Lisa Jorgenson has been AIPLA’sExecutive Director for almost twoyears. She started in the role in

November 2014, having previously beenGroup Vice President of Intellectual Propertyand Licensing at STMicroelectronics.Jorgenson quickly realized that the work

of the Association has increased since hertime on the Board from 2005-2008. “A lotmore activity goes on at headquarters that Iever imagined,” she says. “As one person putit, it is like drinking from a fire hose on a con-stant basis.”AIPLA’s diversity of membership and

diversity of issues has grown tremendously.AIPLA has taken a bigger role in internation-al issues, such as patent harmonization, glob-al dossier, the Industry Trilateral and theIndustry IP5. This year alone, theAssociation has submitted comment lettersto seven different countries or patent offices.It has also grown its regional IP PracticeCommittees, which now includes LatinAmerica. AIPLA’s IP Practice Committeedelegations traveled to six different overseasregions this year.With so much going on domestically and

globally, AIPLA is challenged with prioritiz-ing the issues on which to focus its resources.“It is an ongoing balancing act to find the

right mix between being reactive to whatcomes up and being proactive to find a wayto get ahead of what we believe will be thecritical issues, whether here in the US orabroad. We have to choose the ones webelieve are most important to our membersand get ahead of the curve.”One recent example of an important issue

came up on October 14 when the USPTOannounced in a notice published in theFederal Register that it will begin a nation-wide conversation on patent eligible subjectmatter through two roundtable discussions,one in Alexandria, Virginia on November 14and one at Stanford University in Stanford,California on December 5.“We’ve had a task force working in the

patent subject matter eligibility area forabout a year and a half,” says Jorgenson. “Webelieve we are ahead of the game. We havebeen proactively identifying and analyzingthe issues. We may not have all the solutionsbut when the Federal Register Notice cameout, we were already on top of the issues.”Jorgenson notes that subject matter eli-

gibility is one of the issues where consensus

will be difficult to achieve. “The answers arenot easy and a fair amount of time is neededbefore people will be able to finally coalescearound more of a single solution,” she says.“We are making sure we can get the bestpeople in a room on a regular basis to dis-cuss the issues.”Another big issue on members’ minds is

the Patent Trial and Appeal Board (PTAB).

“It is still fairly new to many people andthere is still some uncertainty about howthings will be played out at the Patent Officeas well as the Federal Circuit,” saysJorgenson. “Any time there is somethingnew in intellectual property, it does havesome uncertainty to it. So we are watchingvery carefully, paying close attention tocases that come out of the PTAB includingthe cases that go to the Federal Circuit, andof course keeping our members updated.”Attendees will have the chance to gain

further insights into the PTAB today. Theluncheon keynote speaker is DavidRuschke, who became the PTAB ChiefJudge this past May. He was previouslymanaging the IP portfolio of Medtronic’sCSH business unit.“Chief Judge Ruschke has a lot of experi-

ence that he is bringing to the table for theUSPTO,” says Jorgenson. “The discussionthat he and Denise DeFranco will have prom-ises to be very enlightening in terms of how hewould like to see the PTAB move forward. SoI am really looking forward to that lunch.”Another constant issue for AIPLA is

legal reform. For example, the Association

was involved in discussions around theDefend Trade Secrets Act of 2016, whichwas signed into law in May. “We workedhard on that bill which was a truly biparti-san bill. This was a good bill for theAmerican economy, and good for ourmembers and their clients. So we are veryhappy with the result,” says Jorgenson.“We’ve remained very active on the

issues on the Hill, and that includes patentlitigation reform,” says Jorgenson. “Weanticipate that this activity will increaseagain and we will be paying close attentionto it, staying involved in the process andeducating people on the issues.”Advocacy is a core activity for AIPLA.

This includes amicus issues, with theAssociation filing briefs in nine cases thisyear. “Both the areas of the law and thetypes of issues are very diverse whichmakes it interesting and challenging to pulltogether a really well thought out and verypurposeful amicus brief. We have a verygood reputation in the courts so whenAIPLA submits a brief, the courts knowthat a lot of thought has gone into theissues.”

The duty of candor inpatent prosecutionNEWS Page 4

The recent oral arguments inSamsung v Apple marked the firstdesign patent case at the Supreme

Court in more than a century. Samsungappealed the Federal Circuit’s ruling that itshould pay $399 million in profits from itsGalaxy phones to Apple. The judgment ofinfringement is no longer in question.Instead each party, as well as the Office ofthe Solicitor General, proposed their respec-tive approaches to two questions aboutdesign patents remedies: what test or stan-dard should be used to identify the “article ofmanufacture” in question, and how shouldthe value of that article be determined.Sarah Burstein a professor of law at the

University of Oklahoma who teaches copy-right and courses on design patents and whoattended the oral arguments, says that Apple“changed its tune” between the time that thewrit of certiorari was granted and briefingwas completed. Instead of defending the

position that the Federal Circuit had cor-rectly defined the article of manufacture asApple had done before, the iPhone-makeragreed with Samsung and the governmentthat an article of manufacture is not necessar-ily the entire product.Samsung and Apple stopped arguing

over whether or not the statute definitivelymeans that the whole product is the “articleof manufacture”. “The fight became ‘how dowe effectuate that?” says Burstein.Samsung’s lawyer, Kathleen Sullivan of

