Tag Archives: patent

Teva held responsible for Induced Infringement of Eli Lilly’s Blockbuster drug ALITMA

In Teva Parenteral Medicines, Inc.; APP Pharmaceuticals LLC; Pliva Hrvatska D.O.O.; Teva Pharmaceuticals USA, Inc.; and Barr Laboratories, Inc. (hereinafter referred to be as Defendants/Appellants/Teva) Vs. Eli Lilly & Co. (hereinafter referred to as Plaintiff/Appelle/Eli Lilly) decided by United States Court of Appeals for the Federal Circuit (CAFC) on January 12, 2017, Plaintiff had filed Hatch Waxman suit against defendant to prevent them from launching generic version of the lung cancer drug whose rights are reserved with the plaintiff. The decision from CAFC came after an appeal from the United States District Court for the Southern District of Indiana in No. 1:10-cv-01376-TWPDKL, Judge Tanya Walton Pratt.

Eli Lilly owns a patent US 7772209 (hereinafter referred to as US‘209) issued in 2010, relating to method of treatment administering the chemotherapy drug pemetrexed disodium (hereinafter referred to as “pemetrexed”) (used to treat certain types of lung cancer and mesothelioma) after pretreatment with two common vitamins—folic acid and vitamin B12 (reduce the toxicity of pemetrexed in patients). Eli Lilly markets pemetrexed under the brand name ALIMTA®.

In 2008-2009, Defendants notified Eli Lilly that they had submitted ANDA seeking approval to market generic version of ALIMTA®. After issuance of US’209 patent, Teva sent additional notice that they had filed Para IV certifications, declaring that US’209 patent was invalid, unenforceable, or would not be infringed. Subsequent to which Eli Lilly alleged Teva of induced infringement. Eli Lilly asserted that Teva’s generic drug would be administered with folic acid and vitamin B12 pretreatments and thus will result in infringement of the 209 patent.

Eli Lilly asserted claims 9, 10 (dependent on claim 1), Independent claim 12, and its dependent claims 14, 15, 18, 19, and 21 of the US’209 patent at trial.

Independent claims 1 and 12 have been reproduced below for reference:

Claim 1:

A method of administering pemetrexed disodium to a patient in need thereof comprising administering an effective amount of folic acid and an effective amount of a methylmalonic acid lowering agent followed by administering an effective amount of pemetrexed disodium, wherein the methylmalonic acid lowering agent is selected from the group consisting of vitamin B12, hydroxycobalamin, cyano-10-chlorocobalamin, aquocobalamin perchlorate, aquo-10-cobalamin perchlorate, azidocobalamin, cobalamin, cyanocobalamin, or chlorocobalamin.

Claim 12:

An improved method for administering pemetrexed disodium to a patient in need of chemotherapeutic treatment, wherein the improvement comprises:

  1. a) administration of between about 350 μg and about 1000 μg of folic acid prior to the first administration of pemetrexed disodium;
  2. b) administration of about 500 μg to about 1500 μg of vitamin B12, prior to the first administration of pemetrexed disodium; and
  3. c) administration of pemetrexed disodium.

It is important to note that current case involves issue of induced infringement i.e. a type of indirect infringement that may be committed under section 271 (b) (dealing with infringement of Patents).

In June 2013, Defendants conditionally conceded induced infringement under then-current law set forth in Akamai Technologies, Inc. v. Limelight Networks, Inc. (Akamai II) which at that time was the subject of a petition to the Supreme Court for a writ of certiorari. The parties’ stipulation included a provision reserving Defendants’ right to litigate infringement if the Supreme Court reversed or vacated Akamai II.

District court had rejected contentions of the defendant that Patent was invalid for obviousness or obviousness-type double patenting and also due to indefiniteness of the term vitamin B12.

Defendants filed an appeal on invalidity. While that appeal was pending, the Supreme Court reversed Akamai II, holding that liability for inducement cannot be found without direct infringement, and remanding for CAFC court to possibly reconsider the standards for direct infringement. In view of that development, the parties in this case filed a joint motion to remand the matter to the district court for the limited purpose of litigating infringement. CAFC granted the motion.

The district court held a second bench trial in May 2015 and concluded in a decision issued on August 25, 2015 that Defendants would induce infringement of the US’209 patent. This was after considering the effect of Akamai V decision, which had broadened the circumstances in which others’ acts may be attributed to a single actor to support direct infringement liability in cases of divided infringement.

Defendants appealed.

Below given factors are taken into consideration while deciding cases of induced infringement:

  • Whoever actively induces infringement of a patent shall be liable as an

Infringer;

  • There cannot be indirect infringement without direct infringement;
  • Patentee needs to prove alleged infringer knew or should have known his actions would induce actual infringements; and
  • Standard of proof required by Patentee to claim relief under induced infringement is ‘preponderance of the evidence’.

It was agreed by parties that Defendants’ proposed product labeling would be materially the same as the ALIMTA® product labeling and consists of two documents: the Physician Prescribing Information and the Patient Information. District court found that both the documents included instructions regarding the administration of folic acid—the step that the district court found would be performed by patients but attributable to physicians.

According to Akamai V, where no single actor performs all steps of a method claim, direct infringement only occurs if the acts of one are attributable to the other such that a single entity is responsible for the infringement. The performance of method steps is attributable to a single entity in two types of circumstances:

  • when that entity “directs or controls” others’ performance, or

 

  • when the actors “form a joint enterprise.”

In Akamai V, CAFC had 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.”

District court found taking folic acid in the manner recited by the asserted claims is a critical and necessary step to reduce potentially life threatening toxicities caused by the Pemetrexed amounts to receive the benefit of the patented method.

Regarding first of the two pronged test, the court found, based on the product labeling, that taking folic acid in the manner specified is a condition of the patient’s participation in the Pemetrexed treatment. Regarding the second prong, the court found that physicians would prescribe an exact dose of folic acid and direct that it be ingested daily. Hence court held all steps of the asserted claims would be attributable to physicians.

Court further observed that the mere existence of direct infringement by physicians, while necessary to find liability for induced infringement, is not sufficient for inducement but there has to be also specific intent and action to induce infringement. Court went on to find intent on the part of physician for the inducement and held that there was no error in district court’s decision. Some important observations of court have been mentioned below.

CAFC made two important observations as below:

  • The intent for inducement must be with respect to the actions of the underlying direct infringer, here physicians.

 

  • Second, it is not required to show evidence regarding the general prevalence of the induced activity. When the alleged inducement relies on a drug label’s instructions, the question is not just whether those instructions describe the infringing mode,..but whether the instructions teach an infringing use such that we are willing to infer from those instructions an affirmative intent to infringe the patent. Court further observed that the label must encourage, recommend, or promote infringement and it is irrelevant that some users may ignore the warnings in the proposed label.

