IPO COMMITTEE NEWSLETTER December 2013

Produced by Members of the IPO

International Patent Law and Practice Committee

Chair: Larry Welch, Eli Lilly

Vice Chairs: Samson Helfgott, Katten Muchin Rosenman LLP Elizabeth Lester, Sutherland Asbill & Brennan LLP

Board Liaison: Daniel J. Staudt, Siemens

CONTENTS

ANVISA’S INTERFERENCE IN THE PROSECUTION OF BRAZILIAN PHARMACEUTICAL PATENT APPLICATIONS Eduardo Camara and Bernardo Alexandre

Dannemann Siemsen

THE DETERMINATION OF INVENTIVE STEP Crystal J. Chen

Tsai, Lee & Chen

CHALLENGES AND OPPORTUNITIES FOR PHARMACEUTICAL COMPANIES IN BRAZIL: A BRIEF INTRODUCTION TO PATENTS, DATA PACKAGE PROTECTION AND

FOOD AND DRUG LAW Ricardo Dutra Nunes

Luiz Leonardos Advogados

RECENT RULE CHANGES IN THE EUROPEAN PATENT CONVENTION Dr. Aloys Hüttermann

Michalski · Hüttermann & Partner

A DISAPPOINTING WEEK FOR EUROPEAN SPC LAW Edward Oates, Partner

Carpmaels & Ransford LLP

LEGAL FRAMEWORK FOR DESIGN PROTECTION IN TAIWAN Candy K.Y. Chen Tsai, Lee & Chen

***These articles were created for the Intellectual Property Owners Association by the authors, each of whom is a member of IPO, to provide background

to IPO members. They should not be construed as providing legal advice or as representing the views of IPO.***

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ANVISA’S INTERFERENCE IN THE PROSECUTION OF BRAZILIAN

PHARMACEUTICAL PATENT APPLICATIONS Eduardo Camara and Bernardo Alexandre

Dannemann Siemsen Rio de Janeiro, Brazil

1. Introduction The Brazilian agency responsible for determining whether products or services may be potentially harmful to public health and for granting market approval for products (including pharmaceuticals) is called Agência Nacional de Vigilância Sanitária (ANVISA). This Brazilian agency corresponds to the U.S. Food and Drug Administration (FDA).

In view of a political interest by the Brazilian government to control the granting of patents in the sensitive field of pharmaceuticals, ANVISA was included in the prosecution of Brazilian pharmaceutical patent applications from December 1999 through the issuance of Provisional Measure #2006.

This provisional measure was converted into Brazilian Law #10,196 in February 2001, which amended the Brazilian IP Law #9,279 of May 14, 1996 through the inclusion of, among other provisions, Article 229-C.

According to Article 229-C, instead of being exclusively prosecuted at the Brazilian Patent Office, called Instituto Nacional da Propriedade Industrial (INPI), in a clear violation of the provisions of Article 27.1 of the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement, any patent application directed to a pharmaceutical product or process must be submitted to the prior consent of ANVISA before being granted by INPI.

2. ANVISA vs. INPI Based on Brazilian Law #9,782 of January 26, 1999, which created ANVISA, the legal attribution of this agency embraces only the surveillance and determination of whether products or services may be potentially harmful to public health. Accordingly, the analyses and decisions issued by ANVISA on pharmaceutical patent applications must be limited to its legal competence to address public health issues.

However, clearly overstepping its bounds as a public health regulatory agency, ANVISA has been examining patentability requisites in pharmaceutical patent applications, based on the provisions of the Brazilian IP Law, instead of analyzing public health issues. For instance, ANVISA has been checking whether the claimed

invention meets the novelty and inventive step requirements.

As determined by Brazilian Law #5,648 of December 11, 1970, INPI has the legal competence and attribution to review the merits of patent applications, including the analysis of patentability requisites.

Due to the conflict between INPI and ANVISA on the prosecution of pharmaceutical patent applications, an administrative proceeding was opened before the Attorney General’s Office (AGU), driven by INPI. Hence, AGU issued two opinions on the interference of ANVISA in pharmaceutical patent prosecution.

The first AGU’s opinion was issued in December 2009 (Opinion #210/PGF/AE/2009), which declared that ANVISA, in the exercise of its statutory duty to assess pharmaceutical patent applications for prior consent, should be limited to examining the issues closely related to its institutional purposes, i.e., issues related to public health.

After ANVISA’s request for reconsideration, the AGU confirmed its earlier opinion, by issuing Opinion #337/PGF/EA/2010, approved by the Attorney General on July 1, 2011, which ratified the determination that ANVISA shall limit its examination of patent applications to the perspective of public health, for purposes of prior consent.

Nevertheless, claiming that it will only be bound by the AGU’s opinions after a confirmation thereof by the Brazilian President, ANVISA continues to review and deny prior consent based on an assessment of patentability criteria.

3. ANVISA’s examination As said, ANVISA ignores its legal statutory competence of addressing public health issues by performing a substantive examination based on the Brazilian IP Law in order to give its prior consent.

In order to regulate the administrative procedure (represented below) for performing its examination, ANVISA issued Resolution #45 in June 2008. This resolution essentially reproduced the very same steps executed by INPI during the examination for patent applications, provided in the Brazilian IP Law.

 

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ANVISA’s decisions regarding prior consent (both granting and denial) are published in the Brazilian Official Gazette. Written opinions are not published in the Brazilian Official Gazette, but a hard copy thereof is sent by regular mail to the applicant or his/her attorney in Brazil.