Quinn Emanuel Urquhart & Sullivan,argued for a two-step test: “First, determinewhat is the article of manufacture. Then, sec-ond step, determine the quantum of dam-ages, quantum of profits from that article.” Brian Fletcher, assistant to the Solicitor

General, suggested a four-step test to deter-mine the article of manufacture and itsvalue. He suggested consumer research andexpert witnesses be used to help to deter-

mine the value of the article of manufactureas opposed to the whole product, citingmethods used in other areas of law such ascases dealing with utility patents. He also,like Sullivan, suggested evaluation of factorssuch as component production costs versuspercentages of revenue; “a bottom up calcu-lation,” he said.The Justices – particularly Justice

Kennedy – cautioned that a test wouldneed to be practically applicable, in termsof cost, time, and accuracy. “It was difficultto discern whether the Supreme Court hadmade up its mind” about what theythought the test should be “or if it was giv-ing real consideration to the proposalsmade,” says Richard Stockton, a patentattorney at Banner & Witcoff. What is clearto him, however, is that “Samsung con-trolled the narrative. Samsung had theDepartment of Justice’s wind in its sails,and it used that to its full advantage.”

THURSDAY EDITION

AIPLA ANNUAL MEETING, WASHINGTON DC, THURSDAY, OCTOBER 27 2016

What’s at stake in theTam Supreme Court caseNEWS Page 2

PUBLISHED BY

Design patents put to the test

DAILYREPORTAIPLA

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A continuous balancing act

The trademark world has beenclosely following Lee v Tam, thedispute over the constitutionality

of the USPTO’s provision barring the regis-tration of disparaging marks. The case wasgranted cert by the Supreme Court inSeptember. Betty Anne Morgan, of counselat Paz Horowitz, and Bill Barber, a partner atPirkey Barber, will discuss the case in a ses-sion today. The Tam case concerns the name of the

band: The Slants. Simon Tam, the bassist anda founding member of the Asian-Americanband, attempted to register a trademark for“The Slants.” The USPTO’s Trademark Trialand Appeal Board (TTAB) affirmed theoffice’s denial of the mark. Its rejection wasbased on Section 2(a) of the Trademark Act,which bars the registration of “disparaging”marks. The Supreme Court is being askedwhether the provision is “contrary to the FirstAmendment.” The Federal Circuit en banc ruled last

December that the bar against registering dis-paraging marks violated the FirstAmendment, and the USPTO appealed to theSupreme Court. Barber, who will argue that the provision is

constitutional is concerned that “without thisprovision, the register is going to opened up tothe most vile, racist trademarks imaginable,”and will become “cluttered with these marksthat the US government is going to have tosend to WIPO or foreign governments.”

Morgan of Paz Horowitz doesn’t believethat doing away with Section 2(a) will “havethat much effect.” She says that there aren’tmany applications for scandalous or disparag-ing marks and that, for most brand owners, thepossibility of “market backlash” is discourage-ment enough. Rather, registrants of suchmarks will be “people like the band The Slants,artists and people with products that are morefringe,” such as the apparel brand “FUCT,”which has also appealed the USPTO’s denialof its trademark registration.

The closely-watched Tam case also hasimplications for the even more buzzed-aboutRedskins case, which is pending at the FourthCircuit. The Redskins petitioned the SupremeCourt for cert under an extraordinary provi-sion that would allow its case to bypass thelower courts and be heard with the Tam case,but was denied. Furthermore, Barber worries,if the provision is struck down, it could clearthe way for the registration not only of raciallydisparaging marks, but of parodies of famousmarks. On the other hand, Morgan argues that

allowing the provision to remain in placewould overrule the Court’s own precedent inthe Citizens United case.“One sign of how divisive this is – and there

are good arguments on both sides – is that ifyou look at that, none of the major IP organi-zations filed amicus briefs,” says Barber of theTam case, adding that INTA was the excep-tion, filing a brief on one, relatively minor,issue of the case. The examination of the casepromises a heated debate between Morganand Barber.

2 TRADEMARK PREVIEW THURSDAY, OCTOBER 27 2016 AIPLA DAILY REPORT

Catching up with TTAB casesThe Trademark Trial and Appeal

Board (TTAB) has seen a slew ofunusual cases this year. John Welch,

an attorney with Wolf Greenfield in Bostonwho writes about the TTAB on his appropri-ately named site The TTABlog, will this after-noon discuss a number of interesting andprecedential cases, from motion to marijuanaand fire power to fraud. In the In re Loggerhead Tools decision the

TTAB upheld the denial of Loggerhead’sattempt to register a trademark for themotion of the jaws of a wrench or crimperopening and closing. Loggerhead tried anumber of novel arguments about its designpatents, but ultimately these failed theBoard’s four-part Morton-Norwich test.“The Board said, ‘Sorry, there’s a patent onthis,” says Welch, “this is a function of adevice, and a trademark can’t be for some-thing that’s functional.” Welch will delvemore deeply into the intricate crossovers ofdesign and utility patents and trademarks atplay in the case.

