Long gone are the days when leading pharmaceutical companies managed the entire value chain from drug discovery and development, clinical trials, and manufacturing, to marketing and distribution. Leading companies such as Novartis, Eli Lilly, Pfizer, and GlaxoSmithKline have continually outsourced labor-intensive, time-consuming activities around the world. Various contract research organisations (CROs) and contract manufacturing organisations (CMOs) bill themselves as low-cost service providers, capable of reducing the time-to-clinic and decreasing the overall cost of a drug, from development through manufacturing. Predictably, in recent years many outsourcing organisations have emerged in Asia — including China, Singapore, and India — where biology and chemistry PhDs are abundant, patient enrollment rates for clinical trials are high, labour costs are low, and tax concessions are generous. With the continuous knowledge transfer from pharmaceutical companies to outsourcing organisations, what will the industry look like in 5 to 10 years? If leading pharmaceutical companies are to sustain their competitive advantages, how will they operate? Rather than a new phenomenon, the current industry trend closely parallels what has already occurred in the personal computer (PC) sector. Because of the open modular architecture of PCs, contract manufacturers in Asia were able to bypass an integrated, complex system and supply western PC firms with subsystems such as motherboards, CD-ROM drives, monitors, keyboards and mice. Initially, these contract manufacturers could only assemble the simplest components according to specifications. But by collaborating with western PC firms, contract manufacturers benefited from continuous knowledge transfer. Over time, they took on additional responsibilities for product design and component procurement, becoming more involved at the design stage of the computers. (Industry practitioners refer to these sophisticated contract manufacturers as original design manufacturers - ODMs.) Western PC firms, after offloading the less profitable operations, focused on marketing activities and performance metrics for quality control. Dell, for example, invested very little in mechanical and electronic R&D. It relied on contract manufacturers to innovate the next generation of machines. HP, on the verge of shutting down its laptop division in 1999, outsourced its entire business operations to several Taiwanese firms. Services that were outsourced included hardware assembly, software installation, product testing, final packaging, and direct shipment to customers. As they progressively "hollowed out," western PC firms (with the exception of Apple) essentially became technology companies without technologies. Today, Taiwan has captured nearly half of the global integrated circuit market share; it has become the biggest producer of flat panel displays in the world; and it supplies over 90 per cent of the global laptop shipment volume. While leading pharmaceutical companies may not follow Dell and HP to exclusively focus on sales and marketing, the widespread knowledge transfer to CROs / CMOs, particularly those in Asia, will cause an irrevocable shift in the industry. In search of greater profits, outsourcing organisations continue to vertically integrate in order to provide a broader range of product offerings. Joint ventures and acquisitions abound: the strategic alliance between PPD and CMIC in Japan, the merger between Tokyo-based GNI and Shanghai-based Genomics, the acquisition of AppTec by Wuxi Pharmatech of Shanghai, and the investment in Commonwealth Biotechnologies by Beijing-based Venturepharm Laboratories. Services offered by these outsourcing organisations include developing, formulating and manufacturing drugs, managing clinical trials, monitoring safety, preclinical trial, toxicology, processing trial samples, and other complementary services. (Industry practitioners refer to these vertically integrated, single-source providers as contract development and manufacturing organizations - CDMOs.) As outsourcing organisations in Asia progressively develop a fuller set of capabilities, it is not hard to imagine that some may eventually develop new drugs of their own. But unlike other global products like PCs, drug discovery is — by nature — fragmented into geographical regions that each has distinctive disease classes. Unique disease mechanisms exist in China, for example. Gastric and liver cancers are much more prevalent in the region, with different disease etiologies. This implies different "white spaces" in which drug discovery efforts can specialize. More importantly, medical treatments for disease classes commonly found in emerging economies are often deemed unprofitable by established pharmaceutical companies. The local population's ability to pay and the corresponding institutional