product to others; and

3) “stockpiling,” standing alone, does not trigger the on-

sale bar.


Medgraph, Inc. v. Medtronic, Inc.,

2015-2019 (Fed. Cir. December 13, 2016)

United we Stand, Divided we Fall – or United we

Infringe, Divided we Don’t


Quick background on Akamai

• The final en banc Federal Circuit Akamai decision came down in 2015 (Akamai Techs., Inc. v. Limelight Networks, Inc., 797 F.3d 1020 (Fed. Cir. 2015) (en banc) – named Akamai V).

• In Akamai V, the Fed. Cir. held that for purposes of divided infringement, in addition to an agency or contractual relationship, attribution is proper “when an alleged infringer conditions participation in an activity or receipt of a benefit upon performance of a step or steps of a patented method and establishes the manner or timing of that performance.”



• Under Akamai V, the Federal Circuit had found that

Limelight “conditions customers’ use of its content

delivery network” upon its customers performing the

certain claimed steps of “tagging” and “serving.”

• Evidence supporting this conclusion was, first, a

requirement in Limelight’s standard contract that its

customers perform the tagging and serving steps if

they want to use Limelight’s service.



• Second, Limelight’s welcoming letter telling customers

that a Limelight Technical Account Manager will lead

implementation of Limelight’s services and providing

“step-by-step instructions” that customer must follow

with respect to the “tagging” and “serving.”

• Accordingly, the Federal Circuit held Limelight liable

for direct infringement because “all steps of the

claimed methods were performed by or attributable to

Limelight.”


Medgraph owns by assignment U.S. 5,974,124 and U.S. 6,122,351.

• The patents are generally directed to a method (and

system) for improving and facilitating diagnosis and

treatment of patients, whereby data relating to

“medically important variable[s],” for example, blood

sugar levels of a diabetic patient, measured from a

patient’s body, are uploaded onto a computer and

transmitted to a central storage device, from which

they can be accessed remotely by medical

professionals treating the patient.


The accused product

• Medtronic manufactures and markets a variety of

integrated diabetes management solutions, including

the CareLink® Therapy Management System for

Diabetes, which integrates CareLink Personal Therapy

Management Software (“CareLink Personal”) for

patients and CareLink Pro Diabetes Therapy

Management Software (“CareLink Pro”) for healthcare

professionals (collectively, the “CareLink System”).


Medgraph sued Medtronic over the CareLink System. • The CareLink System allows patients to upload data

relating to management of their diabetes, including

blood glucose readings, to Medtronic’s central

computer server, where the data are collected and

stored in a database so that the patients can keep an

online record of the information, and/or share the

information remotely with a healthcare provider.


In Medgraph, the Federal Circuit did not find facts sufficient to attribute the claimed method steps to Medtronic.

• The Federal Circuit found that Medgraph had not

pointed to any evidence that would permit attribution

of patient- and doctor-performed steps to Medtronic.

Medgraph, slip opinion at 9.

• The Court explained: “The evidence presented to the

District Court indisputably shows that Medtronic does

not condition the use of, or receipt of a benefit from,

the CareLink System on the performance of all of

Medgraph’s method steps.


In Medgraph, the Federal Circuit did not find facts sufficient to attribute the claimed method steps to Medtronic.

• For example, Medtronic does not deny users the ability to use CareLink Personal and CareLink Pro without performance of the claim step of ensuring detachment of the measuring device from the patient after each measurement. Nor does it offer an incentive for such detachment. Indeed, the evidence indicates that Medtronic benefits when patients use its continuous glucose monitoring device, which does not involve ensuring detachment after each measurement.” Medgraph, slip opinion at 10.


The evidence was insufficient to meet the requirements of Akamai V.

• The Federal Circuit also pointed out that the evidence further showed that Medtronic freely permits using the CareLink System without performing synchronization, and it denies no benefit to such users for their choices to do so.

• Patients can freely choose to bring their devices to their physician’s office and have their data extracted locally there. Patients also can print or email reports and bring them to their medical practitioner.

• No infringement.