As marijuana becomes legal or decriminal-ized in an increasing number of states, theissue is drifting into the TTAB too. But appli-cants for marijuana-related marks face stickyissues when trying to register nationally-recog-nized marks for marijuana because the prod-uct is still illegal in most states. That leaves thebooming marijuana industry to either attemptto circumvent Trademark Act provisions, or“would leave them to get state registrations,but in states where they can’t get a Federal reg-istration,” says Welch. Some surprising registrations have survived

the TTAB this year too, such as a color mark for“white” for “preformed gunpowder charges formuzzleloading firearms” in the In re HodgdonPowder Company decision. As Welch com-ments on his blog, “I can’t remember the lasttime that a single-color mark passed muster atthe TTAB.” As if that weren’t novel enough, thecolor wasn’t even a true color and the product isanother subject of legal contention. Welch willexplain how a trademark for a single color couldbe issued on the grounds of being an anomaly.

Welch will also discuss a fraud case hand-ed down from the TTAB in September.Since the laws governing fraud in the TTABwere changed in 2009 (following In re:Bose), only once such case has been upheldby the TTAB. This case, involving an autodealer, was no exception to the rule that “it’sstill very hard to prove fraud,” as Welch says,and the details of the case that he will unpackwill demonstrate why. The TTAB this month published a notice

of final rule making of its “MiscellaneousChanges to Trademark Trial and AppealBoard Rules of Practice.” The amended rules require all plaintiffs to

file complaints through the Electronic Systemfor Trademark Trials and Appeals, with theexception of ex parte appeals. The Board alsoshifted the responsibility for serving the defen-dant with a complaint back from the plaintiffto the Board itself. Now, however, this service,as well as all other correspondences and stipu-lations, will be done online, through email oronline links, and not through mail.The new rules require all discovery to be

served in time so that the responses are sub-mitted before the discovery period is over.This deprives practitioners of a tactical tool,but it is hoped that the discovery period will beprevented from bleeding over into the testi-mony period, which “kind of screws up every-thing and causes delays,” says Welch. In thefinal rule, parties are limited to 75 requests foradmissions and document production and all

discovery must be done in a six-month discov-ery period.The amendments also allow plaintiffs to

submit a declaration or affidavit for their testi-monies. “Once you get this sort of canned dec-laration, you can use it over and over again,”says Welch, “so you don’t have to go throughthe rigmarole of live testimony every time.”The amendments are meant to streamline

and make TTAB proceedings more efficient,but that doesn’t necessarily mean they willmove any faster. The new rules are “more effi-cient in the sense that less effort has to go intoit to get through the hoops,” says Welch. “Butit’s still the same hoops, more or less, in thesame order, with the same timing.”

The Tam session and the TTAB Update arepart of the Trademark track taking placebetween 2-3.30pm in Maryland Ballroom,Lobby Level

13th Fl., 27 Sec. 3, Chung San N. Rd., Taipei 104, Taiwan, R.O.C.Tel: 886-2-25856688 Fax: 886-2-25989900/25978989Email: email@deepnfar.com.tw www.deepnfar.com.tw

ProsecutionInfringementLitigationIP

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Division over disparaging marks

John Welch

Four months after the UK voted toleave the European Union on June23, the impact on IP rights in

Europe is gradually becoming clearer. But,as speakers at two sessions on Friday willexplain, there remain many issues up fordiscussion. The most important point to note, says

Chartered Institute of Patent Attorneys(CIPA) President Tony Rollins, who ismoderating an afternoon panel “Updateand Practical Tips: European IP PracticePost Brexit,” is that for the time being it isbusiness as usual. The formal process forthe UK to leave the EU will not begin untilSpring 2017, when the new UK PrimeMinister Theresa May says she will triggerthe Article 50 notification. This sets theclock ticking on a two-year process thatwill likely see the UK separated from EUlaw and regulations by April 2019.IP practitioners, and their professional

bodies, in the UK are already looking at howexisting and future IP rights will be affected.“We are discussing the different possibilities.There are a lot of discussions going on with

government, but many of these questionsare ultimately political,” says Rollins.“However, we hope there will be someprogress by the end of this year.” Lastmonth, CIPA published a 12-page guide tothe impact of Brexit on all IP rights.Some of the most pressing questions

concern EU trademarks and designs andwhat measures can be put in place toensure protection is maintained in the UK.The Institute of Trade Mark Attorneys(ITMA) published a paper examiningseven scenarios and Tania Clark will dis-cuss these in detail in tomorrow’s panel.ITMA is pushing for an outcome that min-imises cost and disruption while maximis-ing legal certainty.The situation regarding European

patents is much simpler, as these are notaffected by Brexit. However, there arequestions about Brexit’s impact on the pro-posed Unitary Patent and Unified PatentCourt (see box) as well as EU regulationson supplementary protection certificates,regulatory data protection and orphandrugs (among other areas), which will be

discussed today by Michael Williams ofCleveland IP.May has stated that the UK government

will introduce a Great Repeal Act, which willin the short term implement EU directivesand regulations directly into UK law. Thesewill then be revised or replaced over subse-quent years. “Now is a good opportunity tohold discussions with government on howthe UK can implement and even improve onEU regulations. Once the Great Repeal Billis in force, then we can hopefully implementthem quite quickly,” says Rollins.

“If we, as attorneys, have all the rightswe currently have post-Brexit, that wouldbe the ideal outcome, but clearly there aremany issues ranging from transitionalmeasures to rights of representation thatneed to be resolved,” says Rollins.

