View source for Directive on the legal protection of biotechnological inventions

{{short description|European Union directive in the field of patent law}}
{{EngvarB|date=July 2018}}
{{Use dmy dates|date=July 2018}}
{{Infobox EU legislation
|type=Directive
|number=98/44/EC
|title=Directive on the legal protection of biotechnological inventions
|madeby=[[European Parliament]] & [[European Council|Council]]
|madeunder=Art. 100a
|OJref=L213, 30 July 1998, pp.&nbsp;13–21
|OJrefurl=http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:1998:213:0013:0021:EN:PDF
|made=1998-07-06
|commenced=1998-07-30
|implementation=2000-07-30
|CommProp=C296, 1996-10-08, p.&nbsp;4.<br/>C311, 1997-10-11, p.&nbsp;12.
|ESCOpin=C295, 1996-10-07, p.&nbsp;11
|ParlOpin=C286, 1997-09-22, p.&nbsp;87.<br/>C167, 1998-06-01
|Reports=COM(2002) 2<br/>COM(2002) 545<br/>COM(2005) 312
|replaces=—
|amends=—
|amendedby=—
|replacedby=—
|status=Current
}}

'''Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions''' 
is a [[European Union directive]] in the field of patent law, made under the [[Single European market|internal market]] 
provisions of the [[Treaty of Rome]]. It was intended to harmonise the laws of Member States regarding the [[patentability]] 
of [[Biotechnology|biotechnological]] [[invention]]s, including [[Plant variety (law)|plant varieties (as legally defined)]] and [[Human gene|human]] [[Gene patent|genes]].

== Content ==
The Directive is divided into the following five chapters:
  
* Patentability (Chapter I)
* Scope of Protection (Chapter II)
* Compulsory cross-licensing (Chapter III)
* Deposit, access and re-deposit of biological material (Chapter IV)
* Final Provisions (entering into force) (Chapter V)

==Timeline==
The original proposal was adopted by the [[European Commission]] in 1988. The procedure for its adoption was slowed down by primarily [[ethics|ethical]] issues regarding the patentability of living matter. The [[European Parliament]] eventually rejected the joint text from the final [[Conciliation]] meeting at 3rd reading on 1 March 1995 so the first directive process did not yield a directive.<ref>{{cite web|url=http://ec.europa.eu/prelex/detail_dossier_real.cfm?CL=en&DosId=100993 |title=EURLex – 100993 – EN – EUR-Lex |publisher=European Commission |access-date=24 February 2015}}</ref>

On 13 December 1995, the Commission adopted a new proposal was nearly identical to the rejected version, was changed again, but the Parliament put aside its ethical concerns on patenting of human genes in on 12 July 1998 in its second reading and adopted the Common Position of the [[Council of the European Union|Council]], so in the second legislative process, the directive was adopted.<ref>{{cite web|url=http://www.europarl.europa.eu/omk/omnsapir.so/calendar?APP=PDF&TYPE=PV1&FILE=19980512EN.pdf&LANGUE=EN |title=Part 1 : Proceedings of the sitting |publisher=European Parliament |access-date=24 February 2015}}</ref><ref>{{cite web|url=http://ec.europa.eu/prelex/detail_dossier_real.cfm?CL=en&DosId=11643 |title=EURLex – 11643 – EN – EUR-Lex |publisher=European Commission |access-date=24 February 2015}}</ref> The drafts person of the Parliament for this second procedure was Willi Rothley and the vote with the most yes votes was Amendment 9 from the Greens which got 221 against 294 votes out of 532 members voting
with 17 abstentions but 314 yes votes would have been required to reach the required an absolute majority to adopt it.

On 6 July 1998, a final version was adopted. Its code is 98/44/EC.

The [[Kingdom of the Netherlands]] brought Case C-377/98<ref>[http://www.curia.europa.eu/en/actu/activites/act01/0125en.htm#ToC1]  {{webarchive |url=https://web.archive.org/web/20070819165356/http://www.curia.europa.eu/en/actu/activites/act01/0125en.htm#ToC1 |date=19 August 2007 }}</ref> before the [[European Court of Justice]] against the adoption of the directive with six different pleas but the Court granted none of them.

Nevertheless, the ECJ decision does not preclude a further test of the validity of the directive on the ground that it is inconsistent with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).<ref>{{cite web|url=http://www.wto.org/english/tratop_e/trips_e/t_agm0_e.htm |title=intellectual property (TRIPS) – agreement text – contents |publisher=WTO |access-date=18 August 2013}}</ref> Art. 27.1 TRIPS provides that patents are only to be granted with respect to 'inventions'.  The directive, however, provides that "biological material which is isolated from its natural environment ... may be the subject of an invention even if it previously occurred in nature."  It is clearly arguable that merely isolating a human gene or protein from its natural environment is not an activity that can come within the meaning of the word 'invention'.  The Danish Council of Bioethics in its Patenting Human Genes and Stem Cells Report<ref>[http://www.etiskraad.dk/sw475.asp]  {{webarchive |url=https://web.archive.org/web/20061010131657/http://www.etiskraad.dk/sw475.asp |date=10 October 2006 }}</ref> noted that "In the members' view, it cannot be said with any reasonableness that a sequence or partial sequence of a gene ceases to be part of the human body merely because an identical copy of the sequence is isolated from or produced outside of the human body."  TRIPS applies to the European Community as it is a member of the World Trade Organization (WTO) in its own right and accordingly must ensure "the conformity of its laws, regulations and administrative procedures with obligations as provided" by the WTO.<ref>{{cite web|url=http://www.wto.org/english/docs_e/legal_e/04-wto_e.htm |title=legal texts – Marrakesh agreement |publisher=WTO |access-date=18 August 2013}}</ref>