In April 2013, ANVISA issued new Resolution #21/2013 stating that any pharmaceutical patent application considered to be contrary to public health will have prior consent denied. Based on said resolution, a pharmaceutical patent application is considered to be contrary to public health when its subject matter:

l Represents a risk to the human health, i.e., it is related to a substance which use has been prohibited in Brazil. The prohibited substances are listed in List F of Ordinance #344/1998 from the Brazilian Ministry of Health; or

l Is considered strategic for the Brazilian Universal Healthcare System (SUS), and does not comply with the requirements under the Brazilian IP Law (such as novelty, inventive step, enablement, preciseness, etc.).

Pharmaceutical patent applications not related to (i) a prohibited substance, or (ii) a substance or therapeutic use considered strategically therapeutic for SUS will not undergo an examination by ANVISA, and prior consent will be granted.

Based on Ordinance #1284/2010 from the Brazilian Ministry of Health, a product of high social significance or of high technological or economic value is considered strategic for SUS. Hence, a pharmaceutical product or process patent application related to the following will be examined by ANVISA based on the Brazilian IP Law:

l Antiviral and antiretroviral; l Neglected diseases (malaria, Chagas disease,

Hansen’s disease, leishmaniasis, schistosomiasis, and tuberculosis);

l Non-transmissible chronic diseases (degenerative disease (e.g., Parkinson’s), mental disease (e.g., Alzheimer), asthma, antipsychotic, anticonvulsant, antirheumatic, anti-inflammatory, immunosuppressant, osteoporosis, pulmonary arterial hypertension, oncology products, and others);

l Products obtained through biologic pathways (monoclonal antibodies, enzymes, hormones, and proteins);

l Vaccines and hemoderivatives; and l Drugs for treating accidents and incidents

related to nuclear accidents.

Until now, it was not possible to detect a trend of which therapeutic destinations would be considered of interest to SUS by ANVISA.

4. Administrative prosecution of a pharmaceutical patent application With the purpose of suggesting procedures for the execution of Article 229-C, an Interministerial Working Group was created in August 2011. In May 2012, this Group issued Interministerial Ordinance #1065 recommending that pharmaceutical patent applications first be assessed by ANVISA. Due to said ordinance, nowadays there are two administrative workflows:

l The pharmaceutical patent application is substantively examined by INPI and, if considered acceptable, it is forwarded to ANVISA; or

l After INPI’s formal examination, the application is forwarded to ANVISA. If approved by ANVISA, it is sent for further examination by INPI. If definitively denied, the application would be shelved by INPI without even being examined by INPI.

There is no provision in the resolutions of INPI or ANVISA for determining the criteria for whether a patent application falls under the first or the second situation.

INPI forwards a patent application to ANVISA through the issuance of a written opinion, which is noted in the Brazilian Industrial Property Journal. Based on such written opinion, it is possible to know whether the patent application was examined by INPI, or not.

If a patent application would be “shelved” without being examined by INPI (only by ANVISA), this would be illegal, since through the payment of an examination fee to INPI, the applicant of this patent application would have the right to have its application examined by INPI. So far, no patent application for which prior consent has been denied has been shelved by INPI.

If INPI indeed shelves a patent application due to denial of prior consent, it is possible to submit an administrative appeal. If the administrative appeal is rejected, the only remaining option available is to file a lawsuit before the Brazilian Federal Courts against ANVISA and INPI (challenging the intervention of ANVISA in the substantive examination of the pharmaceutical patent application and INPI’s refusal to examine the application).

5. Statistical data regarding ANVISA’s interference After the issuance of Interministerial Ordinance #1065 (i.e., from June 2012 to August 2013), 940 pharmaceutical patent applications had been forwarded to ANVISA. Among these applications, 341 applications had been forwarded to ANVISA after INPI considered them acceptable, and 599

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applications had been forwarded without INPI carrying out the substantive examination.

Since the implementation of ANVISA’s new rules regarding prior consent up to August 2013, ANVISA:

l Granted prior consent for 158 pharmaceutical patent applications: o 61 applications have been considered

acceptable by INPI after its substantive examination, and

o 97 applications had not been examined yet by INPI;

l Denied prior consent for seven Brazilian patent applications (all of these cases had been considered acceptable by INPI after its substantive examination); and

l Finally denied prior consent (i.e., after an administrative appeal) to only one case.

6. Judicial front On the judicial front, decisions have been issued recognizing the excesses of ANVISA in the alleged exercise of its statutory duty in connection with the procedure for granting patents. Also Article 229-C of the Brazilian IP Law was declared unconstitutional, thus determining directly that INPI should conclude the administrative process relating to a patent application, although ANVISA had denied its prior consent.

These decisions embrace only the patent applications involved in the lawsuits (and not all applications pending at INPI).

Specifically, the Federal Court of Appeals has expressed the same view, determining that ANVISA should only assess whether there are any risks to public health present:

“I – It is contrary to good sense to think that the requirements of a pharmaceutical patent require double analyzes and from two separate public bodies, which translates into unnecessary bureaucratic procedures, with conceptual, economic and human losses. II – If the understanding prevails that Article 229-C confers ANVISA the authority to assess the patentability requirements, this would mean that the INPI would be deprived of its independence and autonomy, being subordinated to ANVISA, thus resulting in a true absurd. III – It is clear that the only possible interpretation of Article 299-C does not involve any new assignment to ANVISA (analysis of patentability requirements), but rather the opportunity given by the legislature to anticipate its health surveillance administration, by

identifying any possible health risks before the grant of the letters patent; before such provision, this risk was only identified at the time the product was effectively traded in the market.” (Civil Appeal #2005.51.01.5004279)

