Patent strategy: The patent decision-making and prosecution process explained.

Transcription

1 Patent strategy: The patent decisin-making and prsecutin prcess explained. Intrductin: The gal f the cmmercializatin prcess is a license that leads t cmmercial use r develpment f the technlgy/inventin, and nt t btain a patent per se. We make the decisin t file a patent when we believe that patent prtectin is necessary t stimulate cmmercial interest in an inventin s that we can successfully land a licensee. The types f inventins that we mst frequently patent are therapeutics (mlecules & methds), devices, and vaccines. The decisin t file a patent applicatin n an early-stage, but prmising inventin represents a calculated risk n ur part that we ll be able t find a licensee fr it. In sme cases taking that risk is rewarded and we license the inventin, and in thers it is nt, and the underlying reasns vary frm case t case. Patent prtectin, and the exclusivity that cmes with it, is necessary t stimulate a cmpany t expend the resurces that it will take t develp an inventin and t shepherd it thrugh the regulatry apprval prcess. What is a patent? A patent is a dcument granted by a gverning bdy that cnfers an exclusinary right t an inventr t make, use, and sell the inventin claimed in the patent fr a set time perid. In the United States, the basis fr the patent system is described in Article 1, Sectin 8, Clause 8, f the U.S. Cnstitutin, which states: The Cngress shall have the pwer T prmte the prgress f science and the useful arts, by securing fr limited times t authrs and inventrs the exclusive right t their respective writings and discveries; The fact that a patent is an exclusinary right means that the patent hlder has the right t exclude thers frm practicing the claimed inventin, but it des nt guarantee the patent hlder the right t practice the inventin. Fr example, an inventr develps an autmated navigatin system fr a car t allw a car t be perated withut a driver. The inventr files a patent applicatin and btains an issued patent with claims directed t an autmbile cntaining the autmated navigatin system. Other parties, like car manufacturers, have patents with claims directed t autmbiles, s the inventr f the autmated navigatin system can t manufacture cars cntaining the navigatin system withut btaining licenses t the third party patents claiming autmbiles. But, the inventr has the right t exclude anyne, including these hlders f autmbile patents, frm manufacturing cars cntaining the claimed navigatin system. This is what is meant by the exclusinary right the patent hlder desn t necessarily have freedm-t-perate with the claimed inventin if there are third-party patents cvering ther cmpnents f a final prduct, but the inventr can exclude thers frm practicing his/her claimed inventin in a prduct in the absence f a license agreement with the inventr. Basic patent strategy cnsideratins. The gal f the patent prsecutin prcess is t prsecute and btain claims that wuld be f interest t a cmmercial licensee. The patent must add value t the inventin in a manner that is necessary t induce cmmercial investment in it. Claims that describe the inventin in ways that are relevant t hw it will be marketed and sld (pharmaceutical cmpsitins, frmulatins, kits, devices, etc.) by a cmmercial licensee are ptimal. We are mst likely t receive clearly enfrceable claims if the claims cver a cmpsitin f matter cmprising the inventin. Claims that nly describe an inventin in terms f methds fr using it may be mre challenging t enfrce and easier fr third parties t wrk arund. Therefre, they generally aren t as valuable t a licensee as cmpsitin f matter claims. As a matter f practice we dn t patent research tls genetically engineered mice, cell lines, etc. If the tl is useful, the gal is nt t exclude use, but rather t prmte it and disseminate the tl widely. This gal is cnsistent with NIH guidance n the sharing f