arrangement present an operating environment in which it is difficult to generate a level of profits comparable to that of advanced economies. Consequently, infectious diseases such as hepatitis, tuberculosis, syphilis, dysentery, gonorrhea, and foot-and-mouth disease still wreak havoc in China even though the scientific understanding on how to treat these diseases exists. For an established pharmaceutical company, commercialising a large-scale prevention and treatment regimen for these diseases is far less attractive financially than tackling diseases important to the Western world. The fact that charity organisations like the Bill & Melinda Gates Foundation are needed to fund the development of a variety of vaccines and drugs for impoverished communities in Africa underscores this broader phenomenon. But to a vertically integrated outsourcing organisation in China, moving up the value chain to develop these once-ignored drug classes can be commercially attractive because of the company's different cost structures and business models. In other words, emerging firms are motivated to fill the market void. These emerging firms, in the long run, however, are unlikely to compete directly with established pharmaceutical companies in the same market. In contrast to consumer electronics, personal computers, or home appliances where consumer needs converge on a global basis, disease classes vary greatly across geographic regions. These variations persist because of different climatic conditions, dietary habits, living standards, and lifestyle. The pharmaceutical industry may be one of the rare examples where industry incumbents and new entrants are able to achieve a peaceful co-existence, each specialising in drug discovery activities in their core markets. This is indeed good news for everyone.Industries will develop differently, however. Managers must be able to recognise the basic patterns of their own sectors before devising the firm's strategy for capitalising in the new consumption-driven Chinese economy. Blindly following others is not only ineffective, but downright dangerous. Ultimately, the wait-and-see approach of many multinationals seeking to expand into the Chinese market could be doomed before they even get started. So how can these companies strike the right strategic balance? (The author is a professor of Strategic Management and Innovation at IMD, where he teaches in the Orchestrating Winning Performance and Building on Talent programs. His teaching and research activities focus on why and how some firms can sustain new growth while others cannot)
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Delhi-based drug firm Panacea Biotec has entered into a 10 year collaboration agreement with Osmotica Pharmaceutical, USA, for late phase development and marketing of high end generic medicines. Eighteen products from Panacea’s research pipeline will initially be part of the pact, with a provision to add more.The products, which belong to the therapeutic categories that enjoy approximately $25-billion market in the US, will be developed and marketed on a 50:50 partnership basis, Rajesh Jain, joint managing director, Panacea said.Under the agreement, Panacea will be in charge of product identification, research, development and manufacturing while Osmotica would lead product registration, legal matters, marketing, sales and distribution in the US and key foreign markets. “The collaboration is based on a 50:50 risk, investment and profit sharing by both companies. Panacea will receive initial research fee from Osmotica and, as the research progresses, milestone payments representing 50 per cent of the development cost”, Jain said.The companies expect to file the first product in its research pipeline for regulatory approval next year. “We expect to launch the first product developed under the collaboration in 2015”, Forrest Waldon, CEO, Osmotica said.According to Jain, the partnership is unique as it is trying to develop a highly complex category of products that will require clinical trials under US law before being given marketing approval. “It is not just vanilla generic that require only bio-equivalance studies for regulatory approval. We are working on novel drug delivery systems and nanoparticle based drug delivery platforms”, he said.The research collaboration is in line with Panacea’s long-term objective to diversify its product portfolio from predominantly vaccines to other medicines. Panacea had registered a loss last year after WHO suspended its approval towards its key product, oral polio vaccine. The vaccine is expected to be back in the WHO approved list soon.Panacea shares rose to a month’s high to close at Rs 107.25 a share on Bombay Stock Exchange today after the announcement.Privately held Osmotica is a speciality pharmaceutical company focusing on neurology and central nervous system based drugs.