“1. ANVISA has started to examine pharmaceutical applications after Provisional Presidential Decree #2006/1999 was issued, which created the legal procedure of prior consent, later consolidated by Law #10,196/2001, including it in the Industrial Property Law as Article 229-C. 2. The laws must be interpreted and enforced within the limits that comprise the legal framework of the nation as a whole, and not separately, being reconciled, so as to effectively ensure the accomplishment of the common good without compromising the guarantees of the Rule of Law. In this sense, it does not seem reasonable or efficient that the legislature intended that two government agencies – the INPI and ANVISA – concurrently analyzed the patentability requirements set forth in the Brazilian Industrial Property Law, because this would create situations of extreme mismatch, in the cases of insurmountable divergent opinions between these agencies, such as happened in the second patent. Thus, a reasonable interpretation of the law would understand that, at the time of prior consent, ANSIVA should inform if there is any obstacle in the area of public health to the grant of the patent, based on the provisions of Law #9,782/99 and according to its jurisdiction. 3. The recognition of the constitutionality and applicability of Article 229-C of the IP Law is essential, considering that the Constitution establishes in its Article 5 (XXIII) that the property shall fulfill its social function and that the economic order shall abide by the social function of property [Article 170 (III)]. In this vein, the supremacy of the common good over individual rights of property is highlighted, legitimizing the role of ANVISA in the granting of pharmaceutical patents, provided it is within the strict limits of the mission for which it was created.” (Civil Appeal #2004.51.01.5170540)

“51 – In view of the foregoing, for the reasons above, we suggest that:

a) It is not ANVISA’s duty to carry out examinations (assessment/

 

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reassessment) of technical criteria specific of patentability (novelty, inventive step and industrial use) when working for prior consent (article 229-C of Law #9279 of 1996, added by Provisional Measure #2006, of December 15, 1999, later converted into Law #10,196, of 2001), once this is an attribution of the INPI, as established in the very law (article 2 of Law #5,648/70);

b) ANVISA, for purposes of article 229-C of Law #9,279/96, shall act in accordance with its institutional attributions (article 6 of Law #9,782/99): prevent, by means of sanitary control, the production and commercialization of products and services potentially harmful to human health.” (Civil Appeal #2009.34.00.037368-5)

The Circuit Courts have also handed down rulings contrary to the intervention of ANVISA in the assessment of patentability. One decision rendered by the 8th Federal Court of Brasília recognized ANVISA’s excesses during alleged compliance of its legal duty during the patent granting procedure, and incidentally declared Article 229-C of the Brazilian IP Law to be unconstitutional, thus directly determining that INPI should conclude the administrative proceeding for a patent application, although prior consent was denied by ANVISA (Record #29724-10.2010.4.01.3400):

“Based on the foregoing, I hereby DECLARE incidenter tantum the unconstitutionality of Article 229-C of Law #9,279/96 and, therefore, GRANT the claim, ruling that the administrative proceeding referring to the pharmaceutical product indicated in the complaint must be immediately forwarded to the INPI, within 48 (forty eight) hours of the judgment rendered, for due conclusion of the patent granting procedure; I hereby also GRANT the interlocutory relief requested and, therefore, disallow any writ to stay the proceedings of an eventual appeal filed against the decision by ANVISA.”

In view of these decisions, the courts are cancelling the analysis on patentability requisites carried out by ANVISA and, subsequently, determining that INPI should grant the patents (previously denied by ANVISA). In this regard, it is necessary to file a court action at the Federal Court to cancel the decision issued by ANVISA that denied approval of a patent application. (The decisions issued by the courts embrace only those specific patent applications indicated in the respective lawsuits.)

7. Conclusion The legal attribution of ANVISA embraces only the surveillance and determination of whether products or services may be potentially harmful to public health. Accordingly, the analyses and decisions issued by ANVISA on pharmaceutical patent applications must be limited to its legal competence to address public health issues. In spite of that, ANVISA’s prior consent opinions have taken into account patentability matters, such as denying applications on grounds that they lack novelty or inventive activity. These are opinions which, by law, may only be manifested by INPI. It seems that the reason for ANVISA to take into account patentability matters is that granting certain patents would inhibit and deter the entry of generics into the Brazilian market thus making access to medicine more difficult. In any event, ANVISA is clearly overstepping its bounds as a public health regulatory agency to supplement the examination of patent applications in such a way.

Accordingly, as mentioned, ANVISA’s prior consent is not legal, particularly in the circumstance that ANVISA rejects an application resulting in the permanent shelving of the patent application procedure, and effectively bypassing outright any examination of the merits of the patent application by INPI.

THE DETERMINATION OF INVENTIVE STEP Crystal J. Chen

Tsai, Lee & Chen Taipei, Taiwan

The inventive step of an invention always takes center stage when prosecuting patent applications or enforcing patent rights in Taiwan.

Article 22 of the Patent Act provides that, where an invention can be easily made by a person having ordinary skill in the art (PHOSITA) based on prior art, no invention patent shall be granted, notwithstanding the other requirements of patentability. From a literal interpretation of the provision, when an invention filed for a patent can be easily accomplished by a PHOSITA based on the prior art before filing, the invention will be regarded as lacking an inventive step over the prior art, even though it may be novel.

To facilitate the determination of an inventive step, the Patent Examination Guidelines specify five steps: (1) determining the scope of an invention for which a patent application has been filed; (2) determining the contents disclosed by related prior art; (3) determining the technical level of a PHOSITA of the invention; (4)

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determining the difference(s) between the invention and the relevant prior art; and (5) determining whether the invention may be readily accomplished by a PHOSITA by referring to the contents disclosed in the relevant prior art, and by using common knowledge when the application is filed.

In addition to this five-pronged test, secondary factors should also be taken into consideration, as long as the applicant or right holder can provide auxiliary proof for support. The secondary factors include whether the invention (a) has an unexpected efficacy; (b) solves a long-existing problem; (c) overcomes technical skepticism; or (d) has achieved commercial success.

