Patent case in India highlights tensions between public health, protecting innovation

By Ned Pagliarulo, BioPharmaDIVE | March 24, 2016

Earlier this month, the humanitarian organization Doctors Without Borders (MSF) began legal proceedings to block Pfizer’s attempts to patent its top-selling pneumonia vaccine in India. Called Prevnar 13, the vaccine pulled in over $6 billion dollars last year.

MSF hopes to prevent Pfizer from successfully patenting the drug in India in order to ensure other manufacturers can produce the vaccine at prices more affordable for India’s population and for MSF itself. Only one other drugmaker, GlaxoSmithKline, makes a pneumococcal conjugate vaccine and both versions can be expensive.

Interestingly, this is not the first time a patent on Prevnar 13 has been challenged. In 2014, rival drugmakers Merck and Novartis successfully petitioned the European Patent Office to revoke Pfizer’s patent there, citing lack of novelty and inventiveness. (It is currently under appeal.) MSF’s patent opposition in India shares some similarities with that case.

More broadly, the case in India highlights some of the intersections between drug affordability, the need for patent protection on innovation, and differences between national patent law. India is unique because it makes many of the world’s generic drugs, and has strengthened its own patentability criteria to raise the bar on what deserves brand-name exclusivity.

Competing sides

Severe pneumonia is a leading cause of childhood death, claiming the lives of almost one million children worldwide each year. Over 60,000 Indian children died from the lung infection in 2013. Vaccinations are increasingly a large part of MSF’s work, and as many of the vaccines the organization purchases come from India, it has an interest in seeing the prices kept low.

Both Pfizer and GlaxoSmithKline’s vaccines can be expensive compared to other vaccines. According to MSF’s legal documents in the case, pneumococcal vaccines account for 39.2% of purchases by the United Nation International Children’s Emergency Fund (UNICEF) Supply Division, but only 3% in terms of volume.

“India must rebuff demands from pharmaceutical companies, which are backed by diplomatic pressure tactics of the US and other governments, that India change its patentability standards to restrict generic competition,” said Leena Menghaney, head of MSF’s Access Campaign, at the time of the challenge. “Pfizer’s unmerited patent application on the pneumonia vaccine should be rejected, opening the door to more affordable versions of the vaccines being produced.”

MSF wants to see greater competition in the pneumococcal vaccine market to help bring down the price it pays for its vaccines. A successful patent by Pfizer would enable the drugmaker to shut out other generic manufacturers in India and potentially keep the price higher for longer.

The patent opposition document makes this case explicit: “The introduction of competition in the market through affordable versions of the vaccine produced by Indian vaccine manufacturers is one way to bring the product price down for treatment providers in developing countries.”

For its part, Pfizer says it has been in talks with the Indian government to better understand its needs and priorities. The company is working with GAVI, a vaccines alliance, to supply up to 740 million doses of Prevnar 13 and has already shipped 200 million doses to meet that goal.

“We are committed to creating an affordable and sustainable program supporting administration of our pneumococcal conjugate vaccine, which has the broadest serotype coverage of any pneumococcal conjugate vaccine available in the world today,” the company said in an e-mailed statement.

An innovative vaccine?

Prevnar 13 is a conjugate vaccine, meaning it combines different serotypes of streptococcus pneumonia, thirteen in this case. The different serotypes are attached to a carrier protein which helps makes the vaccine immunogenic and prompt an immune system response in the body. A non-toxic mutant form of diphtheria is used for Prevnar.

In its attempt to patent the drug in India, Pfizer is arguing the method of conjugating the 13 serotypes into one carrier represents an innovative product which would merit patent protection.

MSF, on the other hand, claims that none of Pfizer’s 21 patent claims are novel and says the 13 serotype vaccine is merely an addition of already-known serotypes to Pfizer’s existing 7-serotype vaccine. The organization points to literature and research to allege such an addition would be anticipated, rather than an unexpected invention.

Similarities to European case

This argument shares similarities with the case made by Merck and Novartis when they successfully opposed a similar Pfizer patent in Europe, which was revoked in 2014. (Merck and Novartis’ challenges were independent of each other.)

Unlike the case in India, Pfizer had already been awarded the patent and the other drugmakers sought to have it revoked by the European Patent Office.

In Merck’s documents filed in 2012, the German drugmaker cited a lack of inventive steps in Pfizer’s vaccine patent. The opposition document argued what Pfizer claimed to be an invention was simply the addition of six serotypes to Pfizer’s existing vaccine.

Several days after Merck, Novartis took the same route in opposing the patent. “Providing the 13-valent vaccine composition of the patent was, for example, the obvious next step in view of [Pfizer’s] earlier licensed heptavalent vaccine Prevnar (PCV7)…” the company said in its December 2012 filing.

In a lengthy 2013 rebuttal, Pfizer sought to disprove its rival’s claims. “The opponents arguments on inventive step seek to make appear obvious what at the time was a major and surprising success in designing a new highly multivalent pneumococcal vaccine,” Pfizer’s counter argument reads. Pfizer attempted to show that the addition of new serotypes was not obvious at the time of the vaccine’s development.

The European Patent Office sided with the opponents, however, and revoked Pfizer’s patent under appeal.

Stricter patent law

India has taken a stricter approach to patentability recently. While the international Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) sets the broad patentability criteria, nations are permitted to define their specific domestic interpretations.

“One thing we think India patent law has tried to do is have stricter criteria and say not everything can be patented if you apply for a small change on old molecules. You need stronger evidence to convince the patent controller this is really new. Otherwise it wouldn’t get the patent,” said Yuan Qiong Hu, a legal and policy advisor at MSF’s Access Campaign.

Hu said pre-grant opposition and stakeholder input into the patent process was critical for organizations and civic society to provide public health input.

Controversy over compulsory licensing

Additionally, India has been more willing to consider the use of compulsory licensing to allow generic manufacturers make patented drugs for public health or emergency purposes. This has generated some controversy of late, after documents filed with the US Trade Representative by industry groups suggested India had privately promised to restrict the use of compulsory licensing. The Indian government subseeuqently publicly denied the reports and maintained its right to use the tool.

While India has used this mechanism sparingly, the pharmaceutical industry has strongly opposed its use and pushed for strong patent protection in India. The global pharma industry sees compulsory licensing as a way India can unfairly boost its domestic generics industry at the expense of brand drugmakers. India, however, emphasizes it is operating within international law and has the right to use the tool to protect its domestic population.

Predictably, MSF favors preserving its use. “Compulsory license is definitely a very critical tool safeguarding public health, from our perspective… India is one of the champion countries who has actually used compulsory license before for public health purposes,” said Hu.

As for Prevnar, Pfizer is currently reviewing MSF’s pre-grant opposition. The India Patent Office can call Pfizer and opposing patents into hearings to present their arguments.

While it may take time to play out, the case represents a good gauge of the competing industry, government, and NGO interests in how best to protect intellectual property while at the same time promoting public health. Issues like Prevnar’s patent and India’s use of compulsory licensing have broad ramifications for the country’s pharmaceutical manufacturing as well.

This entry was posted in Patent Opposition, Uncategorized, Vaccines. Bookmark the permalink.

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