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The Intellectual Property Appellate Board (IPAB) has revoked the first product patent India had granted on a medicine after the country amended its patent laws in 2005. The patent that got revoked on 2 November pertains to the Hepatitis C injection Pegasys (pegylated interferon alfa-2a) of Swiss pharmaceutical major F. Hoffmann-La Roche AG (Roche). The company had received the patent for Pegasys in 2006.The decision was based on a post (patent) grant opposition filed by Sankalp, an organisation that provides treatment and rehabilitation support for injecting drug users. The civil society group had challenged the patent with technical and legal aid from the HIV/AIDS Unit of Lawyers Collective.“We hope that the absence of patent barrier will spur generic competition to bring down the price of this much-needed drug for those suffering from Hepatitis C. We also hope that the Government will now take concrete steps to start providing access to this medicine. It is unacceptable that people are dying due to Hepatitis C because they cannot afford to buy the medicine,” Eldred Tellis, Director of Sankalp Rehabilitation Trust, who had challenged the patent, said.It is estimated that 10–12 million people in India, including 50 per cent of injecting drug users nationally and 90 per cent of such addicts in the northeast, are infected with the Hepatitis C virus (HCV). Left untreated, Hepatitis C can lead to liver cirrhosis, liver cancer or liver failure. Hepatitis C is especially of concern for those co-infected with HIV, as HIV-HCV co-infection leads to increased rates of disease progression."Patients with chronic Hepatitis C, who need a six-month course of treatment of Roche’s pegylated interferon alfa2a, have to purchase it at a cost of approximately Rs 4,36,000 (available at a discounted price of Rs 3,14,496). Again, it has to be taken in combination with ribavarin, which alone costs Rs 47,160", Lawyers Collective states. "This victory will facilitate early entry of generics which is likely to lower the prices. If this happens, millions suffering from Hepatitis C, both in India and globally, will benefit", Anand Grover, senior counsel and Director of Lawyers Collective HIV/AIDS Unit said.Despite Sankalp’s case that Roche’s claims did not satisfy the patentability requirements under Indian law, in 2009, the Patent Office rejected the post-grant oppositions filed by Sankalp and an Indian company and upheld the validity of Roche’s patent. Sankalp then filed an appeal before the IPAB challenging this decision.Before the IPAB, Roche also challenged Sankalp’s standing to file the post-grant opposition as well as the appeal. Roche argued that because Sankalp was not a business competitor or a researcher in the sector, it could not have challenged its patent at all. Sankalp argued that its members were directly affected by Hepatitis C as well as that it represented a community of drug users who are particularly at risk to Hepatitis C. The IPAB observed that “public interest is a persistent presence in intellectual property law” and also held that it was against public interest to “allow unworthy patents to be on the Register”. Holding that “the appellant who works for the community which needs the medicine, is definitely ‘a person interested’”, the IPAB noted that a successful challenge would “break the monopoly” and “bring the drug within reach of the community for whom it works, not only by reduction in cost, but also because of increase in supply”, Lawyers Collective said.“We are happy that the IPAB has recognised the element of public interest in setting aside undeserving patents and held that patients’ groups, who are directly impacted by patents on medicines, can challenge granted patents. This will be of import as concerned patients’ groups will now have better clarity in challenging patents on medicines for HIV, cancer and other diseases.” Grover said.IPAB decisions can be challenged in the Supreme Court.
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It’s a business dictum that when uncertainty is high, you don’t dig big holes. Companies in two industries that may be in big holes just now are telecom and power. So one has to wonder: does it make strategic sense for the promoters of Sun Pharmaceuticals, the largest drug company by market capitalisation to diversify into those sectors?On October 26, Sudhir V Valia, the brother-in-law of Dilip Shanghvi, managing director and founder of Sun Pharma, hit the headlines by entering into a joint venture with Norwegian telecom firm Telenor; Valia’s Lakshdeep Investments & Finance will be Telenor’s partner in their new venture Telewings Communications, which will participate in the forthcoming 2G spectrum auction.Lakshdeep Investments & Finance holds just over one per cent of Sun Pharma. Media reports cited InGovern Research Services, a consultancy firm that advises investors on corporate governance and proxy voting, as saying that Lakshdeep’s 26 per cent equity in the Telenor joint venture is in the range of Rs 2,000 to Rs 2,500 crore. The firm’s current funding sources amount to Rs 1000- Rs 1200 crore; the balance will have to be loans, Ingovern adds.Earlier this month, Sun Pharma’s board approved a resolution that would allow the company to raise Rs 8,000 crore in loans; the firm also has about Rs 6,000 crore in cash and cash equivalents on its books. So there has been speculation among industry observers that this could be used to part-finance the telecom business.But Sun Pharma denies the move. "We don't have any plans to fund Lakshdweep Investments,” says a company spokesman. “The resolution passed by the board was an enabling resolution; we will be seeking shareholder approval to raise the money.”"This is baseless speculation, and at this point of time even I do not know how much assets we (Telewings) are going to get in the auction (2G spectrum),” says Valia. “We have to wait till the auction to decide how much I will have to invest." He says that he has various funding options available in his personal capacity to complete the deal.In fact, both the telecom and power generation ventures – more on that later – are personal investments of Shanghvi (he is worth $9 billion, according to Forbes magazine) and Valia, not part of the company. Is it possible that these moves were in the offing for quite some time? A few months ago, in May this year, Dilip Shanghvi stepped down as chairman of the company in May paving way for Israel Markov, the former CEO of Teva Pharma to become chairman. Valia also stepped down as chief financial officer (CFO) to make way for Uday Baldota, another long-serving Sun Pharma executive.Readers may recall that a year ago, Shanghvi made the surprising announcement that he was setting up a power generating business with a 2,600 MW plant in Andhra Pradesh. He also then picked Valia to spearhead that venture, Alpha Infra Projects.But since that time, the scenario has changed somewhat. "We have the various clearances in place and are waiting for coal linkages and other problems related to the thermal power segment of the sector to settle down to launch this project," says Valia.Will there be other such investments? Valia doesn’t duck the question. “We are looking at good opportunities (to invest) and that may take time,” he says. But for Shanghvi, Sun Pharma will continue to be the center of his solar system.