The courts rarely mention aspects of the five-pronged test suggested in the examination guidelines, and instead rely heavily on a literal interpretation of Article 22 of the Patent Act. In practice, adjudication typically involves a determination of whether a PHOSITA may accomplish the invention through combining, modifying, replacing, or converting the techniques based on the prior art disclosed by one or more cited documents and with reference to common knowledge.

Therefore, whether the cited references teach or disclose the “technical features” of the patent at issue is what the Taiwan IP Office or the courts actually consider. It is commonly seen that if all features of the invention at issue can be found in the prior art, examiners and courts will reach a quick determination that a combination of such features is easily accomplished by a PHOSITA, deeming the invention to lack an inventive step. The current controlling test for determination of an inventive step is thus relatively subjective and disadvantageous to inventors and patent right holders.

Patent disputes According to statistics from January 2008 to March 2012, 152 patent disputes concerning the issue of inventive step have been appealed to the Supreme Administrative Court, including rejections of patent applications and patent invalidations. Among these 152 appealed cases, 31 judgments ruling that the inventions at issue had an inventive step were sustained, and 100 judgments ruling that the inventions at issue lacked an inventive step were sustained. Moreover, eight judgments confirming that the inventions at issue had an inventive step were overruled, and 13 judgments determining that the inventions at issue lacked an inventive step were overruled.

These statistics demonstrate the vulnerability of inventive step under the scrutiny of a technical

feature comparison. Just 44 out of 152 patents survived from the issue of lacking an inventive step in the administrative remedial procedures.

Under the stringent scrutiny of an inventive step, an “unexpected efficacy of an invention,” or “any new purpose of use attained from an invention” will help in making a persuasive argument against the determination of “lacking an inventive step.” According to the guidelines, an invention will be deemed to possess an inventive step if “unexpected efficacy of an invention,” or “any new purpose of use attained from an invention” can be obtained, whether or not the technical features of the invention are known prior art.

Hence, to avoid a situation in which a patent becomes vulnerable under a challenge of inventive step, we recommend that applicants always specify in the application the unexpected efficacy of an invention, or any new purpose of use attained from an invention.

CHALLENGES AND OPPORTUNITIES FOR PHARMACEUTICAL COMPANIES IN BRAZIL: A BRIEF INTRODUCTION TO PATENTS, DATA

PACKAGE PROTECTION AND FOOD AND DRUG LAW

Ricardo Dutra Nunes

Luiz Leonardos Advogados Rio de Janeiro, Brazil

The Brazilian patent system is one of the oldest: it was created more than 200 years ago, in 1809, by royal decree. Since then, the country has experienced many changes in this area, including several developments in our legal framework in the recent past.

Our current federal constitution was enacted in 1988, establishing that the law will provide temporary protection for inventions. Brazil is also a member of most of the international treaties governing patent protection. The current intellectual property statute (Law #9.279/96) was enacted in 1996, just after Brazil became a member of the World Trade Organization (WTO) in 1995, to adapt the local rules to the minimum standards established by the WTO-TRIPS Agreement. For that reason, the Brazilian patent statute is reasonably similar to the ones in force in the U.S., Europe and other WTO members, although its implementation by the Brazilian executive and judiciary powers can be quite different.

Since Brazil joined the WTO, the Brazilian PTO (BPTO) must issue patents in all fields of technology, including the pharmaceutical area,

 

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which was not allowed according to the previous legal framework. In theory, the BPTO issues a patent as long as the application discloses a technical solution to a technical problem, complies with the technical requirements – such as novelty, inventive step and industrial applicability – and is not prohibited by the statute.

According to the statute, a few matters are not considered as inventions, and cannot be subject to patent protection. Relevant examples for pharmaceutical companies are the bans on patents covering methods of treatment, methods of diagnostic, natural living beings and biological material found in nature or isolated therefrom. Some other matters are considered “non-patentable inventions,” such as anything contrary to public safety, order or health, and living beings, except for transgenic microorganisms that are not mere discoveries.

Brazil has a first-to-file system, with a priority scheme that assimilates the Paris Convention and a 12-month grace period for disclosures made by the inventor or third parties (including the BPTO) based on information received directly or indirectly from the inventor or as a result of his acts. In case the patent issues, it gives the patent owner the right to prevent third parties from manufacturing, using, offering for sale, selling or importing the invention without his consent, for a period of 20 years as from the filing date – or 10 years from issuance, whichever is longer. The bounds of the protection are defined by the claims, which are construed based on the specification and drawings.

The statute provides for a few exceptions to patent rights, such as the experimental use exception and the Bolar exception, the latter related to acts performed for the sole purpose of producing test results and data in order to obtain marketing registration for the patented product after the patent expires, which is especially relevant in the case of pharmaceutical technologies.

Although extremely rare, a patent might be subject to compulsory licensing in some very specific circumstances. For political reasons, pharmaceutical patents are more vulnerable to such extreme measures. In fact, the Brazilian government recently issued a compulsory license over one of the patents covering Efavirenz, a drug for the treatment of a human immunodeficiency virus.

In Brazil, patent infringement lawsuits are filed by the patent owner before state trial courts. Preliminary ex parte injunctions are available, allowing the trial court judge to immediately order the defendant to stop using or selling the patented invention, to conduct searches and seizures, or to

order a recall of the infringing products, for instance. Depending on the amount of evidence the plaintiff presents with the complaint to show the plaintiff will most likely prevail on the merits and may suffer irreparable harm if the injunction request is not granted, it is possible to obtain a preliminary ex parte injunction order in less than 24 hours after filing the complaint. Declaratory non-infringement lawsuits are also available and must be filed before state trial courts as well.