Eli Lilly v. Teva Parenteral Medicines

(Fed. Cir. January 12, 2017)


Eli Lilly & Co. (“Eli Lilly”) is the owner of U.S. Patent No. 7,772,209

• A consolidated suit against Defendants to prevent Defendants from launching a generic version of a chemotherapy drug with accompanying product literature that would allegedly infringe methods of treatment claimed by the ’209 patent.

• The district court found that no single actor performs all steps of the asserted claims because the actions of both physicians and patients are required. Nonetheless, under Akamai V, the court found direct infringement attributable to physicians and held Defendants liable for inducing infringement.


Eli Lilly markets pemetrexed as ALIMTA®

• The ’209 patent, which issued in 2010, relates to methods of administering the chemotherapy drug pemetrexed disodium (“pemetrexed”) after pretreatment with two common vitamins - folic acid and vit. B12.

• Pemetrexed is an antifolate that kills cancer cells by inhibiting the function of folates, a class of nutrients necessary for cell reproduction. The purpose of the dual vitamin pretreatments is to reduce the toxicity of pemetrexed in patients.


ANDA Para IV certifications give rise to suit.

• Around 2008–2009, Defendants notified Eli Lilly that

they had submitted ANDAs seeking approval by the

FDA to market generic versions of ALIMTA®.

• After the ’209 patent issued, Defendants sent Eli Lilly

additional notices regarding their ANDAs, including

notices that they had filed Paragraph IV certifications

declaring that the ’209 patent was invalid,

unenforceable, or would not be infringed.


Eli Lilly subsequently brought a consolidated action against Defendants for infringement under 35 U.S.C. § 271(e)(2). • Eli Lilly alleged that Defendants’ generic drugs would

be administered with folic acid and vitamin B12

pretreatments and, thus, result in infringement of the

’209 patent. Defendants raised noninfringement and

invalidity defenses.

• Eli Lilly asserted claims 9, 10, 12, 14, 15, 18, 19, and

21 of the ’209 patent at trial. All asserted claims

require patient pretreatment by “administering” or

“administration of” folic acid.


Claim 1 of the ‘209 patent reads:


The additional limitations of claims 9 and 10 restrict the

dose of folic acid to particular ranges.

Asserted claim 12 is independent and recites:


The parties agree for purposes of this appeal that no single actor performs all steps of the asserted claims

• Physicians administer vitamin B12 and pemetrexed.

• Patients self-administer folic acid with guidance from physicians.

• Eli Lilly’s theory of infringement therefore requires establishing liability for divided infringement—an area of law that the CAFC was actively reconsidering during the pendency of the case.

• With different actors practicing different aspects of the claims, the issue of divided infringement exists.


After several stages, Akamai V is decided

• The Akamai V decision broadens the circumstances in

which others’ acts may be attributed to a single actor

to support direct infringement liability in cases of

divided infringement.

• At that stage the case is back at the District Court,

which entered final judgement against the Defendants

barring the launch of generic products prior to the

expiration of the ‘209 patent.

• Defendants appealed.


The product labeling of the generic would have been materially the same as that of ALIMTA® • The district court relied in part on Defendants’ proposed

product labeling as evidence of infringement. Defendants’

product labeling would consists of two documents:

– the Physician Prescribing Information; and

– the Patient Information.

• Both documents include instructions regarding the

administration of folic acid—the step that the district court

found would be performed by patients but attributable to

physicians.


“directs or controls” or “form a joint enterprise”

• Under Akamai V, the performance of method steps is

attributable to a single entity in two types of

circumstances: (1) when that entity “directs or

controls” others’ performance, or (2) when the actors

“form a joint enterprise.”

• Eli Lilly did not pursue a joint enterprise theory. The

issue is therefore whether physicians direct or control

their patients’ administration of folic acid.


Akamai V standard for “directs or controls”

• In Akamai V, it was held that directing or controlling

others’ performance includes circumstances in which

an actor:

–(1) “conditions participation in an activity or

receipt of a benefit” upon others’ performance

of one or more steps of a patented method, and

–(2) “establishes the manner or timing of that

performance.”