The “Update and Practical Tips: European IPPractice Post Brexit” session will take place onFriday 3.30-5.30pm as part of theInternational and Foreign Law/IP Practice inEurope Committee Education Session in theMaryland Ballroom, Lobby Level

AIPLA DAILY REPORT THURSDAY, OCTOBER 27 2016 NEWS 3

Your Brexit briefingThere is no need for IP owners and advisers to panicfollowing the UK vote to leave the EU. But now is agood time to consider how rights could be affectedin the medium term

Attendees at this year’s AIPLA AnnualMeeting might have expected to attenda session on the launch of the UnitaryPatent and UPC. Unfortunately, theBrexit vote has delayed that. Whilemany participating EU member stateshave now ratified the UPC Agreement,the UK (which is one of three countriesthat must ratify before it can come intoforce) has not.

That means that, despite consider-able progress being made in the pastyear on matters such as fees, theappointment of judges and the locationsof the court divisions, there remainsmuch uncertainty about when the newpatent system will come into effect.

Much of this uncertainty arises fromthe question of whether – and if so

how – the UK can participate in an EUinitiative when it is planning to leavethe EU, particularly as the UPC will besubject to EU law in certain areas. Arecent legal opinion commissioned bythe UK profession indicated that inprinciple the country could continue totake part, even after Brexit, but itremains to be seen if there is politicalwill to do this. Further advice is beingsought in the light of developmentssince it was written.

These questions will be discussed inFriday morning’s session “The UPC andthe European Patent System: What isHappening Next (and What are theConsequences of the UK’s Brexit Vote)?”,which will include views from both aprosecution and litigation perspective.

How Brexit affects the UPC

4 PATENT PROSECUTION PREVIEW THURSDAY, OCTOBER 27 2016 AIPLA DAILY REPORT

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No part of this publication may be reproducedwithout prior written permission. Opinionsexpressed in the AIPLA Daily Report do notnecessarily represent those of AIPLA or any of itsmembers.

This morning’s patent prosecutiontrack will address information dis-closure in the patent acquisition

and patent litigation spaces by way of goodold fashioned debate between a patent pros-ecutor and litigator. Patent prosecutors are bound by a “duty

of candor,” or “duty of disclosure,” whichrequires them to report known prior art. Butthe scope of doing so is limited by practicali-ty, says Drinker Biddle & Reath’s MercedesMeyer, who will present the prosecutor’s per-spective in the portion of this morning’spatent prosecution track titled “Enough isEnough.” Litigators argue that prosecutorsshould “be doing more,” says Meyer.Insufficient searches and disclosures leavepatent holders vulnerable to invalidity claimson those grounds, and, therefore, to expen-sive litigation. Meyer says that instances of failure to ful-

fill the duty of candor rarely come before theUSPTO’s Office of Enrollment andDiscipline (OED). But, according to Meyer,many prosecutors live in fear of the OED. Will Covey, Director of the OED, who

will also be speaking today, agrees that hisOffice has had to reprimand very few practi-tioners for failure to do their duty of disclo-

sure and defrauding the USPTO on thosegrounds, as compared to broader claims offraudulent conduct. He adds: “I don’t wantthem to think we’re watching every movethey make.” But patent prosecutors may have reason

for worry, according to litigators like Kirkland& Ellis’s Ken Adamo. He says there havealready been several cases involvinginequitable conduct before the district courtsand Federal Circuit in the past two years. “Sothis is not just something that had happenedin the dark old ages,” says Adamo, “this is stillgoing on today.”In 2011, the Federal Circuit handed down

an en banc decision in Therasense v BD, rul-ing that if the prosecutor had done its duty ofdisclosure, the patent would not have beengranted and the case wouldn’t have landedbefore the court. But the decision also man-dates that shirking the duty of candor mustbe the sole basis for a determination of willfulinfringement in order for treble damages tobe awarded. To the minds of patent litigators,this is too hard to prove, and too strict a stan-dard. But, says Meyer, “there is an incentiveto prove it” for litigators. Prior to the Therasense decision, Adamo

says, “I saw a lot of cases where people would

wing accusing someone of failing to do theirduty of disclosure.” The Therasense decisionhelped to curtail these unfounded accusa-tions, but, many have thought that they wouldnever see inequitable conduct or duty of dis-closure defenses that will be successful againbecause the test is too hard to satisfy now. Butthat has proved untrue. According to Adamo,patent prosecutors should be even more ful-some than the Patent Office requires. “If you want a strong patent, you don’t

want a bad story going around out thereabout how you got the patent by not reallydisclosing the information that you shouldhave disclosed so the patent examiner didn’treally get a fair shake at evaluating whetheryou had an invention or not,” says Adamo. According to Meyer, the cost of global fil-

ing quickly climbs into the multi-hundred-thousand dollar range. That’s more than manypatent applicants can or want to pay, especiallywhen it isn’t even clear yet whether or not theinvention will make it to market, or when thefilings are for a patent for a small componentof a product. The aftermath of the AIA has

also made some prosecutors (includingMeyer) nervous that a patent is still liable to beinvalidated, even after the most exhaustive(and expensive) prior art searches and disclo-sures. “So, how do you keep the cost down andprovide the duty of candor?” asks Meyer. “Idon’t wake up in the morning trying to pull afraud on the Patent Office.” Although Covey says that “the IP bar is

relatively well behaved, and they’re conscien-tious about their obligations before theOffice, I think it’s always helpful, before a barlike this, to give some examples of cases we’vehad where the attorney showed up on ourradar and then we took some action againstthem.” To that effect, Covey will announce aproposed revision to rule 56 (which dictatesthe standard of disclosure for patent attor-neys) during the session and explain how itdiffers from the current rule, its basis, andwhat changes it will affect.