On the other hand, lawsuits challenging an act performed by the BPTO, such as a decision issuing or rejecting a patent application, are typically filed before a federal district court in the city of Rio de Janeiro. Because the city has specialized district and appellate courts to deal with intellectual property matters, each case is randomly assigned to one of its four specialized IP district courts, and each appeal is assigned to one of its two specialized appellate divisions. From our experience, the few district court and appellate judges in charge of those cases in Rio de Janeiro are generally reluctant to overrule a decision issued by the BPTO, and are frequently considered “anti-patent judges.” In light of that, our law firm developed an innovative – and successful – forum-shopping strategy to be able to file those lawsuits in Brasilia, the federal capital, where one of its more than 50 non-biased federal district court judges will deal with the case.

Another big challenge for the pharmaceutical research-based industry is that pharmaceutical patents cannot be issued without the Brazilian FDA’s prior consent. Since there is no legal provision expressly regulating the grounds for the BFDA to grant or reject its prior consent with regard to an application, the BFDA was insisting on re-examining the patentability requirements already examined by the BPTO, and denying prior approval in in cases where it disagreed with the technical opinions issued by the BPTO. Two years ago, after our law firm filed many lawsuits on behalf of our clients to challenge such illegal understanding, the Attorney General’s Office issued an opinion clarifying that the patentability analysis should only be performed by the BPTO, and that the BFDA should grant or deny prior approval exclusively based on issues related to public health.

Until now, the BPTO would examine a pharmaceutical application and, only in cases where the examination established that the patentability requirements were met, the application would be forwarded to the BFDA. To avoid further controversy, the government decided to change the procedure with regard to pharmaceutical applications. Now, the application is filed with the BPTO, which immediately

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forwards it to the BFDA if the application is related to a pharmaceutical product or process. Subsequently, the BFDA will examine the application in light of public health issues, granting or rejecting its prior approval. The application will then be returned to the BPTO, which will shelve the application if the prior approval was denied by the BFDA, or perform the examination of the patentability requirements, eventually issuing or denying the patent.

Because it is so hard to obtain and enforce patent protection for pharmaceutical inventions in Brazil, due to the BPTO’s huge backlog (sometimes taking more than 10 years to examine a pharmaceutical application), the peculiar participation of the BFDA, and the governmental and judicial political alignment, some alternative strategies were developed.

In the recent years, for example, our law firm was a pioneer in filing lawsuits to enforce our clients’ data package exclusivity rights, provided for by both the TRIPS Agreement and the local provisions regarding unfair competition. According to section 195, XIV of the intellectual property statute, “unfair competition is committed by any person who discloses, exploits or uses, without authorization, the results of tests or other undisclosed data that have been elaborated with considerable effort and submitted to government entities as a condition for the marketing approval of products.” Such rights are especially relevant to the research-based pharmaceutical companies, which must submit a huge amount of information to the BFDA to demonstrate their innovative products are safe and effective. The statute does not stipulate how long the data package submitted before the BFDA would remain protected.

Case law is still unsettled on how to construe the statute, that is, whether the statute is sufficient to prevent generic companies to rely on the data submitted by the innovator companies, or if the statute only prevents the BFDA from disclosing the data to competitors. Case law is also unsettled with regard to the duration of such rights. In some situations, however, enforcing the mentioned data package exclusivity rights may be the only way to avoid the “free ride” generic industries take by relying on the innovator company’s data package to obtain marketing approval for their generic versions, instead of performing their own clinical trials.

Some of situations can be solved using Food & Drug Law, rather than the intellectual property statute. Substandard drugs are a serious problem in the country, and judges are generally more sympathetic with the idea of enforcing F&D Law to protect consumers instead of looking after IP

rights owned by international pharmaceutical companies.

Despite the many challenges faced by national and foreign companies with regard to the ever-evolving Brazilian intellectual property system, the country has witnessed a few positive advances in recent years. We hope the executive, legislative and judiciary powers will gradually understand the importance of having vigorous and practical structures that stimulate technological and economic development, particularly in the essential pharmaceutical field.

RECENT RULE CHANGES IN THE EUROPEAN PATENT CONVENTION

Dr. Aloys Hüttermann Michalski • Hüttermann & Partner

Düsseldorf/Munich, Germany

On October 16, the Administrative Council of the EPC approved changes to the rules of the European patent convention, some of which may certainly improve the applicant’s life before the Office.

1. Back to the future – divisional applications In 2009, the Administrative Council had – quite to the discomfort of applicants – set a rather complicated time limit for filing divisional applications. The purpose of this amended rule was to limit what the Council and former EPO President Alison Brimelow considered “abuse” of filing divisional applications, including second and third generations of divisionals. However, the amendment led to an even higher number of divisional applications, since now applicants chose to file divisionals as a safeguard measure shortly before the deadline ended.

Now the Administrative Council has decided1 to give Rule 36 the wording it had before, i.e., to allow divisional applications for any pending application without any further time restrictions. This means that divisionals can be filed:

− for granted applications one day before the publication of the notice of grant2

− for refused applications, since the EPO has adopted the “Anders-Rule” from the German practice,3 while the appeal deadline is still running, even if no appeal is filed later.

1 http://www.epo.org/law-practice/legal-texts/official-journal/ac-

decisions/archive/20131024a.html. 2 cf. OJ EPO 2002, 112. 3 Decision G1/09, taking over the decision, Graustufenbild from the

German High Court, GRUR 2000,688, which confirmed a former ruling of the German Patent Court (Bundespatentgericht). Since Judge Anders of the Bundespatentgericht was the judge who highly advocated this jurisdiction, this decision was nicknamed after him.

