Patents

European Patent Court to Be DividedAmong Three Countries

—In Response to Question of Whether Court

Should Be in London, Paris, or Munich,

EU Says ‘‘Yes’’

BRUSSELS, BELGIUM 6/29/12—After more than30 years of negotiations, the European Union has fi-nally decided its Unified Patent Court should be seatedin London, Paris, and Munich. All three cities hadbeen in contention to be the only site. The main officewill be in Paris, whereas Munich will handle mechan-ical engineering patents and London will deal withpharmaceutical and life sciences patents.

It is hoped the new system will reduce the costs ofobtaining European patents, which now are morethan 10 times the cost of obtaining a U.S. patent.The system also may make enforcement cheaper.However, prices probably will go up for companiesinterested in patenting in fewer than six countries.An increase in European competitiveness also isforecast.

To date, Spain and Italy have not agreed to abide bythe new system.

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FTC Argues That Agreements BetweenPatent Holders and Generics Companies

Are Anti-competitive

—Files Amicus Brief in Wyeth, Teva Case

WASHINGTON, D.C. 8/13/12—An amicus curiaebrief filed by the Federal Trade Commission says thatmakers of branded drugs are using patent deals todelay generic competition. The FTC has said foryears that agreements between generic companiesand holders of drug patents in which the generic com-pany agrees not to challenge patents in exchange forcash or other consideration are costing consumers mil-lions of dollars. However, the agency’s attempts to sellthe courts on this idea have failed.

The amicus brief was filed in federal court in NewJersey, which is hearing a private antitrust challenge toan agreement between Wyeth, a division of Pfizer, andTeva Pharmaceutical Industries.

‘‘Empirical evidence confirms what the pharmaceu-tical industry has long understood: that a no-(autho-rized generic) commitment provides a convenientmethod for branded drug firms to pay generic patent

challengers for agreeing to delay entry,’’ the FTCsaid in its brief. It encouraged the court to ‘‘carefullyconsider the economic realities of no-AG commit-ments and their impact on consumers.’’

In the suit, CVS Caremark Corp and Rite Aid Corphave accused Pfizer and Teva of conspiring to keep ge-neric versions of the popular antidepressant EffexorXR off the market. Wyeth responded that its agree-ment with Teva will bring generic Effexor XR to mar-ket 7 years before its patent expires. Teva has filed amotion to dismiss.

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Inviting Bids to Become a PreferredSupplier Does Not Violate Patents

in Europe

THE HAGUE, THE NETHERLANDS 9/26/12—The Court of Appeals here has found that healthcareinsurance companies do not infringe patents whenthey invite bids to become the preferred supplier of adrug still under patent (SPC) protection provided cer-tain conditions are in effect. Under EU law, clients ofinsurers receive reimbursement only if they buy fromthe preferred supplier.

Pfizer held an SPC for latanoprost, which it soldunder the trade name Xalatan. Six importers wereactive in the market, and several generic companiesheld marketing authorizations. Two healthcare insur-ers organized a sealed bid tender agreement to ap-point a preferred supplier. The date for sealed bidsinitially was during the time the SPC was in force.Pfizer claimed this action would infringe its patent,so the deadline for filing bids was moved to afterthe patent expiry. In its filing, Pfizer argued that thetender would cause the insurers to ‘‘otherwise tradein’’ the patent drug in violation of the Dutch PatentAct or would amount to unlawful aiding of patentinfringement.

The Court rejected the argument that the insurerswould be ‘‘otherwise trading in’’ Pfizer’s patent prod-uct, as they would not actually be making the drugavailable to third parties. It also said that the insurerswould not have committed an act of tort becausethey were not directly inciting patent infringement. Itcalled attention to the fact that the invitation to bid re-quired the applicants to say they would respect thirdparty patent rights.

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India Revokes Pfizer’s CancerDrug Patent

—Finds Lack of Inventive Step;

Is Cost Real Reason?

