Monthly Archives: August 2013

IIPRD assists Venus Remedies in Successful Technology Out-licensing of Potentox to Adcock, South Africa

Venus Remedies Ltd. has successfully out-licensed its new generation antibiotic drug Potentox to Adcock Ingram Ltd. in South Africa earlier this year. Potentox is a Fixed Dose Combination (FDC) of Cefepime Hydrochloride & Amikacin Sulphate developed by Venus Remedies Ltd., indicated for treatment of Nosocomial Pneumonia & Febrile Neutropenia and available as dry powder for reconstitution before Intravenous administration. Potentox is patented drug product in South Africa and a number of countries including United States, Europe, Australia, New Zealand, Canada, Mexico, and Korea. Potentox replaces twin therapies of Cefapime and Amikacin with a single dose, administered as a single unit.

IIPRD had initiated Patent/Technology out-licensing process of Potentox and focused on the South African market following our market analysis report. A few of the reasons included a large overall systemic anti-bacterial market size of around USD 280 which grows approx. 10.5% annually, and having one of the highest reported rates of pneumococcal penicillin resistance in the world, as high as 76%. South Africa has a significantly more incidence rate for diseases such as Noscomial Pneumoina that is contracted in Hospitals. Potentox, being a first of its kind product with a synergistic effect of Cefepime & Amikacin in a single FDC, showed promise in reducing dependency on hospitals/external personnel for injecting the individual drugs.

IIPRD, as part of the exercise, focused on major players in the Antibiotics domain with specific interest in fixed dose combinations and, through Venus Remedies,shared non-confidential data relating to the product for further evaluation. Based on concrete interest levels, IIPRD then prepared the term sheet of the technology by taking inputs on valuation and proposed the same to Adcock for engagement on an exclusive marketing rights based relationship.

In general, IIPRD typically follows an effective two-step approach for Patent and IP Commercialization, wherein the first step involves comprehensive Due-Diligence and Commercial Evaluation (CE) of the Patent/Technology/Product intended to be Out-Licensed from a technology, commercial, marketability, and other parameters. This step helps IIPRD understand the market potential of the technology, competing products, pricing strategies, potential licensees, strength of Patent protection, coverage and enforceability of the concerned patent among other commercial and technical issues. Once the commercial evaluation comes out positive, IIPRD takes the technology forward through an expansive product/technology presentation to all potential licensees and how the same would add value proposition to their product portfolio. IIPRD executes this complete step on success basis and carries out all steps of commercialization including approach, proposition, evaluation, negotiation, and finalization through measured and defined strategies.

For Potentox, IIPRD followed on with the second step of identifying and approaching potential licensees. Amongst a list of companies identified and approached, we zeroed onto Adcock whichalso took a particular interest in the product and the talks were furthered and finally concluded with Venus signing an exclusive marketing alliance with Adcock. Adcock is a second-largest drug maker in South Africa and a largest supplier of hospital and critical-care products.

About IIPRD: IIPRD is a premier IP Consulting and Technology Licensing Firm with a diversified business practice providing services in the domain of IP/Patent Support Services, Legal Support, Research and Analytics, Valuation, and Commercialization/Licensing, of Intellectual Property and allied Product Level Assets along with providing complete IP and Patent Analytics and Litigation Support Services to International Corporates and Global IP Law Firms.

About Venus Remedies Ltd:  Venus Remedies Ltd. has been established in 1989. Venus is a Research & Innovation driven Pharmaceutical Manufacturing Company with an annual turnover of about $60 million. Venus has a particular focus on Critical Care Segment, in parenterals like Cephalosporins, Carbapenems and Oncology drugs in lyophilized form, infusions and small volume parenterals. Venus Remedies is among the world’s 10 leading fixed dosage injectables manufacturers. Venus has a presence in about 60 countries across the globe and covering more than 75 products, with Offices in almost all Major Geographies.

Follow us on Twitter: @KnKIPLaw.

Advertisements

Three-Days International Symposium on Patent Portfolio Management Strategies for IP Groups & R&D Scientists, Patent Agents and Attorneys of Pharmaceutical, Biotech, Chemical & Drug Industries

We are happy to inform you all that IIPRD and Khurana & Khurana, in association with Sughrue Mion (US), Schoen & Partners (EP), and Marietti Gislon S.R.L are holding their annual International Patent Symposium covering all major and relevant Pharmaceutical/Biotechnology Related Patent issues in the month of September, 2013 in India. The Three-Days International Symposium would be covering Strategies for Managing Pharma, Biotech & Chemical Patent Portfolios in US and EP and is being held from 26’th-28’th September 2013 at Hotel Hilton, Mumbai.