 

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− for applications which are deemed to be withdrawn until the non-observed time limit has expired (unless there is a request for further processing)

− for applications under appeal which are refused in the oral hearing, one day before the oral hearing

To discourage applicants from filing too many divisionals, there will be increased filing fees for second or higher order divisional applications. The amount of these fees will be decided separately.

The Rule becomes effective on April 1, 2014, and is applicable to all divisional applications filed on or after that date. This means that if applicants have an application for which the two-year period has already run out, they will have a chance to file divisionals again on or after that date. If they have already received a 71(3) allowance, they should try to prolong the granting procedure until then.

2. Rule 164 – Non-unity objection in case of EESR Rule 164 is especially important for PCT applications entering the European regional phase where the International Search Authority (ISA) is not the EPO. In these cases, the EPO will always conduct a further search on its own and issue an extended European search report (EESR).

However, when non-unity was found, the applicant could not ask the EPO to search for further inventions by paying additional search fees. All the applicant could do at this point was to limit the claims to the first invention and try to convince the EPO in the substantive examination that the application indeed was unitary – or to file divisional applications.

With the amended4 rule 164, the applicant can pay additional search fees and have further inventions searched by the EPO. The applicant still has to limit the claims to one invention. However, this does not need to be the first invention and that is surely an improvement.

In any case, the further inventions may be pursued via divisional applications.

The new Rule 164 will become into effective on November 1, 2014, for all applications for which the extended European Search Report had not been drawn up.

4 http://www.epo.org/law-practice/legal-texts/official-

journal/ac-decisions/archive/20131014b.html.

A DISAPPOINTING WEEK FOR EUROPEAN SPC LAW

Edward Oates

Carpmaels & Ransford LLP London, United Kingdom

Those with an interest in European supplementary protection certificate (SPC) law will not look back with much fondness on the middle week of November 2013. First came the Advocate General’s pronouncement in C-484/12 Georgetown II which added to the uncertainty of whether or not a “one SPC per patent” restriction will be enforced. Then broke the news of two reasoned orders from the Court of Justice of the European Union (CJEU, formerly ECJ) in the C-210/13 GlaxoSmithKline and C-617/12 AstraZeneca matters. Each reasoned order adopted a restrictive view of the SPC Regulations. The GlaxoSmithKline decision held that an adjuvant as such cannot be the subject of an SPC and cannot be used to differentiate the “product” of an SPC from the subject-matter of an earlier marketing authorisation (MA) or an earlier SPC. The AstraZeneca decision confirmed that an earlier substandard (and consequently withdrawn) Swiss MA is to be regarded as the first MA in Europe for purposes of determining the term of an SPC.

The negative news was marginally offset by an endorsement from the CJEU in the C-210/13 GlaxoSmithKline ruling of the principles first expounded in last year’s C-130/11 Neurim judgment; namely that it remains possible to obtain SPCs based on “new applications” of old active ingredients. Another small fillip came from the UK Intellectual Property Office which announced a change in the way that it will calculate SPC durations, which will result in certain SPCs lasting a few days longer than under its previous practice.

C-484/12 Georgetown II The issue referred to the CJEU in C-484/12 Georgetown II related to the possibility of having an SPC granted for each product on the basis of a single basic patent in force which covers several products. This question is of relevance to many different fields, such as chemical patents that cover a range of products in a Markush formula, and biotech patents covering different antigens (perhaps as used in vaccines) and different antibody variants. Indeed, the author of this article has identified more than 50 granted SPCs which would potentially be liable to challenge if such a rule were enforced.

Of most significance (and frustration), the Advocate General considers it unnecessary even to

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answer the question of whether patent holders are allowed one SPC per patent or one SPC per product per patent, on the basis that the CJEU already has enough information to answer this question from its earlier C-22/10 Medeva and C-422/10 Georgetown I decisions. The CJEU’s final decision on this matter is likely to be handed down in mid-December.

In terms of ramifications, companies should prepare for the possibility of a significant change in practice in the near future. If the “one SPC per patent” rule is affirmed, then it seems inevitable that in some scenarios problems in obtaining SPC protection lie ahead. Filing divisional applications to protect the products individually could be one solution. In this regard, it appears that the EPO’s forthcoming (April 2014) relaxation of its rules to permit divisional filings at any time up to the day before grant is particularly timely. Of course, a more serious problem may be posed if the CJEU extends the principle beyond “one SPC per patent” to “one SPC per family,” which would negate the possibility of filing divisionals to circumvent the “one SPC per patent” rule.

Legal Background Until recently, it was generally accepted that there was no restriction on the number of SPCs which could be based on a single patent directed to different products. However, at least some national patent offices altered their practice following comments made by the CJEU in C-322/10 Medeva and C 422/10 Georgetown I. Unfortunately, the comments in question were based on paragraph 28 of an earlier decision (C-185/95 Biogen) which referred to the situation where a single product is protected by multiple basic patents, i.e., the court was really stipulating a restriction to one SPC per product per patent. However, this subtlety has been overlooked by some patent offices which have started implementing a “one SPC per patent” rule, and there is now a very real prospect that this rule will shortly become a universal reality if endorsed by the CJEU following the Advocate General’s opinion.

In his opinion, the Advocate General dropped some hints that a “one SPC per patent” rule will be adopted, without giving any clear guidance on this point. However, he did comment that, if such a rule were adopted, in the event that an applicant has filed several SPC applications for different products which are protected by the same patent, the applicant should be allowed to decide which of these SPC applications is a priority and that, in the absence of a choice by the applicant, the national authorities should decide under national law which application proceeds to grant. He also explained that the surrender of an SPC application should not be deemed to have retroactive effect, which would

mean that a granted SPC would be considered to block further SPCs from being granted on the same basic patent. This would apply at least with regard to the same product, and seemingly for other products too, although again the AG’s comments are not a model of clarity on this point.

