Law Times

www.lawtimesnews.com Law Times / February 11/18, 2008 Page 11 E ver more crowded dockets and increasingly complex evidence has prompted Fed- eral Court judges to invoke new procedures to wrestle with a never- ending stream of pharmaceutical patent litigation. Last fall, in Ottawa, protho- notary Mireille Tabib dismissed a motion brought by the applicant in Purdue Pharma v. Pharma- science Inc. to have its notice of compliance proceeding specially managed. The motion had asked to have the order in which evidence was filed reversed and was based on discussion between lawyers in the matter and the court in previous proceedings. It didn't end there, however. A month later, the court issued a direction of practice which sets a new — as yet untested or tried — direction for future NOC proceed- ings that ostensibly seeks to speed up and streamline the process. Citing the increasing number of intellectual property cases it is facing — and NOCs in particu- lar — the court says the assigned judge or prothonotary has the op- tion to order a case proceed "as a specially managed proceeding." If the case proceeds as such, then a case conference will address whether it is appropriate to reverse the order in which all or some of the evidence is submitted, whether the generic should file some or all of its evidence before the brand does, and other issues. The directive, the court says, is a "a response to the challenges it has faced in dealing with the increasing number of intellectual property cases generally, and NOC proceedings in particular . . . [and ensures] the just, most expeditious and least expensive disposition of the proceeding." NOC litigation results when the owner of a patent, the so-called innovator or brand, takes a generic pharmaceutical to court to block them from gaining a notice of compliance certificate from Health Canada that will allow them to make and distribute the drug. The shift in the court's posi- tion is generally viewed as favour- able to the brand manufacturers, who are pushed into the position of applicant and therefore must file all their materials at the out- set, at considerable cost, says Pat- rick Kierans of Ogilvy Renault LLP. "I think the court recognizes it's a flawed concept and badly flawed process," says Kierans. "We'll have to see how this plays out in 2008." Counsel for the Canadian Ge- neric Pharmaceutical Association (CGPA), Ed Hore, agrees with Kierans about the flawed nature of the process but, not surprisingly, doesn't see the new directive as be- ing helpful to his clients. "It's a bizarre process [the con- cept of NOC litigation overall]," he says. "It's the only area where litiga- tion actually resolves nothing." The directive itself hadn't been invoked when he spoke to Law Times, and while the industry is anxious to see how it plays out, he's certain it will lead to a court challenge. The CGPA is already challeng- ing the federal government on 2006 changes made to the data- protection provisions of the food and drug regulations, claiming they unreasonably extend patent protection and that the govern- ment had no authority to make the changes by regulation. The court-practice directive is another shift that further pushes the burden onto generics and will only result in substantial costs to consumers, says Hore. Gord Zimmerman of Borden Ladner Gervais LLP counters that NOC hearings force the brand to file massive amounts of evidence, because they're uncertain which part of their patent is under attack. By reversing the onus, it allows the brand to respond only to specific claims, cutting the work involved in producing the material — and cutting what the court has to re- view at the outset. "Still, the party that goes last of course has a tacti- cal advantage," he says. With the newly minted direc- tives in mind, however, both ge- nerics and brand manufacturers are watching the upcoming Supreme Court of Canada case involving se- lective patents which may change the landscape in all patent cases. The case of Apotex Inc. v. Sanofi- Synthelabo Canada Inc. is on the docket for this session of the SCC and deals with an issue of whether selection patents are compatible with double-patenting and whether it's an issue of ever-greening. The drug in question is the 75 mg clopidogrel bisulphate used in the treatment of blood clots. Also known as Palavix, it had global sales of US$6.34 billion in 2005 and represents substantial reve- nues for Sanofi-Aventis (up to 12 per cent of profits) and Bristol- Myers-Squibb (up to 40 per cent of its profits). Sanofi (later bought out by Aventis) brought an ap- plication in 2003 to bar an NOC issuance to Apotex for a generic version until after Sanofi's 777 patent expires in 2012. Apotex claims an expired patent — 875, issued in 1985 — covers the class of compounds contain- ing clopidogrel, though that pat- ent does not contain the process on how to separate it out. Apotex holds the 875 patent is prior art and the 777 patent is invalid. If it stands, Apotex says, it would be tantamount to double patenting and ever-greening (that is, unfairly extending the life of the original patent). However, it has lost the argu- ment at federal court and had its appeal dismissed. The SCC agreed to hear the matter last summer about two weeks after a New York judge also upheld the patent in a similar battle there. Not upholding the patent will have the net effect of discourag- ing innovation, says Kierans, who acted for Sanofi-Synthelabo. "If one drug doesn't work out in clinical trials, all that money all that research and investment potentially goes in the trash." Crowded dockets and complex evidence prompt new procedures Pharmaceutical patents under the microscope FOCUS 'I think the court recognizes it's a flawed concept and badly flawed process,' says Patrick Kierans. 'We'll have to see how this plays out in 2008.' 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