Brochure_Pharma_Sept_2013

About the Speakers: The speakers are a unique gathering of Patent Attorneys, Legal Counsels, who have extensive years of experience in their professional fields. These Speakers will put across to the delegates a real insight of Patent Laws & Practices, and Commercial perspectives as prevalent and practiced in Europe, United States, and India. The speakers include:

  • Chid Iyer, Partner at Sughrue Mion PLLC, USA
  • Dr. Christoph Schon, at Dr. Schon & Partners, Europe
  • Michael R. Dzwonczyk, Partner at Sughrue Mion PLLC, USA
  • Ms. Renita S. Rathinam, Partner at Sughrue Mion PLLC, USA
  • Dr. William Simmons, Associate at Sughrue Mion PLLC, USA
  • Ms. Azy S. Kokabi, Associate at Sughrue Mion PLLC, USA
  • Mr. Gabriele Gislon, Founding and Managing partner of MGT – Marietti, Gislon e Trupiano

Please see the complete details including Program Schedule, Topics, Speakers Profiles etc. in a brochure available over here.

If you wish to attend the symposium, please send your nominations to iiprd@iiprd.com.

Follow us on Twitter: @KnKIPLaw.

New Guidelines for Computer Implmented Inventions. Are we still clear on what is Statutory?

It was on 8’th August 2013 that the Patent Office, based on feedback from numerous stakeholders, came out with yet another draft of guidelines on subject matters that relate to Computer Implemented Inventions, interchangeably also referred to as Computer Related Inventions (CRI) hereinafter. The mandate of the instant article is not to assess or question the reasoning behind the defined statute or legislative history thereof, but instead to assume validity of Section(k) and evaluate whether the new guidelines actually give clarity on what would be held statutory from a technology standpoint or whether it “almost” re-iterates the earlier manual guidelines and leaves it on the patent application, the Applicant, its Patent Agent/Attorney, and the Examiner to figure out the fate of the Application.

As a quick background, Section 3(k) was first introduced in Indian patent law by the Patent (Amendment) Act, 2002 and through Patent (Amendment) Ordinance, 2004 prohibiting the grant of patents for: “a mathematical or business method or a computer programme per se or algorithms”. Criticism on the subject of patentability of software inventions came focused on the phrase “per se” that is used in alliance with software inventions in the Indian Patent Act and ironically “per se” is still not defined in Indian statute, but the issued manual now directs to interpret the word per se as per its dictionary meaning. Patent practice Manual published by the Indian Patent Office (IPO) states (page 9)here that “If the claimed subject matter in a patent application is only a computer programme, it is considered as a computer programme per se and hence not patentable. Claims directed at ‘computer programme products’ are computer programmes per se stored in a computer readable medium and as such are not allowable. Even if the claims, inter alia, contain a subject matter which is not a computer programme, it is examined whether such subject matter is sufficiently disclosed in the specification and forms an essential part of the invention.” The major question that loomed even after this clarification was whether the patentability would be assessed merely based on how the claim has been written or whether the underlying claimed technical subject matter would be taken into account to assess whether there is a tangible output and technical effect caused by the subject matter. In an instance, numerous illustrations of issued patents which relate to simple business methods such as for computing applicable tax, answering a dynamic questionnaire have been issued post the publication of existing manual, where a simple amendment to the claims was made by the Applicant to remove the computer readable medium (CRM) claims and get the issuance. Such a situation gave rise to a high priority issue of whether “how we write the claims” dictates if we get an issuance or whether the actual subject matter also makes a difference. I earnestly hope it does!!