MUMBAI, INDIA 10/5/12—The Indian PatentOffice has revoked a patent on a kidney and liver cancerdrug, sunitinib malate (Sutent), issued to Pfizer Ltd.The announced grounds were lack of inventive step.

The Indian Patent Office has recently revoked pat-ents on several cancer and anti-AIDS drugs held byWestern pharmaceutical companies essentially on thegrounds that the drugs were too expensive, and genericcompetitors should be allowed to provide the samemedicines. In other cases, the Office has imposedcompulsory licenses.

Pfizer noted that it has an extensive patient-assistance program to provide the drug to patientswho cannot afford the full price.

In another case, a patent infringement case filedagainst Cipla by Roche over Tarceva was dismissed.The patent was found to be valid, but the Delhi HighCourt said that Cipla’s product did not infringe it.

Pfizer indicated it would appeal to the IntellectualProperty Appellate Board.

Shamnad Basheer, Professor of Intellectual PropertyLaw at the National University of Juridical Sciences inKolkata, supported the decision. ‘‘India’s insistence on ahigher threshold than that of Western countries for rec-ognizing drug patents is justified on the grounds that thecountry has serious public-health problems to address.’’

Patents on pharmaceutical products became avail-able in India only in 2005; previously, only manufactur-ing processes could be patented.

Many drug companies have said what they calledthe lack of respect for intellectual property woulddrive companies from the Indian market, makingtheir products unavailable at any price.

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ACLU, PUBPAT Want Certiorariin Myriad Case

—‘‘Are Human Genes Patentable?’’

WASHINGTON, D.C. 9/25/12—The AmericanCivil Liberties Union and the Public Patent Founda-tion have filed a petition for certiorari with the U.S.Supreme Court in another attempt to have genes de-clared unpatentable.

Gene patents have been issued for many years withno objections from the ACLU. The organization be-came involved over patents on genes linked to breastcancer that are held by the University of Utah and li-censed to Myriad Genetics. One of the documents in

what is known as the Myriad case is tagged by theACLU in part as ‘‘womensrights.’’

The first court to hear the case found genes to beunpatentable, but the Court of Appeals for the FederalCircuit twice said they are, leading to the ACLU’s pe-tition to the Supreme Court. The Federal Circuit notedthat although genes are naturally occurring, the patent-ed forms require human intervention to isolate them.

The petition asks three questions:

1. Are human genes patentable?2. Did the Court of Appeals err in upholding a

method claim by Myriad that according to theACLU and PUBPAT is irreconcilable with thisCourt’s ruling in Mayo Collaborative Servicesv. Prometheus Labs., Inc., 132 S. Ct. 1289(2012)?

3. Did the Court of Appeals err in adopting a newand inflexible rule, contrary to normal standingrules and this Court’s decision in MedImmune,Inc. v. Genentech, Inc., 549 U.S. 118 (2007),that petitioners who have been indisputably de-terred by Myriad’s ‘‘active enforcement’’ of itspatent rights nonetheless lack standing to chal-lenge those patents absent evidence that theyhave been personally and directly threatenedwith an infringement action?

According to the brief, which is reprinted in thedocuments section, ‘‘[t]he question of whetherhuman genes and the information they convey are pat-entable is of paramount importance to the future ofpatent law, the advancement of medical science, andthe health of patients.’’ The ACLU and PUBPATargue that the Myriad patents impede research onbreast cancer genes, a position somewhat underminedby the fact that hundreds of scientific articles havebeen published on the subject.

The brief mistakenly, in the view of many, mergespatents on genes (allowable under current law) withpatents on the information the genes encode (whichis not patentable).

The second question arises from the erroneous ideathat the cells used in testing for drugs active againstbreast cancer are available for purchase from severalsources. In fact, they were created by Myriad Geneticsby insertion of the genes at issue (BRCA1 and BRCA2)into the cells used in the assays and are not a commer-cial product.

According to one commentator, the third question isintended to ‘‘expand[] the scope of declaratory judgmentjurisdiction, so that members of the public affected by apatent but not threatened by suit would have standing [tosue].’’ That is, a favorable decision by the SupremeCourt would give ‘‘every consumer who purchases a pat-ented product . standing to challenge the patent.’’