The first part of the Patent Prosecution tracktakes place between 9am-10.15 today inThurgood Marshall, Mezzanine Level

Making a better patentIt’s been a tough few years for the

patent system. The press has latchedonto claims that patents have been

issued that shouldn’t have been, allegationshave been leveled that patent examinersshirk their responsibilities, and the technol-ogy industry has been exasperated by theaftermath of the Alice decision. “Making aBetter Patent,” clearly means doing so atmultiple levels, and Thursday’s panel of thesame name will address each. The first stop on the way to a better

patent is the USPTO itself. It has not beendeaf to criticism and, in response, has intro-duced a number of initiatives to improve itsperformance. “My speculation is that thepublic press has been slamming patentsrecently, saying patents have poor quality,and I think this is the administrativeresponse to those pronouncements in thepress,” says Paul Kitch of Nixon Peabody. Kitch will moderate a session today that

will include a presentation by ValenciaMartin-Wallace, Deputy Commissionerfor Patent Quality of the USPTO, updatingpractitioners on what they need to knowabout these quality improvement initia-tives. These efforts include the Post-Prosecution Pilot (P3) program, whichuses a number of metrics to analyze theexpediency of patent examinations from

application submission to first officeaction. The P3 program is intended to“allow for more streamlined prosecution,and hopefully shorter timelines,” saysKitch. “If patent examiners do a high quali-ty job at the beginning, it will make every-thing easier for prosecutors down theroad,” he says. Accusations of overly-broad patent

claims have haunted patent practitioners,and, in some cases, resulted in expensivedistrict court and Federal Circuit litigationwhere they’ve been reprimanded for thispractice. But, as Kitch puts it, “attorneyshave a duty to their clients to seek thebroadest possible claims,” in order to pro-vide the broadest protection possible. Bryan Wheelock, a partner at Harness

Dickey & Pierce, will discuss the reasons that,in spite of some public perception, draftingbroad claims is still essential for patent appli-cants, so long as it’s done responsibly. Kitchsays drafting narrow claims may protect aninventor from having his patent rejected, butultimately, narrow claims “make it easier forpeople to take the inventor’s ideas and inven-tion, make slight changes and deprive theinventor and the company of the benefit oftheir own invention.” But making better patents isn’t just

about best administrative and drafting prac-

tices. Ultimately, “you only get a betterpatent if you get a patent, period,” saysKitch. The panel’s final speaker, JamesHallenbeck, of Schwegman Lundberg &Woessner, will examine threats to thepatent system as a whole, and how theymight be addressed. “This is a sharplydivided issue,” says Kitch. Many argumentshave been made that technologies for bio-pharmaceutical and software should not bepatentable, “and, therefore, the betterpatent is one that doesn’t exist at all,” hesays. But doing away with patents for these

technologies could do irreparable harm,not only to important areas of innovationbut to the US economy as a whole,Wheelock will argue. Ten years ago,Microsoft was among the six largest compa-nies in the country, but was joined in thetop ranks by energy and financial compa-nies. Now, five of those top six companiesare software-based or related. So, “hurtingthe US patent system to deprive software,and the largest industries in the US, wherewe have a competitive edge, only hurts UScompanies,” says Kitch.

The second part of the Patent Prosecutiontrack takes place between 10.45am-12pmtoday in Thurgood Marshall, Mezzanine Level

When enough isenough in patentprosecution

Ken Adamo and Mercedes Meyer

In what ways is Indian law on phar-maceutical patents different fromother countries?The test for patentability of an invention isas much the same as in other countries. TheIndian Patents Act provides that to bepatentable an invention apart from satisfyingthe criteria of novelty, inventiveness andindustrial applicability should not fall underthe categories as mentioned in Section 3 andSection 4. Section 3 of the Indian PatentsAct provides the inventions which are notpatentable in India and therefore can be con-sidered as an additional bar for grant of apatent. Section 4 further provides that inven-tions relating to Atomic Energy are notpatentable. In other words, the inventionmust be patent eligible i.e. must not fall with-in the scope of Section 3 or Section 4 beforebeing considered for patentability. Here it isto be noted that the exceptions to patentabil-ity under Section 3 and 4 may be categorizedinto an absolute exception and limitedexception. While Section 4 provides for anabsolute bar to patentability on inventionsrelating to Atomic Energy, Section 3 pro-vides that subject to fulfilment of certaincondition(s) as mentioned therein, theinvention is patentable.

