Susan Haigney is lead editor of Pharmaceutical Technology and Pharmaceutical Technology Europe.

Susan Haigney

	An upcoming report on India’s pharmaceutical industry in PharmTech (check out the October 2012 issue) discusses India’s strict patent policies and got me thinking about the rights of intellectual property versus patients’ rights to needed medicines. PharmTech’s Asia correspondent, Jane Wan, reports that India has set a high bar for patent approval that Western drug manufacturers are finding frustrating.

	Pharmaceutical companies are eyeing the growing market in India; however, a thriving domestic generics industry is backed by a government wishing to keep the cost of drugs down. Strict Indian patent laws require that an invention be novel, and the government does not recognize patents for drugs they view as being changed slightly in order to extend patent protection. According to Wan, the Indian Patent Office also lacks a searchable patent database, which creates a long patent approval process.

	In a potential game changer, Novartis is asking India’s Supreme Court for patent protection of its cancer drug Glivec. India rejected Novartis’ original patent application six years ago, stating the drug was unpatentable under India’s patent laws because it was a modification of an existing drug. Novartis is challenging India’s ruling.

	It is being speculated that the result of the court case could have significant ramifications for both Western pharmaceutical companies and generic drug makers operating in India. If Novartis wins the battle, it could potentially open the door for other companies that have been denied a patent on the grounds their drug was not novel. According to 

, generic drugs make up approximately 90% of the drug market in India. An increase in patents granted to branded drugs could threaten the Indian generic industry and potentially increase the price of drugs in India.

	What do you think? Are India’s patent laws too strict? If Novartis wins their case in India, will it open the door for other companies to gain patents?

Articles

An upcoming report on India’s pharmaceutical industry in PharmTech (check out the October 2012 issue) discusses India’s strict patent policies and got me thinking about the rights of intellectual property versus patients’ rights to needed medicines.

Borders on Intellectual Property

	PhRMA Senior Vice-President Matthew Bennett released a

 today on the state of the biopharmaceutical industry, in response to an analysis in the 

. Bennett states that while the US may be lagging behind in spurring innovation programs, he believes the passage of the Prescription Drug User Fee Act (PDUFA) will improve the situation.

	Bennett insists that the US pharmaceutical market has been making advancements in new and novel therapies. According to Bennett, “Last year alone, the Food and Drug Administration approved 35 new molecular entities–the highest amount of approvals over the last decade–including 11 new medicines for patients with rare diseases and Hepatitis C who previously had few or no treatment options.  And earlier this year, the first treatment of its kind was approved for patients suffering from cystic fibrosis, a debilitating disease that affects about 30,000 children and adults in the US.”

	The industry pipeline is healthy with potential novel treatments for Alzheimer’s, Parkinson’s disease, and cancer, according to Bennett, with PhRMA member companies investing “$49.5 billion in 2011 researching and discovering new medicines.”

	Bennett believes the US is on the right track. “The recent passage of the bipartisan Prescription Drug User Fee Act, which will help bring safe, effective, and innovative medicines to patients in a timely manner, is a step in the right direction”, states Bennett.

	Is the US pharmaceutical industry doing enough in biopharmaceutical innovation? Will PDUFA provide the framework for pro-innovation policy?

PhRMA Senior Vice-President Matthew Bennett released a statement today on the state of the biopharmaceutical industry, in response to an analysis in the British Medical Journal.

PhRMA Defends US Innovation

The European Medicines Agency and its Committee for Medicinal Products for Human Use (CHMP) have started to classify all post-authorization measures for human medicines as it phases out follow-up measures to marketing authorizations. The new classification system is being phased in a stepwise manner. Post-authorization measures will be classified as either: conditions in Annex II (obligations or specific obligations to fulfill post-authorization measures); additional pharmacovigilance activities in the risk-management plan; or recommendations for further development.

  EMA and CHMP are reclassifying all outstanding unclassified follow-up measures, starting in August 2012. The first phase of the new classification system tackled initial marketing-authorization-application opinions as of June 2011, followed by post-authorization procedures starting in November 2011.