2 mdel rganisms. BCM cntrls access t the tl, and by pricing the tls realistically, we find the cmpanies will readily pay fr access t tls and reagents that add value t their R&D effrts. Patentable subject matter. In rder fr an inventin t be patentable, it must meet the fllwing criteria: The inventin must be patent-eligible subject matter: This prvisin essentially stipulates that anything under the sun made by man, can be ptentially be patentable. Nnpatentable subject matter includes: Laws f nature. Natural phenmena. Abstract ideas. The inventin must be nvel: The nvelty requirement means that fr an inventin t be patentable, it must nt be described in a prir art reference anywhere in the wrld. If a patent examiner rejects an inventin n the basis f nvelty, the applicant must describe hw the new inventin differs frm that f the prir art. Many inventins, particularly in the device field where incremental advances are cmmn, will have similarities t inventins described in the prir art, and the patent applicant must describe hw their new inventin teaches away frm the prir art. There is a ne-year grace perid in the United States, meaning that a U.S. patent applicatin can still be filed within ne year f the initial public disclsure f the inventin. Hwever, n such grace perid exists in mst ther cuntries in the wrld, including Eurpean cuntries. Once an inventin has been publicly disclsed, the ability t patent it in mst cuntries f the wrld is permanently lst. With the recent passage f the America Invents Act (AIA), n March 16, 2013, the United States transitined frm a first-t-invent system fr awarding a patent t a first-inventr-t-file system, which is mre cnsistent with patent law in ther cuntries. What this means t an inventr is that if yu invent an inventin, and anther inventr independently develps the same inventin and files a patent applicatin claiming the inventin prir t yur patent filing date, then the ther inventr stands t be awarded the patent. The inventin must be nn-bvius t a persn having rdinary skill in the art. If an inventin represents an bvius extensin r derivative f an inventin described in the prir art, it may nt be patentable. The inventin may face an bviusness rejectin if the patent examiner can cmbine multiple prir art references with the assertin that a persn with skill in the art wuld have been able t develp the same inventin be cmbining the teaching f the prir art references. Obviusness rejectins are very cmmn in the patent prsecutin prcess, particularly with regard t inventins in the bitech arena with its heavy cncentratin f prir art in the scientific and patent literature. Hwever, bviusness rejectins can be vercme if the patent applicant can demnstrate

3 hw the inventin teaches away frm the prir art, particularly if the inventin is based n unexpected results that wuld nt have been anticipated by a review f the relevant prir art. Obviusness rejectins may als be vercme by technical arguments that describe why the teachings f the references in the cmbinatin are incmpatible r cannt therwise be cmbined. The inventin must have a specific, substantial, and credible utility. This requirement means that the inventin must be applicable t sme srt f industrial use. The utility requirement is typically nt ne that cmes in t play during the patent prsecutin prcess. If it were difficult t establish a specific, credible utility assciated with an inventin, we wuldn t elect t file a patent n it in the first place. The inventin must be sufficiently described in the patent applicatin. The inventin must be enabled: This requirement means that the inventin must be sufficiently described in the specificatin f the patent applicatin such that a persn skilled in the art culd make and use the inventin based n the descriptin withut the need fr undue experimentatin. The enablement requirement is frequently used as justificatin by a patent examiner t reject claims in bitechrelated patent applicatins filed by academic institutins in which the patent applicant is attempting t claim a therapeutic cmpsitin r methd fr use in treating a certain human disease, but the inventin is lacking cnclusive data frm relevant animal mdel systems. The decisin t file a patent applicatin in the academic envirnment is ften driven by a pending public disclsure, s we may have t file a patent applicatin in rder t avid a ptential lss f rights, but in ideal wrld, we might wish t wait t file the applicatin until mre enabling/supprting data can be develped. During the examinatin prcess, the examiner will ften assert that a skilled artisan wuld have t engage in undue experimentatin in rder t determine hw t practice the claimed inventin, and the patent applicant must be able t prvide data/evidence (linked t the descriptin f the inventin in the specificatin f the patent applicatin) supprting the cntentin that the inventin can be practiced as claimed. This prcess frequently results