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The pharmaceutical industry will take a Rs 10,000-crore hit in its domestic revenues if the central government approves the suggestion of a group of ministers (GoM) to control the prices of all essential drugs sold in the country.After a three-year-long deliberation, the GoM headed by agriculture minister Sharad Pawar has recommended a formula for capping the prices of all 348 drugs mentioned under the National List of Essential Medicines (NLEM). The Cabinet will look into the GoM recommendations soon.The plan is to take the weighted average price (WAP) of all brands having at least 1 per cent or more market share by volume as the ceiling price of that particular drug. “The average price reduction will be about 11 per cent. However, price reduction of some medicines for many large companies, both domestic and foreign, will be as high as 75 per cent. A study shows that prices of 60 per cent of NLEM medicines will be reduced by more than 20 percent”, D G Shah, secretary general, Indian Pharmaceutical Alliance says.The size of domestic pharmaceutical market is estimated to be around Rs 65,000 crore.Civil society groups that are lobbying for price control over medicines said the inclusion of all NLEM drugs under price control was a foregone conclusion as the Supreme Court had, while hearing one of the public interest litigations related to drug pricing, directed the government to ensure that all essential medicines come under price control. The exact manner in which the inclusion should happen was the only debate before the GoM.Speaking to reporters after the meeting on September 27, Pawar had said that the recommendations of the committee will be sent to the Cabinet for a final view within a week.“We acknowledge the rights of the government to make essential medicines available to the most vulnerable sections of society at affordable prices. The new proposal will have an impact on industry as the span of price controls will now increase to cover around 30 per cent of the pharmaceutical market. Still a market-based policy is a balanced formula and will help improve the availability of essential medicines for patients,” Ranjit Shahani, President, Organisation of Pharmaceutical Producers of India said.Incidentally, Pawar had headed a previous GoM on the same issue during UPA 1 also. The first GoM, set up in January 2007 had held four meetings before the government’s term got over but arrived at no conclusions.NLEM list is a selection of medicines that are most commonly used in all levels of healthcare - primary, secondary and tertiary. While 61 medicines out of the 348 are exclusively used in tertiary care, 181 are common across all levels. The categories covered include anesthesia, analgesics, antipyretics, non-steroidal anti-inflammatory medicines, anti-allergic, anti-poisoning, anti-epileptics, anti-infectives, anti-bacterials, anti-cancer, anti-AIDS, vaccines and medicines used in palliative care among others.