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Is an OncoMouse Patent Still in Effect?

—Impact of Terminal Disclaimer Debated

CYBERSPACE 9/18/12—Today’s issue of thePatently-O blog by Dennis Crouch considers theHarvard OncoMouse�. The animal had a gene insertedthat predisposes it to develop cancer, leading to pro-tests from animal rights activists when its existencewas announced. However, three patents (U.S. Nos.4,736,866, 5,087,571, and 5,925,803) issued to theuniversity; all are licensed exclusively to Du Pont.

The mouse has found considerable acceptance inthe research community.

Two of the patents clearly have expired, but thethird one, the ‘803 patent, is valid until 2016 exceptfor a terminal disclaimer, whose applicability is insome doubt.

In 2010, an anonymous third party filed a reexami-nation request for the ‘803 patent. Although the Pat-ent and Trademark Office upheld the patentability ofthe challenged claims, it agreed with the third partythat the broadly worded terminal disclaimer filedwith the application that became the ‘571 patentmeans that the ‘803 patent expired in 2005. ThePTO refused to allow Harvard to add claims duringthe reexamination.

There is some question about the applicability ofthe terminal disclaimer, as it was never filed with theapplication that became the ‘803 patent. There alsois no record of the patent examiner acknowledging re-ceipt of the disclaimer or of payment of the disclaimerfee. Nevertheless, in its opinion on the reexamination,the PTO accepted the disclaimer.

Harvard is now claiming that it is not applicable toits final remaining patent. Indeed, Harvard filed suit inthe Eastern District of Virginia asking that the PTO de-cision be overturned (Harvard College v. Kappos, 12-cv-1034 [E.D.Va. 2012]).

Being challenged under the PTO’s new inter partesreview system are Patent No. 6,258,540 (non-invasiveprenatal diagnosis using maternal plasma, owned byOxford University (UK) Isis Innovation), challengedby Ariosa Diagnostic; Patent Nos. 7,713,698 and7,790,869 (Columbia University patents on ‘‘massiveparallel methods for decoding DNA and RNA’’), chal-lenged by Ilumina.

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PhRMA Files Amicus Brief in K-Dur Case

The Pharmaceutical Research and Manufacturers ofAmerica (PhRMA) has filed an amicus brief in supportof a grant of certiorari by the Supreme Court in the Inre K-Dur Antitrust Litigation. The organization arguesthat a recent decision by the Third Circuit has con-

fused the situation by deciding a case of reverse pay-ments differently from other courts, specifically byfinding them anticompetitive on their face.

In a reverse payment case, the manufacturer of abrand name drug agrees to pay a potential generic com-petitor not to challenge the validity of a patent until itexpires. The Federal Trade Commission has made sev-eral attempts to declare such agreements illegal, butmost of the courts have so far declined to accept the ar-guments. The finding has been that such agreements arenot violations of antitrust law because courts cannot‘‘restrict[] the ability of innovator companies to managerisk and avoid the costs and uncertainty of litigation’’without ‘‘dramatically diminish[ing] incentives for in-novation and product development.’’

The PhRMA says that the Third Circuit’s decisionimposes ‘‘unwarranted presumption of illegality’’ onsuch agreements and asks the Supreme Court to decide‘‘whether innovator companies can lawfully settleHatch-Waxman patent litigation on terms that restrictthe alleged infringer’s activities within the scope ofthe patent and also include a payment (or other consid-eration) to the alleged infringer.’’ If the Third Circuit’sdecision takes effect, the PhRMA argues, protractedlitigation may follow that will delay the introductionof generic drugs, a goal the Hatch-Waxman law wasintended to counter.

The full text of the brief is available in the docu-ments section of this issue.

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Medecins sans Frontiers Posts Toolto Challenge ‘‘Unwarranted’’ Drug Patents

PARIS, FRANCE 10/11/12—The aid agencyMedecins sans Frontiers has posted an online tool tohelp the public challenge what the agency calls ‘‘un-warranted’’ drug patents. The program is called ‘‘Pat-ent Opposition Database.’’