What specific provisions apply tothe patentability of pharmaceuti-cals in India?Section 2(1)(j) of the Indian Patents Actdefines “invention” as a new product orprocess involving an inventive step and

capable of industrial application. Theinventive step is defined in Section2(1)(ja) and Section 2(1)(l) defines theterm “new invention”. Further, Section3(d) of the Act aims to prevent “ever-greening” of patents by providing that onlythose pharmaceutical derivatives thatdemonstrates significantly enhanced effica-cy are patentable. Section 3(e) allowsinvention where the applicant is able toprove by way of data that the componentsof a combination are working together andare not working independently of eachother and show some synergistic effect.Further, Section 3(i) of the Act excludesfrom patentability methods of treatment ofthe humans or animals by therapy or sur-gery, or methods of diagnosis performed onthe human or animal body. This exclusionapplies only to methods of treatment anddiagnosis and not to the device/apparatus/instrument used in such methods.

How are these interpreted by thepatent office and examiners?There are various concepts embedded in theabove mentioned Section of the IndianPatents Act which the Patent Office inter-prets based upon the Court decisions, guide-lines and manuals of the patent practice. It isto be noted here that for assessing noveltyand inventive step in India, there are limitedcase laws emanating from the Indian Courts.However, novelty and inventive step arebeing interpreted in the same manner asinterpreted worldwide. During practice, if

the cited documents are same then the argu-ments as presented in other countries areusually accepted by the Controllers/Examiners as far as novelty and inventivestep are concerned. Section 3(d) is the most controversial

section when it comes to patents onPharmaceutical inventions. Section 3(d)stipulates that an incremental invention,based upon an already known substance,having established medicinal activity shall bedeemed to be treated as a same substance, ifthe invention in question fails to demon-strate significantly improved efficacy withrespect to that known substance. As regards the interpretation of Section

3(e) is concerned, the Patent Office usuallyidentifies whether there are any functionalinteractions between the components of acomposition/formulation and whether acombined technical effect higher than thesum of the technical effects of the individualfeatures of the each component is achieved.It is to be noted that the synergistic effectshould not be interchangeably used as far asefficacy is concerned and the applicantneeds to be careful also about submission ofthe synergistic data. As far as the interpretation of Section 3(i)

is concerned, the Patent Office outrightlyrejects any claim directed towards a methodof treatment irrespective of any in-vivo or in-vitro treatment. This exclusion applies onlyto methods of treatment and diagnosis andnot to the device/apparatus/instrumentused in such methods.

What are the latest relevant deci-sions from the courts on theseissues?The Novartis judgement on the issue of effica-cy is the most prominent decision in the con-text of pharmaceuticals. The decision has beenwidely discussed and the impacts thereof areseen in the routine proceedings of the PatentOffice. The Novartis judgment has interpretedefficacy as “therapeutic efficacy” for pharma-ceutical inventions. However, it fails to definethe same in terms of other chemical inven-tions. In the Novartis Judgment, the SupremeCourt of India (SC) has not considered anincrease of 30% in Bio-availability as effica-cious. The SC observed in paragraph [189]“whether or not an increase in bioavailabilityleads to an enhancement of therapeutic efficacy inany given case must be specifically claimed andestablished by research data”. This led to a fur-ther debate as to how the efficacy should bedefined. Should it relate to only bio-availabili-ty or there are other criteria too to define effi-cacy? For example heat stability or humidityresistance of a drug could be well within thequalifying criteria to overcome the objectionsrelating to Section 3(d). Further, reduction inside effects, toxicity, New Drug DeliverySystem, quantity of dosage forms, frequency,and manufacturing efficiency could be otherparameters to define efficacy.Another important judgement is Roche v

Cipla where Indian company CIPLA in itscounterclaim contended that the grantedpatent to Roche did not have any inventivestep and also lacked novelty because same

How pharmaceutical patents aretreated in India

Sharad Vadehra is the Managing Partner at Kan and Krishme.He joined the profession in the year 1989, and is among thefew attorneys in the country with both technical and legalqualifications.

Sharad specializes in Intellectual Property Laws, Media,Entertainment, Sweepstake and Promotions, Marketing,Commercial disputes and Litigation and has more than 26years’ experience in these fields and in handling such mat-

ters for both domestic and international companies (including Fortune 500 compa-nies) and research institutions. Sharad has prosecuted, defended, opposed/orenforced directly or in supervisory capacity over 20,000 patent matters in India andabroad. He has been a speaker in over five hundred institutions and corporatebodies in India and overseas, and is the author of the book Indian Patent Law andPractice published by Chosakai in Japan in Japanese language.

Sharad has often been consulted by the Government of India when any new guide-lines or rules are being framed with respect to the Indian Patent Act and Rules.

Sharad, along with other colleagues founded the FICPI India group in the year2009 and has been very closely associated therewith. He is presently the presidentof the FICPI India. He has recently been appointed the coordinator for CET 9 inFICPI for all Asian Countries including but not limited to India, Japan, S. Korea andChina. He has recently been elected as Vice President of APAA India and he will beplaying an active role in organizing the APAA Congress to be held in New Delhi inthe year 2018. He is one of the founding members of GALA and is the PastPresident of its Asia Pacific branch. He holds the membership of FICPI; APAA;AIPLA; AIPPI; INTA; LES; CII and Delhi High Court Bar Association.

Sharad Vadehra

Kshitij Saxena is a Registered Patent Agent and anAdvocate. He is working as a Managing Associate and Headsthe Chemical Department of the firm.