in amendments t the claims f the patent t adjust their scpe t parameters that the examiner believes are enabled. Recent Supreme Curt Cases Impacting Patent-Eligible Subject Matter: May v. Prmetheus: This case revlved arund the measurement f a knwn metablite and use f the measurement t determine therapeutic efficacy f a cmpund. The claimed inventin was ruled as being ineligible fr a patent because the claims invlved interpretatin f a knwn law f nature with n transfrmative step. The decisin is cntrversial, and has had negative impacts n inventins cnsisting f claims drawn t diagnstic methds. Assciatin f Mlecular Pathlgy v. Myriad Genetics: This case invlved a series f patents wned r cntrlled by Myriad Genetics with claims drawn t islated DNA sequences, and methds t diagnse cancer by examining the sequences fr mutatins. The Supreme Curt held that a naturally ccurring DNA segment is nt patentable merely because it has been islated. The

4 curt held that artificially created cdna mlecules are patent eligible because they aren t naturally ccurring. The Bilski case: This Supreme Curt case invlved claims directed t a methd fr hedging risk in cmmdities trading, but the implicatins f the curt s decisin g beynd the claimed methd and state that in rder t be patent eligible, the claim must be tied t a machine r apparatus, r must invlve a transfrmative step that transfrms a particular article int a different state r thing. Cllectively, these three high-prfile cases have had a chilling effect n patent claims drawn t diagnstic methds. In this era f increasingly persnalized medicine and increasing use f diagnstic tests t direct treatment, there is cncern that these cases may lead t decreased cmmercial investment in new diagnstic technlgies and tests. Inventrship n a Patent Inventrship is a legal determinatin, and differs frm authrship n a scientific publicatin. Inventrship n a patent is tied t the act f cnceptin f the inventin. If a persn did nt cntribute t the cnceptin f the inventin, they are nt an inventr, even if they helped reduce the inventin t practice. There is n requirement fr reductin t practice in rder t be an inventr. One can make an inventive cntributin by cntributing t the cnceptin f the inventin withut being persnally invlved in carrying ut the prcess f enabling the inventin, prvided that carrying ut this prcess des nt require additinal inventive cntributin. Hwever, as stated in the sectin abve, in rder fr a patent t actually issue, the inventin must be sufficiently described in the patent t enable a skilled artisan t make and use it. With regard t jint inventrship, if a persn cntributes t ne claim n the patent applicatin, they are an inventr, and will be an inventr n any subsequent patent that issues that cntains the claim t which they made an inventive cntributin. Individuals may be jint inventrs even if they did nt physically wrk tgether r at the same time, and even if the type r amunts f their respective cntributins t the inventin are different. There is n requirement that an inventr make a cntributin t every claim n the patent applicatin t be listed as an inventr. An inventive cntributin t a single claim is sufficient. Differences between inventrship and authrship. An individual wrking under the directin and supervisin f a labratry PI might well be listed as an authr n a scientific publicatin cntaining data develped by the individual. Let s suppse this same wrk leads t the develpment f a patent applicatin; unless this individual als made cntributins t the cnceptin f at least ne claim in the patent applicatin, they shuld nt be listed as an inventr. Additinally, there is n significance assciated with the rder in which inventrs are listed n a patent applicatin. An individual is either an inventr, r they are nt. This differs frm typical practices arund the listing f authrs n a scientific publicatin, such that the individual(s) wh did the lin s share f the wrk are listed first, and the labratry PI is