C-210/13 GlaxoSmithKline The CJEU’s decision in C-210/13 GlaxoSmithKline that an adjuvant is not an “active ingredient” was bad news for the vaccine indusstry. The decision was issued as a reasoned order, without a hearing, because the CJEU considered that the issue was already clearly deducible from C-431/04 MIT, an earlier case relating to pharmaceutical excipients.

An SPC relates to a “product”, which is defined in Article 1(b) of the SPC Regulation (469/2009) as an “active ingredient or combination of active ingredients.” However, the term “active ingredient” is not defined in the SPC Regulation. In the GlaxoSmithKline reasoned order, the CJEU relied heavily on the reasoning given in MIT to conclude that an adjuvant does not fall within the definition of an “active ingredient” and that an adjuvant cannot form part of a “combination of active ingredients” because it does not have a therapeutic effect of its own. The fact that an adjuvant may enhance or be necessary for the therapeutic efficacy of an antigen was not regarded as being sufficient to qualify an adjuvant as an “active ingredient.” The CJEU also drew support from the pharmaceutical regulatory legislation (Directive 2001/83, as amended by Directive 2003/63) which classes adjuvants separately from active substances.

Technical background The GlaxoSmithKline reasoned order follows from two SPC applications filed by GlaxoSmithKline based on the MA for Prepandrix. Prepandrix is a pre-pandemic influenza vaccine consisting of an influenza virus antigen, adjuvanted by a combination of substances (squalene, alpha tocopherol and polysorbate 80) referred to as AS03. The first SPC related to the adjuvant composition, whereas the second SPC related to the combination of adjuvant and antigen.

C-617/12 AstraZeneca Like the C-210/13 GlaxoSmithKline judgment, the C-617/12 AstraZeneca decision was issued as a reasoned order because the CJEU considered the issue could be answered by considering its earlier jurisprudence, in this instance conjoined cases C-207/03 and C-252/03 Novartis and others.

This reasoned order emphasises the importance in appropriate circumstances of using the so-called “negative list” in Switzerland to stop Swiss MAs taking automatic effect in Liechtenstein.

 

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Unfortunately for AstraZeneca, the “negative list” was not available at the time its MA was granted in Switzerland.

Legal background The term of an SPC is determined by the period elapsed between the filing date of the basic patent and the date of the “first authorisation” in the Community, which is reduced by a period of five years. The term of an SPC cannot exceed five years, which means that the holder of a patent and SPC should not enjoy more than 15 years of exclusivity from the time that the medicinal product first receives authorisation to be placed on the market in the Community (Article 13 of Regulation 469/2009). There is, however, a possibility of extending the term to five-and-a-half years based on paediatric studies.

The “first authorisation” in the Community includes first authorisations in Norway, Iceland and Liechtenstein, as well as in EU Member States, because Norway, Iceland and Liechtenstein are European Free Trade Association (EFTA) states. Furthermore, as confirmed in Novartis and others, an MA granted in Switzerland may count as a “first authorisation” in the Community if it is effective in Liechtenstein (part of the EEA), (even though Switzerland is not part of either the EU nr the EEA), as a result of a customs agreement between Switzerland and Liechtenstein, which means that Swiss MAs can be automatically recognised in Liechtenstein.

AstraZeneca had filed a UK SPC application and held the view that the term of the SPC should be calculated by reference to the MA granted by the European Medicines Agency (EMA). However, the UK Intellectual Property Office had calculated the term of AstraZeneca’s SPC application by referring to the date of a Swiss MA, which significantly shortened the SPC term by a period of approximately two years.

AstraZeneca argued that an earlier Swiss MA was not the “first authorisation” in the Community because it did not comply with the relevant EU Directives, which it said was supported by the fact that the EMA refused to grant an MA for the same medicinal product on the basis of similar clinical data. It also derived support from the fact that the Swiss MA was subsequently suspended.

In the AstraZeneca reasoned order, the CJEU used the reasoning handed down in Novartis and others to conclude that an administrative authorisation issued for a medicinal product by the Swiss regulatory authority, which is automatically recognised in Liechtenstein, must be regarded as the “first authorisation” for the purposes of determining the term of an SPC. The fact that the EMA refused to grant an MA for the same

medicinal product on the basis of similar clinical data, and that the Swiss MA was subsequently suspended, was deemed to be irrelevant.

Conclusion December is set to be an important month for European SPC law with three further rulings from the CJEU anticipated, including a final conclusion in the Georgetown II “one SPC per patent” debate. The innovative side of the pharma industry will be hoping that December’s rulings bring more welcome news than the GlaxoSmithKline and AstraZeneca decisions. Both sides of the industry will be united in hoping that the forthcoming rulings are written with a clarity that, sadly, has been lacking from some of the recent SPC jurisprudence.

Edward Oates is a partner at Carpmaels & Ransford LLP.

LEGAL FRAMEWORK FOR DESIGN PROTECTION IN TAIWAN

Candy K.Y. Chen

Tsai, Lee & Chen Taipei, Taiwan

In Taiwan, designs are protected under the patent law framework. A design must meet the patentability criteria of novelty, creativeness and industrial applicability in order to be eligible for patent protection. According to the Patent Act, a design is a visual creation emphasizing the ornamental features of a whole article or part of an article.

The Patent Act underwent a dramatic change in the beginning of 2013, and several new types of design creation are now eligible for design patents, such as:

l designs in part;

l computer-generated icons applied to an article; and

l a graphical user interface (GUI) applied to an article.