The organization’s Director of Policy Advocacy,Michelle Childs, said that many drug patents ‘‘aren’tactually deserved.’’ The group’s history suggests thatit considers most drug patents to be unwarranted andsuitable for attack, particularly drugs active againstHIV.

Doctors without Borders (its English-languagename) recently received the Nobel Peace Prize forits work against disease in the Third World.

The Web site is www.patentoppositions.org

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Drug Companies Filing Citizen Petitions?

ROCKVILLE, MD 11/7/12—‘‘Is it a plea forpatient safety or a tactic to protect profits?’’ is the

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question asked today by David Sell in his review ofcitizen petitions filed with the Food and Drug Admin-istration by brand-name drug makers against genericmanufacturers.

Citizens and patient advocacy groups submit suchpetitions questioning the safety or efficacy of a prod-uct. Their use by pharmaceutical companies is a newand growing application.

The FDA does not have to delay marketing approv-al of a generic drug until the citizen petition is dealtwith.

The question of safety vs. profits has arisen in con-nection with a petition filed by GlaxoSmithKlineagainst Roxane Laboratories over its steroid nasalspray, which Glaxo sells as Flonase. Roxane counter-sued on antitrust grounds.

The FDA rejected the first petition, leading Glaxoto sue.

Recently, U.S. District Judge Anita B. Brody ruledthat former FDA Commissioner David Kessler, M.D.,J.D., could testify in support of Roxane. Reportedly,his testimony will deal with whether Glaxo’s petitionis a sham.

Michael A. Carrier, a Professor of Law at RutgersUniversity and coauthor of a recent paper on the sub-ject of drug company petitions, notes that ‘‘[c]itizenpetitions are consistent with the First Amendmentright to petition the government, and even large com-panies have that right. .. But a lot of petitions arefiled by large companies in an effort to delay genericentry into the market.’’

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Canada Cancels Pfizer’s Viagra Patent

—Court Finds It Too Vague

OTTAWA, CANADA 11/9/12—Canada’s SupremeCourt has ruled unanimously that Pfizer’s patent onsildenafil (Viagra) is invalid as vague.

The suit had been brought by Teva PharmaceuticalIndustries Ltd., which wishes to bring a generic versionof the popular erectile dysfunction drug to market.

Pfizer’s Canadian patent covers 260 quintillionchemical compounds, only one of which has the de-sired vasodilating activity, according to the Court.

Writing for the Court, Justice Louis LeBel said‘‘Pfizer gained a benefit from the (Patent) Act—exclu-sive monopoly rights—while withholding disclosure inspite of its disclosure obligations under the act. As a mat-ter of policy and sound interpretation, patentees cannotbe allowed to ‘game’ the system in this way...(the patent)is invalid.’’ However, the Judge said ‘‘wilful intent tomislead has not been alleged or proven in this case.’’

Pfizer has won similar suits filed in the U.S., NewZealand, Spain, and Norway. The company also wontwo lower court rulings in Canada.

The effect the ruling will have on the market is un-clear, in part because Pfizer is losing sales to anotherdrug, Lilly’s Cialis, which works for a longer timethan Viagra.

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New Patents and Allowances

Agennix AG of Planegg and Munich, Germany,Princeton, N.J. and Houston, Tex. announced on July30 that the U.S. Patent and Trademark Office hasissued a Notice of Allowance for application 12/964,327 entitled, ‘‘Lactoferrin in the Treatment of Malig-nant Neoplasms and Other Hyperproliferative Diseases.’’The application covers the use of the oral dendritic cell-mediated immunotherapy (DCMI) talactoferrin alfa(talactoferrin) for the treatment of non-small cell lungcancer (NSCLC) and renal cancer in combination withchemotherapy, biotherapy, immunotherapy, surgery, ra-diotherapy, or a combination thereof. The product candi-date stimulates the patient’s immune system with thegoal of developing a cancer-specific response. Early clin-ical trials have yielded promising results.