, “Follow-up measures were measures applied to marketing authorizations, setting out studies and other activities that the Agency and CHMP had asked the marketing-authorization holder to perform.” Affected marketing-authorization holders will receive an outcome fax that includes information about the new classification for each of their applicable products. 

The European Medicines Agency (EMA) will soon be phasing out follow-up measures to marketing authorisations in place of a new system of classification that will be introduced in a stepwise manner.

EMA Phases out Follow-Up Measures

 on July 30, 2012, that its efforts to increase interaction and cooperation with regulatory authorities in Japan have paid off. In 2007, confidentiality agreements between the EU and Japan were established for a five-year period to allow for an exchange of information to enhance regulatory and scientific processes. According to EMA, the areas of orphan drugs, pediatrics, advanced therapies, pharmacogenomics, and nanomedicines have especially benefited from the collaboration.

	Specifically, EMA reported on an increase in the exchange of information and interaction between the two regions, including a new Japanese liaison officer and increased conference attendance. EMA stated in a release that the presence of the Japanese liaison “has provided a strong basis for mutual education, awareness of opportunities for interaction and communication between the European and Japanese authorities, helping to address public-health issues and avoid duplication of work.”

	FDA, the Australian Therapeutic Agency, and the United States Pharmacopeia have done similar exchange programs. With the increasing global nature of the pharmaceutical industry, the positive results reported by EMA would seem to prove that this trend in global collaboration is a good one.

The European Medicines Agency announced on July 30, 2012, that its efforts to increase interaction and cooperation with regulatory authorities in Japan have paid off. In 2007, confidentiality agreements between the EU and Japan were established for a five-year period to allow for an exchange of information to enhance regulatory and scientific processes

Cooperation in Global Regulation Sees Benefits

On July 9, 2012, Congress passed the Generic Drug User Fee Act (GDUFA) in an effort to get generic drugs to market in a timely manner. The Act authorizes the collection of user fees from generic-drug manufacturing companies for the first time in the industry’s history. 

As a result of a growing generic drug market, applications for new products have increased, causing a backlog of pending applications. The user fees collected by the generic drug industry will provide FDA with the funds it needs to process new drug applications and meet review deadlines established under the law. 

between FDA and representatives of the generic drug industry, the Act builds on the Prescription Drug User Fee Act program, which has streamlined the premarket program. According to FDA’s

, GDUFA “will enhance global supply chain safety by requiring that generic drug facilities and sites around the world use a self-identification process to include the source of all materials used in the manufacturing of generic drugs.”  

On July 9, 2012, Congress passed the Generic Drug User Fee Act in an effort to expedite the process of bringing generic drugs to market. The Act authorizes the collection of user fees from generic-drug manufacturing companies for the first time in the industry's history.

Congress Passes Generic Drug Act

 on the labeling of OTC products that contain acetaminophen. The draft guidance would give manufacturers an alternative option to properly clarify the risk of liver damage in OTC acetaminophen-containing products.

The current guidelines require manufacturers of OTC products that contain acetaminophen to include a specific warning on the label that exceeding the maximum daily amount of acetaminophen could cause liver damage. The current language refers to the product’s maximum dosage in terms of dosage units or total amount of tablets in a 24-hour period. 

The new draft guidance would give manufacturers the option of stating the maximum daily dosage as 4000 mg. The new language states: “Liver Warning: This product contains acetaminophen. Sever liver damage may occur if you take more than 4000 mg of acetaminophen in 24 hours; with other drugs containing acetaminophen; 3 or more alcoholic drinks every day while using this product.”

According to the draft guidance, FDA “believes that this alternative language should eliminate the potential confusion…and help ensure appropriate dosing of OTC acetaminophen-containing products, while also informing consumers that using more than the currently proposed maximum daily dose of 4000 mg of acetaminophen may result in severe liver damage.”

FDA has issued a draft guidance on the labeling of OTC products that contain acetaminophen. The draft guidance would give manufacturers an alternative option to properly clarify the risk of liver damage in OTC acetaminophen-containing products.