The new Act also allows two or more articles which belong to the same classification and can customarily be sold or used together to be claimed in a single design application. In addition, the associated design category is no longer available; it has been replaced by a derivative design, which extends the protection to cover a design similar to an original design filed by the same applicant.

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Subject matter for designs The design patent system allows the following subject matter to be filed in a design application:

l a design applied to a single article;

l a design with several composition elements united as a single article group (e.g., a chess set or a dominoes set). The entire grouping of the composition elements is regarded as a single design creation;

l a design-in-part applied to an article, which pertains to a specific part of an article that carries design features;

l a computer-generated icon and the GUI applied to an article, as well as the specific animation sequence of the icon or GUI. However, these types of designs must be designated for use in a particular article (e.g., the screen of a tablet computer, a smartphone display or a control panel of a washing machine), otherwise, the icon or the GUI would be just a two-dimensional (2D) image and could not be claimed as a patent;

l a design of a set of articles which belong to the same international classification for industrial designs and are customarily sold or used together (e.g., a tableware set that includes glasses, pans and dishes under Class 7 [Household goods, not elsewhere specified]); and

l a derivative design which is provided for the same applicant that owns two or more similar designs to file several derivative designs originated from or similar to the original design, to obtain a more complete scope of patent protection.

Non-statutory subject matter Non-statutory subject matter for a design patent application includes the shape of an article dictated solely by its function, an artistic work, the layout of an integrated circuit and electronic circuits, and an article that is contrary to public order or morality, even though such a creation may correspond to the definition of a design.

Drawings Requirement When filing a design patent application, an applicant must submit an application form, a specification and drawings to the TIPO. In general, the drawings should include six directional views (i.e., front, rear, left side, right side, top plane and bottom plane views), and a perspective view of the claimed design if the patent application claims a design for a three-dimensional (3D) article, unless certain views are symmetrical or identical to others. If two or more perspective views are to be

submitted together, these views should illustrate all six directions of the claimed design.

(1) Designs claiming a color For designs claiming a color, that color must be illustrated or identified by the industrial standard color code. For designs claiming a pattern applied to a 2D article (e.g., packaging paper or tissue), a 2D view illustrating the overall design and a unitary drawing showing a repetition of the claimed pattern must be submitted (see below).

(2) Partial design or design-in-part For a design-in-part applied to an article, the part to be claimed and the part(s) not claimed must be illustrated in a distinguishable manner (i.e., broken lines versus solid lines, shaded portion versus non-shaded portion, or different grayscales). If none of these ways of distinguishing claimed and non-claimed parts can be used easily, the part that is claimed or not claimed may be highlighted by broken lines and then identified in the description of the drawings. The design drawings shown below show different ways in which claimed and non-claimed parts can be distinguished from each other.

Although the non-claimed parts do not serve to define the scope of the claimed design, they serve to illustrate the relative position, size and

 

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arrangement of the claimed part with respect to the non-claimed parts.

(3) Icon and GUI For icon and GUI designs, the hardware, which is generally not claimed, is usually illustrated by broken lines, as shown below.

(4) GUI animation For GUI designs that consist of a series of images that form an animation, the overall number of images and the sequence of the series of images must be identified, and these features will also serve to define the scope of protection. For example, when interpreting the scope of the GUI animation design below, if the removal of an image, addition of other images or alteration of the image sequence will result in a substantially different visual impression, the result of such removal, addition or alteration will constitute a different design.

(5) Plural icons For a GUI consisting of a set of plural icons, if the relative positions of the plural icons are not claimed, they must be illustrated in a manner that does not require the icons to be in a designated arrangement with respect to each another (i.e., separated by broken lines enclosing the individual icons and clearly explained in the description). For example, with respect to the two designs below, although they consist of the same set of icon elements, they will be interpreted to have different scopes - the relative positions of the plural icons for the design on the left do not form a part of the scope of protection for this design, while the relative positions of the plural icons for the design on the right do form a part of the scope of protection for this design.

Priority claims in design applications According to the patent examination guidelines formulated by TIPO, each design application may claim priority only to a single priority application. If the design to be claimed in the Taiwan application is the result of merging plural designs from more than one priority application, a claim to priority will not be recognized by TIPO. The priority claim will be recognized only if the design claimed in the Taiwan application is fully disclosed by a single priority application. In this regard, if the priority application discloses a design-in-part with parts that are disclaimed being illustrated in broken lines, as exemplified by the design on the left below, the Taiwan design application may claim the same design-in-part or a complete design with the broken lines being replaced with solid lines, as exemplified by the design on the right below.

However, if the priority application does not illustrate the parts that are disclaimed in any form, the priority claim to such a priority application will not be recognized.

Furthermore, since the parts that are disclaimed still serve to illustrate the relative position, size, and arrangement of the claimed part with respect to the disclaimed parts, in order for TIPO to recognize the priority claim to a priority application containing disclaimed parts, if the disclaimed parts cannot be easily separated from the claimed parts or may possibly be deemed by TIPO as essential to illustrate the relative position, size, and arrangement of the claimed part, the Taiwan application must also disclose such parts

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in order to be considered as fully disclosed by the priority application.

For example, a Taiwan design application claiming a pattern as exemplified below on the right would not be considered to be disclosed by the priority application as exemplified below on the left.

Likewise, even if a Taiwan design application illustrates parts that are disclaimed in broken lines, as exemplified below on the right, where such parts are not illustrated in the priority application, as exemplified below on the left, the priority claim will not be recognized by TIPO since addition of the parts illustrated in broken lines would result in a different design with different relative position, size, and arrangement of the claimed part with respect to the disclaimed parts.

In Taiwan, design patent applications are subject to both formality and substantive examinations.