Court went on to observe a label that instructed users to follow the instructions in an infringing manner was sufficient even though some users would not follow the instructions, but vague instructions that require one to look outside the label to understand the alleged implicit encouragement do not, without more, induce infringement.

On the issue of invalidity on the indefiniteness of the term “vitamin B12”, CAFC hold that a person of ordinary skill in the art would understand the scope of the claim term “vitamin B12” with reasonable certainty. Applying Nautilus (outcome of this decision) in this case did not lead CAFC to a different result from the district court’s conclusion on the question of indefiniteness.

Regarding issue of invalidity due to obviousness, CAFC was not convinced that the district court committed clear error in concluding that Defendants failed to carry their burden of proving that it would have been obvious to a person of ordinary skill to use vitamin B12 pretreatment to reduce Pemetrexed toxicities.

Thus CAFC affirmed district court decision.

About the Author :  Ms. Rashmi Goswami, WOS-C at TIFAC, intern at Khurana and Khurana, Advocates and IP Attorneys and can be reached at swapnil@khuranaandkhurana.com

Analysis of the rejection of Lumacaftor (Polymorph) patent application in India

We have been receiving requests from our Pharma clients/readers of the blog for the analysis of the decision/ facts that led to rejection of Lumacaftor (Polymorph) patent application in India since last year.

Here is our take:

Details of the Patent Application and important dates:

Patent application number in India 2056/KOLNP/2010
Title of the invention SOLID FORMS OF 3-(6-(1-(2,2-DIFLUOROBENZO[D][1,3] DIOXOL-5-YL) CYCLOPROPANECARBOXAMIDO)-3-METHYLPYRIDIN-2-YL) BENZOIC ACID
Applicant VERTEX PHARMACEUTICALS INCORPORATED
International application number/ International filing date PCT/US2008/08545/

 

04/12/2008

Priority Application Number/ Priority date US61/012,162

 

07/12/2007

National phase Filing date 04/12/2008
Publication date 03/09/2010
Request for examination date 25/11/2010
Pre-Grant Opposition under section 25 (1) 19/02/2011
First examination report Date 20/08/2014
Date of communication of outstanding objections 01/03/2016
Date of hearing after failure to put the application in condition of allowance 18/03/2016
Date of decision of rejection 31/03/2016

Application Area:

Lumacaftor is given with another active ingredient Ivacaftor in the treatment of cystic fibrosis which is caused by F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) protein.

Facts of the case:

First Examination Report (FER) was issued on 20/08/2014 which not only objected claims based on the prior arts cited in International Preliminary Report on Patentability (IPRP) corresponding to PCT application but also used section 3 (d), 3 (i), 3 (n) of the Patents Act, 1970, and procedural grounds for objection.

As the FER was issued on 20/08/2014 (before 16/05/2016), period of twelve months was allowed to put the application in condition of allowance. Controller found the application not to be in condition of allowance even after 12 months and communicated the objections on 01/03/2016. Finally, hearing was held on 18/03/2016.

As reported in the decision of controller dated 31/03/2016, “There were nine (09) objections mentioned in the hearing letter including major technical objections on the grounds of novelty, inventive step and non-patentability of the claimed subject matter u/s 3(d) of the ‘Act’.”

Section 3 (d) has been reproduced below for the reference:

the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.

Explanation.—For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy;

Analysis of the rejection decision:

Dr. I. S. Bhattacharya, attorney of the applicant, who attended the hearing, relied on the technical data filed as affidavit along with reply statement in respect of pre-grant opposition already filed under section 25(1) for the instant application to argue that form 1 of Lumacaftor ought to be considered be Novel and Inventive. She asserted that better pharmacokinetic properties / superior bioavailability of the formulation of claimed polymorphic Form I compared to the hydrochloride salt of the compound were enough to win the Patent.

Controller in response declined to accept the arguments on the ground ‘Anything beyond the disclosure of complete specification is not acceptable’ as the technical data was not part of the complete specification yet. The technical details were also rebuffed on the ground that different pharmacokinetic properties / superior bioavailability results were natural results of comparison of Form I (free solid) with hydrochloride salt of the same compound. He further opined that better bioavailability does not necessarily lead to better efficacy.

Based on these grounds, controller went on to reject the Patent Application under section 15.

Controller also took into consideration the pre-grant opposition that had also been filed under section 25(1) by Indian Pharmaceuticals Alliance, Mumbai for the instant application. Controller did not conduct a separate hearing under section 25 (1) as the grounds and prior arts were incorporated in the hearing letter and were heard on 18/03/2016. Controller accepted the petition under section 25 (1) while refusing the grant of the patent application no. 2056/KOLNP/2010.

Reference:

http://ipindiaservices.gov.in/decision/2056-KOLNP-2010-16971/2056-KOLNP-2010.pdf

China (SIPO) Proposed Amendments Patent Examination Guidelines

On October 27, 2016, the Chinese Patent Office – State Intellectual Property Office (SIPO) published Revised Patent Examination Guidelines draft to remove the software and business method patents hurdles in Chinese Jurisdiction. The published draft will be open for public comments till November 27, 2016.

Chinese Patent Law, under Article 25(2) mandates that patent rights shall not be granted for “rules and methods for mental activities”. Such provision under Article 25(2) is frequently resorted to by patent examiners during examination for rejecting computer implemented business method patents. SIPO spotted the concern that although many patents are related to technical subject matter but they are concluded as “rules and methods for mental activities”, and hence not a patent eligible subject matter. To address the concern, SIPO proposed to amend the patent examination guidelines that relates to software patents as well as business method patents.

  1. Proposed Amendment clause with respect to Business Method:

Proposed draft elucidates, “Claims related to business methods that contain both business rules and methods and technical characteristics, shall not be excluded from the possibilities of obtaining patent rights be Article 25 of the Patent Law.”.

This proposed amendment, if eventually accepted, will certainly elevates the ease to obtain business method patents as the amendment provides clear elucidation to the patent examiners that the claims would not be rejected under Article 25(2) barely on the basis of a business method or rule.

According to this proposed clause, if a claim contains both business method and technical characteristics, the examiner shall not reject the claim on the grounds that the claim relates to “rules and methods for mental activities” under Article 25.

  1. Proposed Amendment clause with respect to Computer Software:

Another proposed change is made in the second line of Part II, chapter IX, section 5.2, paragraph 1, the third sentence of the Patent Examination Guidelines are amended from, “and describe in detail which parts of the computer program are to be performed and how to perform them” to provide that “The components may not only include hardware, but may also include programs.” Another proposed clause of revised draft states that apparatus claim related to computer software program will be eligible for patent rights, if it includes both hardware features and features pertaining to computer software programs. Such programs feature will be considered equally to the hardware features and shall not be treated as merely features so as to bar for patent rights. Further, the guidelines also clarifies that software per se is not a patent eligible subject matter as they are rules and methods for mental activities.