5 ften listed last. This cnventin des nt apply t the listing f inventrs n a patent. There is n such thing as a senir inventr, r a junir inventr. Wh makes the inventrship determinatin? Why is it s imprtant? Because inventrship is a legal determinatin, this determinatin is made by utside patent legal cunsel at the time that the patent applicatin is being drafted. Verifying crrect inventrship is imprtant fr insuring the enfrceability f the ensuing patent. If the inventrship n a patent is incrrect, it can pen the dr fr a third party t challenge the validity f the patent and ptentially verturn it. The Patent Prsecutin Prcess Patent Prsecutin is a Lengthy Prcess: As a faculty inventr, prepare yurself fr a lng jurney. The span f time frm the date that a patent applicatin is filed until the inventr receives an issued patent (if this happens) is a lengthy ne and can encmpass a range f years. Sme cases can issue in 3-4 years after filing, while mre cmplex cases can take 7-8 years (r mre), befre the patent is granted. It is very difficult t predict the pendency perid when an applicatin is filed. There are nging effrts at the United States Patent & Trademark Office t reduce the patent pendency perid. Patent Life: The term f a patent is 20 years frm the filing date f the earliest nn-prvisinal U.S. applicatin t which the patent claims pririty. Patent Legal Cunsel: Baylr Cllege f Medicine wrks with utside law firms that have experience in patent drafting and prsecutin. These firms are engaged by the BCM Office f General Cunsel (OGC), ften in cnsultatin with BLG prject managers. Outside patent law firms are chsen based n the relevance f their technical expertise t the inventin, the quality and value f their service, and their understanding f factrs that impact university patenting decisins and strategy. Mst utside patent cunsel wh are engaged by the cllege have dual backgrunds in science and law (a cmbinatin f Ph.D. and J.D., fr example). In additin t attrneys, law firms frequently emply Patent Agents (smene wh is admitted t practice befre the USPTO, but nt an attrney) with strng technical backgrunds. Patent agents are ften the trps n the grund and are frequently respnsible fr much f the drafting f a patent applicatin, and they are ften heavily invlved in managing the patent examinatin prcess (acting under supervisin f a mre senir attrney). Prvisinal Patent Applicatins: The first step in the patent prsecutin jurney will almst always invlve the preparatin and filing f a prvisinal patent applicatin. Prvisinal patent applicatins are nt examined by a patent examiner, but they can useful fr establishing the pririty date fr an inventin, t the degree that the inventin is described in the prvisinal applicatin. Like mst academic institutins, ur decisin t file a prvisinal patent applicatin is ften driven by a pending public disclsure f the inventin (meeting abstract, pster, r presentatin; r a manuscript). Filing a prvisinal patent applicatin can prtect prprietary rights assciated with an inventin that wuld therwise be lst thrugh public disclsure. Hwever, the scpe f rights prtected under the prvisinal applicatin limited t the degree that the inventin is described in the initial filing. Althugh a cver sheet prvisinal patent applicatin can be filed as a last minute slutin fr urgent and unexpected situatins, it is t the cllege s strng advantage (and yurs, as a

6 faculty inventr) t file a mre cmpletely develped applicatin that is facilitated by disclsure f the inventin t BLG in plenty f time t craft a fleshed-ut applicatin. Prvisinal patent applicatins must be cnverted t a nn-prvisinal patent applicatin within ne year f the prvisinal filing date. Additinal new data that have been develped during the intervening year can be added t the nn-prvisinal applicatin t mre fully describe and supprt the parameters f the inventin. Cnversin f a prvisinal patent applicatin t a nn-prvisinal applicatin is cstly, s we will nly cnvert a prvisinal applicatin if it makes business sense, i.e., we have fund r will very likely find a licensee in the near future t pay fr nging patent csts. If we ve marketed the inventin and received negative feedback frm ptential licensees, we may elect nt t the cnvert the applicatin. Additinally, if data develped during the year between the prvisinal filing date and the cnversin date fail t supprt the case fr cntinued prsecutin (experiments may have yielded negative r incnclusive data), we may elect nt t cnvert a prvisinal applicatin. The decisin t cnvert is always driven by the degree t which the patent applicatin may add value t the inventin in a way that is necessary t secure a licensee. Nn-Prvisinal Applicatins: When a decisin is made t cnvert a prvisinal applicatin, we will frequently elect t file a nn-prvisinal PCT applicatin. The acrnym PCT stands fr Patent Cperatin Treaty, which is a treaty that has