On 14 January 2002, the Commission submitted an assessment of the implications for basic genetic engineering research of failure to publish, or late publication of, papers on subjects which could be patentable as required under Article 16(b) of this directive.<ref>{{cite web|url=http://ec.europa.eu/prelex/detail_dossier_real.cfm?CL=en&DosId=170903 |title=EURLex – 170903 – EN – EUR-Lex |publisher=European Commission |date=14 January 2002 |access-date=24 February 2015}}</ref>

==Campaigning and lobbying==
According to [[SmithKline Beecham]] lobbyist Simon Gentry, the company allocated 30 million [[European Currency Unit|ECU]] for a pro-Directive campaign.<ref>[http://www.corporateeurope.org/observer1/patents.html ''Industry and the EU Life Patent Directive''] {{Webarchive|url=https://web.archive.org/web/20060629063657/http://www.corporateeurope.org/observer1/patents.html |date=29 June 2006 }}, Corporate Europe Observer, Issue 1, May 1998, citing ECOBP, "''The Big Mirage: The Misuse of the Patient with Hereditary Diseases Before the EP's Vote in 1997''" an ECOBP Background Paper, March 1998, page 4</ref> Part of this campaign was direct support of patient charities and organisations. On the day of the July 1997 vote, a number of people in wheelchairs from these groups demonstrated outside the main hall in [[Strasbourg]], chanting the pharmaceutical industry's slogan, "No Patents, No Cure" in an emotional appeal to Parliamentarians to vote for the Directive.<ref>{{cite web|last=Simpson |first=Alan |url=http://www.thecornerhouse.org.uk/resource/no-patents-life#index-02-00-00-00 |title=No Patents on Life |publisher=The Corner House |date=1 September 1997 |access-date=24 February 2015}}</ref>

== Implementation ==
As of 15 January 2007, all of the 27 EU member states had implemented the Directive.<ref>{{cite web|url=http://ec.europa.eu/internal_market/indprop/docs/invent/state-of-play_en.pdf |title=State of Play of the Implementation of Directive 98/44/EC |publisher=European Commission |access-date=24 February 2015}}</ref>

== See also ==
*[[Biological patent]]
*[[Patent law of the European Union]]
*[[G 2/06]], decision of the Enlarged Board of Appeal of the European Patent Office (EPO) of 25 November 2008, relating to (non-patentability of) inventions involving the use and destruction of human embryos.

== References ==
{{Reflist}}

== External links ==
*[http://europa.eu/legislation_summaries/internal_market/single_market_for_goods/pharmaceutical_and_cosmetic_products/l26026_en.htm EU Legislation summary]
*[http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:1998:213:0013:0021:EN:PDF Text of the directive (pdf)]
*[http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31998L0044:EN:NOT Text of directive with headers (html)]
*[http://register.consilium.europa.eu/pdf/en/05/st11/st11341.en05.pdf Report from the Commission to the Council and the European Parliament, Development and implications of patent law in the field of biotechnology and genetic engineering], 2005-07-14
*[http://ec.europa.eu/internal_market/en/indprop/invent/2k-39.htm FAQ] from the Commission Directorate-General for the Internal Market
*[http://ec.europa.eu/internal_market/indprop/invent/index_en.htm Reports and other documents concerning European Commission activities in the area of biotechnological inventions] from the Commission Directorate-General for the Internal Market
*[https://web.archive.org/web/20050322152642/http://www.patent.gov.uk/about/ippd/issues/bioinvent.htm Issues] from the [[UK Intellectual Property Office]]
*[http://www.ladas.com/Patents/Biotechnology/EPOBiotechInventions/BiologicalInventions.html Some biotechnological inventions] registered at the [[European Patent Organisation|European Patent Office]] (''unofficial site'')
*[http://www.murdoch.edu.au/elaw/issues/v11n1/hakki111.html Paper]
*Baruch Brody, 2007.  "Intellectual Property and Biotechnology: The European Debate,” Kennedy Institute of Ethics Journal 17(2): 69–110. [http://muse.jhu.edu/journals/kennedy_institute_of_ethics_journal/v017/17.2brody.pdf]

{{Intellectual property laws of the European Union}}

{{DEFAULTSORT:Directive On The Legal Protection Of Biotechnological Inventions}}
[[Category:Biological patent law]]
[[Category:Patent law of the European Union]]
[[Category:1998 in law]]
[[Category:1998 in the European Union]]
[[Category:Life sciences industry]]