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Novartis is gearing up for the final round of legal battle to get patent protection for its cancer drug Glivec in India.The Supreme Court will start a two-month long hearing on the case from September 11. The Basel, Switzerland based multinational drug major is challenging a few crucial provisions in the Indian Patent Law on patentability criteria. The ongoing legal battle for the last seven years had attracted international attention.Those who campaign against Novartis say the case is an attempt to threaten the availability of affordable medicines for the world’s poorest patients. Novartis says its attempts are to protect the rights related to innovation made by spending massive money on research and development.Following the rejection of its patent application for Glivec, Novartis had filed a case in May 2006 challenging the patent office’s decision at the Madras High Court. After an year, the court directed the case to be heard by the Indian Patent Appellate Board (IPAB). In July 2009, the IPAB turned down Novartis' patent claim and ratified the decision of the patent office.IPAB observed that the drug cannot be granted patent under Section 3(d) of the Indian Patent Law, since the drug is not a new invention and is only a minor tweak of an older compound that already has apatent, and is therefore only an incremental innovation (‘ever greening’ of patents) without significantly enhancing therapeutic efficacy. Patent experts say Novartis’s arguments to win the case in the apex court are likely to revolve around the interpretation on ‘enhancing therapeutic efficacy’, rather than trying to shot down Section 3 (d) clause of the Indian patent law.Novartis says Glivec, whose chemical name is imatinib mesylate, is not an ‘evergreen’ drug and had got patent in 40 countries, including China, Russia, Taiwan and all major developed countries.“We developed the mesylate salt of imatinib and then the beta crystal form of imatinib mesylate to make it suitable for patients to take in a pill form that would deliver consistent, safe and effective levels of medicine. This process, which took years, was more than just an incremental improvement – it was a breakthrough -- and certainly cannot be interpreted as "evergreening”, says a fact-file on Glivec published by Novartis.Novartis’ decision to continue the legal battle in Supreme Court is despite a global campaign to drop the case. In February, an international non-governmental organisation coalition, which included Oxfam, Act Up and Health Gap, had urged Novartis to drop the Glivec patent case in India.“What is at stake goes far beyond the only granting of a patent for this anti-cancer drug. This legal challenge aims in fact at weakening a legitimate and invaluable public health clause of the Indian law, section 3(d), which intends to limit the multiplication of patents on trivial changes to existing medicines, a common practice by multinational pharmaceutical companies”, says Patrick Durisch, health programme coordinator of the ‘Berne Declaration’, which asked Novartis to drop the case.“With net sales of $4.7 billion in 2011, Novartis can easily survive without a patent for Glivec in India, whilst its designated successor, Tasigna (Nilotinib-a blood cancer drug), was already granted one in India”, he says.Whether Novartis wins the case in Supreme Court or not, the battle for Glivec patent will remain as one of the longest and most controversial intellectual property debates on medicines in India.
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Multinational drug majors’ concern against India’s patent rules now has another example to highlight. On September 14, the Intellectual Property Appellate Board (IPAB) in Chennai dismissed German drug maker Bayer's appeal to stay the Compulsory License (CL) issued to Hyderabad based Natco to manufacture kidney cancer drug sorafenib - branded as Nexavar.In a landmark decision in March, the patent controller had issued India’s first Compulsory License allowing Natco to sell its generic drug at Rs 8,800 or less for a month's treatment and pay 6 per cent royalty to Bayer on the total sales. The patent office had observed the German firm was selling the drug at Rs 2.8 lakh a month. The CL was granted on grounds of affordability to the patients. As per Section 85 of the Indian Patent Act, a CL can be issued if the patented invention is not available ‘at an affordable price to the public’. The CL was granted considering factors like the ‘drug was not reasonably priced’, ‘was not adequately available’, and was ‘not manufactured in the country’.It is estimated that over 30,000 patients in India are suffering from advanced kidney and renal cancer."The right of access to affordable medicine is as much a matter of right to dignity of the patients and to grant stay at this juncture would really affect them and further, it would in effect amount to deciding the main petition itself. Though this is not a reason why we are not granting stay, yet this is an additional factor,” the IPAB said in its 17- page order.The IPAB is yet to take a decision on Bayer’s appeal against the CL granted by the patent office.Sorafenib product patent was granted in India in 2007. This patent was opposed by Cipla at post grant level and launched its generic sorafenib. The patent infringement case filed by Bayer against Cipla is pending at the Delhi High court. Bayer had earlier tried to prevent generic launches of the drug by filing a separate litigation demanding patent-product approval linkage, which was rejected by Delhi high court and by the apex cout in appeal. Earlier, Bayer’s writ petition challenging controller decision on Natco’s CL is disposed of by Bombay high court and asked Bayer to file in Delhi high court.Market sources say Cipla, which is fighting a case against Bayer for launching its generic version of Nexaver, also sells the drug at less than Rs 7,000 for a month’s treatment. Natco is also selling the drug at a discounted price to tap the Rs 22-25 crore market for kidney cancer. Bayer had also offered to sell the drug at about Rs 30,000 per month.“Now the option left before Bayer is to approach the Supreme Court to revoke the decision of IPAB and get a stay”, said a patent attorney, who had represented domestic companies in some of the earlier patent cases. Recently, the Delhi High Court had ruled in favour of Cipla against Swiss drugmaker Roche, over its cancer drug Tarceva. In another high-profile legal battle, Novartis is challenging the Indian Government against the decision of the Indian patent office not to grant patent for its cancer drug Glivec. Novartis is also questioning Section 3(d) of the Indian Patent Act which says ‘frivolous" inventions as non patentable. The case is now before the Supreme Court. With innovator companies beginning to taste domestic industry-friendly decisions by India’s patent office, it is likely that more patent litigations will take place in the future.