Coming back to the recent draft guidelines, it has initially been rationalized that as subject matters relating to computer programmes do not fall under the category of “manner of manufacture”, they are not held statutory. Furthermore, in addition to certain dictionary meanings of “per se”, “firmware”, and “hardware”, the draft highlights what constitutes a technical effect in 3.15, which includes the usual constituents of higher speed, reduced hard-disk access time, compression, but also highlights “improved user interface” as being an acceptable parameter for substantiating “technical effect”. To our understanding, improvement in user interfaces (UI), which includes, without limitation, graphical user interfaces, completely involve a mere programming through a set of instructions which enhance the user feel, look and experience of the underlying software/web application and does not necessarily require an underlying hardware to enable improvement in the UI. Inclusion of such a criterion, might later be relied upon by Applicants to secure patents on their improved user experience, which on the other hand, might well be a subject matter of a Copyright registration.  According to wikipedia, “graphical user interface (GUI, sometimes pronounced ‘gooey’)is a type of user interface that allows users to interact with electronic devices through graphical icons and visual indicators such as secondary notation, as opposed to text-based interfaces, typed command labels or text navigation.”

Section 3.16 also mentions that technical advancement would always result in technical effect, which again raises doubts as technical advancements has not been defined specifically. For instance, an application that relates to a method of booking a ticket online from one location to another, wherein the method claims significant shortening of time for the booking, may involve a technical advancement/means by forming and executing a dynamic query based on user profile and present location, but might still be rendered non-patentable as the method relates to a business method, which is excluded subject matter.

Subsequent to the above, the draft also highlights certain claims that may constitute computer programme per se. In view of the same, as also mentioned above, I wonder if its only the manner in which the claim is written that is being evaluated or even the subject matter in totality being assessed. To help illustrate, in Example 3 on page 14 of the draft, we see a claim that pertains to a method of detecting vulnerabilities in a source code, in which method, the variables in the source code are analyzed to create models of arguments, which are further assessed along with pre-specified criteria to determine if vulnerabilities exist. Even though the above claim has been declared to be a computer program per se, I wonder what the fate of the claim would have been had it been reworded to limit the claimed algorithm to “detect whether the variables face memory allocation/deallocation vulnerability”, as detection of memory allocation/deallocation vulnerability can help optimize the performance of memory as a whole and hence may have fallen under 3’rd point of technical effect parameters mentioned in 3.15 (page 10) of the draft. I wish clarity could have been given on this aspect of wording in claim assessment vs. actual subject matter in context.

Although, we do appreciate that all subject matters showing technical effect (and hence being statutory) might not necessarily result in technical advancement (3.16 of draft), it sometimes becomes subjective to assess if mere inclusion of technical elements, which is believed to output a technical effect, should be held statutory. For instance, point 4.2, page 15 of the draft, gives an exemplary statutory claim, which upon a brief read relates to an apparatus for providing secure communication by receiving an access request from a device, sending the request to a web server, and reconfiguration of the device for authentication based on certain parameters. After going through the claim and segregating the individual elements, which have limitations of various constructional elements such as device, local web server, wireless network, reconfiguration module, I wonder if this aggregation of technical elements is all it takes to constitute a technical effect, as none of these elements, individually or collectively, do practically clearly indicate the actual novel technical feature of the claimed subject matter (which is also mentioned as a test in 5.4.6). For instance, use of a packet traffic filter means and incorporation of a structural element for redirecting web requests before being directly sent to the wireless network have been known ever since web-request security measure have been implemented and companies such as Fortigate have been using such means from years. Moreover, it would have been much easier if the guideline the actual point in the claim that shows the technical effect, keeping in context 3.15. At the same time, subject matters which, for instance, relate to run-time processing of network packets by a gateway device to extract application type of the packet and determine whether the packet is an attack packet or a valid packet, may have a technical effect by being run at a network layer of the OSI but may not result in a technical/hardware efficiency advancement per se, but makes the firewall software more proactive.

Furthermore, Section 5 of the manual mentions the basis of examination and particularly, in section 5.4 mentions grounds relating to technical advancement and technical effect. Sections 5.4.5 and 5.4.6 stress the importance of presence of a novel hardware in the claimed subject matter for it to be held statutory. However, examination of numerous examples of issued patents, not only in India, but even in similar regime based geographies such as EP, that its not necessarily the incorporation of a novel hardware, but instead that the proposed technical effect of the claimed subject matter is that matter, which could well be without incorporation of a new hardware. For instance, a method for storage of data in a particular sequence/manner in the same existing database may lead to enhanced technical effect by reducing the processing time of a given set of instructions, and hence the hardware responsible for the technical enhancement might not actually be new but instead, an existing hardware can also be configured in a manner that makes it optimally and technically efficient. Moreover, it may not be about the hardware itself but instead about a novel computing architecture that configures instructions to be processed in a specific manner and sequence that creates a technically efficient solution. For instance, a multi-mode mobile wireless communications device architecture having an application layer, a services layer interfacing the applications layer, a multi-mode layer interfacing the service layer, and a hardware layer interfacing the multi-mode layer may not include any new change in hardware or any new hardware itself, but instead only the architecture of how different known pieces of hardware share/process data/instructions between themselves that is statutory.