been signed by ver 140 member cuntries, including all majr glbal ecnmic leaders (cuntries where we might wish t file). Once we ve prepared and filed a PCT applicatin, this acts as a gateway t prvide the patent applicant with the ptin t enter the natinal phase f patent prsecutin in any PCT signatry cuntry. The natinal phase entry deadline ccurs eighteen (18) mnths after the cnversin date. During this interim perid, BLG will nrmally actively market the inventin and seek t execute a license with a cmmercial partner prir t the natinal phase entry deadline. The csts assciated with cntinued patent prsecutin dramatically ramp up nce the natinal phase f prsecutin is initiated. Fr inventins that had been publicly disclsed prir t filing a patent applicatin, if we cnvert t a nn-prvisinal applicatin, we will cntinue prsecutin in the U.S. alne. The Natinal Phase Entry Decisin: The natinal phase entry decisin must be made within 18 mnths f the PCT applicatin filing date; r 30 mnths frm the initial prvisinal filing date. At the natinal phase entry pint (actually, a cuple f mnths befre the deadline) we will instruct ur patent cunsel t enter cuntries where we desire t cntinue patent prsecutin. Entry int freign cuntries requires a very substantial investment, and fr this reasn the cllege seldm elects t cntinue freign patent prsecutin int the natinal phase, unless we have a licensee supprting patent prsecutin csts. Natinal stage filing and prsecutin in a limited set f cuntries (U.S., Eurpe (via the Eurpean Patent Office), Canada, Australia, Japan, and ptentially China and India) will easily tp $150,000 r mre. In additin t fees and annuities, translatin csts are big driver f freign patent filing csts. Fr these cst-driven reasns, we aim t have a licensee in place t supprt freign filing and prsecutin csts in advance f the natinal phase deadline. If we re appraching this deadline withut a licensee in place, decisins will have t be made regarding the scpe f cntinued prsecutin. The Patent Examinatin Prcess: Once the decisin has been made t prepare and a file a nnprvisinal applicatin and cntinue prsecutin, the applicatin will be examined by a patent examiner. The examinatin prcess is lengthy - we may nt expect t see an Office Actin frm the patent examiner fr tw years r mre frm the cnversin date. The examinatin prcess, and ur dds f successfully btaining an issued patent, can be impacted by several factrs:

7 (i) (ii) (iii) The prir art that is relevant t the inventin (including the inventr s wn previusly published wrks). If the inventin resides in a ht area f scientific study, it is likely that multiple citatins frm the art will be used by the examiner t assert that the inventin is nt nvel, r that it is anticipated by the existing art. The skill and expertise f the patent examiner this is a factr ver which the applicant has n cntrl. Sme examiners will exhibit a gd grasp f the elements f the inventin, while thers may require cnsiderable effrt n the part f the applicant t educate the examiner regarding the features f the inventin and hw it differs frm the prir art, etc. The willingness f the faculty inventr t be actively engaged in the prcess and wrk prductively with utside patent cunsel. The amunt f time that a faculty member might be expected t cmmit t the patent prsecutin prcess will vary with the cmplexity f the case and the types f bjectins raised by the patent examiner. An engaged inventr is always a strng asset in the quest t btain an issued patent with claims that will appeal t a cmmercial licensee. During the examinatin prcess, the patent applicant can expect t have their claims denied by the patent examiner. The prcess f patent examinatin really bils t a negtiatin between the applicant and the examiner t determine the scpe f the claims f the eventual issued patent. Faculty inventrs can expect t wrk with utside patent cunsel t craft respnses t the examiner in ur effrt t get claims t issue. The utside patent cunsel that the cllege engages will have technical expertise that is relevant t yur inventin, but as the inventr, yur depth f knwledge and expertise related t the inventin and yur field f study will be essential t secure a successful utcme. Restrictin Requirements & Office Actins: The first cmmunicatin that we can expect t receive frm the patent examiner (an Office Actin ) will mst ften be a Restrictin Requirement. The patent examiner will review the claims f