These revised amendments substantiate that red flags generated by examiner indicating non-patentability only on the ground of business method and software will no more exist. The examiners who are more vigilant in treating the patents under business method and software per se are now being addressed by Chinese Patent Office. Amended draft itself explains that claims relating to a business method are not excluded from patentability if they contain sufficient technical features.

iii. With respect to amendment of granted claims:

The proposed revised draft also focuses on amendment of granted claims. As per the current scenario, applicant can only either delete or combine the granted claims, wherein the revised draft proposal allows the applicants to make amendments in granted patent claims. Now, patentees will be able to add limitations from another granted claim in the same patent, but such amendment must be under certain limits. Claim can be amended as far as it is supported by the specification. This amendment will especially benefit those patent assertion entities who mainly focuses on licensing their patent assets.

These amendments will certainly attract worldwide companies that are generating software to enforce and monetize their IP. As China market will become more hospitable in software patents, companies across the globe will certainly try to grab the opportunity in China market.

Also the patent examination guidelines are not to be construed as law but rules for patent examiners at China’s State Intellectual Property Office (SIPO) to get educated about how to appropriately examine the patent applications.

About the Author: Kumar Tushar Srivastava, Sr. Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at tushar@khuranaandkhurana.com

Medicines Patent Pool’s Voluntary Licensing; Unique in its efforts to better treat the Infection

Efforts of Medicines Patent Pool (hereinafter referred to as “MPP”); a United Nations backed public health organisation, founded in July 2010, and based in Geneva, Switzerland are praiseworthy.

The lives of millions of people in poor developing countries depend on access to affordable medicines. However, unfortunately most of the world’s population does not receive the essential medicines in the extent they need and that too at critical times. According to World Health Organization (WHO), 37 million people (globally) require HIV treatment but only 15 million people living in low and middle income countries have access and out of the 3.3 million children, only 32% receives the therapy. Also, Hepatitis C is a major public health threat; with majority of them living in low, middle income developing countries.

With number of patients growing organically, any single manufacturer can’t meet the mandate. At the same time, demand for newer drugs/medicines keeps on increasing as HIV medicines gradually becomes less effective over time for patients developing resistance. Moreover, it is also difficult to develop tailor made medicine for specific population (like children) and to develop combination of multiple medicines in to one pill (FDC-Fixed Dose Combination) because of individual patents on different medicines.

MPP, a public health organisation funded by the United Nations offers a solution to all these problems. It negotiates with owner of the patented medicine (pharmaceutical company, research institute, government universities etc.) to voluntarily share their patents which let another party/producer to manufacture and sell generic versions of the medicine in poor developing countries or to develop adapted formulations. MPP also eases the development and production of FDCs. The pool also works for Patent owners as it ensures them fair royalty and provides them the way to contribute to global health. Most importantly, MPP works for people living with HIV/AIDS/Hepatitis/Tuberculosis by bringing prices to affordable levels and helping them to provide new medicines.

Things have come a long way from the earlier days of MNC’s fighting against generic production and national government who endorse them, to the new arrangement where big pharmaceutical companies eager to share their patents. All credit goes to the efforts of MPP; addition to their constant working to increase availability of medicines of HIV, Hepatitis C and Tuberculosis in poor developing countries, it has signed a sub-licensing agreement with six Indian pharmaceutical companies, Hetero Labs Ltd, Laurus Labs ltd, Lupin Ltd and Zydus Cadila or Cadila Healthcare Ltd to sell generic ARV (antriretrovirals) and Hepatitis C drug Daclatasvir.

This deal would all set to establish a new era of innovative production in the Indian pharmaceutical industry. It will help Indian companies to avoid the stress of seeking voluntary license from innovator firms, or apply for compulsory licenses in those markets where MPP would supply the drug. Most notably it will help battle the disease at our home as we are third in position with the highest number of HIV affected people.

About the Author: Dr.Komal Tomar, Sr. Licensing Associate at IIPRD and Khurana &Khurana, Advocates and IP Attorneys and can be reached at: commercialization@iiprd.com

CIPLA’s plea for revocation of Novartis Patents for Onbrez may face major set back by the Government

As reported in TOI, the Indian Government has found very little merit in Cipla’s plea for waiver and cancellation of Patent rights for chronic obstructive pulmonary disease (COPD) drug over which Novartis has exclusive rights. We have reported on Cipla’s plea here.

Background:

Cipla, previously approached the Department of Industrial Policy and Promotion (DIPP) to exercise its statutory powers under Section 66 and Section 92 (3) to revoke Indian Patents IN222346, IN230049, IN210047, IN230312 and IN214320 granted to Novartis AG for the drug Indacaterol and is currently selling under the brand name Onbrez. The said drug is one of the preferred medications for COPD.

The relevant sections 66 and 92 of the Indian Patents Act are as follows:

  1. Revocation under section 66:

Section 66 states “Where the Central Government is of opinion that a patent or the mode in which it is exercised is mischievous to the State or generally prejudicial to the public, it may, after giving the patentee an opportunity to be heard, make a declaration to that effect in the Official Gazette and thereupon the patent shall be deemed to be revoked”.

  1. Special provision for compulsory licences on notifications by Central Government

Section 92 (3) states Notwithstanding anything contained in sub-section (2), where the Controller is satisfied on consideration of the application referred to in clause (i) of sub-section (1) that it is necessary in—

(i) a circumstance of national emergency; or

(ii) a circumstance of extreme urgency; or

(iii) a case of public non-commercial use,

which may arise or is required, as the case may be, including public health crises, relating to Acquired Immuno Deficiency Syndrome, Human Immuno Deficiency Virus, tuberculosis, malaria or other epidemics, he shall not apply any procedure specified in section 87 in relation to that application for grant of licence under this section:

 Provided that the Controller shall, as soon as may be practicable, inform the patentee of the patent relating to the application for such non-application of section 87.”

Cipla’s Contention in the Representation:

  • Cipla argued that the causes of COPD are several and the sheer magnitude of the disease as per the publicly available data which is sufficient for the Central Government to invoke the provisions of Section 92 and to treat it as an “epidemic” or a “public health crisis”. Such exercise of power in the present case would be in consonance with the avowed purpose for which Section 92 has been enacted.
  • Cipla also contended that Novartis has been granted these patents since 2008-09 but has chosen not to manufacture the same in India. However, Novartis merely imports a negligible quantity of these products manufactured in Switzerland through its licensee Lupin Pharma as per its own data filed before the Patent office. As submitted by Novartis in IPO in Form 27, the import for the year 2013 is a meagre 53,844 units which do not satisfy even 4,500 patients annually which is a shortage is more than 99.97 percent.
  • Further Cipla contended that cost of the drug is also very high for a patient in India. The estimated cost of the drug Indacaterol as imported and sold by Lupin Limited, under the trademark Onbrez is about Rs.2000/- per month per patient. On the contrary, the proposed drug of Cipla under name UNIBREZ would be costing approximately Rs. 400 per month.

