1 May 2011Americas

For better, for worse? How shifting IP laws change the global life sciences regulatory chessboard

Is your life sciences invention—whether pharmaceutical, biologic, medical device or diagnostic—patentable? Can the term of your patent be extended? If so, what conditions apply and how long can you extend it for? Can proprietary data be used by third parties for product registration, marketing approval and market access? Can your data be used for an upcoming and competing biosimilar?

Intellectual property rights axiomatically confer monopolies, and the IP laws that provide answers to such questions frequently also delineate the cutting edge of pharmaceutical regulation around the globe. Not only do the answers differ in different countries, they are in constant flux as governments adjust their IP laws, changing the rules of the game. This can be for better or for worse, depending on whether you are an innovator and first to market, or a generic following the trail of the pioneers.

This article looks at some recent changes to IP rights in selected countries that have a particular impact on the life sciences industry. It is indicative rather than comprehensive, and the picture that emerges is quite mixed. Both innovators and generics can find cause for concern, but there are also incremental gains to be found on each side.

Starting with patents, some of the key issues relate to definitions of patentable subject matter in the life sciences field, the acts that can constitute infringement and whether it is possible to extend the life of a patent. All these themes emerge in amendments to the Taiwan Patent Act, which are expected to be approved shortly by the Legislative Yuan.

A welcome development for innovators is the fact that the amendments will open the door for the patenting of biological processes for the production of animals or plants, as these will become patentable subject matter. On the other hand, patent rights will not extend to stopping research or trials conducted for the purposes of obtaining pharmaceutical inspection and registration approval in Taiwan or to obtain market approval of a pharmaceutical from overseas.

The amendments will also clarify the scope of patent extensions for pharmaceuticals and related processes, limiting them to the particular active ingredients and uses that are covered by relevant prior government approvals.

As a result of Venezuela’s withdrawal from the Andean Pact in April 2006, the Venezuelan Industrial Property Registry stopped applying Decision 486 of the Andean Pact and began applying the 1955 Industrial Property Law. Decision 486 is TRIPS-compliant, whereas the law is not. Article 15 of the law expressly prohibits the patenting of medicines of all types, pharmaceutical preparations and chemical preparations, reactions and combinations.

Article 14 of the law, however, expressly permits the patenting of new procedures for the preparation of chemical products and new methods for the elaboration, extraction and separation of natural substances. Article 14 offers the possibility of protecting the procedure for the preparation of a pharmaceutical product. In spite of this legal framework, pharmaceutical companies continue to file patents for both pharmaceutical products and new procedures for the preparation of chemical (pharmaceutical) products.


The rationale behind these filings includes the fact that the Industrial Property Registry is so far behind in issuing decisions on patents that by the time a decision on a patent application is reached, the legislation and circumstances could have changed in favour of pharmaceutical patents. The Venezuelan authorities recognise that a new IP law is needed since the 1955 law is not TRIPS-compliant and, although workable, is outdated. Compulsory licensing could be an alternative in the new law.

In Thailand, applicants have also been experiencing delays in the examination and grant of patents for drug-related inventions. The patent office is moving to redress the problem by increasing the number of examiners and reducing their workloads, but it is not clear whether this will make a difference.

In Japan, the effect of a recent Supreme Court ruling dismissing an appeal by the Japan Patent Office is to liberalise the rules regarding extensions of pharmaceutical patents. It means that a fiveyear patent extension should be allowed if the application meets the usual requirements and if there is no relevant overlap between medicines that have the same active ingredients and granted patent claims.

Amendments to the People’s Republic of China (PRC) Patent Law have brought a mix of changes. Many innovators are pleased that an absolute novelty standard has been introduced, meaning that prior disclosures or uses anywhere in the world can be cited to pre-empt a patent application in China.

Also, the option to request evaluation reports to test the robustness of utility model and design patents should stem the flow of junk patents onto the register. On the other hand, the introduction of a security examination for inventions in the PRC prior to patent filings being made overseas, and of a patent infringement exemption to apply to the regulatory approval process, are less welcome to innovators.

Moving from patents, the use of confidential innovator information by third parties to accelerate their market entry is a vexed question that is handled differently around the world. Australia has plans to amend its copyright laws to stop innovators using copyright to delay market entry by generic competitors.

If enacted, the Therapeutic Goods Legislation Amendment (Copyright) Bill 2011 would mean that the manufacturer of a generic version of a registered medicine would not infringe copyright if it reproduced an innovator’s Therapeutic Goods Administration-approved product information document in order to apply to register a medicine or for purposes related to the safe and effective use of the medicine.

Poland, on the other hand, is finally implementing the European directive regarding data exclusivity for drugs for human use. Despite the delay since October 2005, the rule will apply to drugs for which marketing authorisation applications were filed after November 1, 2005, with the result that, in practice, there will be no adverse consequences for those wanting to preserve data exclusivity. This is because the data exclusivity periods referred to in the directive and the law currently in force have yet to expire.

Canada has published guidelines that streamline the process for the approval of subsequent entry biologics, also known as biosimilars. The guidelines are applicable to all biologic drug submissions where the sponsor seeks authorisation for sale based on demonstrated similarity to a previously approved biologic drug and relies, in part, on prior information regarding that biologic drug in order to present a reduced clinical and non-clinical trial package as part of the submission.

On the trademark front, in the US, a trademark for a drug cannot be used until it has been approved by the Food and Drug Administration (FDA), even though it may have been registered by the United States Patent and Trademark Office (USPTO). The FDA’s review of the proposed drug name focuses on whether a proposed trademark is likely to be confused by pharmacists and health professionals with other pharmaceutical trademarks.

The FDA recently launched a two-year pilot programme to enable pharmaceutical firms to evaluate their own names and to submit the data from the evaluation to the FDA for review. This does not circumvent the usual FDA trademark review procedures, but the pilot is intended to assist the FDA in determining whether it offers a better model than the current de novo FDA review.

The changes that have been highlighted illustrate the constant adjustments to IP laws and life sciences regulation around the world. The regulatory chessboard is in perpetual flux as governments and industry players continually move the pieces. It is hard to keep up so as to take advantage of the latest developments or to have some prior notice of adverse changes. The only effective strategy is to stay tuned, look ahead and respond nimbly as the game shifts.

The following members of the Baker & McKenzie global IP practice group made contributions for their respective jurisdictions: managing contributor Richard Gough (Australia); Jane Woodhouse (Australia); Bill Richardson (Canada); Ken Nakayama (Japan); Grace Shao (Taiwan); Say Sujintaya and Dhiraphol Suwanprateep (Thailand); Isabella Liu (China); Ewa Rutkowska (Poland): Rebecca Lederhouse (US); Dianne Phoebus (Venezuela). For more information, visit www.bakermckenzie.com/intellectualproperty

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