Kshitij has over 12 years of experience in the practice andis actively involved in work which includes advising clients onvarious IPR issues, conducting FTO searches, prior art search-es, IP due diligence and handling of the work covering theentire gambit of the life cycle of the Patent, Design and

Trade Mark Applications. He also handles and advises on contentious and non-con-tentious issues on IPR. As a Head of the Chemical Department, he is responsiblefor supervision and guidance on legal and technical aspects of all patent mattershandled by the firm in Chemical field.

Kshitij Saxena

6 SPONSORED ROUNDTABLE THURSDAY, OCTOBER 27 2016 AIPLA DAILY REPORT

Sharad Vadehra and Kshitij Saxena of Kan and Krishme discuss how India’s patent office interpretspharmaceutical patents, recent court decisions and how applicants can improve their chances in prosecution

features of the invention had already beendisclosed in prior art. CIPLA failed to proveits allegations in absence of any substantiveevidence. CIPLA also challenged the validityof the granted patent under Section 3(d).The Court, however, has stated that CIPLAhad to prove that the granted patent ofRoche was a new form of a known substancewhich CIPLA had failed to do so.

Are there any pending cases thatare likely to affect the law?The Supreme Court recently accepted thepetition of CIPLA against the order of theDelhi High Court wherein CIPLA is beingheld for infringing the patent of Roche.CIPLA filed this petition seeking the appoint-ment of scientific expert and simultaneouslychallenging the order passed by the DelhiHigh Court. CIPLA contended in theSupreme Court that Delhi High Court haserred in holding that its product Erlocip wasinfringing the Roche’s patent as the productwas subject matter of a rejected patent applica-tion in India and had been in public domain.The Supreme Court in its proceeding maydecide over the issues such as novelty, inven-tive step and on the issue of Section 3(d).

What can applicants in this area todo maximize their chances duringpatent prosecution?An applicant should be aware of the fact thatIndian Controllers take the written opinionin an international application quite seriouslyand in case the written opinion of ISR andIPRP are not favourable, the threshold to sat-isfy the controller/examiner’s increases. Theapplicant must be aware that the IndianPatent Office can see and review all the infor-mation on the corresponding foreign applica-tions in other jurisdictions such as USPTO,EPO and JPO. Further, it is also to be notedby the applicant that in case any document is

not available in English language, the PatentOffice has the required resources for transla-tion of the same and the publication of thatdocument in other languages may not avoidthe citation of the same against an inventionin India. Keeping in mind that the noveltyand inventive step concepts are same all overthe world, an applicant is required to preparethe argument in a more concrete manner. Further, in case of pharmaceutical inven-

tions where the applicability of Sections3(d) and 3(e) is likely to arise, the applicantis required to be prepared with the necessaryand relevant data in hand such that shouldthere be an objection; the said data may beprovided to the controller to overcome theobjection. Specifically for the objection relating to

Section 3(d) an applicant should ascertain asto whether the claimed invention actually fallswithin the purview of a new form of a knownsubstance or not. If not, the applicability ofSection 3(d) does not arise and an argumentneeds to be presented as to why the claimedinvention is not falling within the ambit of newform of a known substance. For instance, NewChemical Entities do not fall under this cate-gory. The applicant in such a case mustrespond stating that applicability of Section3(d) does not arise. On the other hand, in casethe answer is in the affirmative, an applicantshould provide enhanced therapeutic efficacydata (comparative details) of the prior sub-stance and with the claimed substance. If theinvention relates to a process, it has to be seenwhether the process employs at least one newreactant or results in a new product.As far as claims related to method of treat-

ment are concerned, the applicant shoulddraft the claims in a manner so that theessence of the claims appears to be that of aproduct claim rather than a method or treat-ment or method of diagnosis. It is to be notedhere that that these claims would be difficultto amend after the filing of the national phaseentry since any amendment in the claimsshould not go beyond the scope of the earlierfiled claims. Accordingly, care must be takenin drafting the claims during the internationalphase where the applicant intends to file theapplication in India within the specified peri-od. It is to be noted here that pursuant to theamendment in the Patents Rules, 2016, anapplicant can now delete the claims at thetime of national phase entry and hence theapplicant should delete the non-patentableclaims at the time of national phase entry tosave the cost and future objection. The appli-cant should be aware that only deletion isallowed and not the amendment at the timeof national phase entry in India. Further, the applicant must submit the

details of the corresponding foreign applica-tions including the details of the prosecutionshistory, oppositions and the documents cited

against the corresponding foreign applica-tions. The detailed particulars of correspon-ding foreign filing under Section 8(1) includesname of the country, date of filing of the appli-cation (date of national phase entry in case ofPCT applications), application number, statusof application, publication date/publicationnumber of application and grant date/grantnumber of application in prescribed Form-3.As per the recent case laws on this issue, it is tobe noted by the applicant that this is a contin-uous obligation onto the applicant and as apractical solution to the cumbersome require-ment of filing Form-3, it is generally suggestedthat the applicant may file a final updatedForm-3 at the time of filing response to thefirst examination report to show bona fide ofthe applicant that there is no deliberate/inten-tional omission by the applicant, instead of fil-ing a fresh Form-3 every time there is changeof status of any of the corresponding foreignapplication. The Act also requires that an applicant to