 It is pertinent to note that Section 66 has been invoked only on two occasions earlier. Firstly it was invoked for the case of a process patent granted to Agracetus, an American company for genetically engineered cotton cell lines. The said patent was revoked by the Central Government in the year 1994 keeping in mind public interest and the fact that genetically engineered cotton, being a product of concern for the national economy, particularly for agriculturists, ought not to be the subject matter of a patent monopoly. Secondly in 2012, a patent granted to Avesthagan Limited for a “synergistic ayurvedic/ functional food bioactive composition” i.e. the composition consisting of Jamun, Lavangpatti and Chandan to be used for treatment of Diabetes. In light of the public interest in using traditional knowledge for curing and treating Diabetes, the said patent was also revoked under Section 66 of the Act. However pertinently, both the patents were revoked due to cloud over patentable subject matter.

It would be prejudiced to comment on the fate of the matter at this stage. However as per TOI the Govt. may turn down the plea of Cipla for revocation of Novartis patent.

About the Author: Mr Sitanshu Singh, Patent Associate, Khurana & Khurana, Advocates and IP Attorneys and can be reached at: sitanshu@khuranaandkhurana.com

Cipla Files Representation with Govt. Seeking Revocation of Novartis’ Patents

It has been recently reported in Economic times that Cipla has filed representation with the government (Department of Industrial Policy & Promotion) seeking revocation of five patents of Novartis on indacaterol, a respiratory drug for the treatment of chronic obstructive pulmonary disease (COPD) and marketed as Onbrez by Novartis. The central government, under section 66 of the Indian Patent Act, has the power to revoke patent in public interest, after giving patentee an opportunity to be heard.

According to section 66,

“Where the Central Government is of opinion that a patent or the mode in which it is exercised is mischievous to the State or generally prejudicial to the public, it may, after giving the patentee an opportunity to be heard, make a declaration to that effect in the Official Gazette and thereupon the patent shall be deemed to be revoked.”

Cipla has launched its generic version of indacaterol and alleged that Novartis held patents on indacaterol since 2008-09 without manufacturing in India and importing only in negligible amounts, as a result of which there is an urgent and unmet need to provide this drug to patients at affordable prices. According to Cipla, it has potential to manufacture adequate quantities of the drug to make available in the country.  Cipla’s launched generic version of indaceterol is reported to be 1/5th of the price of Novartis’ Onbrez.

This is the first time that an Indian generic company has asked the government to revoke patents on the ground of public interest under section 66. Otherwise, the revocation has always been sought on grounds under section 64 (for example obviousness, anticipation, insufficient disclosure, violation of section 8, 3d etc.), whether an Indian company has filed a revocation petition or a counter claim in an infringement suit. However, public health and drug price play significant role in deciding a patent’s fate in India especially in context of Compulsory Licensing of patent as it happened in Natco’s case. Even in Roche v. Cipla, public health and pricing issues were considered by the India courts, although the decision at the High Court was based on merits of the case and not in public interest.

It is highly expected that Novartis will take a legal course to challenge Cipla’s launch. Novartis has been very active to protect patents for its one of the blockbuster anti-diabetic drugs vildaglipton in India. Novartis has sought, just a few months ago, quia timet interim injunctions against several Indian generic companies including Glenmark generics, Bajaj healthcare, Cadila healthcare, Alembic pharmaceuticals against alleged patent infringement of vildaglipton even before they actually launched their generic versions and after they obtained marketing approvals from DCGI.

Thus Novartis will most likely file patent infringement suits seeking interim/permanent injunctions restraining Cipla from manufacturing and selling generic version of indacaterol in India.

On another note, Cipla could also have applied to obtain a compulsory license to manufacture and sell indacaterol before launching the drug. All three grounds of granting compulsory license under section 84(1) viz. reasonable requirements of public not being met, drug non-affordability and non-working of patent in India could have been proved by Cipla. According to Cipla, Novartis declared import of meagre 53,844 units for the year 2013 which do not satisfy even 4500 patients annually where there are more than 1.5 crore patients in need of the drug. Cipla also urged the government to consider COPD as an epidemic worthy of being qualified as a “public health crisis” as it claims 50 lakh lives annually in India, which is more than the toll from HIV-AIDS, malaria, cancer and tuberculosis.

Till now, we are not aware of any case in India wherein the government has revoked the patent in public interest under section 66. The outcome of government opinion to revoke said patents is thus eagerly awaited. This would act as precedent for all similar future cases. And if the government decides to revoke the patent under this section, the ongoing conflict between multinational innovator companies and Indian generic companies is going to intensify. Innovator companies criticize that India has weak patent laws not in compliance with international standards, whereas Indian government takes a stand that its patent laws are in compliance with TRIPs standards and are designed to meet the objectives of drug availability, affordability and accessibility.

 About the Author: Meenakshi Khurana, Partner at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: meenakshi@khuranaandkhurana.com

Revised Draft Guidelines for Examination of Pharma Patent Applications

We have earlier reported the release of Draft Guidelines for Examination of Pharma Patent Applications. The Patent office has now released revised draft guidelines and in continuation of our earlier article here, we explain herein what those revisions are and impact of the guidelines in general. The revised guidelines are available here.

The revised guidelines of 12th August 2014 are not much different from the earlier guidelines of 28th February 2014 with only some clarity provided at certain places. For example, the scope of the guidelines is clarified by inserting that “Examiners are requested to examine applications on a case-to-case basis, without being prejudiced by the specific illustrations being provided herein.”  Some other clarifications/changes include:

  1. On carrying out a prior art search for pharmaceutical products, if the applicant does not inform the INN even on the request, the examiner should try to find out the INN and use the same in the search strategy.
  2. Further clarity on identification of prior art documents pertaining to Markush formula is provided wherein it is emphasized that “If a markush formula covers innumerable compounds and certain other compounds fall within another prior art, in such cases all these prior art documents are to be cited. A generic disclosure in the prior art may not necessarily take away the novelty of a specific disclosure. A specific disclosure in the prior art takes away the novelty of a generic disclosure”
  3. On the discussion of “skilled person” in section 8.6, the revised guidelines add new IPAB order on Enercon vs alloys Wobbens, ‘We do not intend to visualize a person who has super skills, but we do not think we should make this person skilled in the art to be incapable of carrying out anything but basic instructions”.
  4. On sufficiency of disclosure requirements pertaining to biological materials, the new guidelines add disclosure requirements pertaining to depositing the material to an International Depository Authority (IDA) under the Budapest Treaty.