Administration of folic acid is a condition of premetrexed treatment

• The district court’s finding that physicians “condition”

pemetrexed treatment on the administration of folic

acid was found by the Federal Circuit to be supported

by the record evidence.

• The Physician Prescribing Information, which is

“directed to the physician,” explains that folic acid is a

“[r]equirement for [p]remedication” in order “to reduce

the severity of hematologic and gastrointestinal

toxicity of [pemetrexed].”


Administration of folic acid is a condition of premetrexed treatment

• The product labeling repeatedly states that physicians should “[i]nstruct patients” to take folic acid and includes information about folic acid dosage ranges and schedules.

• The Patient Information also informs patients that physicians may withhold pemetrexed treatment: “You will have regular blood tests before and during your treatment with [pemetrexed]. Your doctor may adjust your dose of [pemetrexed] or delay treatment based on the results of your blood test and on your general condition.”


First Prong of Akamai V was satisfied

• The Federal Circuit found that the product labeling,

combined with the testimony at trial by both sides,

provided sufficient evidence that physicians condition

pemetrexed treatment on folic acid pretreatment.

• What about the second prong, establishing the

manner and timing of performance?


The product labeling is again informative.

• The Physician Prescription Information instructs physicians not only to tell patients to take folic acid orally, but also to take “400 [μg] to 1000 [μg] [of folic acid] once daily beginning 7 days before the first dose of [pemetrexed],” accompanied with warnings about the consequences of non-compliance. The above dosage range and schedule overlaps with all of the asserted claims’ dosage ranges and schedules.

• The Federal Circuit found that based upon the evidence, the District Court’s finding that physicians establish the manner and timing of the patients’ folic acid intake was not clearly erroneous.


There was sufficient evidence to find direct infringement, but what about inducement?

• To show inducement, Eli Lilly carried the burden of

further proving “specific intent and action to induce

infringement.”

• Federal Circuit noted that they had already agreed

with the District Court that the administration of folic

acid before pemetrexed administration was “not

merely a suggestion or recommendation, but a critical

step.”


Is labeling sufficient evidence of specific intent?

• The District Court had held that Defendants induce

physician’s infringement because physicians act “in

accordance with Defendants proposed labeling.”

• The Federal Circuit noted that the instructions are

unambiguous on their face and encourage or

recommend infringement. Finding was that evidence

that the product labeling that Defendants seek would

inevitably lead some physicians to infringe establishes

the requisite intent for inducement.


Rapid Litigation Management Ltd.

v. CellzDirect, Inc.,

No. 2015-1570 (Fed. Cir. July 5, 2016)

Supreme Court – cert denied


Spoilers

• Rapid Litigation Management appealed the

summary judgment determination of the District

Court for the Northern District of Illinois that U.S.

Patent No. 7,604,929 is invalid under 35 U.S.C. §

101.


Spoilers

• The district court concluded that the ‘929 Patent is

directed to a patent-ineligible law of nature (i.e.,

that hepatocytes are capable of surviving multiple

freeze-thaw cycles) and that the patented process

lacks the requisite inventive concept.

• The Federal Circuit held that the claims of the ‘929

Patent are not directed to a patent-ineligible concept,

so the district court’s decision was vacated and

remanded.


Hepatocytes are useful for testing, diagnostic, and treatment purposes.

• Fresh hepatocytes have a short lifespan.

• Prior to the ‘929 Patent, scientists used cryopreservation

techniques comprising freezing the hepatocytes, thawing

them when needed, and recovering the viable cells.

• However, this process damaged the hepatocytes, leading

to poor recovery numbers of viable cells.

• As such, it was considered that hepatocytes could only be

frozen once and then used or discarded.


Inventors discovered that twice frozen cells were still useful

• The inventors discovered that cells twice frozen

behaved like cells that were once frozen.

• In fact, if the cells survived the first freeze, at least

70% of the cells would survive subsequent

freezes.