submit details relating to processing of the

corresponding foreign applications underSection 8(2). It is suggested to voluntarilyfile documents/information if on a later datebefore the grant of Indian Patent, there is aclaim rejection or narrowing down of claims(vis-a-vis claims pending in Indian PatentOffice) in major countries such as US,Europe, Japan, Korea etc. The documentswhich need to be filed to comply with therequirement of Section 8(2) includes SearchReport or Examination report; response tooffice actions submitted by the applicantalong with the claims amended/allowed/rejected together with English translationthereof, if applicable. If translation of entiredocuments is not available, English summa-ry of office action(s), search report(s), etc.shall suffice.The applicant must note here that the non

submissions of the details as regards the corre-sponding foreign applications as mentionedabove is a ground available to a party in a pre-grant or post-grant opposition as well as in anyrevocation proceeding over a granted patent.

AIPLA DAILY REPORT THURSDAY, OCTOBER 27 2016 SPONSORED ROUNDTABLE 7

The Novartis judgement on the issue of efficacy is the most prominent decision in the context of pharmaceuticals. The decision has been widely discussed and the impacts thereof are seen in the routine proceedings of the Patent Office.

TODAY’S SCHEDULE: THURSDAY, OCTOBER 27 20168-9am Opening Plenary Session: Welcome Remarks Featuring: The Honorable Daniel H Marti, IP Enforcement Coordinator, Marriott Ballroom, Salons 2 + 3, Lobby Level

Office of the President; Committee of the Year Announcement

9:30am-1:30pm Spouse/Guest Tour: Women of Washington Tour followed by Anna Weatherley’s Studio Meet near entrance to Harry’s Pub by 9:15am

Committee meetings

6.30-8am Law Practice Management Breakfast Meeting Washington 2, Exhibition Level

6.30-8am Corporate Practice Breakfast Meeting Washington 1, Exhibition Level

7-8am Content and Branding Leadership Group Virginia C, Lobby Level

7-8am Global IP Leadership Group Washington 5-6, Exhibition Level

7-8am Professional Programs Delaware AB, Lobby Level

Concurrent Morning Tracks

9am-12pm Track #1 Patent Prosecution Thurgood Marshall, Mezzanine Level

9am-12pm Track #2 Patent Litigation Marriott Ballroom, Salon 1, Lobby Level

9am-12pm Track #3 Trademark/Copyright Maryland Ballroom, Lobby Level

Lunchtime Events

12-12.30pm Lunch Reception Exhibit Hall A, Exhibition Level

12.30-2pm Luncheon Featuring: The Honorable David Ruschke, Chief Judge, Patent Trial and Appeal Board Marriott Ballroom 2+3, Lobby Level

2-3.30pm Board of Directors’ Meeting Delaware AB, Lobby Level

Concurrent Afternoon Tracks

2-3.30pm Track #1 Corporate Thurgood Marshall, Mezzanine Level

2-3.30pm Track #2 Litigation Marriott Ballroom 1, Lobby Level

2-3.30pm Track #3 Trademark Maryland Ballroom, Lobby Level

Committee Educational Sessions

3.30-5.30pm Antitrust Law/Biotechnology/ Mergers & Acquisitions (120 Minutes of CLE Requested) Thurgood Marshall, Mezzanine Level

3.30-5.30pm Patent Law/Patent-Relations with the USPTO (90 Minutes of CLE Requested) Marriott Ballroom 1, Lobby Level

3.30-5.30pm Trademark Internet/Trademark Law/ Trademark Litigation/Trademark-Relations with USPTO/Trademark Maryland Ballroom, Lobby Level

Treaties and International Law (Madrid Protocol Subcommittee) (90 Minutes of CLE Requested)

Committee Meetings

3.30-4.30pm AIPLA Fellows Washington 4, Exhibition Level

3.30-4.30pm American Intellectual Property Law Education Foundation (AIPLEF) Coolidge, Mezzanine Level

3.30-4.30pm Emerging Technologies Harding, Mezzanine Level

3.30-4.30pm IP Law Associations Hoover, Mezzanine Level

3.30-4.30pm IP Practice in the Far East Virginia C, Lobby Level

3.30-4.30pm Patentable Subject Matter Task Force Capitol Boardroom, Lobby Level

3.30-4.30pm Quarterly Journal Editorial Board McKinley, Mezzanine Level

3.30-5.30pm Antitrust Law/IP Practice in China Wilson AB, Mezzanine Level

3.30-5.30pm Electronic and Computer Law/ USPTO Inter Partes Patent Proceedings Madison AB, Mezzanine Level

4.30-5.30pm Harmonization Task Force Washington 4, Exhibition Level

4.30-5.30pm IP Practice in Israel Virginia C, Lobby Level

4.30-5.30pm Legislation Hoover, Mezzanine Level

4.30-5.30pm Standards and Open Source Harding, Mezzanine Level

5-5.30pm Patent Law Marriott Ballroom 1, Lobby Level

Thursday Evening Events

5.30-6.30pm New Members/First-Time Attendees Reception Lincoln 5-6, Exhibition Level

6-7.30pm LGBT Diversity Reception Washington 1-3, Exhibition Level

7.30-9pm Opening Night Reception: DC Cinema Marriott Ballroom, Salons 2-3, Lobby Level