There are some other minor changes for clarity purposes for example:

  1. Deletion of the following examples: “2) Use of compound A in the process of preparing B. and 3) Use of compound A in the composition of ————– ” from illustrations depicting use claims (non-product and non-process claims)
  2. Deletion of the following one illustration on implicit disclosure: “For example, the invention claims halide salts of a compound whereas the prior art teaches the chloride salts of the same compound but does not explicitly disclose the other halide salts. However, it may be noted that the question of implicit disclosure is often a mixed issue of novelty and inventive step.
  3. Deletion of a following sentence from “8.8 Reasonable expectation of success”:In other words enhanced effects cannot be adduced as evidence of inventive step if they emerge from obvious tests.
  4. Addition of a new illustrative example for section 3(j).
  5. Deletion of one paragraph (para 11.15 in earlier version) on sufficiency of description
  6. Addition of Structures for clarity in the illustrative example for Unity of invention in para 12.13

These guidelines are released with an objective to provide clarity and understanding on various patentability criteria to the Examiners/Controllers so that a uniform standard of examination can be achieved in pharmaceutical inventions. There have been several instances where certain type of claims are allowed by one examiner and rejected by others. For example, even though it is statutorily mentioned that method of treatment claims are not patentable under section 3(i) but still such claims are sometimes filed as use claims for example as “use of compound X in treatment of disease Y…” or compound claims for example as “compound X for use in treatment of disease Y..” which claims have been allowed by some Examiners in the past. These guidelines now clarify that only products or processes will be patentable and no such use claims will be patentable. This strives to provide much needed uniformity in examination standards. Another highlight of the guidelines is that these include recent IPAB and court decisions for providing further clarity. For example, section 3d has been well explained w.r.t Supreme Court’s Novartis decision. Obviousness criteria is well explained giving various illustrations, particularly defining “skilled person”, “reasonable expectation of success” “motivation” w.r.t various IPAB/court decisions. Product by process claims are clearly defined explaining that they are patentable only when the product is novel and non-obvious. Claims containing Markush structures are specifically well-explained w.r.t various patentability criteria. Since all these explanations available in these guidelines on various types of pharmaceutical claims are not explicitly present in the Patent Act, so releasing these guidelines should prove to be a boon to Examiners/Controllers especially in view of inconsistent examination standards seen in the past.

In sum, these guidelines will help Examiners establishing patentability of pharmaceutical inventions with much ease and clarity now avoiding inconsistency in examination standards.

Tesla Motors Decide to Open Source their Patents

On June 12th 2014, Elon Musk, CEO and Chief Product Architect of electric car company Tesla Motors announced that Tesla Motors will let other companies use its inventions under an open source inspired agenda at the company. This is how Elon Musk put it in his blog post- “Tesla will not initiate patent lawsuits against anyone who, in good faith, wants to use our technology.” This initiative came as a huge surprise to the technology space, and got a lot of people thinking. Considering Tesla’s exhaustive Patent portfolio, this move came as a bigger surprise to some, as the company holds the largest number of Patents in the electric vehicle industry having pioneered the technology and having gained constantly improved efficiency in process and technology in the industry. Tesla pioneered innovations lowered cost and increased safety of battery packs. Its cars recharge much faster than others on the market, thanks to connector, software, and power-management advances. Now this public company will offer these novel technologies to its rivals and ask nothing but goodwill in return.

Tesla has set the industry standard as far as their technology is concerned, which is quite evident from the hundred of Patents they hold and a number of applications pending. The question though arises that why would they open source their Patents for competitors to use after having spent huge resources in the process..There is more than one perspective to the argument though. This was probably a step Tesla Motors was contemplating and waiting to initiate once they feel no threat from competition. From a competition standpoint Tesla’s place is secure. “What we are doing is a modest thing,” he said. “You want to be innovating so fast that you invalidate your prior patents, in terms of what really matters. It’s the velocity of innovation that matters.” As long as Tesla keeps inventing and pushing the limits of the technology, it will remain ahead of rivals.

According to Tesla Motors opening up the patents around the charging technology could pave the way for important partnerships and collaborations. Musk has spoken to executives from BMW about sharing the cost of building recharging stations and creating a common infrastructure. Tesla’s nationwide network of recharging stations and its plans to build huge battery factories strengthens Musk’s point of view.  Tesla’s planned gigafactory, due to start production in 2020, will be the biggest battery-making facility in the world. At peak production, it alone will create 500,000 lithium-ion packs a year, more than all batteries produced worldwide last year. That’s more than enough to fuel the competition. No other automaker is planning these types of investments in electric cars. The rate of innovation in the electric car industry when you look at Tesla’s competitors does not in any way match Tesla’s progress. Musk would like to see the industry focus shift and would want automobile manufacturers to invest more heavily in the electric car business, and change their thought process from treating electric vehicles like a hobby to making them a top priority. This could be one of the objectives behind taking such a drastic step to promote a culture that is more environment friendly and realises the pace at which the climate change situation could drastically affect life in the near future, apart from being a culture which seems to be extremely business friendly as well.

An interesting analogy can be drawn when we think of electric cars in terms of smartphones. Tesla, which has been long compared with Apple, with its sleek design, luxury prices and chargers that exclusively plug in to Apple products, now wants to become open-source like Android. Like the micro-USB chargers that fit Android and Blackberry smartphones, all compatible cars could use Tesla’s superchargers. That way, other companies will use and enlarge Tesla’s existing network of 100 charging stations that currently dot a path across the continental United States, making it more and more feasible to swap fuel-burning cars for battery-electric ones, even for long distance travel. Also considering the electric cars account for less than 1% of the total cars manufactured and sold, this decision from Tesla seems like a smart strategy to encourage electric car manufacturing, get more players in the business and initiate profitable collaborations.

Reaction received from Tesla by the big 3 car manufacturers has been interesting though. General Motors Co. and Fiat Chrysler Automobiles haven’t reached out to Tesla, while Ford Motor Co. didn’t comment directly on the matter.

Although multiple reports said BMW inquired about the patents, industry analysts say most automakers find Tesla battery technology outdated or not compatible with their own programs, but would be open to collaboration on other parts like charging stations in the future. In a June blog post, Musk said, “If we clear a path to the creation of compelling electric vehicles, but then lay intellectual property landmines behind us to inhibit others, we are acting in a manner contrary to that goal.” This sentiment was not strongly felt by a number of top automobile companies. The value, some  analysts believe, may lie in Tesla’s charging stations. Tesla in June opened its 100th Supercharger station for its electric Model S car. The stations can charge an electric car in about 20 minutes, about 16 times faster than other public stations.