the patent applicatin, and if he/she believes that the claims represent mre than ne distinct inventin (a pharmaceutical cmpsitin vs. a methd f using it, fr example), the examiner will divide the claims int distinct grups (the prcess f restrictin). The patent applicant must then chse a single claim grup t pursue thrugh cntinued prsecutin. The remaining claim grups may als be prsecuted at a later date in separate patent applicatins called divisinal applicatins. The applicant s respnse t the Restrictin Requirement will be fllwed by a series f Office Actins, during which the patent applicant can generally expect t have their claims denied by the patent examiner. Claims may be rejected n the basis f bviusness, lack f enablement, lack f nvelty, r fr ther reasns. Our experience with prsecuting patents in the bimedical sphere is that claim rejectins based n bviusness and/r lack f enablement are very cmmn. Our utside patent cunsel, wrking in cllabratin with the faculty inventr, will prepare a respnse t the Office Actin. The respnse the Office Actin will state the reasns why we believe the examiner s bjectins t ur claims shuld be vercme and a patent shuld be granted. This prcess will ften invlve amendments t the claims f the applicatin (typically narrwing their scpe) t address the examiner s cncerns and t craft the claims int a frm that the examiner will

8 allw t issue. The examinatin prcess is, at its cre, a negtiatin between the examiner and the applicant. Nt every patent applicatin will result in an issued patent. There are cases in which the prcess by which the claims are amended t place them in a psitin where they will be allwed by the examiner results in claims that are s narrw in scpe that they are f minimal value t a licensee. Ntice f Allwance and Issuance: If the examinatin prcess results in a determinatin by the examiner that the claims are allwable, the examiner will issue a Ntice f Allwance. The applicant must then pay a patent issuance fee fr the patent t be granted. If the applicant wishes t prsecute any divisinal applicatins, this prcess must begin prir t issuance f the parent applicatin. The America Invents Act ( AIA ) and Patenting Practices at BCM On September 16, 2011, the Leahy-Smith America Invents Act ( AIA ) was signed in t law by President Obama. The majr thrust f this patent refrm legislatin was t mre clsely harmnize U.S. patent law with that f the rest f the wrld. Key changes assciated the AIA include: Transitin frm a first t invent system t a first-inventr-t-file system. This change went int effect n March 16, 2013, and gives pririty fr granting a patent t the first inventr t file a patent applicatin. This means that the determinatin f whether an inventin is nvel r nn-bvius will be based n the prir art that existed n the date that the patent applicatin was filed, and nt n the date that the inventin was actually cnceived. Inventrs still have a ne-year grace perid during which the inventr s wn public disclsures r the disclsures f third parties wh btained their infrmatin frm

9 the inventr may nt be used as prir art if the disclsures ccurred within 12 mnths f the filing date f the patent applicatin. New pst grant review prcedures: Pst grant review means that a persn wh is nt the patent wner may request that the USPTO examine the validity f an issued patent within 9 mnths f the date f issuance, but this change impacts patents filed under the new firstinventr-t-file system. Assertins f patent invalidity may be based n grunds f lack f nvelty, bviusness, insufficient written descriptin f the inventin, r lack f enablement. These prceedings will be administered by the Patent Trial and Appeal Bard. Will the AIA change patenting practices at BCM? The AIA will nt significantly change ur patenting practices. There is little advantage t be gained by filing a prvisinal patent applicatin earlier, particularly if the claims f the patent applicatin are nt sufficiently enabled by the written descriptin f the inventin in the specificatin f the patent. Nthing is gained by filing an insufficiently enabled patent applicatin. As is ften the case in the academic envirnment, a pending public disclsure f an inventin will ften trigger the decisin t file a patent applicatin. But, the ptential t receive patent claims that will add value t the inventin and ptentially enable us t land a cmmercial partner will always be the crucial factr in the decisin t file.