Alethia Biotherapeutics of Montreal, Que. has re-ceived a Notice of Allowance for a composition ofmatter patent entitled ‘‘Polynucleotides and Polypep-tide Sequences involved in the Process of BoneRemodeling.’’ It discloses antibodies that targetSiglec-15, a cell-surface receptor expressed specifical-ly on osteoclasts. Two other patents on the technologyhave already issued. Alethia is developing drugs tocounteract osteoporosis.

Lorus Therapeutics Inc. (Toronto, Ont.) has receiveda Canadian patent for interleukin-17E, its cancer immu-notherapy product candidate. The patent covers the useof IL-17E against several cancers, including those ofthe pancreas, breast, ovary, lung, and colon. It also cov-ers the use of the protein in conjunction with severalclassic antineoplastic drugs, including paclitaxel andbevacizumab (Avastin). Applications for U.S. and Euro-pean patents are pending.

The first clinical trials are to be conducted againstpancreatic cancer, for which there is at present no ef-fective treatment (the 5-year survival rate is only4%), and melanoma, which has previously shown re-sponsiveness to cancer immunotherapy agents.

Medistem Inc. (San Diego, Cal.) has received aNotice of Allowance from the PTO for a patent dis-closing the use of fat stem and associated cells forthe treatment of diseases caused by immune dysfunc-tion, such as Type I diabetes, rheumatoid arthritis, andmultiple sclerosis. The patent is titled ‘‘Stem CellMediated Treg Activation/Expansion for TherapeuticImmune Modulation.’’ A pilot trial suggested activityagainst multiple sclerosis.

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Several other groups are working with regulatory Tlymphocytes, and Medistem said it ‘‘believes revenuecan be generated through enforcement of patent rights.’’

Immunovative, Inc. division Immunovative Thera-pies, Ltd. has received a Notice of Allowance forClaims 17–28 in U.S. Patent Application 12/909,517‘‘T-Cell Compositions that Elicit a Type I CytokineResponse.’’ These claims cover the company’s leaddrug candidate, AlloStim, the active ingredient ofwhich is intentionally mismatched CD4 + Th1 naturalkiller cells. The other claims, which cover methodsand uses, are still pending.

On October 11, 2012, the company announced theissuance of U.S. Patent No. 8,273,377 entitled‘‘Method for Allogeneic Cell Therapy,’’ which coversthe Mirror Effect�, which stimulates anti-tumor im-mune responses without the risk of graft vs. host dis-ease or the need for a matched tissue donor.

The PTO has granted Patent No. 8,232,262 to Zio-pharm Oncology’s palifosfamide. The patent coversdrug compositions, formulations, methods of use,and methods of manufacture. A composition of matterpatent has already issued. Corresponding patents havealso issued in Europe and several other countries.

Palifosfamide is a DNA-targeted cancer drug thatbypasses drug resistance mediated by aldehyde de-

hydrogenase, an enzyme produced by cancer stemcells. The drug is in Phase III trials against metastat-ic soft tissue sarcoma and metastatic small cell lungcancer.

Kane Biotech Inc. (Winnipeg, Man.) has received aJapanese patent, No. 4,999,842, entitled ‘‘Antimicro-bial Compositions for Inhibiting Growth and Prolifer-ation of a Microbial Biofilm on Medical Devices.’’This patent covers the Company’s Aledex� technolo-gy for the anti-biofilm coating of medical devices toprevent hospital-acquired infections.

Biofilms are created on the surfaces of medical de-vices by materials secreted by bacterial cells. Bacteriaencased in biofilms become quiescent and resistant toantimicrobial drugs, making the devices foci of infec-tion. Anti-biofilm efforts have been in progress formany years, only recently with any success.

A patent has been issued to Galena Biopharma(Portland, Ore.) for its cancer vaccine, NeuVax,which is being tested as a means of preventingrelapse of breast cancers expressing low to interme-diate amounts of HER2. A late-stage study is inprogress under a special protocol agreement withthe FDA.

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