Detroit’s automakers said they’re open to working with other car companies. “We encourage the adoption of innovative technology across the industry,” Ford said in a statement. “We are the first and only automaker to have dedicated open-source hardware and software platforms, Smart Device Link and OpenXC.” Ford has a Focus Electric vehicle that’s powered by a lithium-ion battery, as well as C-MAX and Fusion hybrids.

GM has three plug-in electric vehicles: the Chevy Volt, the Chevy Spark and Cadillac ELR. “We have not talked to (Tesla) about the patents,” said Kevin Kelly, GM’s manager of electrification communications. “We don’t have anybody looking at those right now. It’s not something that’s on the front burner for us to look at.” Still, Kelly didn’t rule out the use of shared technology in the future. “I think anything that can help to advance the adoption of electric vehicles is a positive,” he said.

While Chrysler Group’s powertrain strategy includes vehicle electrification, a technology we have successfully demonstrated to date, we have no immediate plans for such outreach,” Chrysler said in a statement.

Gloria Bergquest, spokeswoman for the Alliance of Automobile Manufacturers, said, “It’s such a competitive industry, that if anyone can find a benefit in sharing info, they will do so.

If other manufacturers use Tesla technology and make cars that could plug in at Tesla Superstitions, Musk’s company stands to make a fortune simply from giving away its blueprints to competitors..This explains the strategy from purely a business stand point ignoring other theories that this position is taken by Tesla in good faith for society at large. While the consequences of the initiative would definitely help society at large, the reason for Tesla going ahead with the bold move is a subjective matter.

Sun Microsystems (ORCL) once made a similar intellectual-property move in the computer world. Known for its pricey, proprietary software, Sun opted to open-source all its products. The decision was a result of hard times faced by Sun and was looking to generate interest in its products to revive the company.

Tesla is in quite a different situation. Its share price has been rising for a year helped by the excellent response received by the Model S. That car, just the second made by Tesla, has already swept the automotive awards, including top safety and customer-service ratings. Next year, Tesla plans to begin shipping the Model X, a sports-utility vehicle.

Considering Tesla’s excellent rate of innovation, further improving their own Patented technologies sooner than you would expect, their strategy has caused one to rethink patent terms.  Technology and software have shorter life spans than most products in terms of their market value. In industries whose technology will be much different in a couple decades, a twenty year patent term is of little use to companies like Tesla. The benefit to such a lengthy term is enjoyed by Patent trolls who can use old patents and subjectively argue them as prior art that anticipates genuine inventions.

Having said that, just because Tesla has decided not to sue good-faith users of its patents does not mean the company will not face litigation from patent trolls. This kind of mentality would kill the mere purpose of existence of patent trolls who hunt for older patents on technology still used into today’s products, including automobiles and contribute heavily to the rising number of Patent litigations seen in the industry today. While Tesla’s initiative will provide limited relief to automotive companies from a Patent litigation perspective, only time will tell how well Tesla’s invitation to others to use its technology will work.

NOTE: Quoted text taken from certain sources such as ‘The Detroit News’

About the Author: Mr Ankur Sehgal, Patent  Associate at Khurana and Khurana and can be reached at: Ankur@khuranaandkhurana.com.

Patent Trolling and Fee-Shifting

Manish Kumar, intern at Khurana and Khurana, Advocates and IP Attorneys, looks at ‘fee-shifting’ paradigm in US Patent Act in light of US Supreme Court recent judgments.

The US Supreme Court, in its two recent judgments, has re-instituted its pre-2005 stand where the Courts had discretion of awarding reasonable attorney fees to the prevailing party and base their decisions in patent suits subjectively on case to case basis rather than on rigid and stringent conditions.

This stance of the Supreme Court has made the life of so called “patent trolls” difficult as they will not be allowed to bully other patent-holders or manufacturers in courts. These are the companies that bring lawsuits against small business entities with respect to their broad, substantially related or probable invalid patents or products. In such condition, it becomes more viable for these victims to settle the suit compromising their patent rights or seek license and save themselves from otherwise expensive and arduous lawsuits.

History of 35 USC 285

Prior to 1946 amendment of Patent Act, the American rule for awarding of attorney’s fee to the prevailing party in patent litigation did not exist and was governed by Marx v. General Revenue Corp., 568 U. S. 1946 that stated ‘[E]ach litigant pa[id] his own attorney’s fees, win or lose . . . .’ The 1946 amendment of the Patent Act incorporated section 70 in the Act that added a discretionary fee-shifting provision. The provision stated that a court “may in its discretion award reasonable attorney’s fees to the prevailing party upon the entry of judgment in any patent case.” The courts viewed this provision not as a ‘penalty for failure to win a patent infringement suit’ but as appropriate ‘only in extra-ordinary circumstances.’ The majority use of this discretion was based on ‘unfairness or bad faith in the conduct of the losing party, or some other equitable consideration of similar force.’ It was always difficult to enforce since it required adequate justification and establishing fraud practiced on the patent office or vexatious litigation.

The fee-shifting provision of the Patent Act was recodified as 35 USC 285 as “the court in exceptional cases may award reasonable attorney fees to the prevailing party.”The whole debate now shifted to qualification of ‘exceptional cases.’ The courts, for next three decades, ignored the amendment and continued with its previous position under section 70 of the Act. After 1982, district courts started considering the patent suits in totality of the circumstances when taking decision under 35 USC 285.

This continued until the US Federal Court decided Brooks Furniture Mfg., Inc. v. Dutailier Int’l, Inc., 393 F. 3d 1378 (2005), where the US Supreme Court took a more mechanical and rigid formulation which overruled earlier holistic and equitable approach. The court put forth following two conditions to be qualified for awarding fee to the prevailing party’s attorney’s fee:

1)      The litigation is brought in subjective bad faith, and

2)     The litigation is objectively baseless.

The Court stated that the case is to be considered as ‘exceptional’ under section 285 only when there has been material inappropriate conduct related to the matter in litigation, such as willful infringement, fraud or inequitable conduct in procuring the patent,misconduct during litigation, vexatious or unjustified litigation. The litigation was considered to be ‘objectively baseless’ if it is ‘so unreasonable that no reasonable litigant could believe it would succeed.’

The decision on Brooks furniture case can be found here.

Recent Position

The US Supreme Court decided the two cases,Octane Fitness, LLC v. Icon Health and Fitness, Inc. and Highmark Inc. v. Allcare Health Management System, Inc.,on April 29, 2014, that have loosened the restriction on patent lawsuit fee-shifting provision of US Patent Act.

The cases can be found here (Octane) and here (Highmark).