Lastly, section 5-7 mentions exemplary cases giving decisions of the controller in such cases. Unfortunately, none of the cases actually raise confusion between what is statutory and what is not, as all the subject matters are fairly straightforward business methods having clear commercial intent and do not demonstrate any technical enhancement. It is actually the actual non-commercial based technology patents that raise the actual 3k issue. Page 43-46 of the manual does give a flowchart based on which an assessment of computer programmes can be done but it is debatable if all the “OR” cases mentioned on Page 46 are actually exhaustive in nature and cover all possible non-statutory subject matter. Page 44 mentions, line with the EPO practice, to separate the claim into technical and non-technical features but then does not mention how extracted technical features should be further evaluated for patentability. Once it is determined that the subject matter relates to computer programmes, it has been mentioned on Page 46 that it is checked as to whether the subject matter falls in any of the below mentioned categories:

  1. If the claims are directed to a set of instructions/routines (thereby excluding CRM claims)
  2. If the claims are directed to CPP/Storage or Database Mediums
  3. If the claims are directed to automation
  4. If the claims do not include any structural feature.

The question also lies as to whether it should be assumed that the above list is exhaustive and anything that does not fall within the above sphere would be statutory. Take for instance, below mentioned two ?? exemplary cases, which have been recently issued by IPO and take a call on whether they should have been rendered statutory:

  • 160/MUM/2004 corresponding to 256583, wherein it was argued that the claimed subject matter is not a computer program per se as it involves a technical process focusing on changing the presentation of query results from a first format to another format using a configuration file. The scrutiny of the claims is self explanatory and would not be deliberated being a matter of personal opinion.
  • 1398/DELNP/2003corresponding to 256171 makes it hard to believe that 3(k) is strictly applied by the IPO to subject matters and instead it, by looking at prosecution histories, appears that it’s the type of claim (system gaining prominence over method) that makes a dent. Looking at the first issued claim, we do not even find support of “transmitter” in the specification and find it difficult to get a clear and convincing evidence of technical effect of the instant subject matter. Going through the file titled “1398-DELNP-2003-Correspondence-Others-(19-01-2009).pdf”, makes me find it difficult to comprehend as to whether such set of arguments are enough to get issuances.

About the Author: Mr. Tarun Khurana, Partner and Patent Attorney at Khurana & Khurana and can be reached at: Tarun@khuranaandkhurana.com

Follow us on Twitter: @KnKIPLaw.

GSK’s patent on lapatinib ditosylate revoked by IPAB

GSK’s granted patent IN221171 (‘171) on lapatinib ditosylate (marketed as Tykerb), a tyrosine kinase inhibitor for treating breast cancer, was revoked by IPAB by its order of 27th July, 2013.

A revocation application was filed by Fresenius Kabi Oncology Limited. The patent is revoked on ground of non-compliance with S.3d alone on basis of no proof of enhanced therapeutic efficacy vis-a-vis lapatinib di-HCl salt (known compound). Still IPAB discusses the grounds of obviousness and non-compliance with S.8 in detail as it considers these grounds important.

Section 3d

IPAB very straight forwardly failed the test of section 3d for the ‘171 patent. Taking precedent of Novartis Glivec case, it was held that there was no enhancement in therapeutic efficacy of the ditosylate salt as compared to the di-HCl salt and thus “the patent deserves to be revoked”. The only enhancement w.r.t the di-HCl salts was the increase in moisture absorption property and the increase in stability which are physico-chemical properties.

Next IPAB discussed the grounds of obviousness and Section 8, though it considers that non-compliance with Section 3d itself revokes the patent.

Obviousness

GSK’s basic patent (IN221017) on lapatinib was cited as prior art (D1) in view of three other prior art documents D2 to D4. It was argued that D1 describes a list of acid addition salts which exemplify 19 acid addition salts among which p-toluene sulphonic acid salts were one of them and even one Example 29 is a tosylate salt.