Claim 1 of U.S. Patent No. 7,604,929 recites: A method of producing a desired preparation of multi-cryopreserved hepatocytes, said hepatocytes, being capable of being frozen and thawed at least two times, and in which greater than 70% of the hepatocytes of said preparation are viable after the final thaw, said method comprising:

(A) subjecting hepatocytes that have been frozen and thawed to density gradient fractionation to separate viable hepatocytes from non-viable hepatocytes,

(B) recovering the separated viable hepatocytes, and

(C) cryopreserving the recovered viable hepatocytes to thereby form said desired preparation of hepatocytes without requiring a density gradient step after thawing the hepatocytes for the second time, wherein the hepatocytes are not plated between the first and second cryopreservations, and wherein greater than 70% of the hepatocytes of said preparation are viable after the final thaw.


Commercial Embodiment


Rapid Litigation Management sued CellzDirect for infringing the ‘929 Patent

• In response, CellzDirect filed a motion for

summary judgment of invalidity under 35 U.S.C.

§§ 101 and 112.

• The district court granted the motion with respect

to § 101 without reaching the § 112 issues.


• The district court (N.D.

Ill.) applied the

Supreme Court’s two-

step framework for

determining patent

eligibility.

• PTO guidance shown

to the right.


District Court – testing 101

• Step one (2A): whether the claim is directed to one of

the patent-ineligible concepts.

– If the answer is no, the claim recites patent-

eligible subject matter.

– If the answer is yes, the test proceeds to step

two.

• Step two (2B): whether the additional elements

transform the nature of the claim into a patent-eligible

application.


At step one, the district court concluded that the ‘929 Patent is directed to an ineligible law of nature.


At step two, the district court determined that the patented process lacks the requisite inventive concept since the inventors reapplied a well-understood freezing process.


Federal Circuit Appeal – Step One

• For step one, the district court concluded that the

patent is directed to an ineligible law of nature with

respect to the discovery that hepatocytes are

capable of surviving multiple freeze-thaw cycles.

• The Federal Circuit disagreed with this

conclusion.


Federal Circuit – Step One

• The Federal Circuit noted that the claims are not

simply directed to the ability of hepatocytes to

survive multiple freeze-thaw cycles.

• Rather, the claims are directed to a new and

useful laboratory technique for preserving

hepatocytes.


Federal Circuit – Step One (2A)

• Although the inventors discovered the cells’ ability

to survive multiple freeze-thaw cycles, the

inventors then applied their natural discovery to

create a new and improved way of preserving

hepatocyte cells for later use.


Federal Circuit – Step Two

• Although not necessary, the Federal Circuit then

considered step two.

• The Federal Circuit determined that the claims of

the ‘929 Patent recite an improved process for

preserving hepatocytes for later use, which is

sufficient to be considered a patent-eligible

concept.


Federal Circuit – Step Two (2B)

• Although the step of freezing and thawing

hepatocytes was well-known, the Federal Circuit

stated that the process of preserving hepatocytes

by repeating the steps of freezing and thawing

was far from routine and conventional.


Federal Circuit

• Therefore, the Federal Circuit held that the claims

of the ‘929 Patent are not directed to a patent-

ineligible concept, so the district court’s decision

was vacated and remanded.


Comparison

District Court

• Step 1: The claims are

directed to an ineligible

law of nature.

• Step 2: The patented

process lacks the requisite

inventive concept since

the inventors reapplied a

well-understood freezing

process.

Federal Circuit

• Step 1: The claims are directed to a new and useful lab technique for preserving hepatocytes.

• Step 2: The claims recite an improved process for preserving hepatocytes for later use.

– Repeating freezing and thawing was not routine


Practice tips

• If the inventor makes a discovery of what is arguably a law

of nature or other patent-ineligible subject matter, the

inventor is still in a position to claim applications of that

knowledge.

• Thus, inventors should consider how a natural discovery

can be applied in new and improved ways in order to arrive

at a patent-eligible invention.

• Similarly, patent practitioners drafting the patent

specification must consider how a natural discovery can be

applied in new and improved ways in order to draft patent-

eligible claims.


Practice tips

• Importantly, when a practitioner is concerned

about a particular application being patent-

ineligible, he or she must convey those concerns

clearly to the inventor.


Questions?


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