In Octane Fitness, LLC v. Icon Health and Fitness, Inc.both the parties are manufacturers of exercise equipments. The respondent, Icon Health & Fitness, Inc., owns U. S. Patent No. 6,019,710 (’710 patent), which discloses an elliptical exercise machine that allows for adjustments to fit the individual stride paths of users. Icon is a major manufacturer of exercise equipment, but it has never commercially sold the machine disclosed in the ’710 patent. Octane Fitness, also manufactures exercise equipment, including elliptical machines known as the Q45 and Q47. Icon sued Octane, alleging that the Q45 and Q47infringed several claims of the ’710 patent. The District Court granted Octane’s motion for summary judgment on June 17, 2011, concluding that Octane’s machines did not infringe Icon’s patent. Octane then moved for attorney’s fees under 35 US 285. Applying the Brooks Furniture standard, the District Court denied Octane’s motion on September 6, 2011. It determined that Octane could show neither that Icon’s claim was objectively baseless nor that Icon had brought it in subjective bad faith. As to objective baselessness, the District Court rejected Octane’s argument that “judgment of non-infringement should have been a foregone conclusion to anyone who visually inspected Octane’s machines”.

In Highmark Inc. v. Allcare Health Management System, Inc. case, Allcare  owned Patent No. 5,301,105 (‘105 patent), which covers “utilization review” in “‘managed health care systems.” Highmark Inc., a health insurance company, sued Allcare seeking a declaratory judgment that the ’105 patent was invalid and unenforceable and that, to the extent it was valid, Highmark’s actions were not infringing it. Allcare counterclaimed for patent infringement. Both parties filed motions for summary judgment, and the District Court entered a final judgment of non-infringement in favor of Highmark.

Highmark then moved for fees under section 285 for fee-shifting. The District Court granted Highmark’s motion. The court reasoned that Allcare had engaged in a pattern of “vexatious” and “deceitful” conduct throughout the litigation. The district court awarded the Highmark attorney’s fees together with other damages.

Allcare moved to Supreme Court against the judgment to which the Court partly agreed to. It affirmed the District Court’s exceptional-case determination with respect to the allegations that Highmark’s system infringed one claim of the ’105 patent, but reversed the determination with respect to another claim of the patent.In reversing the exceptional-case determination as to one claim, the court reviewed it de novo. The court held that because the question whether litigation is ‘objectively baseless’ under Brooks Furniture ‘is a question of law based on underlying mixed questions of law and fact,’ an objective-baselessness determination is reviewed on appeal de novo and ‘without deference.’ It then determined, contrary to the judgment of the District Court that ‘Allcare’s argument’ as to claim construction was not ‘so unreasonable that no reasonable litigant could believe it would succeed.’

Conclusion:

Both the issues were to be decided regarding the attorney’s fee in which the prevailing parties (Octane and Highmark respectively) in the respective cases demanded the fee-shifting towards the losing parties. The court looked into the issue of law and upon the due consideration sent it back to the district court for reconsideration of the issue by instructing that the court should not decide on the basis of Brooks Furniture case, but take more subjective approach.  Thus, the present stand (as against decision of Brooks Furniture case) of the US Court is toward fee-shifting is more liberal and subjective.

Although there is another angle to this judgment that now that the fee-shifting is to be considered subjectively, the patent holders may restrain themselves from bringing suits even for their legitimate claims since it is never sure that the courts will be in their favor. Each case will have different notion and different courts may decide the same case differently, giving different justification for their subjective interpretation of the case. Therefore, these decisions of the US Supreme Court, on one hand will restrict frivolous patent lawsuits; on the other hand, it may encourage ‘patent trolls’ to strike more settlements and licensing than ever.

Why Protecting Patents in India is Giving Hard Time to Drug Patent Holders

Introduction

A lot has been discussed on the Novartis ruling indicating much higher standards of patentability under Indian law under section 3d. The ruling decided that any new form of known compound (in medicine) would be patentable only if there is enhanced ‘therapeutic efficacy’ over the known compound. Post Novartis ruling, a couple of patent revocation decisions at Intellectual Property Appellate Board (IPAB) ruled on section 3d giving precedent of Novartis. In addition, these decisions also seem to be setting higher standards of non-obviousness as compared to countries such as United States.

Case I: Fresenius Kabi Oncology Limited v. Glaxo Group Limited, decided in July 2013

a)     Case Facts:

Fresenius Kabi filed a revocation petition against Glaxo’s patent IN221171 (referred to us ‘171 hereinafter) claiming di-tosylate salts of Lapatinib on grounds of obviousness, section 3d and section 8. Fresenius alleged that the ‘171 patent was obvious to a person skilled in the art with reasonable expectation of success in view of the combined teachings of  D1  read along with D2 to D4.  D1 was a basic product patent of Glaxo (IN221017) disclosing Lapatinib free base and its various salts. Amongst salts, hydrochloride (HCl) salts were the ones selected and exemplified, however D1 also disclosed ditosylate salts as one example. Furthermore, background section of D1 discussed problems of hygroscopicity and instabity of HCl salts.  D2 was a prior patent disclosing ditosylate salts of different compounds disclosing the problems solved by the ditosylate salts such as better moisture sorption and better stability. D3 and D4 were general prior art literature articles disclosing pharmaceutical salts and selection of salts for basic drugs. Fresenius also alleged that the ditosylate salts of the said patent are new forms of known HCl salts of Lapatinib showing no enhancement in therapeutic efficacy and hence not patentable under section 3d as well. b)     Decision:  i. On Obviousness: IPAB, first of all, reinforced that under Indian law, it is the “person skilled in the art” (referred to as Ms. P. SITA) who would decide obviousness of the invention, rather than person having ordinary skill in the art as in United States and other geographies. It was held that Ms. P.SITA was not a dumb person who was ignorant of happenings in her field of art, but had skill to perform experiments with the knowledge of state of the art. It would be obvious for Ms. SITA to solve the problem of hygroscopicity and instability by combined teachings of D1 to D4. She already knew the problems being faced with HCl salts and the said prior art would give her motivation to prepare the ditosylate salts to arrive at the invention of the ‘171 patent with reasonable expectation of success. ii. On Section 3d: Citing precedent of Novartis ruling, it was held that the salts were shown not to have enhanced ‘therapeutic efficacy’. Better stability, better moisture sorption properties and other physicochemical properties exhibited by di-tosylate salts were rejected as proof of better ‘therapeutic efficacy’ over known HCl salts. Note: Fresenius also filed another patent revocation application against the basic product patent IN221017 claiming Lapatinib, which was dismissed by IPAB. Case II: Ajanta Pharma Limited v. Allergan Inc., Allergan India Private Limited and The Controller of Patents and Designs, decided in August 2013  a) Case Facts: Two Revocation Petitions were filed by Ajanta Pharma against Allegan’s two patents, one claiming fixed dose combination of Timolol and Bimatoprost (IN212695, referred to as IN‘695 hereinafter) marketed as Ganfort® and the other claiming fixed dose combination of Brimonidine and Timolol (IN219504, referred to as IN‘504 hereinafter) marketed as Combigan®. Both drug combinations are for treatment of ocular hypertension. Both patents were revoked by IPAB on ground of obviousness and section 8.