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Thanks to the fierce pulls and pressures from civil society groups, domestic pharmaceutical industry and the global drug multinationals in different directions, uncertainties surrounding India's policy outlook on foreign direct investment (FDI) in domestic pharmaceutical sector is far from over.Nine months after Prime Minister Manmohan Singh and his senior cabinet colleagues decided to give Competition Commission of India (CCI) the key responsibility of monitoring foreign direct investment (FDI) inflow in brown-field pharmaceutical projects, India's policy outlook on pharma FDI is back to the drawing board.A new committee set up by the government to understand the progress of the implementation of the proposed changes in the pharma FDI policy has now favoured the Foreign Investment Promotion Board (FIPB) of the commerce ministry over CCI to clear brown-field investments in pharmaceuticals. The earlier decision was to ask CCI to approve all brown-field FDIs in pharma sector irrespective of its size. The new proposal is to allow investments up to 49 per cent without any restriction.Though the proposal to allow FDI up to 49 per cent in brownfield projects through automatic route was seen as a relaxation of the government's more stringent plan, the drug industry is awaiting the conditionality attached to this decision to understand its real implication.Ranjit Shahani, president, Organisation of Pharmaceutical Producers of India (OPPI) said that any policy which restricts freedom of trade and investment will further restrict capital flows. He felt that the current position of the committee "will not only have a chilling effect on FDI flows to the Pharma Industry but will also have a serious knock-on effect in other Industries – particularly since it is a reversal of a policy liberalisation which took place only 10 years ago"."Today, when the world is looking at India to kickstart the economy following changes at the centre this certainly is a retrograde step. We are seeing ghosts where there are no ghosts", Shahani said in an emailed response.According to officials, even when up to 49 per cent investment in domestic drug companies get cleared automatically, the foreign partner that will gain substantial shareholding in the company will have to assure the government that none of the essential drugs produced by the Indian company will be discontinued after the foreign investment. "They may also be asked to invest 5 per cent of their turnover in research and development relating to drug that address India specific health problems", the official said.The representatives of the domestic industry, who have been actively lobbying to restrict FDI in pharma – and thereby resist takeover attempts by foreign drug companies – expressed happiness over the government move, despite an apparent attempt to retain control only on transactions that result in majority stake sale."This is a good development because any restriction on brown field pharma projects will result in more Greenfield investments. It will create new assets in the country", D G Shah, secretary general, of Indian Pharmaceutical Alliance, the association of domestic drug firms, said.In a letter to Prime Minister on July 24, civil society thinktank, the Centre for Trade and Development (Centad), wanted the pharmaceutical sector to be considered as a strategic sector. It wanted a ban on all FDI investments in brown-field pharmaceutical sector.FDI in pharmaceuticals used to be unrestricted for almost a decade until the government decided to limit 100 per cent FDI to Greenfield investments and roping CCI to clear all brown field proposals last year.A six-month transition period was provided to CCI to equip itself and until then, FIPB was asked to clear all brownfield investments in the pharma sector. It was expected that during this period, CCI will put in necessary enabling regulations for effective oversight on mergers and acquisitions to ensure that there is a balance between public health concerns and attracting FDI in the pharma sector.CCI is yet to be empowered to do this job and FIPB continues to handle the task of clearing brown-field pharma investments even today.
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