It was held that at the time of invention of ‘171 patent, the inventors knew that the HCl salts of lapatinib were hygroscopic and thus having stability issues (described in background section of the ‘171 patent). D3 and D4 are non-patent basic literature articles describing selection of salts and pharmaceutical salts respectively. D2 is a prior patent WO 98/25920 disclosing tosylate salts of 3-pyridoxyl alkylene azetidine-2-yl compound and that these are less hygroscopic, more crystalline, more stable, have a higher melting point and are readily purifiable as compared to hydrochloride salts. It was argued that D3 discloses that aryl groups are said to minimize hygroscopicity as opposed to the poorly stable hydrochloride and sulphate salts which teaches towards tosylate or ditosylate salt with reasonable expectation of success in combination with D1, D2 and D4. D2 further teaches tosylate salts to sorb less moisture, are more stable and crystalline.

IPAB clarified that the skilled person in obviousness analysis in Indian law is the person skilled in the art (Ms. SITA) rather than the person having ordinary skill in the art (PHOSITA) as used in US law, in reply to the Respondent’s citing of US case laws and description of skilled person as PHOSITA. IPAB held that the skilled person (Ms. SITA) would know at the time of the invention of the problem of the hygroscopicity and stability of HCl salts and it would be obvious to try for her to select ditosylate salt as taught by D1 in view of D2 to D4. IPAB further held that whether D2 belonged to another class of compounds (read analgesics) would be immaterial. IPAB asserts that:

“Salt selection especially if there is a wide range is not a matter of routine, according to the respondent. Even if we accept this as correct, it does not help the respondent. Ex D is about salt selection and it shows that aryl groups present a hydrophobic barrier to minimize hygroscopicity. The Person Skilled in the Art would look at Ex.C  and find that the tosylate salt of such 3-pyridoxyl alkylene azetidine-2-yl compound shows exactly the same qualities that the persons in this field are looking for in relation to Lapotinib. She knows that tosylate compound is a preferred compound from Ex B and that it can be prepared by Procedure D. She is not a dullard she can do experiments with skill. She is more likely to think “Let me try a tosylate first. If it demonstrates the same improvements as it has in Ex-C then I need not search further.” She would have tried a tosylate with a reasonable expectation of success.”

                                                                              Ex D = D3, Ex C = D2 and Ex B = D1

IPAB finally held that if the salt selection were to be made from a vast variety of salts by testing each compound with no clue available, then selection of one particular salt is not easy but in this case the clue is provided by D2 to D4 which makes the invention obvious.

Section 8

IPAB rejects the ground of Section 8 in the absence of pleading and proof of violation. IPAB stated that:

“It is not enough to merely reproduce the language of the section. A S.8 violation has severe consequences and the case for it has to be made out. The facts have to be pleaded and the applicant must state how the particular undisclosed application was for the same or substantially the same invention. It is also not enough to just file the documents along with an affidavit. The least that the deponent shall state is how each application mentioned therein is for the same or substantially the same invention”

On another note, IPAB stressed the importance of compliance with S. 8 in a number of ways as shown below. In the opening sentence under the S. 8 heading itself, IPAB states that

S.8 destroys a patent which is otherwise patentable on grounds which have nothing to do with the invention, but only with the Inventor’s lapse during the grant proceedings”.

Further excerpts of IPAB are as below:

“The Controllers cannot ignore it and condone the breach. The patentee cannot  tell the Examiners, ” We are filing applications nineteen to the dozen, compliance is very difficult, and in any case there is the Super Kamadhenu the Internet which will give you what you want.”

In view of what is stated in the Ayyangar Committee Report, we are of the opinion if in any of the foreign offices the patentee had made a division or was required to make a division, in respect of the same or substantially the same invention or had amended or was required to amend in respect of the same invention or substantially the same invention such information regarding division or amendment would also be information required to be furnished under Section 8.”

Patentees must comply with S.8 (1) provision however inconvenient it is.”

Fresenius Kabi also filed revocation petition against GSK’s basic patent IN 221017 claiming Markush structure encompassing lapatinib and pharmaceutically acceptable salts (discussed as D1 hereinabove) on grounds of obviousness, non-compliance with S.3d and S.8. This revocation petition however was dismissed by IPAB. We would discuss this in detail in an upcoming article.

About the Author: Ms. Meenakshi Khurana, Patent Attorney at Khurana & Khurana and can be reached at: Meenakshi@khuranaandkhurana.com

Follow us on Twitter: @KnKIPLaw.