b)Decision:

i.On obviousness:

· IN‘695 Patent:

IPAB held that it was obvious for Ms SITA to arrive at the fixed dose combination of Timolo and Bimatoprost for the treatment of ocular hypertension in view of the combined teachings of known serial (five minute gap) administration of these two drugs further in view of Diestelhorst M. et al disclosing fixed dose combination of Latanoprost and TImolol for treatment of glaucoma, and two other prior art documents teaching better efficacy and potency of Bimatoprost over Latanoprost. Latanoprost was a predecessor of Bimatoprost, both belonging to the same class of Prostaglandin Analogs. The fixed dose combination of Latanoprost and TImolol was known to reduce side effects and increase potency to treat glaucoma as compared to individual drugs. IPAB rejected Allergan’s contentions that both drugs were structurally different or acted on different receptors. IPAB further rejected Allergan’s contentions of achieving unexpected effects of reduced side-effects and increased potency. Secondary considerations were not considered relevant in determining obviousness. IPAB held that Ms. P. SITA would find the drugs closely related and be motivated by teachings of Diestelhorst M. et al to produce fixed dose combination of Timolol and Bimatoprost with reasonable expectation of reduced side-effects and increased potency. She would know the trend going from monotherapy to adjunct therapy to fixed dose combination in order to optimize the convenience and the patient compliance. ·IN ‘504 Patent IPAB held that it was obvious for Ms. P.SITA to arrive at the fixed dose combination of Brimonidine and Timolol in view of the combined teachings of known topical administration of Brimonidine in combination with Timolol spaced 5 minutes further in view of Desantis disclosing fixed dose combination of Timolol and alpha 2 agonists. It was held that both Timolol and Brimonidine were commercially available. It was known that serial administration of Brimonidine and Timolol reduced intraocular pressure better than TImolol and Brimonidine alone. It was held that DeSantis expressly provided motivation for fixed combination to increase patience compliance.  It was held that when viewed under a proper standard, the evidence establishes a motivation to combine since it was common at that time to provide Brimonidine and Timolol sequentially and DeSantis taught fixed combination. IPAB also cited the US Court of Appeals judgement in respect of the US equivalent patent in Allergan Inc vs. Sandoz wherein the US equivalent patent was held invalid as obvious. Key take-aways:

a)Prepare to clear a higher bar: Ms. P Sita has more than ordinary skill

Obviousness standards in India are higher as compared to countries such as US, in such a manner that the skilled person in US is a “person having ordinary skill in the art”, called as PHOSITA whereas in India she is a “person skilled in the art” called as Ms. P.SITA. The level of skill of Ms. SITA looks to be higher than PHOSITA. IPAB, in above cases, cited Roche v Cipla wherein the judge highlighted in context of obviousness that Ms. P.SITA is a not a dumb person who is ignorant of happenings in her field of art, but has skill to perform experiments with the knowledge of state of the art.  Glaxo (the respondent in the above first case) cited various foreign decisions to show how obviousness is decided, who is the person Skilled in the Art, what is the Common General Knowledge and so on, however, IPAB citing Roche v. Cipla highlighted that observations made in foreign judgements would not be guiding factors. May be that is a reason that the US counterpart of the IN‘171 patent is a granted and unopposed patent whereas its Indian equivalent patent is held to be obvious and revoked. Not only US, even the corresponding EP granted patent passed EPO’s obviousness standards. Again for the combination therapy patents in India, as seen in the above Ajanta v. Allergan IPAB decision, standards of obviousness seem to be stricter. Both the patents of Allergan covering ophthalmic compositions were revoked. Ganfront®, for example, in US and EP is protected as EP and US patents, but here in India the patent is revoked. For combination therapy of A and B, if serial administration of A and B is known to alleviate the condition better than monotherapy and a fixed dose combination of A or B with C is known for alleviating the same condition, it seems that it will be difficult to pass the obviousness challenge in India, owing to Ms. P. SITA who would be knowing the happenings in her field and would know the trend going from monotherapy to adjunct therapy to fixed dose combination in order to optimize the convenience and the patient compliance. Furthermore, it seems that secondary considerations in India have not been considered relevant in India in determining non-obviousness. Unexpected effects are generally accepted in US as a means to rebut obviousness rejection. Thus, person skilled in the art in India is considered to be having more skill, more creative imagination as compared to the person having ordinary skill in the art in other important geographies such as US, and hence clearing obviousness challenge is tougher. For patent holders around the globe, to clear these higher standards of obviousness is becoming problematic. b)3d after Novartis: Physico-chemical properties are not enough This is clear that after Novartis case, salts (or other new forms) of known compounds would always be hit by section 3d unless enhancement of therapeutic efficacy is not proven. Physico-chemical properties would not be considered to impart therapeutic efficacy. The “therapeutic efficacy” test as laid down by Supreme Court (SC) in Novartis will be cited as precedent in all such cases. Again, patent holders around the globe would have hard time pursuing their salts (or other new forms) patent applications in India unless enhancement in therapeutic efficacy is proven. Considering that the pharmacophore remains the same in developing these new forms, proving enhancement in therapeutic efficacy would be very difficult. The enhancement in physico-chemical properties, which impart inventive step over the known compounds, would not generally be able to comply with “enhancement in efficacy” clause in section 3d till Novartis precedent prevails. Even though SC clearly laid down that physico-chemical properties such as increased stability, absorption, lower hygroscopicity etc. could not be said to enhanced therapeutic efficacy, regarding bioavailability, SC pointed that increased bioavailability may or may not lead to enhanced therapeutic properties and would be dependent on case to case basis. But again, proving enhanced bioavailability leading to enhanced therapeutic efficacy would be difficult. No matter how enhanced bioavailablity has helped the drug to perform better, the test relied by India is to prove therapeutic efficacy enhancement over the known compound.

The law of the land

The Indian Patent Office has been receiving criticism from the US and other developed countries for following such stricter standards of patentability in refusing applications and revoking patents. The intention behind section 3(d) and setting higher standards of obviousness is to prevent evergreening and frivolous pharmaceutical patents in India, so that the public access to medicines is ensured. Such provisions are necessary for protecting public interest and ensuring public access to medicines in developing countries like India. However, steps should be taken to ensure that genuine innovative inventions should not be rejected so that the right balance between patent protection and public access is maintained to further research and development of newer medicines.

About the Author: Meenakshi Khurana, Partner at Khurana and Khurana and can be reached at: meenakshi@khuranaandkhurana.com

Note: This Article was first published in a premier Managing IP magazine in March 2014 here